Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6858650 DS* [Extended 1149 days (3.1 years)] Stable salts of novel derivatives of 3,3-diphenylpropylamines Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): All strengths: None | Jan 3, 2023 *PED | U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency |
| Pat. No. 7807715 DP* Pharmaceutical compositions comprising fesoterodine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Dec 7, 2027 *PED | U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency |
| Pat. No. 8088398 DP* Pharmaceutical compositions comprising fesoterodine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Dec 7, 2027 *PED | U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency |
| Pat. No. 8501723 DP* Pharmaceutical compositions comprising fesoterodine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 20, 2013 | Dec 7, 2027 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 17, 2024 PED | I-861: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg |
INTUNIV (TABLET, EXTENDED RELEASE) (ORAL) GUANFACINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022037 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 3MG BASE); 004 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6811794 DP* Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: None | Jan 4, 2023 *PED | U-494: Treatment of Attention-Deficit Hyperactivity Disorder |
VANOS (CREAM) (TOPICAL) FLUOCINONIDE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: BAUSCH NDA No.: 021758 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7220424 Compositions and methods for enhancing corticosteroid delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jan 7, 2023 | U-861: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older |
| Pat. No. 8232264 DP* Compositions and methods for enhancing corticosteroid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 2, 2012 | Mar 9, 2023 |
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: ABBVIE NDA No.: 022315 Prod. No.: 001 RX (0.7MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8034366 DP* Ocular implant made by a double extrusion process Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 23, 2011 | Jan 9, 2023 | U-1204: Treatment of uveitis U-1205: Treatment of macular edema |
| Pat. No. 8034370 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 23, 2011 | Jan 9, 2023 | |
| Pat. No. 8506987 Ocular implant made by a double extrusion process Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 11, 2013 | Jan 9, 2023 | U-1204: Treatment of uveitis U-1205: Treatment of macular edema |
| Pat. No. 9192511 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Jan 9, 2023 | |
| Pat. No. 10076526 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 17, 2018 | Jan 9, 2023 | |
| Pat. No. 10702539 Ocular implant made by a double extrusion process Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 7, 2020 | Jan 9, 2023 | U-1597: Treatment of diabetic macular edema U-2868: Treatment of non-infectious uveitis affecting the posterior segment of the eye U-985: Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) |
| Pat. No. 6899717 Methods and apparatus for delivery of ocular implants Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Nov 1, 2023 | U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX |
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE NDA No.: 022256 Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6602911 [Extended 435 days (1.2 years)] Methods of treating fibromyalgia Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 14, 2023 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None | Sep 19, 2029 | U-819: Management of fibromyalgia |
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC NDA No.: 210238 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 | Jan 15, 2023 | U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure |
| Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 30, 2023 | U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment |
| Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018 | May 5, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 21, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 26, 2026 | ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 022369 Prod. No.: 001 RX (0.03%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263054 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2012 | Jan 15, 2023 | U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin |
| Pat. No. 8632760 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2014 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 8986715 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2015 | Jan 15, 2023 | U-1217: Method of increasing hair growth |
| Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1799: Method of increasing growth of hair including eyelashes |
| Pat. No. 8038988 DS* DP* Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2011 | Aug 25, 2023 | U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness |
| Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012 | May 25, 2024 | U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth |
IBRANCE (CAPSULE) (ORAL) PALBOCICLIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER NDA No.: 207103 Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | |
| Pat. No. 7208489 DS* DP* DLR* 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | |
| Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | U-1998: Treating HR-pos., HER2-neg. advanced or metastatic breast cancer with palbociclib in combo with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression after endocrine therapy U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy |
| Pat. No. RE47739 DS* DP* [Extended 1509 days (4.1 years)] 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Dec 19, 2019 | Mar 5, 2027 | |
| Pat. No. 10723730 DS* DP* Solid forms of a selective CDK4/6 inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Aug 27, 2020 | Feb 8, 2034 |
IBRANCE (TABLET) (ORAL) PALBOCICLIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER NDA No.: 212436 Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Nov 26, 2019 | Jan 16, 2023 | |
| Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 26, 2019 | Jan 16, 2023 | U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy |
| Pat. No. RE47739 DS* DP* [Extended 1509 days (4.1 years)] 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Nov 26, 2019 | Mar 5, 2027 | |
| Pat. No. 10723730 DS* DP* Solid forms of a selective CDK4/6 inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Aug 27, 2020 | Feb 8, 2034 | |
| Pat. No. 11065250 DP* Solid dosage forms of palbociclib Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 12, 2021 | Aug 19, 2036 |
NOURIANZ (TABLET) (ORAL) ISTRADEFYLLINE
NDA Applicant: KYOWA KIRIN NDA No.: 022075 Prod. No.: 001 RX (20MG); 002 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7727994 Methods of treating patients suffering from movement disorders Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Jan 18, 2023 | U-2623: A method of reducing off time from L-dopa therapy, comprising administering, to a human patient with parkinson's disease, an effective amount of istradefylline, wherein the patient currently receives said L-dopa therapy |
| Pat. No. 7541363 DS* DP* Microcrystal Claim Types: Physical characteristic of a bulk compound; Composition; Product-by-process Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Nov 13, 2024 | |
| Pat. No. 8318201 DP* Method of stabilizing diarylvinylene compound Claim Types: Process Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Sep 5, 2027 | |
| Pat. No. 7727993 DP* Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Jan 28, 2028 | U-2623: A method of reducing off time from L-dopa therapy, comprising administering, to a human patient with parkinson's disease, an effective amount of istradefylline, wherein the patient currently receives said L-dopa therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 27, 2024 |
VIZAMYL (INJECTABLE) (INTRAVENOUS) FLUTEMETAMOL F-18
NDA Applicant: GE HEALTHCARE NDA No.: 203137 Prod. No.: 002 RX (121.5mCi/30ML (4.05mCi/ML)) NDA No.: 203137 Prod. No.: 001 DISC (40.5mCi/10ML (4.05mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7351401 DS* DP* Thioflavin derivatives for use in the antemortem diagnosis of Alzheimers disease and in vivo imaging and prevention of amyloid deposition Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Mar 28, 2014 | Jan 24, 2023 | U-336: Diagnostic radioimaging |
| Pat. No. 8691185 Benzothiazole derivative compounds, compositions and uses Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): All strengths: May 28, 2014 | Jan 24, 2023 | U-336: Diagnostic radioimaging |
| Pat. No. 8236282 DS* DP* Benzothiazole derivative compounds, compositions and uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 25, 2013; 002: None | May 21, 2024 | |
| Pat. No. 7270800 DS* DP* [Extended 953 days (2.6 years)] Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Mar 28, 2014 | Sep 3, 2025 | U-336: Diagnostic radioimaging |
| Pat. No. 8916131 DP* Radiopharmaceutical composition Claim Types: Composition Pat. Sub. Date(s): All strengths: Feb 18, 2015 | Sep 16, 2028 |
JANUMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 022044 Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): All strengths: None | May 24, 2027 *PED | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8414921 DP* Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 9, 2013; 002: None | Jan 21, 2029 *PED | U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 4, 2024 PED | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
| Exclusivity Code: M - Miscellaneous | Feb 12, 2023 PED | M-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus |
JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 202270 Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): All strengths: None | May 24, 2027 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 4, 2024 PED | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
| Exclusivity Code: M - Miscellaneous | Feb 12, 2023 PED | M-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus |
JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 202270 Prod. No.: 003 RX (1GM;EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: None | Jan 26, 2023 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: None | Jan 26, 2023 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 003: None | May 24, 2027 *PED | U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 12, 2023 PED | M-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus |
JANUVIA (TABLET) (ORAL) SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 021995 Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 7125873 Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin U-1037: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with a PPAR-gamma agonist U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): All strengths: None | May 24, 2027 *PED | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 4, 2024 PED | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
| Exclusivity Code: M - Miscellaneous | Feb 12, 2023 PED | M-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus |
JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG-CoA reductase inhibitor (statin) == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 202343 Prod. No.: 001 DISC (10MG;EQ 100MG BASE**); 002 DISC (20MG;EQ 100MG BASE**); 003 DISC (40MG;EQ 100MG BASE**); 004 DISC (10MG;EQ 50MG BASE**); 005 DISC (20MG;EQ 50MG BASE**); 006 DISC (40MG;EQ 50MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Jan 26, 2023 *PED | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
| Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Jan 26, 2023 *PED | U-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin U-1190: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with insulin U-1192: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a sulfonylurea (such as glipizide, glimepiride and glyburide) U-1193: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a PPAR-gamma agonist (such as pioglitazone and rosiglitazone) |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Oct 11, 2026 *PED | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
STEGLUJAN (TABLET) (ORAL) ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 209805 Prod. No.: 001 RX (5MG;EQ 100MG BASE); 002 RX (15MG;EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Jan 26, 2023 *PED | U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): All strengths: Jan 16, 2018 | May 24, 2027 *PED | U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes |
| Pat. No. 8080580 DS* DP* Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Jul 13, 2030 | U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes |
| Pat. No. 9308204 DP* Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Oct 21, 2030 | |
| Pat. No. 9439901 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Oct 21, 2030 | U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Sep 17, 2024 | M-275: Revision to the labeling to include results from clinical study, mk-8835-004/b1521021, VERTIS CV |
| Exclusivity Code: NCE - New chemical entity | Dec 19, 2022 |
ZYKADIA (CAPSULE) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 205755 Prod. No.: 001 DISC (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2014 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jun 15, 2017 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* [Extended 586 days (1.6 years)] 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2014 | Apr 29, 2028 | |
| Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: May 13, 2014 | Jun 29, 2030 | |
| Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 22, 2016 | Jan 18, 2032 | |
| Pat. No. 8703787 Methods of using ALK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Feb 2, 2032 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 26, 2024 | ODE-145: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test |
ZYKADIA (TABLET) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 211225 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* [Extended 586 days (1.6 years)] 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Apr 29, 2028 | |
| Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 2, 2019 | Jun 29, 2030 | |
| Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 18, 2032 | |
| Pat. No. 8703787 Methods of using ALK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Feb 2, 2032 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | May 26, 2024 |
KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: dopaminergic agonist
NDA Applicant: SUMITOMO PHARMA AM NDA No.: 210875 Prod. No.: 001 DISC (10MG); 002 DISC (15MG); 003 DISC (20MG); 004 DISC (25MG); 005 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8663687 DP* Film compositions for delivery of actives Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 2, 2023 | |
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 20, 2024 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 3, 2024 | |
| Pat. No. 10821074 DP* Sublingual and buccal film compositions Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 12, 2020 | Aug 7, 2029 | |
| Pat. No. 9044475 DP* Sublingual apomorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | |
| Pat. No. 9283219 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9326981 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669019 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669021 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10420763 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8414922 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8846074 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 11419769 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2022 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10449146 Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10959943 Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2021 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 21, 2023 |
CHANTIX (TABLET) (ORAL) VARENICLINE TARTRATE
Drug Classes: cholinergic agonist == nicotinic receptor partial agonist
NDA Applicant: PF PRISM CV NDA No.: 021928 Prod. No.: 001 DISC (EQ 0.5MG BASE**); 002 DISC (EQ 1MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7265119 DS* DP* Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7- ,9-pentaene and pharmaceutical compositions thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Feb 3, 2023 *PED | U-56: Aid to smoking cessation |
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 021610 Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**); 003 DISC (20MG**); 004 DISC (40MG**); 005 DISC (7.5MG**); 006 DISC (15MG**); 007 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276250 DP* Sustained release formulations of oxymorphone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Feb 4, 2023 | U-826: Relief of moderate to severe pain |
| Pat. No. 8309112 DP* Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 21, 2027 | U-3085: Dose modification for renal impairment |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Nov 22, 2029 |
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 201655 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309122 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 13, 2011; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Aug 8, 2024 | |
| Pat. No. 8192722 DP* Abuse-proof dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Sep 15, 2025 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Jun 21, 2027 | U-1598: Method of administration of controlled release oxymorphone |
| Pat. No. 7851482 DS* Method for making analgesics Claim Types: Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Jul 10, 2029 | |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Nov 22, 2029 |
NEXAVAR (TABLET) (ORAL) SORAFENIB TOSYLATE [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021923 Prod. No.: 001 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618141 Aryl ureas with angiogenesis inhibiting activity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2014 | Feb 11, 2023 | U-1480: Treatment of advanced renal cell carcinoma |
| Pat. No. 8877933 DS* DP* Thermodynamically stable form of a tosylate salt Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 22, 2014 | Dec 24, 2027 | U-1624: Treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, or differentiated thyroid carcinoma. |
| Pat. No. 9737488 DP* Pharmaceutical composition for the treatment of cancer Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Sep 20, 2017 | Sep 10, 2028 | U-1480: Treatment of advanced renal cell carcinoma U-1696: Treatment of unresectable hepatocellular carcinoma U-2107: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment |
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ABBVIE NDA No.: 021323 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED | |
| Pat. No. 7420069 DP* Crystalline composition containing escitalopram Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | May 12, 2026 |
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist == opioid antagonist
NDA Applicant: INDIVIOR NDA No.: 022410 Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None | Feb 13, 2023 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 3, 2024 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9687454 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2017 | Aug 7, 2029 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 11135216 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Aug 7, 2029 | U-3111: Treating opioid use disorder |
| Pat. No. 8475832 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None | Mar 26, 2030 | U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence |
RYANODEX (FOR SUSPENSION) (INTRAVENOUS) DANTROLENE SODIUM
Drug Classes: skeletal muscle relaxant
NDA Applicant: EAGLE PHARMS NDA No.: 205579 Prod. No.: 001 RX (250MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8685460 Treatment using dantrolene Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 8, 2014 | Feb 15, 2023 | U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk. |
| Pat. No. 7758890 DP* Treatment using dantrolene Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2014 | Jun 30, 2025 |
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 022522 Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Claim Types: Product-by-process Pat. Sub. Date(s): 001: None; 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2016; 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2014; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2014; 002: Mar 14, 2018 | Mar 8, 2024 |
LEQVIO (SOLUTION) (SUBCUTANEOUS) INCLISIRAN SODIUM
NDA Applicant: NOVARTIS NDA No.: 214012 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8232383 DS* DP* RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA) Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 18, 2022 | Feb 20, 2023 | |
| Pat. No. 10266825 Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Nov 4, 2023 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 11078485 DS* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Nov 4, 2023 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Jan 1, 2024 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 10669544 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 11530408 DS* Therapeutic compositions Claim Types: Composition Pat. Sub. Date(s): 001: Jan 18, 2023 | May 18, 2024 | |
| Pat. No. 8809292 DS* DP* Compositions and methods for inhibiting expression of the PCSK9 gene Claim Types: Compound; Composition; Cell; Vector; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | May 10, 2027 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 8222222 Compositions and methods for inhibiting expression of the PCSK9 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 29, 2027 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 24, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 9370582 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | |
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 12, 2029 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10125369 DS* DP* PCSK9 iRNA compositions and methods of use thereof Claim Types: Compound; Composition; Cell; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 18, 2034 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10851377 Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 25, 2036 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 22, 2026 |
TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: alkylating drug
NDA Applicant: MERCK SHARP DOHME NDA No.: 022277 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents Claim Types: Formulation Pat. Sub. Date(s): 001: None | Feb 21, 2023 | |
| Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jan 28, 2014 | Feb 21, 2023 | |
| Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Sep 8, 2023 |
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE NDA No.: 021656 Prod. No.: 001 RX (48MG); 002 RX (145MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276249 DP* Nanoparticulate fibrate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | |
| Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
ZECUITY (SYSTEM) (IONTOPHORESIS) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TEVA BRANDED PHARM NDA No.: 202278 Prod. No.: 001 DISC (EQ 6.5MG BASE/4HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6745071 DP* Iontophoretic drug delivery system Claim Types: Device Pat. Sub. Date(s): 001: Feb 15, 2013 | Feb 21, 2023 | |
| Pat. No. 7973058 Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8155737 Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8470853 Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8597272 DP* Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 9, 2013 | Apr 12, 2027 | |
| Pat. No. 9427578 DP* Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Method of administration; Formulation Pat. Sub. Date(s): 001: Sep 15, 2016 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 9272137 DP* Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Mar 14, 2016 | Sep 7, 2027 | |
| Pat. No. 8366600 Polyamine enhanced formulations for triptan compound iontophoresis Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 21, 2029 | U-1327: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof, using a flowable hydrogel formulation |
| Pat. No. 8983594 DP* Electronic control of drug delivery system Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 8, 2015 | Nov 19, 2030 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 9327114 DP* User-activated self-contained co-packaged iontophoretic drug delivery system Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: May 26, 2016 | Oct 8, 2032 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 206321 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6268343 DS* DP* [Extended 5 years] Derivatives of GLP-1 analogs Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 22, 2023 *PED | U-1255: Method for chronic weight management by treating obesity |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Dec 30, 2023 *PED | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Oct 11, 2022 | Oct 20, 2025 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 13, 2026 *PED | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Apr 20, 2026 *PED | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 22, 2021 | Jul 17, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Jul 26, 2026 *PED | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Jan 17, 2027 *PED | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 13, 2017 | Jan 17, 2027 *PED | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 1, 2019 | Jan 17, 2027 *PED | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Feb 3, 2027 *PED | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2017 | Aug 27, 2027 *PED | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Oct 26, 2016 | Mar 27, 2028 *PED | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Aug 1, 2032 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2018 | Jul 9, 2037 *PED | U-2438: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with Type 2 diabetes and cardiovascular disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 4, 2023 |
VICTOZA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NORDISK INC NDA No.: 022341 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6268343 DS* DP* [Extended 5 years] Derivatives of GLP-1 analogs Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 22, 2023 *PED | U-968: A method for improving glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2019 | Dec 30, 2023 *PED | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 8114833 DS* DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 13, 2012 | Feb 13, 2026 *PED | |
| Pat. No. 9265893 DP* Injection button Claim Types: Device Pat. Sub. Date(s): 001: Mar 14, 2016 | Mar 23, 2033 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Jul 9, 2037 *PED | U-2313: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with Type 2 diabetes mellitus and established cardiovascular disease by administering liraglutide |
YOSPRALA (TABLET, DELAYED RELEASE) (ORAL) ASPIRIN; OMEPRAZOLE
Drug Classes: anti-platelet agent == nonsteroidal anti-inflammatory drug == proton pump inhibitor
NDA Applicant: GENUS LIFESCIENCES NDA No.: 205103 Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Jan 2, 2033 | U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers |
| Pat. No. 9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2017 | Mar 13, 2033 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
NORMOCARB HF 25 (SOLUTION) (INJECTION) MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
NDA Applicant: DIALYSIS SUPS NDA No.: 021910 Prod. No.: 001 RX (0.21GM/100ML;2.8GM/100ML;9.07GM/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300674 DP* Sterile low bicarbonate dialysis concentrate solutions Claim Types: Formulation; Kit; Process; Method of administration; Method of use Pat. Sub. Date(s): 001: None | Mar 4, 2023 | U-785: Use as replacement solution, hemofiltration solution or hemodiafiltration solution in continuous renal replacement therapy |
ZOLINZA (CAPSULE) (ORAL) VORINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 021991 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7652069 DP* Polymorphs of suberoylanilide hydroxamic acid Claim Types: Composition; New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): 001: None | Mar 4, 2023 | |
| Pat. No. 7732490 Methods of treating cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Mar 4, 2023 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 8067472 Methods of treating Hodgkin's and non-Hodgkin's lymphoma Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 15, 2011 | Mar 4, 2023 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 8101663 Polymorphs of suberoylanilide hydroxamic acid Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 4, 2023 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 7851509 DP* Polymorphs of suberoylanilide hydroxamic acid Claim Types: Formulation; Composition; Method of use Pat. Sub. Date(s): 001: Dec 15, 2010 | Feb 21, 2024 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 7399787 Methods of treating cancer with HDAC inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2025 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 8093295 DP* Formulations of suberoylanilide hydroxamic acid and methods for producing the same Claim Types: Formulation; Composition Pat. Sub. Date(s): 001: None | May 16, 2026 | |
| Pat. No. 7456219 DS* Polymorphs of suberoylanilide hydroxamic acid Claim Types: New polymorph, salt or hydrate; Product-by-process Pat. Sub. Date(s): 001: None | Mar 11, 2027 | |
| Pat. No. 8450372 Formulations of suberoylanilide hydroxamic acid and methods for producing same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 14, 2013 | Mar 18, 2028 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
NDA Applicant: RADIUS NDA No.: 202344 Prod. No.: 001 RX (EQ 70MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7964212 DS* DP* Effervescent compositions comprising phosphonates and methods related thereto Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2012 | Mar 6, 2023 | |
| Pat. No. 7488496 DS* DP* Effervescent compositions comprising bisphosphonates and methods related thereto Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2012 | Aug 11, 2023 | |
| Pat. No. 9592195 DP* Stable effervescent bisphosphonate formulations with rapid solubilization characteristics Claim Types: Formulation Pat. Sub. Date(s): 001: May 12, 2021 | Dec 5, 2031 |
SUPREP BOWEL PREP KIT (SOLUTION) (ORAL) MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE [GENERIC AA]
NDA Applicant: BRAINTREE LABS NDA No.: 022372 Prod. No.: 001 RX (1.6GM/BOT;3.13GM/BOT;17.5GM/BOT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6946149 DP* Salt solution for colon cleansing Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Mar 7, 2023 | U-837: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 5, 2027 | ODE-315: For cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older |
DIFFERIN (GEL) (TOPICAL) ADAPALENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021753 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7834060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 19, 2010 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 7838558 DP* Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Mar 12, 2023 | |
| Pat. No. 7868044 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2011 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: May 21, 2014 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 7737181 DP* Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 29, 2024 | |
| Pat. No. 7579377 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 23, 2025 | U-818: Topical treatment of acne vulgaris |
EPIDUO FORTE (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS NDA No.: 207917 Prod. No.: 001 RX (0.3%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8729127 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9381179 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 4, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9387187 Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |
KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 213756 Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 6, 2020 | Mar 13, 2023 | |
| Pat. No. 7425637 DS* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: May 6, 2020 | Mar 13, 2024 | |
| Pat. No. 9156795 DS* DP* Hydrogen sulfate salt Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: May 6, 2020 | Dec 12, 2026 | |
| Pat. No. 9562017 DS* Hydrogen sulfate salt Claim Types: Method of use; Product-by-process of a new polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: May 6, 2020 | Dec 12, 2026 | U-2800: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 10, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2027 | ODE-288: Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210498 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 13, 2023 | |
| Pat. No. 8193229 Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 13, 2023 | U-2330: Method of treating melanoma |
| Pat. No. 8513293 Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 13, 2023 | U-2331: Indicated in combination with encorafenib for the treatment of melanoma |
| Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 13, 2024 | |
| Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2333: Indicated in combination with encorafenib for the treatment of melanoma with a BRAF mutation |
| Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 27, 2030 | U-2331: Indicated in combination with encorafenib for the treatment of melanoma U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jul 4, 2031 | U-2332: Indicated in combination with encorafenib for the treatment of melanoma mediated by a B-Raf protein kinase U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test |
| Pat. No. 9562016 DS* DP* Preparation of and formulation comprising a MEK inhibitor Claim Types: Product-by-process; Formulation; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | |
| Pat. No. 9598376 Preparation of and formulation comprising a MEK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | U-2330: Method of treating melanoma |
| Pat. No. 9980944 Preparation of and formulation comprising a MEK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 18, 2033 | U-2334: Treatment of melanoma with a BRAF mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 27, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 27, 2025 | ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test |
CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 002 OTC (2%;70% (26ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 14, 2023 | |
| Pat. No. 7241065 DP* Applicator for coloring antiseptic Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 14, 2023 | |
| Pat. No. 7182536 DP* Antiseptic applicator with mechanism for fracturing multiple ampoules Claim Types: Device Pat. Sub. Date(s): 002: None | Dec 30, 2023 | |
| Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules Claim Types: Device; Process Pat. Sub. Date(s): 002: None | Jan 31, 2024 | |
| Pat. No. 7422388 DP* Applicator for coloring antiseptic Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: May 22, 2013 | Apr 25, 2027 | U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery |
CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 005 OTC (2%;70% (10.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Claim Types: Device Pat. Sub. Date(s): 005: None | Mar 14, 2023 | |
| Pat. No. 7241065 DP* Applicator for coloring antiseptic Claim Types: Device Pat. Sub. Date(s): 005: None | Mar 14, 2023 | |
| Pat. No. 7422388 DP* Applicator for coloring antiseptic Claim Types: Device; Method of administration Pat. Sub. Date(s): 005: None | Apr 25, 2027 | U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery |
CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 007 OTC (2%;70% (3ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Claim Types: Device Pat. Sub. Date(s): 007: None | Mar 14, 2023 | |
| Pat. No. 7241065 DP* Applicator for coloring antiseptic Claim Types: Device Pat. Sub. Date(s): 007: None | Mar 14, 2023 | |
| Pat. No. 7422388 DP* Applicator for coloring antiseptic Claim Types: Device; Method of administration Pat. Sub. Date(s): 007: None | Apr 25, 2027 | U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery |
AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 205718 Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6297375 DS* [Extended 1119 days (3.1 years)] 4-phenyl-pyridine derivatives Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2014 | Mar 17, 2023 | |
| Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2014 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 6, 2015 | Nov 18, 2030 | |
| Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 2, 2015 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2018 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 11559523 DP* Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Feb 22, 2023 | Nov 18, 2030 | U-3522: Method of treating emesis |
| Pat. No. 10828297 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2020 | Dec 17, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 14, 2016 | Sep 9, 2031 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 16, 2018 | Sep 25, 2035 | |
| Pat. No. 10233154 DS* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 28, 2019 | Sep 25, 2035 | |
| Pat. No. 10676440 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 8, 2020 | Sep 25, 2035 | |
| Pat. No. 10961195 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 15, 2021 | Sep 25, 2035 |
PATANASE (SPRAY, METERED) (NASAL) OLOPATADINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: NOVARTIS NDA No.: 021861 Prod. No.: 001 DISC (0.665MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8399508 Olopatadine formulations for topical nasal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2013 | Mar 17, 2023 *PED | U-726: Allergic rhinitis |
| Pat. No. 7977376 DP* Olopatadine formulations for topical nasal administration Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2011 | Aug 2, 2023 *PED |
SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO VENTURES LTD NDA No.: 022239 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8267903 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Oct 10, 2012 | Mar 18, 2023 | |
| Pat. No. 8118771 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Process Pat. Sub. Date(s): 001: Mar 9, 2012 | Aug 10, 2023 | |
| Pat. No. 8241243 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2012 | Aug 10, 2023 | |
| Pat. No. 8287489 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 16, 2012 | Dec 6, 2024 | |
| Pat. No. 7901385 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Mar 23, 2011 | Jul 31, 2026 | |
| Pat. No. 7776007 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 4, 2011 | Nov 22, 2026 |
GATTEX KIT (POWDER) (SUBCUTANEOUS) TEDUGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: TAKEDA PHARMS USA NDA No.: 203441 Prod. No.: 001 RX (5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056886 DP* GLP-2 formulations Claim Types: Formulation; Process; Kit; Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | Mar 18, 2023 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 7847061 DLR* Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9060992 DLR* Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 17, 2015 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 16, 2026 | ODE-240: Treatment of pediatric patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support |
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: ACORDA NDA No.: 209184 Prod. No.: 001 RX (42MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8404276 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8586093 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 9155699 DP* Pulmonary delivery for levodopa Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | |
| Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 22, 2024 | |
| Pat. No. RE43711 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 3, 2029 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 |
OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC NDA No.: 205437 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4 U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2014 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 18, 2015 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2018 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Dec 9, 2023 | |
| Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)] (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Feb 16, 2028 | |
| Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2018 | May 29, 2034 | U-2232: Treatment of psoriatic arthritis using a dosage titration schedule U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent |
| Pat. No. 10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 9, 2018 | May 29, 2034 | U-2403: Treatment of psoriasis using a dosage titration schedule U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 19, 2022 | I-803: Treatment of adult patients with oral ulcers associated with Behcets disease |
| Exclusivity Code: I - New Indication | Dec 20, 2024 | I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication |
| Exclusivity Code: M - Miscellaneous | Apr 10, 2023 | M-257: Information added to the clinical studies section of the labeling regarding the use of plaque psoriasis of the scalp |
| Exclusivity Code: M - Miscellaneous | Jul 20, 2026 | M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasis |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 19, 2026 | ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease |
KYNAMRO (SOLUTION) (SUBCUTANEOUS) MIPOMERSEN SODIUM
Drug Classes: apolipoprotein B-100 synthesis inhibitor == transthyretin-directed antisense oligonucleotide
NDA Applicant: KASTLE THERAPS LLC NDA No.: 203568 Prod. No.: 001 DISC (200MG/ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: None | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: None | Sep 5, 2023 | |
| Pat. No. 7511131 DS* [Extended 412 days (1.1 years)] Antisense modulation of apolipoprotein B expression Claim Types: Compound; Composition Pat. Sub. Date(s): 001: None | Jan 29, 2027 |
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Sep 5, 2023 | |
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 1, 2025 | |
| Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 5, 2025 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 203975 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: May 14, 2014 | Mar 23, 2023 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema." |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema." |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema." |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Nov 21, 2025 *PED | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema." |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Dec 14, 2027 *PED | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema." |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 9, 2014 | Dec 18, 2027 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Apr 2, 2028 *PED | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Aug 5, 2028 *PED | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Sep 8, 2030 *PED | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Nov 29, 2030 | |
| Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2021 | Nov 29, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 | Apr 11, 2031 *PED |
BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 204275 Prod. No.: 001 RX (0.1MG/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: Jun 27, 2014 | Mar 23, 2023 | U-1548: For the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in patients with a history of exacerbations U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jun 4, 2013 | Nov 21, 2025 *PED | U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in pts with a history of exacerbations U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-2099: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema U-2100: Indicated for the once-daily treatment of asthma in patients 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Sep 6, 2013 | Dec 14, 2027 *PED | U-1424: Long-term, once daily maintenance treatment of airflow obstruction in pts with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in patients with a history of exacerbations U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Apr 2, 2028 *PED | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 4, 2013 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 4, 2013 | Aug 5, 2028 *PED | |
| Pat. No. 11116721 DP* Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 12, 2021 | Aug 26, 2029 *PED | U-1401: Indicated for long-term, once-daily maintenance treatment of airflow obstruction in PTS with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in pts with a history of exacerbations U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2013 | Sep 8, 2030 *PED | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jul 8, 2014 | Apr 11, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 13, 2026 PED |
BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 204275 Prod. No.: 002 RX (0.2MG/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 002: May 7, 2015 | Mar 23, 2023 | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 7, 2015 | Nov 21, 2025 *PED | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-2099: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema U-2100: Indicated for the once-daily treatment of asthma in patients 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 002: May 7, 2015 | Dec 14, 2027 *PED | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: May 20, 2016 | Apr 2, 2028 *PED | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Aug 5, 2028 *PED | |
| Pat. No. 11116721 DP* Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 12, 2021 | Aug 26, 2029 *PED | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older U-3623: Maintenance treatment of asthma in patients aged 5 years and older. recommended dosages: BREO 100/25 or 200/25 ages 18 years and older; BREO 100/25 ages 12-17 years, and BREO 50/25, ages 5-11 years |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Sep 8, 2030 *PED | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Apr 11, 2031 *PED |
TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 209482 Prod. No.: 001 RX (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: Oct 6, 2017 | Mar 23, 2023 | U-2127: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema U-2955: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; and asthma |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Oct 6, 2017 | Apr 27, 2025 | |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 6, 2017 | Apr 27, 2025 | U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2017 | Jul 27, 2025 | U-2128: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via inhalation U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 6, 2017 | Nov 21, 2025 *PED | U-2127: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema U-2957: Maintenance treatment of asthma in patients 18 yrs and older, or chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 6, 2017 | Dec 14, 2027 *PED | U-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Oct 6, 2017 | Dec 18, 2027 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Oct 6, 2017 | Apr 2, 2028 *PED | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Aug 5, 2028 *PED | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Sep 8, 2030 *PED | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 6, 2017 | Nov 29, 2030 | |
| Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2021 | Nov 29, 2030 | U-3202: Maintenance treatment of chronic obstructive pulmonary disease (COPD) comprising the once per day administration of trelegy ellipta, 100 mcg fluticasone furoate/62.5 mcg umeclidinium/25 mcg vilanterol |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Apr 11, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 9, 2023 | I-843: Maintenance treatment of asthma in patients aged 18 years and older |
TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 209482 Prod. No.: 002 RX (0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 002: Oct 6, 2020 | Mar 23, 2023 | U-2955: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; and asthma |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Oct 6, 2020 | Apr 27, 2025 | |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Oct 6, 2020 | Apr 27, 2025 | U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 6, 2020 | Jul 27, 2025 | U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Oct 6, 2020 | Nov 21, 2025 *PED | U-2957: Maintenance treatment of asthma in patients 18 yrs and older, or chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Oct 6, 2020 | Dec 14, 2027 *PED | U-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 002: Oct 6, 2020 | Dec 18, 2027 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: Oct 6, 2020 | Apr 2, 2028 *PED | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Aug 5, 2028 *PED | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Sep 8, 2030 *PED | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 6, 2020 | Nov 29, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Apr 11, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Sep 9, 2023 |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203214 Prod. No.: 001 RX (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Nov 30, 2012 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 001: Nov 30, 2012 | Dec 8, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
| Exclusivity Code: NPP - New patient population | Sep 25, 2023 |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203214 Prod. No.: 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Jun 28, 2018 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 002: Jun 28, 2018 | Dec 8, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 208246 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 18, 2016 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 001: Mar 18, 2016 | Dec 8, 2025 | |
| Pat. No. 9937181 DP* Tofacitinib oral sustained release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: May 9, 2018 | Mar 14, 2034 | |
| Pat. No. 11253523 Tofacitinib oral sustained release dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2022 | Mar 14, 2034 | U-3326: A method of treating ankylosing spondylitis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, and 87-98 U-3327: A method of treating psoriatic arthritis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, and 87-98 U-3328: A method of treating rheumatoid arthritis by administering the formulation of tofacitinib of claims 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 and 87-98 U-3329: A method of treating ulcerative colitis, by administering the formulation of tofacitinib of claims 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 and 87-98 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 208246 Prod. No.: 002 RX (EQ 22MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Jan 9, 2020 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 002: Jan 9, 2020 | Dec 8, 2025 | |
| Pat. No. 10639309 DP* Tofacitinib oral sustained release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 3, 2020 | Mar 14, 2034 | |
| Pat. No. 11253523 Tofacitinib oral sustained release dosage forms Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 23, 2022 | Mar 14, 2034 | U-3326: A method of treating ankylosing spondylitis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, and 87-98 U-3327: A method of treating psoriatic arthritis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, and 87-98 U-3328: A method of treating rheumatoid arthritis by administering the formulation of tofacitinib of claims 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 and 87-98 U-3329: A method of treating ulcerative colitis, by administering the formulation of tofacitinib of claims 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 and 87-98 |
ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED |
REYVOW (TABLET) (ORAL) LASMIDITAN SUCCINATE
NDA Applicant: ELI LILLY AND CO NDA No.: 211280 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE) NDA No.: 211280 Prod. No.: 003 DISC (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8748459 Pyridinoylpiperidines as 5-HT.sub.1F agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 25, 2020; 002: Feb 25, 2020; 003: Jul 28, 2021 | Mar 27, 2023 | U-1719: Acute treatment of migraine |
| Pat. No. 7423050 DS* DP* [Extended 1788 days (4.9 years)] Pyridinoylpiperidines as 5-HT.sub.1F agonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 25, 2020; 002: Feb 25, 2020; 003: Jul 28, 2021 | Feb 17, 2028 | U-1719: Acute treatment of migraine |
| Pat. No. 11053214 DS* DP* Compositions and methods related to pyridinoylpiperidine 5-HT.sub.1F agonists Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Dec 5, 2037 | U-1719: Acute treatment of migraine |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 31, 2025 |
VENLAFAXINE BESYLATE (TABLET, EXTENDED RELEASE) (ORAL) VENLAFAXINE BESYLATE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALMATICA NDA No.: 215429 Prod. No.: 001 RX (EQ 112.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6717015 DS* DP* Venlafaxine besylate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation claimed by its inherent performace characteristics; Method of use; Process Pat. Sub. Date(s): 001: Jul 20, 2022 | Mar 27, 2023 | U-451: Treatment of depression and generalized anxiety disorder |
| Pat. No. 7776358 DP* Extended release venlafaxine besylate tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 20, 2022 | May 16, 2028 |
AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM NDA No.: 203985 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 | Mar 27, 2023 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2025 | ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC NDA No.: 021748 Prod. No.: 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8323692 DP* Controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 12, 2012 | Mar 30, 2023 | |
| Pat. No. 7780987 DS* DP* Controlled release dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): 002: None | Mar 23, 2025 |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 1, 2017 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 6, 2018 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 003 DISC (20MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): 003: Dec 20, 2016 | Mar 30, 2025 |
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 DISC (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 29, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 209210 Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 4, 2031 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 DISC (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | May 12, 2028 *PED | |
| Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Jul 12, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Sep 25, 2028 *PED | |
| Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 25, 2028 *PED | |
| Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Aug 4, 2029 *PED | |
| Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Nov 19, 2029 *PED | |
| Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 7, 2030 *PED | |
| Pat. No. 8721615 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibito == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 212888 Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): All strengths: Feb 16, 2021 | Apr 11, 2023 | |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: Feb 16, 2021 | Apr 21, 2025 | U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg |
| Pat. No. 8410103 DS* DP* (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2021 | Apr 28, 2026 | U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg |
| Pat. No. 10927129 DS* DP* N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Mar 22, 2021 | Apr 28, 2026 | |
| Pat. No. 11389447 Aqueous suspensions of TMC278 Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 17, 2022 | Jun 30, 2027 | U-3405: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg by monthly administration of rilpivirine suspension as part of combination therapy |
| Pat. No. 11224597 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 15, 2022 | Sep 15, 2031 | U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jan 31, 2025 | D-184: New dosing schedule for cabotegravir/rilpivrine injection every 2 months |
| Exclusivity Code: NCE - New chemical entity | Jan 21, 2026 | |
| Exclusivity Code: NPP - New patient population | Mar 29, 2025 |
COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 202123 Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jun 15, 2012 | Apr 11, 2023 | |
| Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2014 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 10, 2016 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 19, 2017 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Sep 6, 2011 | Apr 21, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 8841310 DP* Combinations of a pyrimidine containing NNRTI with RT inhibitors Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Oct 20, 2014 | Dec 9, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 10857102 DP* Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 6, 2021 | Jan 14, 2033 |
EDURANT (TABLET) (ORAL) RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: JANSSEN PRODS NDA No.: 202022 Prod. No.: 001 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jan 12, 2012 | Apr 11, 2023 | |
| Pat. No. 7638522 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 16, 2011 | Apr 14, 2023 | |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jun 16, 2011 | Apr 21, 2025 | U-1153: In combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients, as set forth in the labeling, including I&U section U-1307: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 at the start of therapy U-1740: In combination with other antiretroviral agents for the treatment of hiv-1 infection in treatment-naive patients with hiv-1 rna less than or equal to 100,000 at the start of therapy U-3353: Treatment in combination with cabotegravir of HIV-1 infection in adults and adolescents 12 and older to replace current regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure |
JULUCA (TABLET) (ORAL) DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 210192 Prod. No.: 001 RX (EQ 50MG BASE;EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Dec 20, 2017 | Apr 11, 2023 | |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Dec 20, 2017 | Apr 21, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 20, 2017 | Apr 5, 2028 *PED | |
| Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 20, 2017 | Jun 8, 2030 *PED | |
| Pat. No. 10426780 DS* DP* Antiviral therapy Claim Types: Formulation; Method of use; Method of administration; Kit Pat. Sub. Date(s): 001: Oct 25, 2019 | Jan 24, 2031 | U-257: Treatment of HIV infection |
ODEFSEY (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208351 Prod. No.: 001 RX (200MG;EQ 25MG BASE;EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Mar 24, 2016 | Apr 11, 2023 | |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Mar 24, 2016 | Apr 21, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)] Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Mar 24, 2016 | Oct 17, 2025 *PED | |
| Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 24, 2016 | Feb 15, 2033 *PED | U-257: Treatment of HIV infection |
| Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 19, 2016 | Feb 15, 2033 *PED | U-257: Treatment of HIV infection |
REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE [GENERIC AB]
Drug Classes: thalidomide analog
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 021880 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (25MG); 005 RX (2.5MG); 006 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7189740 Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes Claim Types: Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: None; 005: Jan 17, 2012; 006: None | Apr 11, 2023 | U-1982: Use of REVLIMID (lenalidomide) for treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities |
| Pat. No. 8404717 Methods of treating myelodysplastic syndromes using lenalidomide Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 10, 2013; 002: None; 003: None; 004: None; 005: None; 006: None | Apr 11, 2023 | U-1982: Use of REVLIMID (lenalidomide) for treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities |
| Pat. No. 9056120 Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 9, 2015 | Apr 11, 2023 | U-1982: Use of REVLIMID (lenalidomide) for treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities |
| Pat. No. 8530498 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 26, 2013 | May 15, 2023 | U-1984: Use of REVLIMID (lenalidomide) for the treatment of patients with multiple myeloma, in combination with dexamethasone |
| Pat. No. 8648095 Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 15, 2023 | U-1984: Use of REVLIMID (lenalidomide) for the treatment of patients with multiple myeloma, in combination with dexamethasone |
| Pat. No. 9101621 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | May 15, 2023 | U-1985: Use of REVLIMID (lenalidomide) for the treatment of patients with multiple myeloma, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) |
| Pat. No. 9101622 Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | May 15, 2023 | U-1986: Use of REVLIMID (lenalidomide) for the treatment of patients with multiple myeloma, in combination with dexamethasone, wherein those patients have not received previous treatment for multiple myeloma |
| Pat. No. 9155730 Methods for treating non-Hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2019 | May 15, 2023 | U-2550: Use of REVLIMID (lenalidomide) for the treatment of previously treated follicular lymphoma in combination with a rituximab product |
| Pat. No. 9393238 Methods for treating non-Hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2019 | May 15, 2023 | U-2550: Use of REVLIMID (lenalidomide) for the treatment of previously treated follicular lymphoma in combination with a rituximab product |
| Pat. No. 7468363 Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 27, 2013 | Oct 7, 2023 | U-1983: Use of REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib U-2550: Use of REVLIMID (lenalidomide) for the treatment of previously treated follicular lymphoma in combination with a rituximab product U-2551: Use of REVLIMID (lenalidomide) for the treatment of previously treated marginal zone lymphoma in combination with a rituximab product |
| Pat. No. 7968569 Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 14, 2011; 002: Jul 14, 2011; 003: Jul 14, 2011; 004: Jul 14, 2011; 005: Jan 17, 2012; 006: None | Oct 7, 2023 | U-1984: Use of REVLIMID (lenalidomide) for the treatment of patients with multiple myeloma, in combination with dexamethasone |
| Pat. No. 8492406 Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2019 | Oct 7, 2023 | U-2550: Use of REVLIMID (lenalidomide) for the treatment of previously treated follicular lymphoma in combination with a rituximab product |
| Pat. No. 7855217 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Jan 13, 2011; 002: None; 003: Jan 17, 2012; 004: None; 005: Jan 17, 2012; 006: None | Nov 24, 2024 | |
| Pat. No. 7465800 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: None; 005: Jan 17, 2012; 006: None | Apr 27, 2027 | |
| Pat. No. 8741929 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 17, 2014 | Mar 8, 2028 | U-1983: Use of REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 22, 2024 | ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct) |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 28, 2026 | ODE-241: Indicated in combination with a rituximab product for the treatment of adult patients with previously treated follicular lymphoma (FL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 28, 2026 | ODE-245: Indicated in combination with a rituximab product for the treatment of adult patients with previously treated marginal zone lymphoma (MZL) |
ZOSYN (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Drug Classes: penicillin class antibacterial == beta-lactamase inhibitor
NDA Applicant: WYETH PHARMS NDA No.: 050684 Prod. No.: 001 DISC (EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL**); 002 DISC (EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL**); 003 DISC (EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL**); 004 DISC (EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900184 DP* Compositions containing pipercillin and tazobactam useful for injection Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
| Pat. No. 7915229 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 22, 2011; 002: None; 003: None; 004: None | Apr 14, 2023 | |
| Pat. No. 8133883 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2012; 002: None; 003: None; 004: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
ZOSYN IN PLASTIC CONTAINER (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Drug Classes: penicillin class antibacterial == beta-lactamase inhibitor
NDA Applicant: BAXTER HLTHCARE CORP NDA No.: 050750 Prod. No.: 001 RX (EQ 40MG BASE/ML;EQ 5MG BASE/ML); 002 RX (EQ 60MG BASE/ML;EQ 7.5MG BASE/ML); 003 RX (EQ 4GM BASE/100ML;EQ 500MG BASE/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900184 DP* Compositions containing pipercillin and tazobactam useful for injection Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
| Pat. No. 7915229 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 22, 2011; 002: None; 003: None | Apr 14, 2023 | |
| Pat. No. 8133883 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2012; 002: None; 003: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Apr 15, 2023 | U-3: Treatment of hypertension |
| Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Oct 5, 2029 | U-3: Treatment of hypertension |
TESTIM (GEL) (TRANSDERMAL) TESTOSTERONE [GENERIC AB2]
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC NDA No.: 021454 Prod. No.: 001 RX (50MG/5GM PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7608605 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608606 Pharmaceutical composition Claim Types: Method of adminstration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608607 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608608 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608609 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7608610 Pharmaceutical composition Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 7935690 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2011 | Apr 21, 2023 | U-1009: Method for administration of testosterone |
| Pat. No. 8063029 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 8, 2011 | Apr 21, 2023 | U-843: Method for administration of testosterone |
| Pat. No. 8178518 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2012 | Apr 21, 2023 | |
| Pat. No. 7320968 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 18, 2025 | U-843: Method for administration of testosterone |
DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcript == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MERCK SHARP DOHME NDA No.: 206510 Prod. No.: 001 DISC (150MG;EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2015 | Apr 21, 2023 *PED | U-1663: Treatment of HIV-1 infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2015 | Apr 21, 2023 *PED | U-1663: Treatment of HIV-1 infection |
| Pat. No. 7820660 DS* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2015 | Apr 25, 2023 | |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 4, 2015 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 4, 2015 | Sep 11, 2029 *PED | U-1663: Treatment of HIV-1 infection |
ISENTRESS (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK NDA No.: 022145 Prod. No.: 001 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 21, 2023 *PED | U-257: Treatment of HIV infection U-900: Integrase inhibition for the treatment of HIV infection |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: None | Apr 3, 2024 *PED | |
| Pat. No. 8852632 DS* DP* Pharmaceutical formulation containing a release rate controlling composition Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 27, 2023 | Jan 28, 2028 | U-257: Treatment of HIV infection |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK NDA No.: 203045 Prod. No.: 001 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2012 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2012 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 20, 2012 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 20, 2012 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK NDA No.: 203045 Prod. No.: 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 002: None | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 002: None | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 002: None | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK NDA No.: 205786 Prod. No.: 001 RX (EQ 100MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 16, 2014 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 16, 2014 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 16, 2014 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 16, 2014 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
ISENTRESS HD (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK NDA No.: 022145 Prod. No.: 002 RX (EQ 600MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 21, 2023 *PED | U-257: Treatment of HIV infection U-900: Integrase inhibition for the treatment of HIV infection |
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 002: Jun 23, 2017 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
| Pat. No. 9649311 DP* Solid pharmaceutical compositions containing an integrase inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 21, 2031 *PED | |
| Pat. No. 10772888 Solid pharmaceutical compositions containing an integrase inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 27, 2020 | Mar 30, 2032 | U-1663: Treatment of HIV-1 infection |
CLINDESSE (CREAM) (VAGINAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: PADAGIS US NDA No.: 050793 Prod. No.: 001 RX (EQ 2% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899890 DP* Bioadhesive drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 27, 2023 | U-137: Method of treating bacterial vaginosis |
| Pat. No. 9789057 DP* Pharmaceutical delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jan 9, 2018 | Dec 2, 2026 | U-137: Method of treating bacterial vaginosis |
AGGRASTAT (INJECTABLE; SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE NDA No.: 020912 Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)) NDA No.: 020912 Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016 | May 1, 2023 | U-1444: a dosing regimen of aggrastat (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-st elevation ACS |
AGGRASTAT (SOLUTION) (INTRAVENOUS) TIROFIBAN HYDROCHLORIDE [GENERIC AP]
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE NDA No.: 020913 Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913 Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 7, 2013 | May 1, 2023 | U-1444: a dosing regimen of aggrastat (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-st elevation ACS |
STENDRA (TABLET) (ORAL) AVANAFIL
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS NDA No.: 202276 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7501409 DP* Preparations for oral administration Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 5, 2023 | |
| Pat. No. 6656935 DS* DP* [Extended 1687 days (4.6 years)] Aromatic nitrogen-containing 6-membered cyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: May 29, 2012 | Apr 27, 2025 | U-155: Treatment of erectile dysfunction |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 18, 2025 | M-282: Revisions to the labeling to add the results of a clinical study (TA-303) in patients with ED following bilateral nerve-sparing radical prostatectomy |
BONIVA (TABLET) (ORAL) IBANDRONATE SODIUM
NDA Applicant: HOFFMANN LA ROCHE NDA No.: 021455 Prod. No.: 002 DISC (EQ 150MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7192938 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 002: None | May 6, 2023 | U-798: Treatment and prevention of osteoporosis in postmenopausal women by once-monthly oral administration of ibandronate sodium monohydrate equivalent to 150mg of ibandronic acid |
| Pat. No. 7410957 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 002: None | May 6, 2023 | U-887: Treatment and prevention of osteoporosis |
| Pat. No. 7718634 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 002: None | May 6, 2023 | U-642: Treatment and prevention of osteoporosis |
PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 6, 2023 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 19, 2025 | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | May 19, 2025 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Mar 26, 2028 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 28, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 002: Mar 19, 2020 | Jan 1, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jan 13, 2032 | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 18, 2021 | Dec 14, 2035 | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 12, 2020 | Aug 16, 2036 | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 002: Jun 29, 2022 | Feb 10, 2038 | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 002: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 002: Jun 10, 2021 | Dec 18, 2038 | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Jun 29, 2022 | Sep 26, 2039 | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 002: Nov 10, 2022 | Jun 19, 2040 | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 002: Dec 8, 2021 | Jul 6, 2040 | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Apr 7, 2022 | Feb 22, 2041 |
PROAIR RESPICLICK (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | May 6, 2023 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Nov 8, 2016 | May 19, 2025 | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 19, 2025 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Mar 26, 2028 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 14, 2018 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | May 18, 2031 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jun 28, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jan 1, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jan 13, 2032 |
NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 001 DISC (0.0277MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220747 Methods using desmopressin acetate in orodispersible form Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 9504647 DP* Pharmaceutical formulations of desmopressin Claim Types: Formulation; Process; Method of administration Pat. Sub. Date(s): 001: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 9919025 Pharmaceutical formulations of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 10307459 DP* Pharmaceutical formulations of desmopressin Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 12, 2019 | May 7, 2023 | |
| Pat. No. 7947654 DP* Pharmaceutical formulations Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jul 25, 2018 | Dec 29, 2023 | |
| Pat. No. 8802624 Methods of treatment using orodispersible desmopressin pharmaceutical formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2018 | Dec 29, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 7560429 DP* Orodispersible dosage forms of desmopressin acetate Claim Types: Formulation; Process; Method of use; Kit Pat. Sub. Date(s): 001: Jul 19, 2018 | Feb 2, 2024 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 11020448 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 17, 2021 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 9974826 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2018 | Apr 13, 2030 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 002 DISC (0.0553MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9220747 Methods using desmopressin acetate in orodispersible form Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 9504647 DP* Pharmaceutical formulations of desmopressin Claim Types: Formulation; Process; Method of administration Pat. Sub. Date(s): 002: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 9919025 Pharmaceutical formulations of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 19, 2018 | May 7, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 10307459 DP* Pharmaceutical formulations of desmopressin Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 12, 2019 | May 7, 2023 | |
| Pat. No. 7947654 DP* Pharmaceutical formulations Claim Types: Formulation; Kit Pat. Sub. Date(s): 002: Jul 25, 2018 | Dec 29, 2023 | |
| Pat. No. 8802624 Methods of treatment using orodispersible desmopressin pharmaceutical formulations Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 19, 2018 | Dec 29, 2023 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 7560429 DP* Orodispersible dosage forms of desmopressin acetate Claim Types: Formulation; Process; Method of use; Kit Pat. Sub. Date(s): 002: Jul 19, 2018 | Feb 2, 2024 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 10137167 Methods comprising desmopressin Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Dec 12, 2018 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 9974826 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 19, 2018 | Apr 13, 2030 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS NDA No.: 022526 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227471 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Pat. No. 7151103 [Extended 5 years] Method of treating female hypoactive sexual desire disorder with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2028 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS NDA No.: 021669 Prod. No.: 001 OTC (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7595021 DP* Method of providing alcohol-free disinfection Claim Types: Method of administration Pat. Sub. Date(s): 001: None | May 12, 2023 | U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection |
| Pat. No. 7066916 Disinfectant delivery system, and method of providing alcohol-free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2024 | U-737: Disinfection of patient skin prior to an invasive procedure |
| Pat. No. 7717889 DP* Disinfectant delivery system and method of providing alcohol free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2012 | Feb 27, 2025 | U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection |
| Pat. No. 7427574 DP* Non-woven wash cloth Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 25, 2026 | |
| Pat. No. 7935093 DP* Disinfectant delivery system and method of providing alcohol-free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: May 24, 2011 | Oct 2, 2027 | U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection |
BANZEL (TABLET) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC NDA No.: 021911 Prod. No.: 002 RX (200MG); 003 RX (400MG) NDA No.: 021911 Prod. No.: 001 DISC (100MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)] Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: None | May 14, 2023 *PED |
BANZEL (SUSPENSION) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC NDA No.: 201367 Prod. No.: 001 RX (40MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)] Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Apr 1, 2011 | May 14, 2023 *PED |
AMTURNIDE (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor == calcium channel blocker == dihydropyridine calcium channel blocker == thiazide diuretic
NDA Applicant: NOVARTIS NDA No.: 200045 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None | May 16, 2023 |
EXFORGE HCT (TABLET) (ORAL) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN [GENERIC AB]
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker == thiazide diuretic == angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022314 Prod. No.: 001 RX (EQ 5MG BASE;12.5MG;160MG); 002 RX (EQ 5MG BASE;25MG;160MG); 003 RX (EQ 10MG BASE;12.5MG;160MG); 004 RX (EQ 10MG BASE;25MG;160MG); 005 RX (EQ 10MG BASE;25MG;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101599 DP* Pharmaceutical composition containing anti-hypertensive agents Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 30, 2012; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8475839 DP* Formulation Claim Types: Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Nov 16, 2023 *PED |
NAROPIN (SOLUTION) (INJECTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA NDA No.: 020533 Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8118802 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 18, 2023 | |
| Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 23, 2024 | |
| Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Oct 18, 2025 | |
| Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Nov 28, 2026 |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 001 RX (EQ 25MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 001: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 002 RX (EQ 50MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 002: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 002: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 002: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 003 RX (EQ 75MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 003: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 003: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 003: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 004 RX (EQ 12.5MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 004: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 004: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 004: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Dec 21, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 005 DISC (EQ 100MG ACID**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 005: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 005: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 005: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA KIT (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 207027 Prod. No.: 001 RX (EQ 25MG ACID/PACKET); 002 RX (EQ 12.5MG ACID/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: Sep 21, 2015; 002: Apr 5, 2019 | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2015; 002: Apr 5, 2019 | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: Sep 21, 2015; 002: Apr 5, 2019 | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Nov 16, 2025 |
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 24, 2023 | U-2025: Treatment of attention deficit hyperactivity disorder |
| Pat. No. 9173857 Controlled dose drug delivery system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 12, 2026 | U-2025: Treatment of attention deficit hyperactivity disorder |
| Pat. No. 8846100 DP* Controlled dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 7, 2017 | Aug 24, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2023 PED | M-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age |
SELZENTRY (TABLET) (ORAL) MARAVIROC [GENERIC AB]
Drug Classes: CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE NDA No.: 022128 Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (25MG); 004 RX (75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368460 Tropane derivatives useful in therapy Claim Types: Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016 | May 25, 2023 *PED | U-824: Method of treating patients infected with CCR5-tropic HIV-1 |
SELZENTRY (SOLUTION) (ORAL) MARAVIROC
Drug Classes: CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE NDA No.: 208984 Prod. No.: 001 RX (20MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368460 Tropane derivatives useful in therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 23, 2016 | May 25, 2023 *PED | U-824: Method of treating patients infected with CCR5-tropic HIV-1 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Apr 30, 2024 PED |
DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 202236 Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9901585 DP* Combination of azelastine and fluticasone for nasal administration Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 27, 2018 | Jun 13, 2023 | |
| Pat. No. 9259428 Combination of azelastine and fluticasone for nasal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2016 | Dec 13, 2023 *PED | U-644: Treatment of seasonal allergic rhinitis |
| Pat. No. 8163723 Combination of azelastine and steroids Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2012 | Feb 29, 2024 *PED | U-1667: Treatment of allergic rhinitis, including seasonal allergic rhinitis U-644: Treatment of seasonal allergic rhinitis U-707: Allergic rhinitis U-77: Treatment of symptoms of seasonal allergic rhinitis U-81: Relief of symptoms associated with seasonal allergic rhinitis |
| Pat. No. 8168620 DP* Combination of azelastine and steroids Claim Types: Formulation; Process Pat. Sub. Date(s): 001: May 11, 2012 | Aug 24, 2026 *PED |
LOSEASONIQUE (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: TEVA BRANDED PHARM NDA No.: 022262 Prod. No.: 001 RX (0.02MG,0.1MG;0.01MG,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7615545 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 15, 2023 | U-1: Prevention of pregnancy |
| Pat. No. 7858605 DP* Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 28, 2011 | Jun 23, 2023 | |
| Pat. No. 7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2011 | Dec 5, 2028 | U-1: Prevention of pregnancy |
SEASONIQUE (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: TEVA BRANDED PHARM NDA No.: 021840 Prod. No.: 001 RX (0.03MG,0.01MG;0.15MG,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7615545 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 15, 2023 | U-1: Prevention of pregnancy |
| Pat. No. 7858605 DP* Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 28, 2011 | Jun 23, 2023 | |
| Pat. No. 7320969 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 30, 2024 | U-828: Prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception |
| Pat. No. 7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2011 | Dec 5, 2028 | U-1: Prevention of pregnancy |
HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 206627 Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9084816 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015 | Aug 24, 2027 | |
| Pat. No. 9095614 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2015 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9095615 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 4, 2015 | Aug 24, 2027 | |
| Pat. No. 9486412 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016 | Aug 24, 2027 | |
| Pat. No. 9486413 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492390 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9545380 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 17, 2017 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775809 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8808740 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014 | Dec 21, 2031 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9572779 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 21, 2017 | Dec 21, 2031 | |
| Pat. No. 9750703 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 14, 2017 | Dec 21, 2031 | |
| Pat. No. 9861584 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 10, 2018 | Dec 21, 2031 | |
| Pat. No. 9872837 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 23, 2018 | Dec 21, 2031 |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894987 DP* Tamper resistant dosage forms Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Mar 29, 2030 |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 203340 Prod. No.: 002 RX (6MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7070581 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | Jun 23, 2023 | |
| Pat. No. 8517997 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | May 14, 2024 | |
| Pat. No. 10342787 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 10576070 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11207306 Non-aqueous liquid nimodipine compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11413277 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment Pat. Sub. Date(s): 002: Aug 25, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11806338 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Device Pat. Sub. Date(s): 002: Nov 17, 2023 | Apr 16, 2038 |
KENGREAL (POWDER) (INTRAVENOUS) CANGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: CHIESI NDA No.: 204958 Prod. No.: 001 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6130208 DP* Formulation containing a nucleotide analogue Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jul 16, 2015 | Jun 29, 2023 | U-1715: P2Y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a P2Y12 platelet inhibitor and not given a glycoprotein IIb/IIIa inhibitor |
| Pat. No. 9925265 Methods of treating or preventing stent thrombosis Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | May 13, 2029 | U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion |
| Pat. No. 9427448 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2016 | Nov 10, 2030 | U-1926: Method of treating, reducing the incidence of, or preventing an ischemic event in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and continuous infusion of 4 ug/kg/min for at least 2 hours or the duration of the PCI |
| Pat. No. 8680052 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 16, 2015 | Mar 9, 2033 | U-2979: Method comprising iv administration of cangrelor before PCI then continuous infusion for at least 2 hours or the duration of PCI and, during or after continuous infusion, administration of a loading dose of ticagrelor, or an equivalent method |
| Pat. No. 9295687 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Product-by-process; Drug in a container Pat. Sub. Date(s): 001: Mar 29, 2016 | Jul 10, 2035 | |
| Pat. No. 9439921 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Dec 9, 2016 | Jul 10, 2035 | |
| Pat. No. 9700575 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Composition; Formulation; Drug in a container Pat. Sub. Date(s): 001: Jul 28, 2017 | Jul 10, 2035 | |
| Pat. No. 10039780 Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 30, 2018 | Jul 10, 2035 | U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion |
FERAHEME (SOLUTION) (INTRAVENOUS) FERUMOXYTOL [GENERIC AB]
NDA Applicant: COVIS NDA No.: 022180 Prod. No.: 001 RX (EQ 510MG IRON/17ML (EQ 30MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6599498 DS* DP* [Extended 1209 days (3.3 years)] Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives Claim Types: Method of administration; Process; Formulation Pat. Sub. Date(s): 001: None | Jun 30, 2023 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2019 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Sep 27, 2027 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 16, 2023 | I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 002 RX (4MG/3ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Sep 24, 2020 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Dec 21, 2020 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 16, 2023 | I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 003 RX (8MG/3ML (2.68MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Apr 29, 2022 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Mar 20, 2026 | U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Dec 5, 2031 | U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Feb 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Mar 28, 2025 | D-185: Addition of a 3rd maintenance dose of semaglutide |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 004 RX (2MG/3ML (0.68MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 004: Nov 14, 2022 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Mar 20, 2026 | U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Dec 5, 2031 | U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Feb 1, 2032 | |
| Pat. No. 10335462 DP* Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
ONZETRA XSAIL (POWDER) (NASAL) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 206099 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8047202 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Jul 2, 2023 | |
| Pat. No. 8327844 Nasal delivery method Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 3, 2023 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9119932 DP* Nasal delivery device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 23, 2024 | |
| Pat. No. 7975690 DP* Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 8590530 DP* Nasal delivery devices Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9108015 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | |
| Pat. No. 11571531 Powder delivery devices Claim Types: Method of administration Pat. Sub. Date(s): 001: May 19, 2023 | Feb 23, 2026 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 10, 2018 | Mar 6, 2027 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 10398859 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Sep 30, 2019 | Dec 19, 2027 | |
| Pat. No. 8875704 DP* Nasal administration Claim Types: Device; Method of use; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 7, 2028 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10722667 DP* Nasal administration Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 | Dec 30, 2028 | |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 22, 2029 | |
| Pat. No. 8899229 DP* Powder delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2030 | |
| Pat. No. 9649456 DP* Nasal administration Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: May 26, 2017 | Oct 21, 2030 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Dec 6, 2030 | |
| Pat. No. 10478574 Nasal administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 9, 2019 | Nov 4, 2033 | U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 |
DEXYCU KIT (SUSPENSION) (INTRAOCULAR) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: EYEPOINT PHARMS NDA No.: 208912 Prod. No.: 001 RX (9%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6960346 DP* Vehicles for delivery of biologically active substances Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 5, 2018 | Jul 3, 2023 | |
| Pat. No. 10799642 DP* Dose guides for injection syringe Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Jun 11, 2021 | May 11, 2032 | |
| Pat. No. 10028965 Use of sustained release dexamethasone in post-cataract surgery inflammation Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 3, 2018 | May 23, 2034 | U-2340: Treatment of postoperative inflammation |
| Pat. No. 10159683 DP* Use of sustained release dexamethasone in post-cataract surgery inflammation Claim Types: Kit; Formulation Pat. Sub. Date(s): 001: Jan 23, 2019 | May 23, 2034 | |
| Pat. No. 10022502 Dose guides for injection syringe Claim Types: Device Pat. Sub. Date(s): 001: Aug 3, 2018 | Jun 22, 2034 | U-2340: Treatment of postoperative inflammation |
| Pat. No. 11097061 DP* Systems, kits and methods for loading and delivering a small volume dose from a syringe Claim Types: Kit; Device; Method of administration Pat. Sub. Date(s): 001: Sep 9, 2022 | Jun 23, 2039 | U-3418: A method of loading medication into a syringe and delivering the medication to a treatment site |
LEVITRA (TABLET) (ORAL) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021400 Prod. No.: 001 DISC (EQ 5MG BASE**); 002 DISC (EQ 10MG BASE**); 003 DISC (EQ 2.5MG BASE**); 004 DISC (EQ 20MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8841446 DP* Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 4, 2014 | Jul 3, 2023 | |
| Pat. No. 8273876 Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Oct 24, 2012; 002: None; 003: None; 004: None | Jul 23, 2027 | U-1288: Treatment of erectile dysfunction by administering a film-coated tablet |
XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 208090 Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8840928 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9044398 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | |
| Pat. No. 9248195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9592200 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Mar 20, 2017 | Jul 7, 2023 | |
| Pat. No. 9763883 DP* Abuse-deterrent drug formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 20, 2017 | Jul 7, 2023 | |
| Pat. No. 10525052 DP* Abuse-deterrent drug formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 7, 2020 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10525053 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 7, 2020 | Jul 7, 2023 | |
| Pat. No. 8557291 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 21, 2025 | |
| Pat. No. 7399488 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 7771707 DP* Abuse-deterrent drug formulations Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 8449909 DP* Abuse-deterrent drug formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 8758813 Abuse-deterrent drug formulations Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jun 10, 2025 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9682075 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 20, 2017 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10004729 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jul 10, 2018 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10668060 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 3, 2020 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9737530 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Method of use; Process Pat. Sub. Date(s): All strengths: Aug 23, 2017 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9968598 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Process; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10188644 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Method of use of a product-by-process; Product-by-process Pat. Sub. Date(s): All strengths: Jan 29, 2019 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10646485 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): All strengths: May 13, 2020 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
VISTOGARD (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite == nucleoside analog antiviral == nucleoside metabolic inhibitor == pyrimidine analog
NDA Applicant: BTG INTL NDA No.: 208159 Prod. No.: 001 RX (10GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2015 | Jul 10, 2023 | |
| Pat. No. 7776838 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2015 | Aug 17, 2027 | U-1791: Emergency treatment of adult & pediatric patients following fluorouracil or capecitabine overdose,or who exhibit early-onset,severe or life-threatening cardiac or cns toxicity or unusually severe adverse reactions within 96 hours |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 11, 2022 | ODE-104: Emergency tx of pts following a FU or capecitabine OD, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac system or CNS, and/or early-onset, unusually severe ar w/in 96 hrs following the end of FU or capecitabine admin. |
XURIDEN (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite == nucleoside analog antiviral == nucleoside metabolic inhibitor == pyrimidine analog
NDA Applicant: BTG INTL NDA No.: 208169 Prod. No.: 001 RX (2GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Oct 22, 2015 | Jul 10, 2023 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 4, 2022 | ODE-98: Treatment of hereditary orotic aciduria |
AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO NDA No.: 022504 Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Aug 7, 2014 | Jul 13, 2023 | U-1545: A method of transdermally delivering testosterone |
| Pat. No. 8993520 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 9180194 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8419307 Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 | Feb 26, 2027 | U-1386: A method of increasing the testosterone blood level of a person in need thereof |
| Pat. No. 8807861 DP* Spreading implement Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Sep 10, 2014 | Feb 26, 2027 | U-1563: A method of transdermal administration of a physiologically active agent to a subject. |
| Pat. No. 9289586 Spreading implement Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 19, 2016 | Feb 26, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8435944 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 27, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP NDA No.: 207620 Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8404744 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | |
| Pat. No. 8796331 Methods of treatment and pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | U-1723: Treatment of heart failure |
| Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Aug 6, 2015 | May 27, 2024 *PED | |
| Pat. No. 8101659 DP* [Extended 732 days (2 years)] Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 15, 2025 *PED | |
| Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 7, 2016 | May 8, 2027 *PED | U-1723: Treatment of heart failure |
| Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Nov 27, 2027 *PED | |
| Pat. No. 9517226 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 9937143 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11135192 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 18, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11058667 Sacubitril-valsartan dosage regimen for treating heart failure Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Jul 13, 2021 | May 9, 2036 | U-3170: Treating chronic heart failure with reduced ejection fraction in patients not taking an ACE inhibitor or an ARB or previously taking low doses of these agents, by titrating up from half the usually recommended starting dose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 16, 2024 | M-82: Labeling revisions related to clinical studies |
| Exclusivity Code: NPP - New patient population | Apr 1, 2023 PED |
NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: sigma-1 agonist == uncompetitive NMDA receptor antagonist == antiarrhythmic == CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS NDA No.: 021879 Prod. No.: 001 RX (20MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227484 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 1, 2012 | Jul 17, 2023 | U-1093: Treatment of pseudobulbar affect |
| Pat. No. 7659282 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 13, 2026 | U-1093: Treatment of pseudobulbar affect |
TOLAK (CREAM) (TOPICAL) FLUOROURACIL
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: HILL DERMACEUTICALS NDA No.: 022259 Prod. No.: 001 RX (4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169401 DP* Topical skin care composition containing refined peanut oil Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Nov 4, 2015 | Jul 18, 2023 |
MOZOBIL (SOLUTION) (SUBCUTANEOUS) PLERIXAFOR [GENERIC AP]
Drug Classes: hematopoietic stem cell mobilizer
NDA Applicant: GENZYME NDA No.: 022311 Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6987102 Methods to mobilize progenitor/stem cells Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
| Pat. No. 7897590 Methods to mobilize progenitor/stem cells Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 22, 2011 | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
NEUPRO (FILM, EXTENDED RELEASE) (TRANSDERMAL) ROTIGOTINE
Drug Classes: non-ergoline dopamine agonist
NDA Applicant: UCB INC NDA No.: 021829 Prod. No.: 001 RX (2MG/24HR); 002 RX (4MG/24HR); 003 RX (6MG/24HR); 004 RX (1MG/24HR); 005 RX (3MG/24HR); 006 RX (8MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617591 DP* Transdermal delivery system for the administration of rotigotine Claim Types: Drug in a container; Method of use Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jul 22, 2023 | U-1474: A method for the treatment of a patient suffering from a disease treatable with rotigotine, comprising applying the claimed transdermal delivery system (tds) to the skin of the patient |
| Pat. No. 8246980 DP* Transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Nov 27, 2025 | |
| Pat. No. 8246979 DP* Transdermal delivery system for the administration of rotigotine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Sep 1, 2027 | U-1272: Treatment of signs and symptoms of Parkinson's disease by application of claimed transdermal system U-1273: Treatment of restless legs syndrome by application of claimed transdermal delivery system |
| Pat. No. 10130589 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 30, 2018 | Dec 22, 2030 | |
| Pat. No. 10350174 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 18, 2019 | Dec 22, 2030 | |
| Pat. No. 9925150 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Apr 2, 2018 | Mar 1, 2032 |
CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE NDA No.: 020866 Prod. No.: 001 RX (EQ 0.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888310 Methods of identifying responders to dopamine agonist therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2011 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137992 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137993 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137994 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8877708 DP* Combination of dopamine agonists plus first phase secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2015 | Jun 7, 2030 | U-1706: Treatment of Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue wherein the combined therapeutic effect is greater than the additive effect of administering each agent alone |
| Pat. No. 9352025 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disordersClaim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jun 7, 2030 | U-2111: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1-5 and wherein the effects are as recited in claims 1-5 U-2112: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 6 and wherein the effects are as recited in claim 6 U-2113: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 7 and wherein the effects are as recited in claim 7 U-2114: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 9 and wherein the effects are as recited in claim 9 U-2115: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 10 and wherein the effects are as recited in claim 10 U-2116: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 12 and wherein the effects are as recited in claim 12 U-2117: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 14-15 and wherein the effects are as recited in claims 14-15 U-2118: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 16-18 and wherein the effects are as recited in claims 16-18 U-2119: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 19 and wherein the effects are as recited in claim 19 |
| Pat. No. 9895422 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2018 | Jun 7, 2030 | U-2114: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 9 and wherein the effects are as recited in claim 9 U-2116: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 12 and wherein the effects are as recited in claim 12 U-2281: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claim 1 U-2282: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 2 and wherein the effects are as recited in claim 2 U-2283: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 3-7 and wherein the effects are as recited in claims 3-7 U-2284: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 8 and wherein the effects are as recited in claim 8 U-2285: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 11 and wherein the effects are as recited in claim 11 U-2286: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 14 and wherein the effects are as recited in claim 14 U-2287: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 16-19 and wherein the effects are as recited in claims 16-19 |
| Pat. No. 10688155 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2020 | Jun 7, 2030 | U-2281: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claim 1 U-2890: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 2 and wherein the effects are as recited in claim 1 U-2891: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 3 and wherein the effects are as recited in claim 1 U-2892: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 4 and wherein the effects are as recited in claim 1 U-2893: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 5 and wherein the effects are as recited in claim 1 U-2894: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 6 and wherein the effects are as recited in claim 1 U-2895: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 7 and wherein the effects are as recited in claim 1 U-2896: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 8 and wherein the effects are as recited in claim 1 U-2897: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 9 U-2898: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 10 U-2899: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 11 U-2900: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 13 U-2901: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 15 and wherein the effects are as recited in claim 1 U-2902: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 16 and wherein the effects are as recited in claim 1 U-2903: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 17 and wherein the effects are as recited in claim 1 U-2904: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1, 17 and 18 and wherein the effects are as recited in claim 1 U-2905: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 19 and wherein the effects are as recited in claim 1 U-2906: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 22 wherein the effects are as recited in claim 22 U-2907: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 23 and wherein the effects are as recited in claim 22 U-2908: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 24 and wherein the effects are as recited in claim 22 U-2909: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 25 and wherein the effects are as recited in claim 22 U-2910: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 26 and wherein the effects are as recited in claim 26 U-2911: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 27 and wherein the effects are as recited in claim 26 U-2912: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 28 and wherein the effects are as recited in claim 26 U-2913: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 29 and wherein the effects are as recited in claim 26 U-2914: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 30 wherein the effects are as recited in claim 26 U-2915: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 31 and wherein the effects are as recited in claim 26 U-2916: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 32 wherein the effects are as recited in said claims U-2917: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 33 wherein the effects are as recited in claims U-2918: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 34 wherein the effects are as recited in said claims U-2919: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 36 wherein the effects are as recited in said claims U-2920: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 38 and wherein the effects are as recited claim 26 U-2921: Once daily topical treatment of persistent facial erythema associated with rosacea in adults U-2922: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 39 and wherein the effects are as recited in claim 26 U-2923: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 40 and wherein the effects are as recited in claim 26 U-2924: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 42 and wherein the effects are as recited in claim 42 U-2925: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 42 and 43 wherein the effects are as recited in claim 42 U-2926: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 44 and wherein the effects are as recited in claim 44 U-2927: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 45 and wherein the effects are as recited in claim 44 U-2928: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 46 and wherein the effects are as recited in claim 44 U-2929: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 47 and wherein the effects are as recited in claim 44 U-2930: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 48 and wherein the effects are as recited in claim 44 U-2931: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 49 and wherein the effects are as recited in claim 44 U-2932: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 50 wherein the effects are as recited in said claims U-2933: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 51 wherein the effects are as recited in said claims U-2934: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 52 wherein the effects are as recited in said claims U-2935: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 44 and wherein the effects are as recited in claims 44 and 54 U-2936: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 56 and wherein the effects are as recited in claim 44 U-2937: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 57 and wherein the effects are as recited in claim 44 |
| Pat. No. 8431155 DP* Bromocriptine formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: May 2, 2013 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 8613947 DP* Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 3, 2014 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9192576 DP* Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 9, 2016 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9522117 DP* Bromocriptine formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jan 18, 2017 | Apr 30, 2032 | U-1939: Administration once daily within two hours after waking in the morning for improvement of glycemic control in a Type 2 diabetes patient U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9700555 DP* Bromocriptine formulations Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 18, 2017 | Apr 30, 2032 | U-2183: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 13 U-2184: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 13, and 14 U-2185: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 15 and 27 U-2186: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 15, 27, and 28 U-2187: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 29 and 39 U-2188: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 29, 39, and 40 U-2189: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 41 and 52 U-2190: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 41, 52, and 53 U-2191: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 54 and 64 U-2192: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 54, 64, and 65 U-2193: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 66 and 75 U-2194: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 66, 75, and 76 U-2195: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 77 and 87 U-2196: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 77, 87, and 88 U-2197: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 89 and 99 U-2198: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 89, 99, and 100 |
| Pat. No. 9993474 Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 12, 2018 | Apr 30, 2032 | U-2384: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 1 and 10 U-2385: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 1,10 and 11 U-2386: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12 and 19 U-2387: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12, 19 and 20 U-2388: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 21 and 28 U-2389: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 21, 28, and 29 U-2390: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 30 and 41 U-2391: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 30, 41, and 42 U-2392: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 43 and 50 U-2393: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 43, 50 and 51 |
| Pat. No. 10688094 Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 11, 2020 | Apr 30, 2032 | U-2870: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 2 U-2871: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 2 and 3 U-2872: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 4 and 5 U-2873: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 4, 5, and 6 U-2874: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 7 and 8 U-2875: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 7, 8, and 9 U-2876: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 10 and 11 U-2877: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 10, 11, and 12 U-2878: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 13 and 14 U-2879: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 13, 14, and 15 U-2880: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 16 and 17 U-2881: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 16, 17, and 18 U-2882: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 19 and 20 U-2883: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 19, 20, and 21 U-2884: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 22, 23, and 24 U-2885: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 25 and 26 U-2886: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 25, 26, and 27 U-2887: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 28 and 29 U-2888: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 28, 29, and 30 |
| Pat. No. 11000522 Bromocriptine formulations Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jun 3, 2021 | Apr 30, 2032 | U-3119: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 11 U-3120: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 11, and 12 U-3121: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13 and 23 U-3122: Adjunct to diet exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13, 23, and 24 |
NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: pediculicide
NDA Applicant: PARAPRO LLC NDA No.: 022408 Prod. No.: 001 RX (0.9%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6063771 DP* [Extended 1494 days (4.1 years)] Formulations for controlling human lice Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 24, 2015 | Jul 25, 2023 | U-1670: NATROBA topical suspension is a pediculicide indicated for the topical treatment of head lice infestation in patients six (6) months of age and older. |
| Pat. No. 9895388 Methods and compositions useful for controlling cutaneous mites Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2022 | Nov 25, 2033 | U-3365: The product composition (NATROBA) is for the topical treatment of human scabies mite infestations by melting and delivering the active ingredient, spinosad, to the stratum corneum where scabies mites live and breed |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 28, 2024 | I-858: For the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older |
TOLSURA (CAPSULE) (ORAL) ITRACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MAYNE PHARMA NDA No.: 208901 Prod. No.: 001 RX (65MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8771739 DP* Pharmaceutical compositions for poorly soluble drugs Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jul 25, 2023 | |
| Pat. No. 8921374 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | |
| Pat. No. 9272046 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | |
| Pat. No. 9713642 Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | U-2453: Treatment of fungal infections, including blastomycosis, histoplasmosis, and aspergillosis |
| Pat. No. 10463740 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 27, 2019 | Jun 21, 2033 | U-2453: Treatment of fungal infections, including blastomycosis, histoplasmosis, and aspergillosis |
| Pat. No. 10806792 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 24, 2020 | Jun 21, 2033 |
SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE [GENERIC AB]
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA NDA No.: 021929 Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7759328 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 8143239 DP* Composition for inhalation Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 26, 2012; 002: None | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 8575137 DP* Composition for inhalation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): All strengths: Dec 4, 2013 | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 10166247 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 7, 2019 | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 11311558 DP* Composition for inhalation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 20, 2022 | Jul 29, 2023 *PED | |
| Pat. No. 8875699 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2014 | May 10, 2025 *PED | |
| Pat. No. 7587988 DP* Inhaler device counter Claim Types: Device Pat. Sub. Date(s): All strengths: None | Oct 10, 2026 *PED | |
| Pat. No. 8387615 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None | Sep 26, 2027 *PED | |
| Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 9, 2013 | Apr 16, 2029 *PED | |
| Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Jan 29, 2014 | Oct 7, 2029 *PED |
BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE [GENERIC AT]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC NDA No.: 022288 Prod. No.: 001 RX (1.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8877168 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 25, 2014 | Jul 30, 2023 | |
| Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2014 | Jan 13, 2025 |
DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022287 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): All strengths: None | Jul 30, 2023 *PED | U-1507: To maintain healing of EE and relief of heartburn U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 8722084 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Apr 15, 2024 *PED | |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Apr 15, 2024 *PED | U-1552: For healing of all grades of erosive esophagitis (EE) U-1553: To maintain healing of EE and relief of heartburn U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD) |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 1, 2015 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 17, 2026 *PED | |
| Pat. No. 7790755 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None | Feb 2, 2027 *PED | |
| Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None | Mar 27, 2027 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jan 11, 2028 | |
| Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None | Sep 17, 2030 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Mar 5, 2032 | U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions |
DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208056 Prod. No.: 001 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 30, 2023 *PED | U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Apr 15, 2024 *PED | |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 17, 2026 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 11, 2028 *PED | |
| Pat. No. 9241910 DP* Orally-disintegrating solid preparation Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 10, 2029 |
KOMBIGLYZE XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 200678 Prod. No.: 001 DISC (500MG;EQ 5MG BASE); 002 DISC (1GM;EQ 5MG BASE); 003 DISC (1GM;EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2013 | Jul 31, 2023 | U-1097: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate U-1838: Method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 31, 2014; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 9339472 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2016; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 |
ONGLYZA (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: ASTRAZENECA AB NDA No.: 022350 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 24, 2013; 002: None | Jul 31, 2023 | U-1837: Method for treating type ii diabetes mellitus by administering saxagliptin alone or in combination with insulin, metformin, a thiazolidinedione, glyburide or metformin plus a sulfonylurea U-995: Method for treating Type II diabetes by administering saxagliptin |
| Pat. No. 7951400 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 29, 2011; 002: None | Nov 30, 2028 |
ORAVERSE (INJECTABLE) (INJECTION) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING NDA No.: 022159 Prod. No.: 001 RX (0.4MG/1.7ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Kit; Drug in a container Pat. Sub. Date(s): 001: None | Jul 31, 2023 | |
| Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Jul 31, 2023 | |
| Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 17, 2023 | U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic |
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 001 RX (10MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Jun 20, 2027 | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 22, 2017 | Dec 16, 2029 |
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 002 RX (5MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: May 24, 2019 | Dec 16, 2029 |
QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 210874 Prod. No.: 001 DISC (2.5MG;1GM;EQ 2.5MG BASE); 002 DISC (5MG;1GM;EQ 2.5MG BASE); 003 DISC (5MG;1GM;EQ 5MG BASE); 004 DISC (10MG;1GM;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: May 24, 2019 | Dec 16, 2029 | |
| Pat. No. 9616028 DP* Bilayer tablet formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Nov 12, 2030 |
ABILIFY ASIMTUFII (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 217006 Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 25, 2023 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension |
| Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension |
| Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 25, 2023 | Mar 15, 2025 | U-1530: Use of aripiprazole in extended release injectable suspension |
| Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: May 25, 2023 | Jun 29, 2025 | |
| Pat. No. 10517951 DP* Injectable preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11097007 DP* Injectable preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11638757 DP* Injectable preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 202971 Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Aug 6, 2023 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia |
| Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 19, 2024 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014 | Jun 29, 2025 | |
| Pat. No. 10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 11154553 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11344547 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2022 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11400087 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2022 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 10525057 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 31, 2020 | Mar 8, 2034 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder U-543: Treatment of schizophrenia |
| Pat. No. 11648347 DP* Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 15, 2023 | Apr 6, 2034 |
SIGNIFOR LAR KIT (FOR SUSPENSION) (INTRAMUSCULAR) PASIREOTIDE PAMOATE
Drug Classes: somatostatin analog
NDA Applicant: RECORDATI RARE NDA No.: 203255 Prod. No.: 001 RX (EQ 20MG BASE/VIAL); 002 RX (EQ 40MG BASE/VIAL); 003 RX (EQ 60MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8822637 Somatostatin analogues Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Aug 6, 2023 | U-1629: Method of treating acromegaly |
| Pat. No. 7759308 DP* Microparticles comprising somatostatin analogues Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Oct 25, 2026 | |
| Pat. No. 7473761 DS* DP* [Extended 871 days (2.4 years)] Somatostatin analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Dec 14, 2026 | |
| Pat. No. 9351923 DP* Extended-release composition comprising a somatostatin derivative in microparticles Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 13, 2017 | May 23, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 29, 2025 | ODE-268: Indicated for treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative |
GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206073 Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 12, 2023 | U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 12, 2023 | U-1653: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without metformin) U-1654: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without insulin or a sulfonylurea) |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Feb 19, 2015 | May 26, 2026 *PED | |
| Pat. No. 9173859 DP* DLR* Uses of DPP IV inhibitors Claim Types: Method of use; Method of administration; Formulation Pat. Sub. Date(s): All strengths: Dec 2, 2015 | May 4, 2027 | U-1772: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Oct 15, 2027 *PED | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Nov 4, 2027 *PED | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 11033552 DP* DPP IV inhibitor formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2021 | Nov 4, 2027 *PED | |
| Pat. No. 7579449 DS* [Extended 1000 days (2.7 years)] Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Claim Types: Compound Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Feb 1, 2029 *PED | |
| Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Claim Types: Composition; Method of use; Formulation; Method of administration Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Apr 14, 2030 *PED | U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 15, 2018 | Jun 11, 2034 | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: Apr 30, 2019 | Oct 3, 2034 *PED | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Pat. No. 11090323 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2021 | Oct 3, 2034 *PED | U-3191: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (30 ml/min/1.73 m2<=egfr<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201281 Prod. No.: 001 RX (2.5MG;500MG); 002 RX (2.5MG;850MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 15, 2012; 002: None | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 8, 2012 | Aug 12, 2023 | U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 22, 2012 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Dec 9, 2014 | May 26, 2026 *PED | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Nov 4, 2027 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2016 | Oct 2, 2029 *PED | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2018 | Oct 2, 2029 *PED | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 10973827 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 5, 2021 | Oct 2, 2029 *PED | |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Oct 21, 2015 | Nov 21, 2030 *PED | |
| Pat. No. 8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2014 | Dec 4, 2030 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
| Exclusivity Code: M - Miscellaneous | Dec 20, 2026 PED | M-295: Revisions to the pediatric use subsection of labeling to include the results from clinical study 1218-0091, conducted to fulfill a pediatric written request |
JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201281 Prod. No.: 003 RX (2.5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 003: None | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jun 8, 2012 | Aug 12, 2023 | U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 22, 2012 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): 003: Dec 9, 2014 | May 26, 2026 *PED | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 15, 2014 | Nov 4, 2027 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 30, 2016 | Oct 2, 2029 *PED | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 6, 2018 | Oct 2, 2029 *PED | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 10973827 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): 003: May 5, 2021 | Oct 2, 2029 *PED | |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): 003: Oct 21, 2015 | Nov 21, 2030 *PED | |
| Pat. No. 8846695 DLR* Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 21, 2014 | Dec 4, 2030 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
| Exclusivity Code: M - Miscellaneous | Dec 20, 2026 PED | M-295: Revisions to the pediatric use subsection of labeling to include the results from clinical study 1218-0091, conducted to fulfill a pediatric written request |
JENTADUETO XR (TABLET, EXTENDED RELEASE) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 208026 Prod. No.: 001 RX (2.5MG;1GM); 002 RX (5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Aug 12, 2023 | U-1853: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and, optionally, a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Jun 22, 2016 | May 26, 2026 *PED | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 4, 2027 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9173859 DP* DLR* Uses of DPP IV inhibitors Claim Types: Method of use; Method of administration; Formulation Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 4, 2027 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2016 | Oct 2, 2029 *PED | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2018 | Oct 2, 2029 *PED | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 21, 2030 *PED | |
| Pat. No. 9555001 DP* Pharmaceutical composition and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 22, 2017 | Sep 6, 2033 *PED | U-1967: Method of treating Type 2 diabetes in patients with insufficient glycemic control despite therapy with one or more conventional antihyperglycemic agents by administering linagliptin in combination with metformin U-1968: Method of treating Type 2 diabetes in patients who have not been previously treated with an antihyperglycemic agent by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
| Exclusivity Code: M - Miscellaneous | Dec 20, 2026 PED | M-295: Revisions to the pediatric use subsection of labeling to include the results from clinical study 1218-0091, conducted to fulfill a pediatric written request |
TRADJENTA (TABLET) (ORAL) LINAGLIPTIN [GENERIC AB]
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201280 Prod. No.: 001 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 20, 2012 | Aug 12, 2023 | U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone) U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 8, 2012 | Aug 12, 2023 | U-1244: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with sulfonylurea U-1245: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with pioglitazone U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone) U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 31, 2011 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): 001: Dec 9, 2014 | May 26, 2026 *PED | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2014 | Nov 4, 2027 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 11033552 DP* DPP IV inhibitor formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2021 | Nov 4, 2027 *PED | |
| Pat. No. 9486526 Treatment for diabetes in patients inappropriate for metformin therapy Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Nov 18, 2016 | Feb 5, 2030 *PED | U-1915: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and who are ineligible for metformin therapy by administering linagliptin |
| Pat. No. 10034877 Treatment for diabetes in patients inappropriate for metformin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 10, 2018 | Feb 5, 2030 *PED | U-2347: Treatment of Type 2 diabetes mellitus in a patient with renal impairment and for whom metformin therapy is inappropriate by administering linagliptin without dose adjustment |
| Pat. No. 8846695 DLR* Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2014 | Dec 4, 2030 *PED | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 8853156 DP* Treatment for diabetes in patients inappropriate for metformin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2015 | Sep 5, 2031 *PED | U-1642: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and for whom metformin therapy is inappropriate by administering linagliptin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
| Exclusivity Code: M - Miscellaneous | Dec 20, 2026 PED | M-295: Revisions to the pediatric use subsection of labeling to include the results from clinical study 1218-0091, conducted to fulfill a pediatric written request |
TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 212614 Prod. No.: 001 RX (5MG;2.5MG;1GM); 002 RX (10MG;5MG;1GM); 003 RX (12.5MG;2.5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Aug 12, 2023 | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Aug 12, 2023 | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Feb 18, 2020 | May 26, 2026 *PED | |
| Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Oct 15, 2027 *PED | |
| Pat. No. 7579449 DS* [Extended 1000 days (2.7 years)] Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Claim Types: Compound Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Feb 1, 2029 *PED | |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Apr 2, 2029 | |
| Pat. No. 10022379 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Apr 2, 2029 | U-2732: Method of treating Type 2 diabetes using a pharmaceutical composition comprising linagliptin, metformin, empagliflozin and a basic amino acid |
| Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Claim Types: Composition; Method of use; Formulation; Method of administration Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Apr 14, 2030 *PED | U-2730: Method of treating Type 2 diabetes mellitus using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Feb 18, 2020 | May 21, 2030 | |
| Pat. No. 10406172 DP* Pharmaceutical composition, methods for treating and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Jun 15, 2030 | U-2733: Method of treating a Type 2 diabetes mellitus patient with insufficient glycemic control despite therapy with metformin using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin |
| Pat. No. 10596120 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 21, 2020 | Mar 7, 2032 | U-2776: Treatment of a Type 2 diabetes mellitus patient with insufficient glycemic control despite metformin therapy using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin U-2790: Treatment of a treatment-naive patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin |
| Pat. No. 11564886 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 1, 2023 | Mar 7, 2032 | U-3531: Treatment of a type 2 diabetes patient with insufficient glycemic control despite metformin therapy using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin |
| Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Oct 3, 2034 *PED | U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin |
| Pat. No. 11090323 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2021 | Oct 3, 2034 *PED | U-3192: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin, linagliptin and metformin hcl if EGFR>=45 ml/min/1.73 m2 and discontinuation if EGFR <30 ml/min/1.73 m2 |
| Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Dec 11, 2034 *PED | U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin |
TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 212614 Prod. No.: 004 RX (25MG;5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Aug 12, 2023 | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Aug 12, 2023 | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): 004: Feb 18, 2020 | Nov 2, 2025 *PED | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): 004: Feb 18, 2020 | May 26, 2026 *PED | |
| Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 004: Feb 18, 2020 | Oct 15, 2027 *PED | |
| Pat. No. 7579449 DS* [Extended 1000 days (2.7 years)] Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Claim Types: Compound Pat. Sub. Date(s): 004: Feb 18, 2020 | Feb 1, 2029 *PED | |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): 004: Feb 18, 2020 | Apr 2, 2029 | |
| Pat. No. 10022379 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Apr 2, 2029 | U-2732: Method of treating Type 2 diabetes using a pharmaceutical composition comprising linagliptin, metformin, empagliflozin and a basic amino acid |
| Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Claim Types: Composition; Method of use; Formulation; Method of administration Pat. Sub. Date(s): 004: Feb 18, 2020 | Apr 14, 2030 *PED | U-2730: Method of treating Type 2 diabetes mellitus using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): 004: Feb 18, 2020 | May 21, 2030 | |
| Pat. No. 10406172 DP* Pharmaceutical composition, methods for treating and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Jun 15, 2030 | U-2733: Method of treating a Type 2 diabetes mellitus patient with insufficient glycemic control despite therapy with metformin using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin |
| Pat. No. 10596120 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Apr 21, 2020 | Mar 7, 2032 | U-2776: Treatment of a Type 2 diabetes mellitus patient with insufficient glycemic control despite metformin therapy using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin U-2790: Treatment of a treatment-naive patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin |
| Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Oct 3, 2034 *PED | U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin |
| Pat. No. 11090323 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Aug 20, 2021 | Oct 3, 2034 *PED | U-3192: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin, linagliptin and metformin hcl if EGFR>=45 ml/min/1.73 m2 and discontinuation if EGFR <30 ml/min/1.73 m2 |
| Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Feb 18, 2020 | Dec 11, 2034 *PED | U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin |
ZERIT XR (CAPSULE, EXTENDED RELEASE) (ORAL) STAVUDINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 021453 Prod. No.: 001 DISC (37.5MG); 002 DISC (50MG); 003 DISC (75MG); 004 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7135465 DP* Sustained release beadlets containing stavudine Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Aug 18, 2023 *PED | U-167: Method for treating HIV-1 infection |
CUVPOSA (SOLUTION) (ORAL) GLYCOPYRROLATE [GENERIC AA]
Drug Classes: anticholinergic == antimuscarinic agent
NDA Applicant: MERZ PHARMS NDA No.: 022571 Prod. No.: 001 RX (1MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638552 Method for increasing the bioavailability of glycopyrrolate Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Aug 20, 2023 | U-1076: Reduce chronic severe drooling (i.e., sialorrhea) in patients with neurologic conditions associated with problem drooling |
| Pat. No. 7816396 Method for increasing the bioavailability of glycopyrrolate Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 20, 2023 | U-1076: Reduce chronic severe drooling (i.e., sialorrhea) in patients with neurologic conditions associated with problem drooling |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 001 RX (30MG); 002 RX (50MG); 003 RX (70MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 3, 2012; 002: None; 003: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 3, 2012; 002: None; 003: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 004 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 004: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 004: Mar 6, 2012 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 005 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 005: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 006 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 007 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 007: Sep 22, 2015 | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
VYVANSE (TABLET, CHEWABLE) (ORAL) LISDEXAMFETAMINE DIMESYLATE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208510 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG); 004 RX (40MG); 005 RX (50MG); 006 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2017 | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
QUTENZA (PATCH) (TOPICAL) CAPSAICIN
NDA Applicant: AVERITAS NDA No.: 022395 Prod. No.: 001 RX (8%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263059 Compositions and kits for the removal of irritating compounds from bodily surfaces Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2020 | Sep 5, 2023 | U-2705: Method of using capsaicin in combination with a gel composition for removal of capsaicin from a treatment area or unintended area |
| Pat. No. 8889113 Compositions and kits for the removal of irritating compounds from bodily surfaces Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2020 | Sep 5, 2023 | U-2705: Method of using capsaicin in combination with a gel composition for removal of capsaicin from a treatment area or unintended area |
| Pat. No. 10463598 DP* Compositions and kits for the removal of irritating compounds from bodily surfaces Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 8, 2020 | Sep 5, 2023 | |
| Pat. No. 10869827 DP* Compositions and kits for the removal of irritating compounds from bodily surfaces Claim Types: Kit Pat. Sub. Date(s): 001: Nov 8, 2021 | Sep 5, 2023 | |
| Pat. No. 10034841 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer Claim Types: Device Pat. Sub. Date(s): 001: Jan 8, 2020 | Sep 6, 2025 | |
| Pat. No. 9226903 DP* Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 8, 2020 | Dec 15, 2028 | |
| Pat. No. 8821920 DP* Therapeutic patch for transdermal delivery of capsaicin Claim Types: Device; Method of use; Process Pat. Sub. Date(s): 001: Jan 8, 2020 | Mar 26, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 17, 2023 | I-838: Treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet |
SPINRAZA (SOLUTION) (INTRATHECAL) NUSINERSEN SODIUM
Drug Classes: survival motor neuron-2 (SMN2)-directed antisense oligonucleotide
NDA Applicant: BIOGEN IDEC NDA No.: 209531 Prod. No.: 001 RX (EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Jan 23, 2017 | Sep 5, 2023 | |
| Pat. No. 8110560 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2017 | Dec 5, 2025 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site |
| Pat. No. 10266822 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences Claim Types: Method of use; Method of initiating or enhancing a biochemical function in vivo Pat. Sub. Date(s): 001: Jul 24, 2019 | Dec 5, 2025 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site |
| Pat. No. 7838657 DS* Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences Claim Types: Compound Pat. Sub. Date(s): 001: Jan 23, 2017 | Jul 11, 2027 | |
| Pat. No. 8361977 DS* DP* Compositions and methods for modulation of SMN2 splicing Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 23, 2017 | May 27, 2030 | |
| Pat. No. 9717750 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 31, 2017 | Jun 17, 2030 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-2093: Treatment of type ii spinal muscular atrophy U-2094: Treatment of type iii spinal muscular atrophy |
| Pat. No. 8980853 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2017 | Nov 24, 2030 | U-1941: Treatment of infantile-onset spinal muscular atrophy |
| Pat. No. 9926559 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 24, 2018 | Jan 9, 2034 | U-1943: Treatment of spinal muscular atrophy |
| Pat. No. 10436802 Methods for treating spinal muscular atrophy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2019 | Sep 11, 2035 | U-1941: Treatment of infantile-onset spinal muscular atrophy U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site U-2093: Treatment of type ii spinal muscular atrophy U-2094: Treatment of type iii spinal muscular atrophy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 23, 2023 | ODE-127: Treatment of spinal muscular atrophy in pediatric and adult patients |
TRI-LUMA (CREAM) (TOPICAL) FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes: melanin synthesis inhibitor == retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021112 Prod. No.: 001 RX (0.01%;4%;0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7915243 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2011 | Sep 8, 2023 | |
| Pat. No. 7939516 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 17, 2011 | Sep 8, 2023 |
TYZEKA (TABLET) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: NOVARTIS NDA No.: 022011 Prod. No.: 001 DISC (600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7589079 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2023 | U-999: Treatment of chronic hepatitis B in adult patients |
| Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2023 | U-999: Treatment of chronic hepatitis B in adult patients |
TYZEKA (SOLUTION) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: NOVARTIS NDA No.: 022154 Prod. No.: 001 DISC (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2023 | U-999: Treatment of chronic hepatitis B in adult patients |
VIBATIV (POWDER) (INTRAVENOUS) TELAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: CUMBERLAND NDA No.: 022110 Prod. No.: 002 RX (EQ 750MG BASE/VIAL) NDA No.: 022110 Prod. No.: 001 DISC (EQ 250MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6635618 DS* DP* [Extended 719 days (2 years)] Glycopeptide phosphonate derivatives Claim Types: Compound; Composition; Process; Method of use Pat. Sub. Date(s): All strengths: None | Sep 11, 2023 | U-728: Method for treating bacterial infection |
| Pat. No. 7531623 DS* Hydrochloride salts of a glycopeptide phosphonate derivative Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: None | Jan 1, 2027 |
PROAIR HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [GENERIC AB2]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 021457 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105152 DP* Suspension aerosol formulations Claim Types: Formulation; Device Pat. Sub. Date(s): 001: None | Sep 12, 2023 | |
| Pat. No. 8132712 DP* Metered-dose inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Mar 27, 2012 | Sep 7, 2028 | |
| Pat. No. 9463289 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Nov 8, 2016 | May 18, 2031 | |
| Pat. No. 9808587 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Device Pat. Sub. Date(s): 001: Nov 16, 2017 | May 18, 2031 | |
| Pat. No. 10022509 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Aug 14, 2018 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 14, 2018 | May 18, 2031 | |
| Pat. No. 10086156 DP* Dose counter for inhaler and method for counting doses Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Oct 17, 2018 | May 18, 2031 | |
| Pat. No. 10695512 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Device Pat. Sub. Date(s): 001: Jul 30, 2020 | May 18, 2031 | |
| Pat. No. 11395889 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Aug 19, 2022 | May 18, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jan 1, 2032 |
ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022024 Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None | Sep 19, 2023 | |
| Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Sep 19, 2023 | |
| Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015 | Sep 19, 2023 | |
| Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 31, 2026 | |
| Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None | Jul 31, 2026 |
LAMICTAL XR (TABLET, EXTENDED RELEASE) (ORAL) LAMOTRIGINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED) == mood stabilizer
NDA Applicant: GLAXOSMITHKLINE LLC NDA No.: 022115 Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG); 004 RX (200MG); 005 RX (300MG); 006 RX (250MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9144547 DP* Oral dosage form for controlled drug release Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Oct 29, 2015 | Sep 22, 2023 | |
| Pat. No. 8637512 DP* Formulations and method of treatment Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 12, 2014 | Jun 14, 2028 |
NUZYRA (TABLET) (ORAL) OMADACYCLINE TOSYLATE
Drug Classes: tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC NDA No.: 209816 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 24, 2023 | |
| Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Jun 2, 2024 | |
| Pat. No. 9265740 Minocycline compounds and methods of use thereof Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 9724358 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 10124014 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2018 | Mar 5, 2029 | U-2449: Treatment of bacterial skin and skin structure infection |
| Pat. No. 8383610 DS* Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 23, 2030 | |
| Pat. No. 9314475 DP* Oral and injectable formulations of tetracycline compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 18, 2031 | |
| Pat. No. 10111890 9-aminomethyl minocycline compounds and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Aug 3, 2037 | U-2444: Treatment of subjects having bacterial skin or skin structure infection |
| Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2019 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Pat. No. 10835542 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2020 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 2, 2028 GAIN |
NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
Drug Classes: tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC NDA No.: 209817 Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 24, 2023 | |
| Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Jun 2, 2024 | |
| Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | |
| Pat. No. 9724358 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 10124014 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2018 | Mar 5, 2029 | U-2449: Treatment of bacterial skin and skin structure infection |
| Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2019 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Pat. No. 10835542 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2020 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 2, 2028 GAIN |
LEVOXYL (TABLET) (ORAL) LEVOTHYROXINE SODIUM [Has competitive generic]
Drug Classes: L-thyroxine (T4)
NDA Applicant: KING PHARMS NDA No.: 021301 Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium) NDA No.: 021301 Prod. No.: 012 DISC (0.3MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101569 Methods of administering levothyroxine pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 2, 2023 | U-759: Method of use of administering levothyroxine |
REBETOL (SOLUTION) (ORAL) RIBAVIRIN
Drug Classes: nucleoside analog antiviral
NDA Applicant: SCHERING NDA No.: 021546 Prod. No.: 001 DISC (40MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6790837 DP* Ribavirin syrup formulations Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 5, 2023 *PED |
ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR NDA No.: 021379 Prod. No.: 001 RX (22.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
| Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Claim Types: Device Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 22, 2041 |
ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR NDA No.: 021488 Prod. No.: 001 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
| Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Claim Types: Device Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 22, 2041 |
ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR NDA No.: 021731 Prod. No.: 001 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
| Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Claim Types: Device Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 22, 2041 |
FENSOLVI KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR NDA No.: 213150 Prod. No.: 001 RX (45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 28, 2020 | Oct 15, 2023 | U-2940: Method of treating pediatric patients 2 years of age and older with central precocious puberty |
| Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Claim Types: Device Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 22, 2041 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 1, 2023 | I-829: Treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP) |
VOTRIENT (TABLET) (ORAL) PAZOPANIB HYDROCHLORIDE [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 022465 Prod. No.: 001 RX (EQ 200MG BASE) NDA No.: 022465 Prod. No.: 002 DISC (EQ 400MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7105530 DS* DP* [Extended 669 days (1.8 years)] Pyrimidineamines as angiogenesis modulators Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Oct 19, 2023 |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 18, 2016 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 27, 2022 | Oct 20, 2023 | U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose |
| Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 24, 2023 | Oct 20, 2023 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 5, 2024 | |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 17, 2014 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 15, 2028 | U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Feb 2, 2021 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Apr 27, 2022 | Oct 20, 2023 | U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose |
| Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 24, 2023 | Oct 20, 2023 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 5, 2024 | |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Feb 2, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 003: May 21, 2021 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Apr 27, 2022 | Oct 20, 2023 | U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose |
| Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 24, 2023 | Oct 20, 2023 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 003: May 21, 2021 | Feb 5, 2024 | |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: May 21, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: May 21, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 | |
| Exclusivity Code: NS - New strength | Apr 28, 2024 |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 004 RX (100MG IRON/2ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 004: Mar 4, 2022 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 004: Mar 4, 2022 | Oct 20, 2023 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 004: Apr 27, 2022 | Oct 20, 2023 | U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose |
| Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Formulation; Method of use Pat. Sub. Date(s): 004: Mar 24, 2023 | Oct 20, 2023 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 004: Mar 4, 2022 | Feb 5, 2024 | |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 004: Mar 4, 2022 | Jan 8, 2027 | U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min |
| Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Jun 28, 2023 | Jan 8, 2027 | U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 4, 2022 | Jan 8, 2027 | U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes |
| Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Nov 21, 2022 | Jan 8, 2027 | U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Mar 4, 2022 | Feb 15, 2028 | U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity |
FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: LEO PHARMA AS NDA No.: 207071 Prod. No.: 001 RX (15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8722021 DP* Foamable carriers Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 26, 2015 | Oct 24, 2023 | |
| Pat. No. 8900554 DP* Foamable composition and uses thereof Claim Types: Composition Pat. Sub. Date(s): 001: Aug 26, 2015 | Oct 24, 2023 | |
| Pat. No. 10322085 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 21, 2019 | Oct 24, 2023 | |
| Pat. No. 8435498 Penetrating pharmaceutical foam Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 26, 2015 | Mar 1, 2024 | U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
| Pat. No. 7700076 DP* Penetrating pharmaceutical foam Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 26, 2015 | Sep 18, 2027 | |
| Pat. No. 10117812 DP* Foamable composition combining a polar solvent and a hydrophobic carrier Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2018 | Oct 18, 2027 | U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
| Pat. No. 9265725 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2016 | Dec 8, 2027 | |
| Pat. No. 9211259 Antibiotic kit and composition and uses thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 14, 2016 | Feb 28, 2029 | U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC NDA No.: 209022 Prod. No.: 001 RX (0.093MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8327844 Nasal delivery method Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2017 | Oct 24, 2023 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 8522778 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: None | Apr 20, 2024 | |
| Pat. No. 7975690 Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2017 | Dec 29, 2025 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 6, 2018 | Mar 6, 2027 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 11602603 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 5, 2023 | Oct 27, 2028 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Oct 22, 2029 | |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Dec 6, 2030 | |
| Pat. No. 10252010 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: May 8, 2019 | Feb 7, 2031 | |
| Pat. No. 11033696 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Jul 6, 2021 | May 20, 2033 | |
| Pat. No. 10179216 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Feb 8, 2019 | Jul 8, 2033 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10478574 Nasal administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 10, 2019 | Nov 4, 2033 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 | |
| Pat. No. 10300229 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 18, 2019 | Jul 7, 2035 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 11554229 Nasal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2023 | Feb 23, 2036 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
RECLAST (INJECTABLE) (INTRAVENOUS) ZOLEDRONIC ACID [GENERIC AP]
NDA Applicant: SANDOZ NDA No.: 021817 Prod. No.: 001 RX (EQ 5MG BASE/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8052987 Method of administering bisphosphonates Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 27, 2023 | U-1199: Treatment and prevention of postmenopausal or glucocorticoid-induced osteoporosis and treatment to increase bone mass in men with osteoporosis |
| Pat. No. 7932241 DP* Pharmaceutical products comprising bisphosphonates Claim Types: Drug in a container Pat. Sub. Date(s): 001: May 25, 2011 | Aug 5, 2028 *PED |
RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA NDA No.: 021745 Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None | Oct 27, 2023 |
ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 210922 Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9943538 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 4, 2023 | |
| Pat. No. 9943539 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 4, 2023 | |
| Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | May 27, 2025 | |
| Pat. No. 8642076 DP* Lipid containing formulations Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 3, 2027 | |
| Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8492359 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11141378 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2021 | Apr 15, 2029 | |
| Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Compound; Composition; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8741866 Compositions and methods for inhibiting expression of transthyretin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 10240152 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation claimed by its inherent performace characteristics; Method of Use claimed by its inherent performace characteristics; Composition Pat. Sub. Date(s): 001: Sep 3, 2021 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8802644 DP* Lipid formulation Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 21, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8158601 DP* Lipid formulation Claim Types: Compound; Composition; Formulation; Method of administration Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 10, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11079379 DS* DP* Methods of treating transthyretin (TTR) mediated amyloidosis Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2021 | Aug 27, 2035 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL NDA No.: 020835 Prod. No.: 005 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7192938 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None | Nov 6, 2023 *PED | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 7718634 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None | Nov 6, 2023 *PED | U-662: Treatment of osteoporosis in postmenopausal women |
AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 004: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Aug 25, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 004: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 004: Nov 10, 2022 | Jun 19, 2040 | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Aug 25, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): All strengths: Nov 10, 2022 | Jun 19, 2040 | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 | Aug 22, 2041 *PED |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Jul 3, 2018 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Mar 5, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 5, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 004 RX (0.055MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Aug 25, 2032 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 004: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 004: Nov 10, 2022 | Dec 19, 2040 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 25, 2032 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): All strengths: Nov 10, 2022 | Dec 19, 2040 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 | Aug 22, 2041 *PED |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 008 DISC (0.03MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 008: May 5, 2022 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | May 8, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 008: May 5, 2022 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Jul 13, 2032 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Feb 28, 2036 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Jun 14, 2036 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Feb 16, 2037 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 008: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 008: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 008: May 5, 2022 | Jun 18, 2039 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 008: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 008: Nov 10, 2022 | Dec 19, 2040 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Aug 22, 2041 *PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 001 DISC (0.055MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Mar 5, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 5, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Aug 25, 2032 *PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 007 DISC (0.03MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 6, 2023 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Mar 1, 2025 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 19, 2025 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 19, 2025 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Sep 26, 2028 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Aug 14, 2031 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Dec 28, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 007: Aug 5, 2021 | Jul 1, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Jul 13, 2032 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Aug 25, 2032 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Jan 9, 2025 PED |
LONHALA MAGNAIR KIT (SOLUTION) (INHALATION) GLYCOPYRROLATE
Drug Classes: anticholinergic == antimuscarinic agent
NDA Applicant: SUMITOMO PHARMA AM NDA No.: 208437 Prod. No.: 001 DISC (25MCG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8511581 DP* Fluid droplet production apparatus and method Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 8, 2023 | |
| Pat. No. 7458372 DP* Inhalation therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 18, 2024 | |
| Pat. No. 7931212 DP* Fluid droplet production apparatus and method Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 25, 2025 | |
| Pat. No. 11278683 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Aug 16, 2026 | |
| Pat. No. 9265900 DP* Disposable ampoule for an aerosol generating device Claim Types: Drug in a container; Product-by-process; Method of use Pat. Sub. Date(s): 001: Jan 2, 2018 | Dec 7, 2028 | |
| Pat. No. 10940110 DP* Method and system for the treatment of chronic COPD with nebulized anticholinergic administrations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2021 | Feb 26, 2029 | U-1773: Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9789270 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Oct 30, 2030 | |
| Pat. No. 9168556 DP* Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 2, 2018 | Sep 1, 2032 | |
| Pat. No. 9604018 DP* Aerosol therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | May 16, 2033 | |
| Pat. No. 10376661 DP* Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Sep 5, 2019 | Sep 14, 2035 | |
| Pat. No. 10688518 DP* Method of manufacturing a vibratable head for an aerosol generator and vibratable head for an aerosol generator Claim Types: Part of a dosage form; Device; Process Pat. Sub. Date(s): 001: Jun 30, 2020 | Nov 12, 2036 | |
| Pat. No. 10744277 DP* Aerosol delivery device and method of operating the aerosol delivery device Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 1, 2020 | Dec 7, 2036 | U-2941: A method of using an aerosol delivery device to aerosolize glycopyrrolate for the treatment of chronic obstructive pulmonary disease (COPD) |
XEPI (CREAM) (TOPICAL) OZENOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: FERRER INTERNACIONAL NDA No.: 208945 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6335447 DS* [Extended 1678 days (4.6 years)] Quinolonecarboxylic acid derivatives or salts thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 19, 2018 | Nov 9, 2023 | |
| Pat. No. 9399014 Pharmaceutical topical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Dec 15, 2029 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Pat. No. 9180200 DP* Pharmaceutical topical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Jan 29, 2032 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 11, 2022 |
STIOLTO RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206756 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7491719 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments Claim Types: Compound; New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jun 10, 2015 | Nov 10, 2023 | |
| Pat. No. 7786111 DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jun 10, 2015 | Nov 10, 2023 | |
| Pat. No. 8044046 Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2015 | Nov 10, 2023 | U-1702: Treatment of copd |
| Pat. No. 7056916 DS* DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jun 10, 2015 | Dec 7, 2023 | |
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2015 | Feb 26, 2025 *PED | |
| Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 10, 2015 | May 12, 2025 | U-1703: Treatment of respiratory complaints |
| Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2015 | May 12, 2025 | U-1702: Treatment of copd |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Jun 10, 2015 | May 26, 2025 | |
| Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 10, 2015 | Jan 19, 2027 | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Jun 10, 2015 | Mar 31, 2027 | |
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 10, 2015 | Apr 10, 2027 *PED | |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2015 | Sep 13, 2028 *PED | |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 10, 2015 | Oct 16, 2030 |
STRIVERDI RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 203108 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7491719 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments Claim Types: Compound; New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 15, 2014 | Nov 10, 2023 | |
| Pat. No. 7786111 DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Aug 15, 2014 | Nov 10, 2023 | |
| Pat. No. 8044046 Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2014 | Nov 10, 2023 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 7056916 DS* DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 15, 2014 | Dec 7, 2023 | |
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Aug 15, 2014 | Aug 26, 2024 | |
| Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 15, 2014 | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2014 | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Aug 15, 2014 | May 26, 2025 | |
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 15, 2014 | Oct 10, 2026 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 15, 2014 | Jan 19, 2027 | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 3, 2015 | Mar 31, 2027 | |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Aug 15, 2014 | Mar 13, 2028 | |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 3, 2015 | Oct 16, 2030 |
KYLEENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: BAYER HLTHCARE NDA No.: 208224 Prod. No.: 001 RX (19.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7252839 DP* Delivery system and a manufacturing process of a delivery system Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 11, 2016 | Nov 13, 2023 | |
| Pat. No. 11628088 DP* Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Claim Types: Device; Process; Diagnostic or surgical method Pat. Sub. Date(s): 001: Aug 24, 2023 | Feb 7, 2027 | |
| Pat. No. 9615965 DP* Inserter Claim Types: Device; Kit; Diagnostic or surgical method Pat. Sub. Date(s): 001: May 9, 2017 | Sep 16, 2029 | U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system |
| Pat. No. 10561524 Inserter Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 28, 2020 | Sep 16, 2029 | U-2948: A method of positioning an intrauterine system (IUS) by determining a depth of the uterus, holding an inserter handle with one hand, inserting the IUS into the uterus, and retracting a slider on the handle to release the IUS into the uterus |
| Pat. No. 9668912 DP* Inserter Claim Types: Device Pat. Sub. Date(s): 001: Jun 28, 2017 | Apr 1, 2031 | |
| Pat. No. 10987244 DP* Inserter Claim Types: Device Pat. Sub. Date(s): 001: May 25, 2021 | Apr 1, 2031 |
SKYLA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: BAYER HLTHCARE NDA No.: 203159 Prod. No.: 001 RX (13.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7252839 DP* Delivery system and a manufacturing process of a delivery system Claim Types: Device; Process Pat. Sub. Date(s): 001: Feb 5, 2013 | Nov 13, 2023 | |
| Pat. No. 11628088 DP* Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Claim Types: Device; Process; Diagnostic or surgical method Pat. Sub. Date(s): 001: Aug 24, 2023 | Feb 7, 2027 | |
| Pat. No. 9615965 DP* Inserter Claim Types: Device; Kit; Diagnostic or surgical method Pat. Sub. Date(s): 001: May 9, 2017 | Sep 16, 2029 | U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system |
| Pat. No. 10561524 Inserter Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 28, 2020 | Sep 16, 2029 | U-2948: A method of positioning an intrauterine system (IUS) by determining a depth of the uterus, holding an inserter handle with one hand, inserting the IUS into the uterus, and retracting a slider on the handle to release the IUS into the uterus |
| Pat. No. 9668912 DP* Inserter Claim Types: Device Pat. Sub. Date(s): 001: Jun 28, 2017 | Apr 1, 2031 | |
| Pat. No. 10987244 DP* Inserter Claim Types: Device Pat. Sub. Date(s): 001: May 25, 2021 | Apr 1, 2031 |
AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: muscle relaxant
NDA Applicant: TEVA PHARMS INTL NDA No.: 021777 Prod. No.: 001 RX (15MG); 002 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7544372 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | U-979: Relief of muscle spasm |
| Pat. No. 7790199 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | |
| Pat. No. 7820203 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | |
| Pat. No. 7829121 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | U-1088: Relief of muscle spasm |
| Pat. No. 8877245 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 1, 2018 | Nov 14, 2023 | U-979: Relief of muscle spasm |
| Pat. No. 9375410 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 12, 2016 | Nov 14, 2023 | U-1088: Relief of muscle spasm |
| Pat. No. 9399025 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2016 | Nov 14, 2023 | U-979: Relief of muscle spasm |
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: ABBVIE NDA No.: 021883 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin. |
| Pat. No. 6900175 [Extended 1611 days (4.4 years)] Methods of administering dalbavancin for treatment of bacterial infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | May 23, 2028 | U-3499: Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients using a two-dose regimen of dalbavancin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 23, 2024 GAIN | |
| Exclusivity Code: NPP - New patient population | Jul 22, 2024 |
POMALYST (CAPSULE) (ORAL) POMALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: BRISTOL NDA No.: 204026 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (3MG); 004 RX (4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8673939 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 9, 2014 | Nov 15, 2023 *PED | U-1360: Use of pomalidomide for the treatment of multiple myeloma U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy |
| Pat. No. 8735428 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Nov 15, 2023 *PED | U-1360: Use of pomalidomide for the treatment of multiple myeloma U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy |
| Pat. No. 8198262 [Extended 241 days (0.7 years)] Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 15, 2018; 002: None; 003: Mar 15, 2018; 004: Mar 15, 2018 | Dec 17, 2025 *PED | U-1360: Use of pomalidomide for the treatment of multiple myeloma U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy |
| Pat. No. 9993467 DP* Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 11, 2018 | Nov 19, 2030 *PED | |
| Pat. No. 10555939 DP* Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 21, 2020 | Nov 19, 2030 *PED | |
| Pat. No. 8828427 DS* DP* Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 29, 2014 | Dec 21, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | May 20, 2024 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 14, 2027 PED | ODE-296: Indicated for the treatment of adult patients with AIDS-related Kaposi Sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 14, 2027 PED | ODE-297: For the treatment of Kaposi Sarcoma (KS) in adult patients who are HIV-negative |
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7166722 DS* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Nov 16, 2023 | |
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Apr 26, 2024 | U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor |
| Pat. No. 11504365 Use of tivozanib to treat subjects with refractory cancer Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Dec 1, 2022 | Nov 5, 2039 | U-3476: Treatment of adults with moderate hepatic impairment and relapsed or refractory advanced renal cell carcinoma following two or more prior systemic anti-cancer therapies with 1mg tivozanib HCl orally for 21 days followed by no drug for 7 days |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2026 |
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 200533 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8420056 DP* Abuse-proofed dosage form Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None | Oct 10, 2024 | |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None | Jun 27, 2025 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 11344512 Titration of tapentadol Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Apr 21, 2028 | U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Sep 22, 2028 | U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
RUBRACA (TABLET) (ORAL) RUCAPARIB CAMSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ZR PHARMA NDA No.: 209115 Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6495541 DS* DP* [Extended 1412 days (3.9 years)] Tricyclic inhibitors of poly(ADP-ribose) polymerases Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Nov 22, 2023 | |
| Pat. No. 7351701 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 7531530 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8754072 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9045487 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9861638 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 6, 2018 | Feb 10, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 10278974 DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jun 4, 2019 | Feb 10, 2031 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 4, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 9987285 DP* High dosage strength tablets of rucaparib Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 28, 2018 | Aug 17, 2035 | |
| Pat. No. 10130636 High dosage strength tablets of rucaparib Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2018 | Aug 17, 2035 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 15, 2023 | I-830: Treatment of adult patients with a deleterious brca mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 6, 2025 | ODE-168: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy |
OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ZYLA NDA No.: 202080 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7510726 DP* Methods and compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 14, 2011 | Nov 26, 2023 | |
| Pat. No. 7981439 DP* Methods and compositions for deterring abuse of drugs susceptible to abuse and dosage forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 9, 2011; 002: None | Nov 26, 2023 | |
| Pat. No. 8409616 DP* Extended release opioid abuse deterrent compositions and methods of making same Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 26, 2023 | |
| Pat. No. 8637540 DP* Compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 20, 2014 | Nov 26, 2023 | |
| Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 18, 2016 | May 26, 2024 | |
| Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 14, 2011 | Mar 16, 2025 |
ZAVZPRET (SPRAY, METERED) (NASAL) ZAVEGEPANT HYDROCHLORIDE
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: PFIZER NDA No.: 216386 Prod. No.: 001 RX (EQ 10MG BASE/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7314883 Anti-migraine treatments Claim Types: Composition; Compound Pat. Sub. Date(s): 001: Apr 6, 2023 | Dec 5, 2023 | U-3555: Administration of zavegepant for acute treatment of migraine with or without aura |
| Pat. No. 7220862 DS* DP* Calcitonin gene related peptide receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Apr 6, 2023 | Jan 21, 2024 | |
| Pat. No. 8481546 DS* DP* CGRP receptor antagonist Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 6, 2023 | Oct 7, 2031 | U-3555: Administration of zavegepant for acute treatment of migraine with or without aura |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 9, 2028 |
XOPENEX HFA (AEROSOL, METERED) (INHALATION) LEVALBUTEROL TARTRATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: LUPIN NDA No.: 021730 Prod. No.: 001 RX (EQ 0.045MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8765153 DP* Levalbuterol salt Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2014 | Dec 8, 2023 | |
| Pat. No. 7256310 DS* DP* Levalbuterol salt Claim Types: Compound; Composition; Formulation; Device; Process; Method of use Pat. Sub. Date(s): 001: None | Oct 8, 2024 | U-636: Treatment or prevention of bronchospasm or asthmatic symptoms |
THALOMID (CAPSULE) (ORAL) THALIDOMIDE
NDA Applicant: BRISTOL-MYERS NDA No.: 020785 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7230012 DP* Pharmaceutical compositions and dosage forms of thalidomide Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Dec 9, 2023 |
PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE [GENERIC AB]
Drug Classes: direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 022512 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 110MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2018 | Dec 14, 2023 *PED | |
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 1, 2011; 002: None; 003: Dec 15, 2015 | Mar 7, 2026 *PED | |
| Pat. No. 7866474 DP* DLR* Film container Claim Types: Device Pat. Sub. Date(s): 001: Aug 1, 2011; 002: Aug 1, 2011; 003: Dec 15, 2015 | Mar 2, 2028 *PED | |
| Pat. No. 9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 9, 2015; 002: Nov 9, 2015; 003: Dec 15, 2015 | Jul 20, 2031 *PED | U-1759: Method of reversing the anticoagulant effect of dabigatran using idarucizumab |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 21, 2024 PED | I-862: Treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated |
PRADAXA (PELLETS) (ORAL) DABIGATRAN ETEXILATE MESYLATE
Drug Classes: direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 214358 Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 30MG BASE/PACKET); 003 RX (EQ 40MG BASE/PACKET); 004 RX (EQ 50MG BASE/PACKET); 005 RX (EQ 110MG BASE/PACKET); 006 RX (EQ 150MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Dec 14, 2023 *PED | |
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Mar 7, 2026 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 21, 2024 PED |
RAPIVAB (SOLUTION) (INTRAVENOUS) PERAMIVIR
Drug Classes: influenza neuraminidase inhibitor (NAI)
NDA Applicant: BIOCRYST NDA No.: 206426 Prod. No.: 001 RX (200MG/20ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562861 DS* [Extended 1825 days (5 years)] Substituted cyclopentane and cyclopentene compounds useful as neuraminidase inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 13, 2015 | Dec 16, 2023 | |
| Pat. No. 10391075 Antiviral treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2019 | Feb 12, 2027 | U-2622: Treatment of acute uncomplicated influenza in patients 2 years and older U-3069: Treatment of acute uncomplicated influenza in patients 6 months and older |
| Pat. No. 8778997 Antiviral treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 13, 2015 | May 7, 2027 | U-1627: Treatment of acute uncomplicated influenza in adults U-2622: Treatment of acute uncomplicated influenza in patients 2 years and older U-3069: Treatment of acute uncomplicated influenza in patients 6 months and older |
VYNDAQEL (CAPSULE) (ORAL) TAFAMIDIS MEGLUMINE
NDA Applicant: FOLDRX PHARMS NDA No.: 211996 Prod. No.: 001 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168663 DS* DP* Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: May 30, 2019 | Dec 19, 2023 | |
| Pat. No. 8653119 Methods for treating transthyretin amyloid diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2019 | Dec 19, 2023 | U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) |
| Pat. No. 7214695 DS* DP* Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 30, 2019 | Dec 19, 2024 | |
| Pat. No. 7214696 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2019 | Dec 19, 2024 | U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 3, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 3, 2026 | ODE-237: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization |
ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 021254 Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2012; 002: None; 003: None | Dec 19, 2023 *PED | |
| Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None | Aug 26, 2026 *PED |
FLOVENT HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD NDA No.: 021433 Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH); 003 RX (0.044MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2012; 002: None; 003: None | Dec 19, 2023 *PED | |
| Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None | Aug 26, 2026 *PED |
VENTOLIN HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [Has competitive generic]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020983 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 7, 2012 | Dec 19, 2023 *PED | |
| Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: None | Aug 26, 2026 *PED |
NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
NDA Applicant: ESPERION THERAPS INC NDA No.: 211616 Prod. No.: 001 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8497301 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9000041 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9624152 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2748: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10118881 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10941095 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021 | Dec 23, 2023 | U-2747: Use of NEXLETOL as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 7335799 DS* Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 3, 2025 | |
| Pat. No. 11613511 DS* Methods of making bempedoic acid and compositions of the same Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 20, 2023 | Jun 19, 2040 | |
| Pat. No. 11760714 DP* Methods of making bempedoic acid and compositions of the same Claim Types: Composition; New polymorph, salt or hydrate; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 3, 2023 | Jun 19, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 |
NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC NDA No.: 211617 Prod. No.: 001 RX (180MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8497301 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9000041 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 9624152 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2749: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10118881 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 10941095 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021 | Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat. No. 7335799 DS* Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 3, 2025 | |
| Pat. No. 10912751 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2021 | Mar 14, 2036 | U-3224: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using a fixed dose combination of 180 mg bempedoic acid and 10 mg ezetimibe |
| Pat. No. 11744816 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 3, 2023 | Mar 14, 2036 | U-3692: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using 180 mg bempedoic acid and 10 mg ezetimibe |
| Pat. No. 11613511 DS* Methods of making bempedoic acid and compositions of the same Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 20, 2023 | Jun 19, 2040 | |
| Pat. No. 11760714 DP* Methods of making bempedoic acid and compositions of the same Claim Types: Composition; New polymorph, salt or hydrate; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 3, 2023 | Jun 19, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 | |
| Exclusivity Code: NP - New product | Feb 26, 2023 |
ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 DISC (1MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 16, 2024 | |
| Pat. No. 11476952 DP* Pharma-informatics system Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Apr 28, 2026 | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 14, 2026 | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 8674825 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 9, 2029 | U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 8956288 DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 6, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| Pat. No. 8945005 DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Aug 19, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 15, 2029 | |
| Pat. No. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 5, 2029 | |
| Pat. No. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| Pat. No. 8847766 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 29, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 27, 2030 | |
| Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| Pat. No. 11464423 DP* In-body power source having high surface area electrode Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Sep 15, 2030 | |
| Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 17, 2030 | |
| Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 25, 2030 | |
| Pat. No. 8547248 DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 18, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 18, 2022 | Jul 11, 2031 | |
| Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2031 | |
| Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020 | Jun 13, 2032 | |
| Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Oct 15, 2033 | U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver |
COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: alpha adrenergic blocker == beta-adrenergic receptor inhibitor
NDA Applicant: WOODWARD NDA No.: 022012 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7268156 DS* DP* Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Dec 27, 2023 *PED | U-313: Treatment of congestive heart failure U-3: Treatment of hypertension |
| Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None | Mar 11, 2026 *PED |
CHLORAPREP ONE-STEP (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 006 OTC (2%;70% (26ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7182536 DP* Antiseptic applicator with mechanism for fracturing multiple ampoules Claim Types: Device Pat. Sub. Date(s): 006: None | Dec 30, 2023 | |
| Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules Claim Types: Device; Process Pat. Sub. Date(s): 006: None | Jan 31, 2024 |