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: Cardiovascular Agents:Alpha-adrenergic Agonists == Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines
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: Dermatological Agents:Dermatitis and Pruritus Agents
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: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories
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: Central Nervous System Agents:Fibromyalgia Agents
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
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
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: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents
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: Antineoplastics:Molecular Target Inhibitors
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
Drug Classes: Antineoplastics:Molecular Target Inhibitors
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 | May 24, 2036 |
NOURIANZ (TABLET) (ORAL) ISTRADEFYLLINE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other
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. 7727993 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, 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 | |
| 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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: MERCK SHARP DOHME 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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: MERCK SHARP DOHME 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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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: Antineoplastics:Molecular Target Inhibitors
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: Antineoplastics:Molecular Target Inhibitors
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: Antiparkinson Agents:Dopamine Agonists
NDA Applicant: SUNOVION PHARMS INC NDA No.: 210875 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (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: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Antineoplastics:Molecular Target Inhibitors
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: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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 |
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: INDIVIOR INC 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: Antispasticity Agents
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: Respiratory Tract/ Pulmonary Agents:Phosphodiesterase Inhibitors, Airways Disease
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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), 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: Antineoplastics:Alkylating Agents
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: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives
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: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists
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: Anti-Obesity Agents == Blood Glucose Regulators:Antidiabetic Agents
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: Anti-Obesity Agents == Blood Glucose Regulators:Antidiabetic Agents
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: Blood Products and Modifiers:Platelet Modifying Agents == Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
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: Antineoplastics:Antineoplastics, Other
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 wtih [sic, 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 wtih [sic, 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 wtih [sic, 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 wtih [sic, 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 wtih [sic, 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 wtih [sic, with] cutaneous T-cell lymphoma (CTCL) |
BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: ASCEND THERAPS US 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 |
PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Contraceptives:Contraceptives, Other
NDA Applicant: EVOFEM INC NDA No.: 208352 Prod. No.: 001 RX (1%;1.8%;0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6706276 DP* Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 6, 2023 | |
| Pat. No. 10568855 Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 15, 2033 | U-1: Prevention of pregnancy |
| Pat. No. 11337989 Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2022 | Mar 15, 2033 | U-1: Prevention of pregnancy |
| Pat. No. 11439610 DS* DP* Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 15, 2022 | Mar 15, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 22, 2023 |
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: Dermatological Agents:Acne and Rosacea Agents
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: Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives
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: Antineoplastics:Molecular Target Inhibitors
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
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210498 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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, 2023 | |
| 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. 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 |
| 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 |
| 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
Drug Classes: Dental and Oral Agents
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
Drug Classes: Dental and Oral Agents
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
Drug Classes: Dental and Oral Agents
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: Antiemetics:Emetogenic Therapy Adjuncts
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 [GENERIC AB]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines
NDA Applicant: NOVARTIS NDA No.: 021861 Prod. No.: 001 RX (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: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists
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: Gastrointestinal Agents:Gastrointestinal Agents, Other
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: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors
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: Dermatological Agents:Dermatological Agents, Other
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: 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
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: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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. 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 | May 21, 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. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Jun 14, 2027 | 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. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Oct 23, 2027 | |
| 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. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Feb 5, 2028 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 | Oct 11, 2030 | |
| 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) |
BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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 | May 21, 2025 | 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 |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Sep 6, 2013 | Jun 14, 2027 | 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 |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 4, 2013 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 4, 2013 | Feb 5, 2028 | |
| 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 | Feb 26, 2029 | 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 |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2013 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jul 8, 2014 | Oct 11, 2030 |
BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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 | May 21, 2025 | 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 |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 002: May 7, 2015 | Jun 14, 2027 | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Feb 5, 2028 | |
| 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 | Feb 26, 2029 | U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: May 7, 2015 | Oct 11, 2030 |
TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic
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. 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 | May 21, 2025 | 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. 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. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 6, 2017 | Jun 14, 2027 | U-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Oct 6, 2017 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Oct 23, 2027 | |
| 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. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Feb 5, 2028 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2017 | Oct 11, 2030 | |
| 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 |
| 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: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic
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. 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 | May 21, 2025 | 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. 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. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Oct 6, 2020 | Jun 14, 2027 | U-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: Oct 6, 2020 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Oct 23, 2027 | |
| 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. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Feb 5, 2028 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | Oct 11, 2030 | |
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Sep 9, 2023 |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE [GENERIC AB]
Drug Classes: Immunological Agents:Immunological Agents, Other
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: Immunological Agents:Immunological Agents, Other
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: Immunological Agents:Immunological Agents, Other
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: Immunological Agents:Immunological Agents, Other
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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
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
Drug Classes: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists
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* 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 | Mar 27, 2024 | 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: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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: Antineoplastics:Molecular Target Inhibitors == Immunological Agents:Immunosuppressants
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: Blood Glucose Regulators:Antidiabetic Agents
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: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Blood Glucose Regulators:Antidiabetic Agents
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: Blood Glucose Regulators:Antidiabetic Agents
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: Blood Glucose Regulators:Antidiabetic Agents
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 inhibitor (INSTI) == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (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: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-hepatitis B (HBV) Agents
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: Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (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 thearpy [sic, 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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (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 | Oct 5, 2027 | |
| 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 | Dec 8, 2029 | |
| 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: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-hepatitis B (HBV) Agents
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: Antineoplastics:Antiangiogenic Agents
NDA Applicant: CELGENE 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: Antibacterials:Beta-lactam, Penicillins
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: Antibacterials:Beta-lactam, Penicillins
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: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors
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: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
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: Antivirals:Anti-hepatitis B (HBV) Agents == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI)
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: Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives
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
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]
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: Sexual Disorder Agents:Sexual Disorder Agents (Male)
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
Drug Classes: Metabolic Bone Disease Agents
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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
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: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 001 RX (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: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 002 RX (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
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Female)
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
Drug Classes: Dental and Oral Agents
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]
Drug Classes: Anticonvulsants:Sodium Channel Agents
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]
Drug Classes: Anticonvulsants:Sodium Channel Agents
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: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Diuretics, Thiazide
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: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == Cardiovascular Agents:Diuretics, Thiazide == Cardiovascular Agents:Angiotensin II Receptor Antagonists
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]
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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: Blood Products and Modifiers:Blood Products and Modifiers, Other
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 [Has competitive generic]
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
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: Antivirals:Anti-HIV Agents, Other
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: Antivirals:Anti-HIV Agents, Other
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 |
FYCOMPA (TABLET) (ORAL) PERAMPANEL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: CATALYST PHARMS NDA No.: 202834 Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 19, 2012 | Jun 8, 2023 | U-106: Treatment of epilepsy U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older |
| Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 6, 2014 | Jul 1, 2026 |
FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: CATALYST PHARMS NDA No.: 208277 Prod. No.: 001 RX (0.5MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 27, 2016 | Jun 8, 2023 | U-106: Treatment of epilepsy U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older |
| Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: May 27, 2016 | Jul 1, 2026 |
DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
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: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
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: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines
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. 11517563 DP* DLR* Liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Dec 6, 2022 | Apr 16, 2038 |
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ONCOPEPTIDES AB NDA No.: 214383 Prod. No.: 001 DISC (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6992207 DS* DP* Melphalan derivatives and their use as cancer chemotherapeutic drugs Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Jun 25, 2023 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 11344622 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of using a product-by-process Pat. Sub. Date(s): 001: Jun 17, 2022 | Apr 25, 2032 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2028 | ODE-348: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody |
KENGREAL (POWDER) (INTRAVENOUS) CANGRELOR
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]
Drug Classes: iron replacement product
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: Blood Glucose Regulators:Antidiabetic Agents
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: Blood Glucose Regulators:Antidiabetic Agents
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: Blood Glucose Regulators:Antidiabetic Agents
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: Blood Glucose Regulators:Antidiabetic Agents
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 excercise 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. Dat |