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 == central alpha-2 adrenergic agonist
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022037 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 3MG BASE); 004 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6811794 DP* Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: None | Jan 4, 2023 *PED | U-494: Treatment of Attention-Deficit Hyperactivity Disorder |
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: ALLERGAN 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 == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN 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: I - New Indication | Jun 26, 2022 | I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
| 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 == prostaglandin analog
NDA Applicant: ALLERGAN 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 == kinase inhibitor
NDA Applicant: PFIZER NDA No.: 207103 Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | |
| Pat. No. 7208489 DS* DP* DLR* 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | |
| Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 26, 2015 | Jan 16, 2023 | U-1998: Treating HR-pos., HER2-neg. advanced or metastatic breast cancer with palbociclib in combo with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression after endocrine therapy U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy |
| Pat. No. RE47739 DS* DP* 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 == kinase inhibitor
NDA Applicant: PFIZER NDA No.: 212436 Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Nov 26, 2019 | Jan 16, 2023 | |
| Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 26, 2019 | Jan 16, 2023 | U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy |
| Pat. No. RE47739 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 | 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
Drug Classes: radioactive diagnostic agent
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 == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME 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 == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
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 == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
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 == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 021995 Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 7125873 Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jan 26, 2023 *PED | U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin U-1037: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with a PPAR-gamma agonist U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): All strengths: None | May 24, 2027 *PED | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 4, 2024 PED | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
| Exclusivity Code: M - Miscellaneous | Feb 12, 2023 PED | M-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus |
STEGLUJAN (TABLET) (ORAL) ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME 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 == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 205755 Prod. No.: 001 DISC (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2017 | Jan 31, 2023 | |
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2014 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jun 15, 2017 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* 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 == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 211225 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188276 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 8835430 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 9018204 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 9416112 DS* DP* 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 31, 2023 | |
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* 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 |
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 021610 Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (20MG); 004 DISC (40MG); 005 DISC (7.5MG); 006 DISC (15MG); 007 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276250 DP* Sustained release formulations of oxymorphone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Feb 4, 2023 | U-826: Relief of moderate to severe pain |
| Pat. No. 8309112 DP* Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Feb 4, 2023 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 21, 2027 | U-3085: Dose modification for renal impairment |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Nov 22, 2029 |
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 201655 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309122 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8329216 DP* Oxymorphone controlled release formulations Claim Types: Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Feb 4, 2023 | |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 13, 2011; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Aug 8, 2024 | |
| Pat. No. 8192722 DP* Abuse-proof dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Sep 15, 2025 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Jun 21, 2027 | U-1598: Method of administration of controlled release oxymorphone |
| Pat. No. 7851482 DS* Method for making analgesics Claim Types: Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Jul 10, 2029 | |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Nov 22, 2029 |
NEXAVAR (TABLET) (ORAL) SORAFENIB TOSYLATE [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021923 Prod. No.: 001 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618141 Aryl ureas with angiogenesis inhibiting activity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2014 | Feb 11, 2023 | U-1480: Treatment of advanced renal cell carcinoma |
| Pat. No. 8877933 DS* DP* Thermodynamically stable form of a tosylate salt Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 22, 2014 | Dec 24, 2027 | U-1624: Treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, or differentiated thyroid carcinoma. |
| Pat. No. 9737488 DP* Pharmaceutical composition for the treatment of cancer Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Sep 20, 2017 | Sep 10, 2028 | U-1480: Treatment of advanced renal cell carcinoma U-1696: Treatment of unresectable hepatocellular carcinoma U-2107: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment |
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ALLERGAN 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 |
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Phosphodiesterase Inhibitors, Airways Disease == phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 022522 Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Claim Types: Product-by-process Pat. Sub. Date(s): 001: None; 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2016; 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2014; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2014; 002: Mar 14, 2018 | Mar 8, 2024 |
TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: MERCK SHARP DOHME NDA No.: 022277 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents Claim Types: Formulation Pat. Sub. Date(s): 001: None | Feb 21, 2023 | |
| Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jan 28, 2014 | Feb 21, 2023 | |
| Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Sep 8, 2023 |
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE NDA No.: 021656 Prod. No.: 001 RX (48MG); 002 RX (145MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276249 DP* Nanoparticulate fibrate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | |
| Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
ZECUITY (SYSTEM) (IONTOPHORESIS) SUMATRIPTAN SUCCINATE
Drug Classes: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TEVA BRANDED PHARM NDA No.: 202278 Prod. No.: 001 DISC (EQ 6.5MG BASE/4HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6745071 DP* Iontophoretic drug delivery system Claim Types: Device Pat. Sub. Date(s): 001: Feb 15, 2013 | Feb 21, 2023 | |
| Pat. No. 7973058 Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8155737 Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8470853 Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2013 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 8597272 DP* Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 9, 2013 | Apr 12, 2027 | |
| Pat. No. 9427578 DP* Pharmacokinetics of iontophoretic sumatriptan administration Claim Types: Method of administration; Formulation Pat. Sub. Date(s): 001: Sep 15, 2016 | Apr 12, 2027 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 9272137 DP* Transdermal methods and systems for the delivery of anti-migraine compounds Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Mar 14, 2016 | Sep 7, 2027 | |
| Pat. No. 8366600 Polyamine enhanced formulations for triptan compound iontophoresis Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 15, 2013 | Apr 21, 2029 | U-1327: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof, using a flowable hydrogel formulation |
| Pat. No. 8983594 DP* Electronic control of drug delivery system Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 8, 2015 | Nov 19, 2030 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
| Pat. No. 9327114 DP* User-activated self-contained co-packaged iontophoretic drug delivery system Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: May 26, 2016 | Oct 8, 2032 | U-1328: Method for treating acute migraine in adults, with or without aura, comprising iontophoretic transdermal delivery of sumatriptan or a salt thereof |
VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021977 Prod. No.: 006 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Feb 24, 2023 | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7105486 Abuse-resistant amphetamine compounds Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds Claim Types: Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs Claim Types: Compound Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7659254 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults |
| Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds Claim Types: Compound Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7662788 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7671031 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678770 Abuse-resistant amphetamine prodrugs Claim Types: Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
| Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs Claim Types: Formulation Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | |
| Pat. No. 7713936 Abuse-resistant amphetamine prodrugs Claim Types: Method of administration Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-727: For the treatment of attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 006: None | Aug 24, 2023 *PED | U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) |
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 == histone deacetylase (HDAC) inhibitor
NDA Applicant: 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 |
| 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 == retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021753 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7834060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 19, 2010 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 7838558 DP* Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Mar 12, 2023 | |
| Pat. No. 7868044 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 12, 2011 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: May 21, 2014 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 7737181 DP* Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 29, 2024 | |
| Pat. No. 7579377 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 23, 2025 | U-818: Topical treatment of acne vulgaris |
KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 213756 Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 6, 2020 | Mar 13, 2023 | |
| Pat. No. 7425637 DS* N3 alkylated benzimidazole derivatives as MEK inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: May 6, 2020 | Apr 11, 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 == substance P/neurokinin-1 (NK-1) receptor antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 205718 Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6297375 DS* 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. 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 == H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
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 |
GATTEX KIT (POWDER) (SUBCUTANEOUS) TEDUGLUTIDE RECOMBINANT
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: TAKEDA PHARMS USA NDA No.: 203441 Prod. No.: 001 RX (5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056886 DP* GLP-2 formulations Claim Types: Formulation; Process; Kit; Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | Mar 18, 2023 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 7847061 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 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 |
| Pat. No. 9539310 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9545434 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9545435 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9555079 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9572867 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 22, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9592273 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9592274 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2017 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9968655 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2018 | May 1, 2026 *PED | U-2308: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9968656 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2018 | May 1, 2026 *PED | U-2308: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9968658 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9974835 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9974837 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9981014 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9981016 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9987334 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9987335 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2018 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9993528 Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2018 | 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 |
OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatological Agents, Other == phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC NDA No.: 205437 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4 U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2014 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
| Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 18, 2015 | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2018 | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis U-2656: Treatment of adult patients with active psoriatic arthritis U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease U-3276: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy |
| Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Dec 9, 2023 | |
| Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)] (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Apr 15, 2014 | Feb 16, 2028 | |
| Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2018 | May 29, 2034 | U-2232: Treatment of psoriatic arthritis using a dosage titration schedule U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent |
| Pat. No. 10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 9, 2018 | May 29, 2034 | U-2403: Treatment of psoriasis using a dosage titration schedule U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 19, 2022 | I-803: Treatment of adult patients with oral ulcers associated with Behcets disease |
| Exclusivity Code: I - New Indication | Dec 20, 2024 | I-884: Revisions to the labeling to include data for subjects with mild to moderate plaque psoriasis, and to allow for an expansion of the indication |
| Exclusivity Code: M - Miscellaneous | Apr 10, 2023 | M-257: Information added to the clinical studies section of the labeling regarding the use of plaque psoriasis of the scalp |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 19, 2026 | ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease |
KYNAMRO (SOLUTION) (SUBCUTANEOUS) MIPOMERSEN SODIUM
Drug Classes: apolipoprotein B-100 synthesis inhibitor == transthyretin-directed antisense oligonucleotide
NDA Applicant: KASTLE THERAPS LLC NDA No.: 203568 Prod. No.: 001 DISC (200MG/ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: None | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: None | Sep 5, 2023 | |
| Pat. No. 7511131 DS* [Extended 412 days (1.1 years)] Antisense modulation of apolipoprotein B expression Claim Types: Compound; Composition Pat. Sub. Date(s): 001: None | Jan 29, 2027 |
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Sep 5, 2023 | |
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 1, 2025 | |
| Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 5, 2025 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Immunological Agents:Immunological Agents, Other == Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203214 Prod. No.: 001 RX (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Nov 30, 2012 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 001: Nov 30, 2012 | Dec 8, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
| Exclusivity Code: NPP - New patient population | Sep 25, 2023 |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Immunological Agents:Immunological Agents, Other == Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203214 Prod. No.: 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Jun 28, 2018 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 002: Jun 28, 2018 | Dec 8, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Immunological Agents:Immunological Agents, Other == Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 208246 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 18, 2016 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 001: Mar 18, 2016 | Dec 8, 2025 | |
| Pat. No. 9937181 DP* Tofacitinib oral sustained release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: May 9, 2018 | Mar 14, 2034 | |
| Pat. No. 11253523 Tofacitinib oral sustained release dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2022 | Mar 14, 2034 | U-3326: A method of treating ankylosing spondylitis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, and 87-98 U-3327: A method of treating psoriatic arthritis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, and 87-98 U-3328: A method of treating rheumatoid arthritis by administering the formulation of tofacitinib of claims 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 and 87-98 U-3329: A method of treating ulcerative colitis, by administering the formulation of tofacitinib of claims 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 and 87-98 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 14, 2024 | I-879: Treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers, to the prescribing information |
XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Immunological Agents:Immunological Agents, Other == Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 208246 Prod. No.: 002 RX (EQ 22MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6965027 DS* Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Jan 9, 2020 | Mar 25, 2023 | |
| Pat. No. RE41783 DS* [Extended 5 years] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound Pat. Sub. Date(s): 002: Jan 9, 2020 | Dec 8, 2025 | |
| Pat. No. 10639309 DP* Tofacitinib oral sustained release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 3, 2020 | Mar 14, 2034 | |
| Pat. No. 11253523 Tofacitinib oral sustained release dosage forms Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 23, 2022 | Mar 14, 2034 | U-3326: A method of treating ankylosing spondylitis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, and 87-98 U-3327: A method of treating psoriatic arthritis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, and 87-98 U-3328: A method of treating rheumatoid arthritis by administering the formulation of tofacitinib of claims 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 and 87-98 U-3329: A method of treating ulcerative colitis, by administering the formulation of tofacitinib of claims 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 and 87-98 |
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 | Apr 6, 2025 | 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 |
GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == biguanide
NDA Applicant: SANTARUS INC NDA No.: 021748 Prod. No.: 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8323692 DP* Controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 12, 2012 | Mar 30, 2023 | |
| Pat. No. 7780987 DS* DP* Controlled release dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): 002: None | Mar 23, 2025 |
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) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 212888 Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process Pat. Sub. Date(s): All strengths: Feb 16, 2021 | Apr 11, 2023 | |
| Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: Feb 16, 2021 | Apr 21, 2025 | U-3059: Treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure 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-3060: Treatment of HIV infection in adults 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. 11224597 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 15, 2022 | Sep 15, 2031 | U-3060: Treatment of HIV infection in adults 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 |
REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE [GENERIC AB]
Drug Classes: Antineoplastics:Antiangiogenic Agents == thalidomide analog
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: I - New Indication | May 28, 2022 | I-796: Used in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (FL) |
| Exclusivity Code: I - New Indication | May 28, 2022 | I-797: Used in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL) |
| 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) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 17, 2022 | ODE-88: For use in combination with dexamethasone for the treatment of patients with multiple myeloma who have not received at least one prior therapy (first line treatment) |
ZOSYN (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM [Has competitive generic]
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial == beta-lactamase inhibitor
NDA Applicant: WYETH PHARMS NDA No.: 050684 Prod. No.: 001 DISC (EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL); 002 DISC (EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL); 003 DISC (EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL); 004 DISC (EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900184 DP* Compositions containing pipercillin and tazobactam useful for injection Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
| Pat. No. 7915229 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 22, 2011; 002: None; 003: None; 004: None | Apr 14, 2023 | |
| Pat. No. 8133883 DP* Compositions containing piperacillin and tazobactam useful for injection Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2012; 002: None; 003: None; 004: None | Apr 14, 2023 | U-282: Method of treating bacterial infections |
ZOSYN IN PLASTIC CONTAINER (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Drug Classes: Antibacterials:Beta-lactam, Penicillins == penicillin class antibacterial == beta-lactamase inhibitor
NDA Applicant: WYETH PHARMS 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 == dihydropyridine calcium channel blocker == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == angiotensin converting enzyme inhibitor
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 == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI) == Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1 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) == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME 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. 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 |
ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME NDA No.: 203045 Prod. No.: 001 RX (EQ 25MG BASE); 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): 001: Jan 20, 2012; 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): 001: Jan 20, 2012; 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): 001: Jan 20, 2012; 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): 001: Jan 20, 2012; 002: None | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: Antivirals:Anti-HIV Agents, Integrase Inhibitors (INSTI) == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME 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) == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME 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. 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 |
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Apr 26, 2023 | U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor |
| Pat. No. 7166722 DS* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Nov 16, 2023 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2026 |
CLINDESSE (CREAM) (VAGINAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives == lincosamide antibacterial
NDA Applicant: PADAGIS US NDA No.: 050793 Prod. No.: 001 RX (EQ 2% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899890 DP* Bioadhesive drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 27, 2023 | U-137: Method of treating bacterial vaginosis |
| Pat. No. 9789057 DP* Pharmaceutical delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jan 9, 2018 | Dec 2, 2026 | U-137: Method of treating bacterial vaginosis |
AGGRASTAT (INJECTABLE; SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE NDA No.: 020912 Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)) NDA No.: 020912 Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016 | May 1, 2023 | U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS |
AGGRASTAT (SOLUTION) (INTRAVENOUS) TIROFIBAN HYDROCHLORIDE [GENERIC AP]
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE NDA No.: 020913 Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913 Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 7, 2013 | May 1, 2023 | U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS |
STENDRA (TABLET) (ORAL) AVANAFIL
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Male) == phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS NDA No.: 202276 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7501409 DP* Preparations for oral administration Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 5, 2023 | |
| Pat. No. 6656935 DS* DP* [Extended 1687 days (4.6 years)] Aromatic nitrogen-containing 6-membered cyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: May 29, 2012 | Apr 27, 2025 | U-155: Treatment of erectile dysfunction |
BONIVA (TABLET) (ORAL) IBANDRONATE SODIUM [Has competitive generic]
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 |
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == factor VIII activator == vasopressin analog
NDA Applicant: SERENITY PHARMS LLC NDA No.: 201656 Prod. No.: 001 DISC (0.00083MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7405203 Pharmaceutical compositions including low dosages of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2017 | May 6, 2023 | U-1980: A method of treating nocturia due to nocturnal polyuria in adults |
| Pat. No. 7579321 Pharmaceutical compositions including low dosages of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2017 | May 6, 2023 | U-1980: A method of treating nocturia due to nocturnal polyuria in adults |
| Pat. No. 7799761 DP* Pharmaceutical compositions including low dosages of desmopressin Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2017 | Sep 26, 2024 | |
| Pat. No. 9539302 DP* Safe desmopressin administration Claim Types: Device Pat. Sub. Date(s): 001: Mar 31, 2017 | Jun 15, 2030 |
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == factor VIII activator == vasopressin analog
NDA Applicant: SERENITY PHARMS LLC NDA No.: 201656 Prod. No.: 002 DISC (0.00166MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7405203 Pharmaceutical compositions including low dosages of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 31, 2017 | May 6, 2023 | U-1980: A method of treating nocturia due to nocturnal polyuria in adults |
| Pat. No. 7579321 Pharmaceutical compositions including low dosages of desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 31, 2017 | May 6, 2023 | U-1980: A method of treating nocturia due to nocturnal polyuria in adults |
| Pat. No. 9539302 DP* Safe desmopressin administration Claim Types: Device Pat. Sub. Date(s): 002: Mar 31, 2017 | Jun 15, 2030 |
PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 6, 2023 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 19, 2025 | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Oct 6, 2020 | May 19, 2025 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Mar 26, 2028 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 002: Jan 9, 2019 | May 18, 2031 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jun 28, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 002: Mar 19, 2020 | Jan 1, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Jan 13, 2032 | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 002: Jan 9, 2019 | Aug 28, 2035 | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 18, 2021 | Dec 14, 2035 | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 12, 2020 | Aug 16, 2036 | |
| Pat. No. 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. 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 == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | May 6, 2023 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Nov 8, 2016 | May 19, 2025 | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 19, 2025 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Apr 28, 2015 | Mar 26, 2028 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 14, 2018 | May 18, 2031 | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | May 18, 2031 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jun 28, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jan 1, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2016 | Jan 13, 2032 |
NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == factor VIII activator == vasopressin analog
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) == factor VIII activator == vasopressin analog
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 |
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 == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide == thiazide diuretic
NDA Applicant: NOVARTIS NDA No.: 200045 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None | May 16, 2023 |
EXFORGE HCT (TABLET) (ORAL) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN [GENERIC AB]
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide == thiazide diuretic == Cardiovascular Agents:Angiotensin II Receptor Antagonists == angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022314 Prod. No.: 001 RX (EQ 5MG BASE;12.5MG;160MG); 002 RX (EQ 5MG BASE;25MG;160MG); 003 RX (EQ 10MG BASE;12.5MG;160MG); 004 RX (EQ 10MG BASE;25MG;160MG); 005 RX (EQ 10MG BASE;25MG;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101599 DP* Pharmaceutical composition containing anti-hypertensive agents Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 30, 2012; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8475839 DP* Formulation Claim Types: Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Nov 16, 2023 *PED |
NAROPIN (SOLUTION) (INJECTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA NDA No.: 020533 Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8118802 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 18, 2023 | |
| Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 23, 2024 | |
| Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Oct 18, 2025 | |
| Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Nov 28, 2026 |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 001 RX (EQ 25MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 001: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 002 RX (EQ 50MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 002: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 002: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 002: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 003 RX (EQ 75MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 003: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 003: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 003: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 004 RX (EQ 12.5MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 004: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 004: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 004: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Dec 21, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 005 DISC (EQ 100MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)] Thrombopoietin mimetics Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 005: None | May 20, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Method of use Pat. Sub. Date(s): 005: None | Nov 21, 2023 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 005: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. |
PROMACTA KIT (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 207027 Prod. No.: 001 RX (EQ 25MG 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 | 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 | 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 | 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 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2022 PED | ODE-74: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy |
PROMACTA KIT (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 207027 Prod. No.: 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): 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): 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): 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) | Feb 26, 2022 PED | |
| 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 == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 24, 2023 | U-2025: Treatment of attention deficit hyperactivity disorder |
| Pat. No. 9173857 Controlled dose drug delivery system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 12, 2026 | U-2025: Treatment of attention deficit hyperactivity disorder |
| Pat. No. 8846100 DP* Controlled dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 7, 2017 | Aug 24, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2023 PED | M-248: Information added to the labeling to describe a trial evaluating a lower dose than those approved for pediatric patients 13 to 17 years of age |
NUZYRA (TABLET) (ORAL) OMADACYCLINE TOSYLATE
Drug Classes: Antibacterials:Tetracyclines == tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC NDA No.: 209816 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Jun 2, 2023 | |
| Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 24, 2023 | |
| Pat. No. 9265740 Minocycline compounds and methods of use thereof Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 9724358 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 10124014 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2018 | Mar 5, 2029 | U-2449: Treatment of bacterial skin and skin structure infection |
| Pat. No. 8383610 DS* Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 23, 2030 | |
| Pat. No. 9314475 DP* Oral and injectable formulations of tetracycline compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 18, 2031 | |
| Pat. No. 10111890 9-aminomethyl minocycline compounds and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Aug 3, 2037 | U-2444: Treatment of subjects having bacterial skin or skin structure infection |
| Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2019 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Pat. No. 10835542 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2020 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 2, 2028 GAIN |
NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
Drug Classes: Antibacterials:Tetracyclines == tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC NDA No.: 209817 Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7553828 DS* 9-aminomethyl substituted minocycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Jun 2, 2023 | |
| Pat. No. 7326696 DS* Amino-methyl substituted tetracycline compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Sep 24, 2023 | |
| Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | |
| Pat. No. 9724358 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2019 | Mar 5, 2029 | U-1569: Treatment of bacterial skin and skin structure infections |
| Pat. No. 10124014 Minocycline compounds and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2018 | Mar 5, 2029 | U-2449: Treatment of bacterial skin and skin structure infection |
| Pat. No. 10383884 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2019 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Pat. No. 10835542 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2020 | Oct 31, 2037 | U-2576: Treatment of community acquired bacterial pneumonia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 2, 2028 GAIN |
DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == 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 == progestin-containing intrauterine device (IUD)
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 == progestin-containing intrauterine device (IUD)
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 |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894987 DP* Tamper resistant dosage forms Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Mar 29, 2030 |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 10, 2020 | Nov 20, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Composition Pat. Sub. Date(s): All strengths: Jun 30, 2020 | Mar 30, 2025 | |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | |
| Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
XYREM (SOLUTION) (ORAL) SODIUM OXYBATE
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents == central nervous system depressant
NDA Applicant: JAZZ PHARMS NDA No.: 021196 Prod. No.: 001 RX (0.5GM/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8731963 Sensitive drug distribution system and method Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: May 30, 2014 | Jun 17, 2023 *PED | U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution |
| Pat. No. 7668730 DLR* Sensitive drug distribution system and method Claim Types: Method of distribution Pat. Sub. Date(s): 001: None | Dec 16, 2024 *PED | U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution |
| Pat. No. 10213400 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 15, 2033 | U-2499: Method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium |
| Pat. No. 10864181 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 13, 2021 | Mar 15, 2033 | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Pat. No. 11253494 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 15, 2022 | Mar 15, 2033 | U-3323: Method of reducing adverse effects in patients who are concomitantly administered a salt of gamma-hydroxybutyrate and divalproex sodium U-3324: Method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered |
| Pat. No. 8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2014 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Pat. No. 9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of administration; method of improving a treatment Pat. Sub. Date(s): 001: Jul 8, 2015 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Pat. No. 9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2016 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Apr 26, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 26, 2026 PED | ODE-231: Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy |
ORAVERSE (INJECTABLE) (INJECTION) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING NDA No.: 022159 Prod. No.: 001 RX (0.4MG/1.7ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Kit; Drug in a container Pat. Sub. Date(s): 001: None | Jun 20, 2023 | |
| Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 17, 2023 | U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic |
| Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Apr 21, 2025 |
NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 203340 Prod. No.: 002 RX (6MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7070581 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | Jun 23, 2023 | |
| Pat. No. 8517997 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | May 14, 2024 | |
| Pat. No. 10342787 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 10576070 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11207306 Non-aqueous liquid nimodipine compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
KENGREAL (POWDER) (INTRAVENOUS) CANGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: CHIESI NDA No.: 204958 Prod. No.: 001 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6130208 DP* Formulation containing a nucleotide analogue Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jul 16, 2015 | Jun 29, 2023 | U-1715: P2Y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a P2Y12 platelet inhibitor and not given a glycoprotein IIb/IIIa inhibitor |
| Pat. No. 9925265 Methods of treating or preventing stent thrombosis Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | May 13, 2029 | U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion |
| Pat. No. 9427448 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2016 | Nov 10, 2030 | U-1926: Method of treating, reducing the incidence of, or preventing an ischemic event in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and continuous infusion of 4 ug/kg/min for at least 2 hours or the duration of the PCI |
| Pat. No. 8680052 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 16, 2015 | Mar 9, 2033 | U-2979: Method comprising iv administration of cangrelor before PCI then continuous infusion for at least 2 hours or the duration of PCI and, during or after continuous infusion, administration of a loading dose of ticagrelor, or an equivalent method |
| Pat. No. 9295687 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Product-by-process; Drug in a container Pat. Sub. Date(s): 001: Mar 29, 2016 | Jul 10, 2035 | |
| Pat. No. 9439921 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Dec 9, 2016 | Jul 10, 2035 | |
| Pat. No. 9700575 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Composition; Formulation; Drug in a container Pat. Sub. Date(s): 001: Jul 28, 2017 | Jul 10, 2035 | |
| Pat. No. 10039780 Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 30, 2018 | Jul 10, 2035 | U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion |
FERAHEME (SOLUTION) (INTRAVENOUS) FERUMOXYTOL [GENERIC AB]
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 == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 003 RX (8MG/3ML (2.68MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Apr 29, 2022 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Oct 20, 2025 | |
| Pat. No. 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. 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* 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 |
ONZETRA XSAIL (POWDER) (NASAL) SUMATRIPTAN SUCCINATE
Drug Classes: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 206099 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8047202 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Jul 2, 2023 | |
| Pat. No. 8327844 Nasal delivery method Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 3, 2023 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9119932 DP* Nasal delivery device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 23, 2024 | |
| Pat. No. 7975690 DP* Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 8590530 DP* Nasal delivery devices Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9108015 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 10, 2018 | Mar 6, 2027 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 10398859 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Sep 30, 2019 | Dec 19, 2027 | |
| Pat. No. 8875704 DP* Nasal administration Claim Types: Device; Method of use; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 7, 2028 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10722667 DP* Nasal administration Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 | Dec 30, 2028 | |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 22, 2029 | |
| Pat. No. 8899229 DP* Powder delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2030 | |
| Pat. No. 9649456 DP* Nasal administration Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: May 26, 2017 | Oct 21, 2030 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Dec 6, 2030 | |
| Pat. No. 10478574 Nasal administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 9, 2019 | Nov 4, 2033 | U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 |
LEVITRA (TABLET) (ORAL) VARDENAFIL HYDROCHLORIDE [Has competitive generic]
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Male) == phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021400 Prod. No.: 001 DISC (EQ 5MG BASE); 002 DISC (EQ 10MG BASE); 003 DISC (EQ 2.5MG BASE); 004 DISC (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8841446 DP* Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 4, 2014 | Jul 3, 2023 | |
| Pat. No. 8273876 Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Oct 24, 2012; 002: None; 003: None; 004: None | Jul 23, 2027 | U-1288: Treatement [sic, Treatment] of erectiile [sic, erectile] dysfunction by administering a film-coated tablet |
XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 208090 Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8840928 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9044398 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | |
| Pat. No. 9248195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9592200 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Mar 20, 2017 | Jul 7, 2023 | |
| Pat. No. 9763883 DP* Abuse-deterrent drug formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 20, 2017 | Jul 7, 2023 | |
| Pat. No. 10525052 DP* Abuse-deterrent drug formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 7, 2020 | Jul 7, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10525053 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 7, 2020 | Jul 7, 2023 | |
| Pat. No. 8557291 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 21, 2025 | |
| Pat. No. 7399488 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 7771707 DP* Abuse-deterrent drug formulations Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 8449909 DP* Abuse-deterrent drug formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Mar 24, 2025 | |
| Pat. No. 8758813 Abuse-deterrent drug formulations Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 19, 2016 | Jun 10, 2025 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9682075 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 20, 2017 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10004729 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jul 10, 2018 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10668060 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 3, 2020 | Dec 10, 2030 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9737530 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Method of use; Process Pat. Sub. Date(s): All strengths: Aug 23, 2017 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9968598 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Process; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10188644 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Method of use of a product-by-process; Product-by-process Pat. Sub. Date(s): All strengths: Jan 29, 2019 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10646485 DP* Process of making stable abuse-deterrent oral formulations Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): All strengths: May 13, 2020 | Sep 2, 2036 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
VISTOGARD (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: Antineoplastics:Antineoplastics, Other == Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == pyrimidine analog
NDA Applicant: WELLSTAT THERAP NDA No.: 208159 Prod. No.: 001 RX (10GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2015 | Jul 10, 2023 | |
| Pat. No. 7776838 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2015 | Aug 17, 2027 | U-1791: Emergency treatment of adult & pediatric patients following fluorouracil or capecitabine overdose,or who exhibit early-onset,severe or life-threatening cardiac or cns toxicity or unusually severe adverse reactions within 96 hours |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 11, 2022 | ODE-104: Emergency tx of pts following a FU or capecitabine OD, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac system or CNS, and/or early-onset, unusually severe ar w/in 96 hrs following the end of FU or capecitabine admin. |
XURIDEN (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: Antineoplastics:Antineoplastics, Other == Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == pyrimidine analog
NDA Applicant: WELLSTAT THERAP NDA No.: 208169 Prod. No.: 001 RX (2GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Oct 22, 2015 | Jul 10, 2023 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 4, 2022 | ODE-98: Treatment of hereditary orotic aciduria |
AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE [Has competitive generic]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ELI LILLY AND CO NDA No.: 022504 Prod. No.: 001 DISC (30MG/1.5ML ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Aug 7, 2014 | Jul 13, 2023 | U-1545: A method of transdermally delivering testosterone |
| Pat. No. 8993520 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 9180194 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8419307 Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 | Feb 26, 2027 | U-1386: A method of increasing the testosterone blood level of a person in need thereof |
| Pat. No. 8807861 DP* Spreading implement Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Sep 10, 2014 | Feb 26, 2027 | U-1563: A method of transdermal administration of a physiologically active agent to a subject. |
| Pat. No. 9289586 Spreading implement Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 19, 2016 | Feb 26, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8435944 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 27, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: Cardiovascular Agents:Cardiovascular Combinations == neprilysin inhibitor == Cardiovascular Agents:Angiotensin II Receptor Antagonists == angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP NDA No.: 207620 Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8404744 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | |
| Pat. No. 8796331 Methods of treatment and pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 14, 2023 *PED | U-1723: Treatment of heart failure |
| Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Aug 6, 2015 | May 27, 2024 *PED | |
| Pat. No. 8101659 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 15, 2025 *PED | |
| Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 7, 2016 | May 8, 2027 *PED | U-1723: Treatment of heart failure |
| Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Nov 27, 2027 *PED | |
| Pat. No. 9517226 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 9937143 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11135192 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 18, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11058667 Sacubitril-valsartan dosage regimen for treating heart failure Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Jul 13, 2021 | May 9, 2036 | U-3170: Treating chronic heart failure with reduced ejection fraction in patients not taking an ACE inhibitor or an ARB or previously taking low doses of these agents, by titrating up from half the usually recommended starting dose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 16, 2024 | M-82: Labeling revisions related to clinical studies |
| Exclusivity Code: NPP - New patient population | Apr 1, 2023 PED |
NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: Central Nervous System Agents:Central Nervous System, Other == sigma-1 agonist == uncompetitive NMDA receptor antagonist == Cardiovascular Agents:Antiarrhythmics == CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS NDA No.: 021879 Prod. No.: 001 RX (20MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8227484 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 1, 2012 | Jul 17, 2023 | U-1093: Treatment of pseudobulbar affect |
| Pat. No. 7659282 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 13, 2026 | U-1093: Treatment of pseudobulbar affect |
TOLAK (CREAM) (TOPICAL) FLUOROURACIL
Drug Classes: Dermatological Agents:Dermatological Agents, Other == nucleoside metabolic inhibitor
NDA Applicant: HILL DERMACEUTICALS NDA No.: 022259 Prod. No.: 001 RX (4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169401 DP* Topical skin care composition containing refined peanut oil Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Nov 4, 2015 | Jul 18, 2023 |
HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC NDA No.: 201532 Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)] Macrocyclic analogs and methods of their use and preparation Claim Types: Compound; Process Pat. Sub. Date(s): 001: Nov 30, 2010 | Jul 20, 2023 | |
| Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 7, 2018 | Jan 8, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 28, 2023 | ODE-107: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen |
MOZOBIL (SOLUTION) (SUBCUTANEOUS) PLERIXAFOR
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other == hematopoietic stem cell mobilizer
NDA Applicant: GENZYME NDA No.: 022311 Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6987102 Methods to mobilize progenitor/stem cells Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
| Pat. No. 7897590 Methods to mobilize progenitor/stem cells Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 22, 2011 | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
NEUPRO (FILM, EXTENDED RELEASE) (TRANSDERMAL) ROTIGOTINE
Drug Classes: Antiparkinson Agents:Dopamine Agonists
NDA Applicant: UCB INC NDA No.: 021829 Prod. No.: 001 RX (2MG/24HR); 002 RX (4MG/24HR); 003 RX (6MG/24HR); 004 RX (1MG/24HR); 005 RX (3MG/24HR); 006 RX (8MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617591 DP* Transdermal delivery system for the administration of rotigotine Claim Types: Drug in a container; Method of use Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jul 22, 2023 | U-1474: A method for the treatment of a patient suffering from a disease treatable with rotigotine, comprising applying the claimed transdermal delivery system (TDS) to the skin of the patient |
| Pat. No. 8246980 DP* Transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Nov 27, 2025 | |
| Pat. No. 8246979 DP* Transdermal delivery system for the administration of rotigotine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Sep 1, 2027 | U-1272: Treatment of signs and symptoms of Parkinson's disease by application of claimed transdermal system U-1273: Treatment of restless legs syndrome by application of claimed transdermal delivery system |
| Pat. No. 10130589 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 30, 2018 | Dec 22, 2030 | |
| Pat. No. 10350174 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 18, 2019 | Dec 22, 2030 | |
| Pat. No. 9925150 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Apr 2, 2018 | Mar 1, 2032 |
CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: Antiparkinson Agents:Dopamine Agonists == Blood Glucose Regulators:Antidiabetic Agents == Hormonal Agents, Suppressant (Pituitary) == ergot derivative
NDA Applicant: VEROSCIENCE NDA No.: 020866 Prod. No.: 001 RX (EQ 0.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888310 Methods of identifying responders to dopamine agonist therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2011 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137992 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137993 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8137994 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jul 25, 2023 | U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors |
| Pat. No. 8877708 DP* Combination of dopamine agonists plus first phase secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2015 | Jun 7, 2030 | U-1706: Treatment of Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue wherein the combined therapeutic effect is greater than the additive effect of administering each agent alone |
| Pat. No. 9352025 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jun 7, 2030 | U-2111: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1-5 and wherein the effects are as recited in claims 1-5 U-2112: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 6 and wherein the effects are as recited in claim 6 U-2113: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 7 and wherein the effects are as recited in claim 7 U-2114: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 9 and wherein the effects are as recited in claim 9 U-2115: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 10 and wherein the effects are as recited in claim 10 U-2116: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 12 and wherein the effects are as recited in claim 12 U-2117: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 14-15 and wherein the effects are as recited in claims 14-15 U-2118: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 16-18 and wherein the effects are as recited in claims 16-18 U-2119: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 19 and wherein the effects are as recited in claim 19 |
| Pat. No. 9895422 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2018 | Jun 7, 2030 | U-2114: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 9 and wherein the effects are as recited in claim 9 U-2116: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 12 and wherein the effects are as recited in claim 12 U-2281: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claim 1 U-2282: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 2 and wherein the effects are as recited in claim 2 U-2283: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 3-7 and wherein the effects are as recited in claims 3-7 U-2284: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 8 and wherein the effects are as recited in claim 8 U-2285: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 11 and wherein the effects are as recited in claim 11 U-2286: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 14 and wherein the effects are as recited in claim 14 U-2287: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 16-19 and wherein the effects are as recited in claims 16-19 |
| Pat. No. 10688155 Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2020 | Jun 7, 2030 | U-2281: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claim 1 U-2890: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 2 and wherein the effects are as recited in claim 1 U-2891: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine meylate and a first-phase insulin secretagogue as recited in claims 1 and 3 and wherein the effects are as recited in claim 1 U-2892: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 4 and wherein the effects are as recited in claim 1 U-2893: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 5 and wherein the effects are as recited in claim 1 U-2894: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 6 and wherein the effects are as recited in claim 1 U-2895: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 7 and wherein the effects are as recited in claim 1 U-2896: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 8 and wherein the effects are as recited in claim 1 U-2897: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 9 U-2898: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 10 U-2899: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 11 U-2900: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 1 and wherein the effects are as recited in claims 1 and 13 U-2901: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 15 and wherein the effects are as recited in claim 1 U-2902: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 16 and wherein the effects are as recited in claim 1 U-2903: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 17 and wherein the effects are as recited in claim 1 U-2904: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1, 17 and 18 and wherein the effects are as recited in claim 1 U-2905: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 1 and 19 and wherein the effects are as recited in claim 1 U-2906: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 22 wherein the effects are as recited in claim 22 U-2907: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 23 and wherein the effects are as recited in claim 22 U-2908: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 24 and wherein the effects are as recited in claim 22 U-2909: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 22 and 25 and wherein the effects are as recited in claim 22 U-2910: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 26 and wherein the effects are as recited in claim 26 U-2911: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 27 and wherein the effects are as recited in claim 26 U-2912: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 28 and wherein the effects are as recited in claim 26 U-2913: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 29 and wherein the effects are as recited in claim 26 U-2914: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 30 wherein the effects are as recited in claim 26 U-2915: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 31 and wherein the effects are as recited in claim 26 U-2916: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 32 wherein the effects are as recited in said claims U-2917: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 33 wherein the effects are as recited in claims U-2918: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 34 wherein the effects are as recited in said claims U-2919: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 36 wherein the effects are as recited in said claims U-2920: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 38 and wherein the effects are as recited claim 26 U-2921: Once daily topical treatment of persistent facial erythema associated with rosacea in adults U-2922: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 39 and wherein the effects are as recited in claim 26 U-2923: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 26 and 40 and wherein the effects are as recited in claim 26 U-2924: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 42 and wherein the effects are as recited in claim 42 U-2925: Adjunct to diet and exercise to treat glucose intolerance in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 42 and 43 wherein the effects are as recited in claim 42 U-2926: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 44 and wherein the effects are as recited in claim 44 U-2927: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 45 and wherein the effects are as recited in claim 44 U-2928: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 46 and wherein the effects are as recited in claim 44 U-2929: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 47 and wherein the effects are as recited in claim 44 U-2930: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 48 and wherein the effects are as recited in claim 44 U-2931: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 49 and wherein the effects are as recited in claim 44 U-2932: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 50 wherein the effects are as recited in said claims U-2933: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 51 wherein the effects are as recited in said claims U-2934: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 52 wherein the effects are as recited in said claims U-2935: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claim 44 and wherein the effects are as recited in claims 44 and 54 U-2936: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 56 and wherein the effects are as recited in claim 44 U-2937: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering bromocriptine mesylate and a first-phase insulin secretagogue as recited in claims 44 and 57 and wherein the effects are as recited in claim 44 |
| Pat. No. 8431155 DP* Bromocriptine formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: May 2, 2013 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 8613947 DP* Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 3, 2014 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9192576 DP* Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 9, 2016 | Apr 30, 2032 | U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9522117 DP* Bromocriptine formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jan 18, 2017 | Apr 30, 2032 | U-1939: Administration once daily within two hours after waking in the morning for improvement of glycemic control in a Type 2 diabetes patient U-976: Improvement of glycemic control in individuals with Type 2 diabetes |
| Pat. No. 9700555 DP* Bromocriptine formulations Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 18, 2017 | Apr 30, 2032 | U-2183: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 13 U-2184: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 13, and 14 U-2185: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 15 and 27 U-2186: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 15, 27, and 28 U-2187: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 29 and 39 U-2188: Adjunct to diet and execrise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 29, 39, and 40 U-2189: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 41 and 52 U-2190: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 41, 52, and 53 U-2191: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 54 and 64 U-2192: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 54, 64, and 65 U-2193: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 66 and 75 U-2194: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 66, 75, and 76 U-2195: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 77 and 87 U-2196: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 77, 87, and 88 U-2197: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 89 and 99 U-2198: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 89, 99, and 100 |
| Pat. No. 9993474 Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 12, 2018 | Apr 30, 2032 | U-2384: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 1 and 10 U-2385: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 1,10 and 11 U-2386: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12 and 19 U-2387: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12, 19 and 20 U-2388: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 21 and 28 U-2389: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 21, 28, and 29 U-2390: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 30 and 41 U-2391: Adjunct to diet and excercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 30, 41, and 42 U-2392: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 43 and 50 U-2393: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes by administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 43, 50 and 51 |
| Pat. No. 10688094 Bromocriptine formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 11, 2020 | Apr 30, 2032 | U-2870: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 2 U-2871: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 2 and 3 U-2872: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 4 and 5 U-2873: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 4, 5, and 6 U-2874: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 7 and 8 U-2875: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 7, 8, and 9 U-2876: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 10 and 11 U-2877: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 10, 11, and 12 U-2878: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 13 and 14 U-2879: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 13, 14, and 15 U-2880: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 16 and 17 U-2881: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 16, 17, and 18 U-2882: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 19 and 20 U-2883: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 19, 20, and 21 U-2884: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 22, 23, and 24 U-2885: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 25 and 26 U-2886: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 25, 26, and 27 U-2887: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 28 and 29 U-2888: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis [sic, diabetes] by orally administering a dosage form comprising micronized bromocriptine and one or more excipients as recited in claims 28, 29, and 30 |
| Pat. No. 11000522 Bromocriptine formulations Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jun 3, 2021 | Apr 30, 2032 | U-3119: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 11 U-3120: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 11, and 12 U-3121: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13 and 23 U-3122: Adjunct to diet exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13, 23, and 24 |
NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: PARAPRO LLC NDA No.: 022408 Prod. No.: 001 RX (0.9%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6063771 DP* [Extended 1494 days (4.1 years)] Formulations for controlling human lice Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 24, 2015 | Jul 25, 2023 | U-1670: NATROBA topical suspension is a pediculicide indicated for the topical treatment of head lice infestation in patients six (6) months of age and older. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 28, 2024 | I-858: For the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older |
TOLSURA (CAPSULE) (ORAL) ITRACONAZOLE
Drug Classes: Antifungals == azole antifungal
NDA Applicant: MAYNE PHARMA INTL NDA No.: 208901 Prod. No.: 001 RX (65MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8771739 DP* Pharmaceutical compositions for poorly soluble drugs Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jul 25, 2023 | |
| Pat. No. 8921374 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | |
| Pat. No. 9272046 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | |
| Pat. No. 9713642 Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 18, 2018 | Jun 21, 2033 | U-2453: Treatment of fungal infections, including blastomycosis, histoplasmosis, and aspergillosis |
| Pat. No. 10463740 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 27, 2019 | Jun 21, 2033 | U-2453: Treatment of fungal infections, including blastomycosis, histoplasmosis, and aspergillosis |
| Pat. No. 10806792 DP* Itraconazole compositions and dosage forms, and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 24, 2020 | Jun 21, 2033 |
BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE [GENERIC AT]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC NDA No.: 022288 Prod. No.: 001 RX (1.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8877168 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 25, 2014 | Jul 30, 2023 | |
| Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2014 | Jan 13, 2025 |
DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022287 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): All strengths: None | Jul 30, 2023 *PED | U-1507: To maintain healing of EE and relief of heartburn U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 8722084 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Apr 15, 2024 *PED | |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Apr 15, 2024 *PED | U-1552: For healing of all grades of erosive esophagitis (EE) U-1553: To maintain healing of EE and relief of heartburn U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD) |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 1, 2015 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 17, 2026 *PED | |
| Pat. No. 7790755 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None | Feb 2, 2027 *PED | |
| Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None | Mar 27, 2027 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jan 11, 2028 | |
| Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None | Sep 17, 2030 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Mar 5, 2032 | U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions |
DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208056 Prod. No.: 001 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 30, 2023 *PED | U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Apr 15, 2024 *PED | |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 17, 2026 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 11, 2028 *PED | |
| Pat. No. 9241910 DP* Orally-disintegrating solid preparation Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 10, 2029 |
KOMBIGLYZE XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 200678 Prod. No.: 001 RX (500MG;EQ 5MG BASE); 002 RX (1GM;EQ 5MG BASE); 003 RX (1GM;EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2013 | Jul 31, 2023 | U-1097: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate U-1838: Method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 31, 2014; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 9339472 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2016; 002: Mar 22, 2017; 003: Mar 22, 2017 | Jul 13, 2025 |
ONGLYZA (TABLET) (ORAL) SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 022350 Prod. No.: 001 RX (EQ 2.5MG BASE); 002 RX (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 24, 2013; 002: None | Jul 31, 2023 | U-1837: Method for treating type ii diabetes mellitus by administering saxagliptin alone or in combination with insulin, metformin, a thiazolidinedione, glyburide or metformin plus a sulfonylurea U-995: Method for treating Type II diabetes by administering saxagliptin |
| Pat. No. 7951400 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 29, 2011; 002: None | Nov 30, 2028 |
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 001 RX (10MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Jun 20, 2027 | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2017 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 22, 2017 | Dec 16, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 2, 2022 | I-804: Expanded indication for use as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 209091 Prod. No.: 002 RX (5MG;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: May 24, 2019 | Dec 16, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | May 2, 2022 |
QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 210874 Prod. No.: 001 DISC (2.5MG;1GM;EQ 2.5MG BASE); 002 DISC (5MG;1GM;EQ 2.5MG BASE); 003 DISC (5MG;1GM;EQ 5MG BASE); 004 DISC (10MG;1GM;EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44186 DS* DP* Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Jul 31, 2023 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8628799 DP* Coated tablet formulation and method Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Jul 13, 2025 | |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Oct 4, 2025 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2019 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Mar 21, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: May 24, 2019 | Dec 16, 2029 | |
| Pat. No. 9616028 DP* Bilayer tablet formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 24, 2019 | Nov 12, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 2, 2022 |
SIGNIFOR LAR KIT (FOR SUSPENSION) (INTRAMUSCULAR) PASIREOTIDE PAMOATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == somatostatin analog
NDA Applicant: RECORDATI RARE NDA No.: 203255 Prod. No.: 001 RX (EQ 20MG BASE/VIAL); 002 RX (EQ 40MG BASE/VIAL); 003 RX (EQ 60MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8822637 Somatostatin analogues Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Aug 6, 2023 | U-1629: Method of treating acromegaly |
| Pat. No. 7759308 DP* Microparticles comprising somatostatin analogues Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Oct 25, 2026 | |
| Pat. No. 7473761 DS* DP* [Extended 871 days (2.4 years)] Somatostatin analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 13, 2015 | Dec 14, 2026 | |
| Pat. No. 9351923 DP* Extended-release composition comprising a somatostatin derivative in microparticles Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 13, 2017 | May 23, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 29, 2025 | ODE-268: Indicated for treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 15, 2021 | ODE-81: Treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option |
GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206073 Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 12, 2023 | U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 12, 2023 | U-1653: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without metformin) U-1654: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without insulin or a sulfonylurea) |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 19, 2015 | May 2, 2025 | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Nov 26, 2025 | |
| Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Apr 15, 2027 | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 19, 2015 | May 4, 2027 | U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin |
| Pat. No. 9173859 DP* DLR* Uses of DPP IV inhibitors Claim Types: Method of use; Method of administration; Formulation Pat. Sub. Date(s): All strengths: Dec 2, 2015 | May 4, 2027 | U-1772: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 11033552 DP* DPP IV inhibitor formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2021 | May 4, 2027 | |
| Pat. No. 7579449 DS* Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Claim Types: Compound Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 1, 2028 | |
| Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Claim Types: Composition; Method of use; Formulation; Method of administration Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Oct 14, 2029 | U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin |
| Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: Apr 30, 2019 | Apr 3, 2034 | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Pat. No. 11090323 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2021 | Apr 3, 2034 | U-3191: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (30 ml/min/1.73 m2<=egfr<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 15, 2018 | Jun 11, 2034 | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201281 Prod. No.: 001 RX (2.5MG;500MG); 002 RX (2.5MG;850MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 15, 2012; 002: None | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 8, 2012 | Aug 12, 2023 | U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 22, 2012 | May 2, 2025 | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Dec 9, 2014 | Nov 26, 2025 | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 15, 2014 | May 4, 2027 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2016 | Apr 2, 2029 | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2018 | Apr 2, 2029 | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 10973827 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 5, 2021 | Apr 2, 2029 | |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Oct 21, 2015 | May 21, 2030 | |
| Pat. No. 8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2014 | Jun 4, 2030 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201281 Prod. No.: 003 RX (2.5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 003: None | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jun 8, 2012 | Aug 12, 2023 | U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 22, 2012 | May 2, 2025 | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): 003: Dec 9, 2014 | Nov 26, 2025 | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 15, 2014 | May 4, 2027 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 30, 2016 | Apr 2, 2029 | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 6, 2018 | Apr 2, 2029 | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 10973827 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): 003: May 5, 2021 | Apr 2, 2029 | |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): 003: Oct 21, 2015 | May 21, 2030 | |
| Pat. No. 8846695 DLR* Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 21, 2014 | Jun 4, 2030 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
JENTADUETO XR (TABLET, EXTENDED RELEASE) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 208026 Prod. No.: 001 RX (2.5MG;1GM); 002 RX (5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Aug 12, 2023 | U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Aug 12, 2023 | U-1853: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and, optionally, a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jun 22, 2016 | May 2, 2025 | |
| Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Claim Types: Compound; Process; Product-by-process Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 26, 2025 | |
| Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | May 4, 2027 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9173859 DP* DLR* Uses of DPP IV inhibitors Claim Types: Method of use; Method of administration; Formulation Pat. Sub. Date(s): All strengths: Jun 22, 2016 | May 4, 2027 | U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin |
| Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2016 | Apr 2, 2029 | |
| Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2018 | Apr 2, 2029 | U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus |
| Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jun 22, 2016 | May 21, 2030 | |
| Pat. No. 9555001 DP* Pharmaceutical composition and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 22, 2017 | Mar 6, 2033 | U-1967: Method of treating Type 2 diabetes in patients with insufficient glycemic control despite therapy with one or more conventional antihyperglycemic agents by administering linagliptin in combination with metformin U-1968: Method of treating Type 2 diabetes in patients who have not been previously treated with an antihyperglycemic agent by administering linagliptin in combination with metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 30, 2023 | M-252: Addition of information to clinical studies section regarding cardiovascular outcome |
| Exclusivity Code: M - Miscellaneous | Jul 3, 2022 | M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4 |
TRADJENTA (TABLET) (ORAL) LINAGLIPTIN [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201280 Prod. No.: 001 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 20, 2012 | Aug 12, 2023 | U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone) U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor |
| Pat. No. 8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 8, 2012 | Aug 12, 2023 | U-1244: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with sulfonlyurea U-1245: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with pioglitazone U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone) U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea |
| Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)] 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 31, 2011 | May 2, 2025 |