Orange Book Companion
Patent Expiration View
Products whose next patent expiration is in 2023

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.


DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC      NDA No.: 210238  Prod. No.: 001 RX (EQ 20MG BASE)
PatentsExpirationPatented 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, 2023U-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, 2023U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 26, 2022I-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 entityMay 21, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJun 26, 2026ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

IBRANCE (CAPSULE) (ORAL) PALBOCICLIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 207103  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
PatentsExpirationPatented 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, 2023U-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: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 212436  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
PatentsExpirationPatented 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, 2023U-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 

NOURIANZ (TABLET) (ORAL) ISTRADEFYLLINE
NDA Applicant: KYOWA KIRIN      NDA No.: 022075  Prod. No.: 001 RX (20MG); 002 RX (40MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 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))
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2025U-336: Diagnostic radioimaging
Pat. No. 8916131 DP* Radiopharmaceutical composition
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Feb 18, 2015
Sep 16, 2028 

JANUMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022044  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 4, 2024 PEDM-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling
Exclusivity Code: M - MiscellaneousFeb 12, 2023 PEDM-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus

JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202270  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 4, 2024 PEDM-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling
Exclusivity Code: M - MiscellaneousFeb 12, 2023 PEDM-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus

JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202270  Prod. No.: 003 RX (1GM;EQ 100MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 12, 2023 PEDM-244: Information added to the labeling regarding efficacy and safety of the continuation of sitagliptin compared with the withdrawal of sitagliptin during initiation and titration of insulin glargine in subjects with Type 2 diabetes mellitus

JANUVIA (TABLET) (ORAL) SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021995  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 4, 2024 PEDM-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling
Exclusivity Code: M - MiscellaneousFeb 12, 2023 PEDM-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: 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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, 2030U-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, 2030U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2022 

OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: ENDO PHARMS      NDA No.: 021610  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**); 003 DISC (20MG**); 004 DISC (40MG**); 005 DISC (7.5MG**); 006 DISC (15MG**); 007 DISC (30MG**)
PatentsExpirationPatented 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, 2023U-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, 2027U-3085: Dose modification for renal impairment
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Nov 22, 2029 

OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ENDO PHARMS      NDA No.: 201655  Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
PatentsExpirationPatented 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, 2027U-1598: Method of administration of controlled release oxymorphone
Pat. No. 7851482 DS* Method for making analgesics
Claim Types: Composition; Method of use; Process
Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Jul 10, 2029 
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 7, 2014
Nov 22, 2029 

NEXAVAR (TABLET) (ORAL) SORAFENIB TOSYLATE [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 021923  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationPatented 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, 2023U-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, 2027U-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, 2028U-1480: Treatment of advanced renal cell carcinoma
U-1696: Treatment of unresectable hepatocellular carcinoma
U-2107: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment

LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ALLERGAN      NDA No.: 021323  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
PatentsExpirationPatented 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: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 022522  Prod. No.: 001 RX (500MCG)
PatentsExpirationPatented 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
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
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
Mar 8, 2024U-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
Mar 8, 2024U-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
Mar 8, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 23, 2021D-171: Revised dosing to include up-titration as a strategy to improve tolerability and thereby reduce treatment discontinuation for roflumilast maintenance dosage of 500 mcg daily

DALIRESP (TABLET) (ORAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 022522  Prod. No.: 002 RX (250MCG)
PatentsExpirationPatented 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): 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): 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): 002: Mar 14, 2018
Mar 8, 2024U-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): 002: Mar 14, 2018
Mar 8, 2024U-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): 002: Mar 14, 2018
Mar 8, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 23, 2021 

TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: alkylating drug
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022277  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Feb 21, 2023 
Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jan 28, 2014
Feb 21, 2023 
Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Sep 8, 2023 

TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE      NDA No.: 021656  Prod. No.: 001 RX (48MG); 002 RX (145MG)
PatentsExpirationPatented 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, 2023U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)

ZECUITY (SYSTEM) (IONTOPHORESIS) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 202278  Prod. No.: 001 DISC (EQ 6.5MG BASE/4HR)
PatentsExpirationPatented 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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2029U-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, 2030U-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, 2032U-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 stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021977  Prod. No.: 001 RX (30MG); 002 RX (50MG); 003 RX (70MG)
PatentsExpirationPatented Use
Pat. No. 7105486 Abuse-resistant amphetamine compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023 
Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023 
Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7659254 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults
Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 3, 2012; 002: None; 003: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671031 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678770 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023 
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 3, 2012; 002: None; 003: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021977  Prod. No.: 004 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 7105486 Abuse-resistant amphetamine compounds
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds
Claim Types: Formulation
Pat. Sub. Date(s): 004: None
Feb 24, 2023 
Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): 004: None
Feb 24, 2023 
Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7659254 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults
Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds
Claim Types: Compound
Pat. Sub. Date(s): 004: None
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671031 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678770 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 004: None
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation
Pat. Sub. Date(s): 004: None
Feb 24, 2023 
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 004: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 004: Mar 6, 2012
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021977  Prod. No.: 005 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7105486 Abuse-resistant amphetamine compounds
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds
Claim Types: Formulation
Pat. Sub. Date(s): 005: None
Feb 24, 2023 
Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): 005: None
Feb 24, 2023 
Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7659254 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults
Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds
Claim Types: Compound
Pat. Sub. Date(s): 005: None
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671031 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678770 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 005: None
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation
Pat. Sub. Date(s): 005: None
Feb 24, 2023 
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 005: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021977  Prod. No.: 006 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 7105486 Abuse-resistant amphetamine compounds
Claim Types: Method of use
Pat. Sub. Date(s): 006: None
Feb 24, 2023U-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
Feb 24, 2023 
Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): 006: None
Feb 24, 2023 
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
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 006: None
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023U-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
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 006: None
Feb 24, 2023U-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
Feb 24, 2023 
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 006: None
Feb 24, 2023U-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
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 006: None
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

VYVANSE (CAPSULE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021977  Prod. No.: 007 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds
Claim Types: Formulation
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7655630 DS* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7659254 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-1034: Treatment of attention deficit hyperactivity disorder (ADHD) in adults
Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds
Claim Types: Compound
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671031 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678770 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Pat. No. 7700561 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023 
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 007: Sep 22, 2015
Feb 24, 2023U-842: Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

VYVANSE (TABLET, CHEWABLE) (ORAL) LISDEXAMFETAMINE DIMESYLATE
Drug Classes: central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208510  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG); 004 RX (40MG); 005 RX (50MG); 006 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 7105486 Abuse-resistant amphetamine compounds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7223735 DP* Abuse resistant lysine amphetamine compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023 
Pat. No. 7655630 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023 
Pat. No. 7659253 DS* DP* Abuse-resistant amphetamine prodrugs
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7659254 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7662787 DS* Abuse resistant lysine amphetamine compounds
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023 
Pat. No. 7662788 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671030 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7671031 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7674774 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7678770 Abuse-resistant amphetamine prodrugs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7678771 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7687466 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023 
Pat. No. 7687467 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7713936 Abuse-resistant amphetamine prodrugs
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7718619 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 7723305 DP* Abuse-resistant amphetamine prodrugs
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2017
Feb 24, 2023U-727: 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)
PatentsExpirationPatented 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, 2023U-785: Use as replacement solution, hemofiltration solution or hemodiafiltration solution in continuous renal replacement therapy

ZOLINZA (CAPSULE) (ORAL) VORINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: MERCK      NDA No.: 021991  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2024U-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, 2025U-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, 2028U-892: Treatment of cutaneous manifestations in patients wtih [sic, with] cutaneous T-cell lymphoma (CTCL)

BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
NDA Applicant: ASCEND THERAPS US      NDA No.: 202344  Prod. No.: 001 RX (EQ 70MG BASE)
PatentsExpirationPatented 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 

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)
PatentsExpirationPatented Use
Pat. No. 6946149 DP* Salt solution for colon cleansing
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 7, 2023U-837: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 5, 2027ODE-315: For cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older

DIFFERIN (GEL) (TOPICAL) ADAPALENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021753  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2025U-818: Topical treatment of acne vulgaris

KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
NDA Applicant: ASTRAZENECA      NDA No.: 213756  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
PatentsExpirationPatented 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, 2026U-2800: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 10, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2027ODE-288: Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210498  Prod. No.: 001 RX (15MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-2331: Indicated in combination with encorafenib for the treatment of melanoma
Pat. No. 9593100 DP* Compounds and compositions as protein kinase inhibitors
Claim Types: Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030 
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, 2030U-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, 2030U-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, 2031U-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, 2033U-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, 2033U-2334: Treatment of melanoma with a BRAF mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 27, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJun 27, 2025ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 002 OTC (2%;70% (26ML))
PatentsExpirationPatented 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, 2027U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 005 OTC (2%;70% (10.5ML))
PatentsExpirationPatented 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, 2027U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 007 OTC (2%;70% (3ML))
PatentsExpirationPatented 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, 2027U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery

AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist; serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
PatentsExpirationPatented 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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2031U-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 

PATANASE (SPRAY, METERED) (NASAL) OLOPATADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021861  Prod. No.: 001 RX (0.665MG/SPRAY)
PatentsExpirationPatented 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 *PEDU-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: glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: NPS PHARMS INC      NDA No.: 203441  Prod. No.: 001 RX (5MG/VIAL)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 16, 2026ODE-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: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC      NDA No.: 205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
PatentsExpirationPatented 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, 2023U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
U-2656: Treatment of adult patients with active psoriatic arthritis
U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
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, 2023U-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, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
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, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
U-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
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, 2023U-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, 2023U-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-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
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, 2023U-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-2657: Treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
U-2658: Treatment of adult patients with oral ulcers associated with Behcet's disease
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, 2034U-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, 2034U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 19, 2022I-803: Treatment of adult patients with oral ulcers associated with Behcets disease
Exclusivity Code: M - MiscellaneousApr 10, 2023M-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 exclusivityJul 19, 2026ODE-248: Treatment of adult patients with oral ulcers associated with Behcets disease

TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS      NDA No.: 211172  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
PatentsExpirationPatented 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, 2031U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityOct 5, 2025ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 203214  Prod. No.: 001 RX (EQ 5MG BASE)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 30, 2021I-780: Treatment of adult patients with moderately to severely active ulcerative colitis (UC)
Exclusivity Code: NPP - New patient populationSep 25, 2023 

XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 203214  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 30, 2021I-780: Treatment of adult patients with moderately to severely active ulcerative colitis (UC)

XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER      NDA No.: 208246  Prod. No.: 001 RX (EQ 11MG BASE)
PatentsExpirationPatented 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 

XELJANZ XR (TABLET, EXTENDED RELEASE) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER      NDA No.: 208246  Prod. No.: 002 RX (EQ 22MG BASE)
PatentsExpirationPatented 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 

REYVOW (TABLET) (ORAL) LASMIDITAN SUCCINATE
NDA Applicant: ELI LILLY AND CO      NDA No.: 211280  Prod. No.: 001 RX (50MG); 002 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 8748459 Pyridinoylpiperidines as 5-HT.sub.1F agonists
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 25, 2020
Mar 27, 2023U-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): All strengths: Feb 25, 2020
Apr 6, 2025U-1719: Acute treatment of migraine
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 31, 2025 

GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC      NDA No.: 021748  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented 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 

UPTRAVI (TABLET) (ORAL) SELEXIPAG
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION      NDA No.: 207947  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
PatentsExpirationPatented Use
Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Apr 4, 2023U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Pat. No. 9173881 Therapeutic compositions containing macitentan
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Aug 12, 2029U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan
Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 12, 2016
Jun 25, 2030U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag
Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Aug 1, 2030 
Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020
Dec 1, 2036U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag
Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020
Dec 1, 2036U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2022ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah

REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE
Drug Classes: 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)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2028U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 28, 2022I-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 IndicationMay 28, 2022I-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 exclusivityFeb 22, 2024ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct)
Exclusivity Code: ODE - Orphan drug exclusivityMay 28, 2026ODE-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 exclusivityMay 28, 2026ODE-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 exclusivityFeb 17, 2022ODE-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: 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)
PatentsExpirationPatented 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, 2023U-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, 2023U-282: Method of treating bacterial infections

ZOSYN IN PLASTIC CONTAINER (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Drug Classes: penicillin class antibacterial; beta lactamase inhibitor
NDA Applicant: 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)
PatentsExpirationPatented 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, 2023U-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, 2023U-282: Method of treating bacterial infections

PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: dihydropyridine calcium channel blocker; 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)
PatentsExpirationPatented 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, 2023U-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, 2029U-3: Treatment of hypertension

TESTIM (GEL) (TRANSDERMAL) TESTOSTERONE [GENERIC AB2]
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC      NDA No.: 021454  Prod. No.: 001 RX (50MG/5GM PACKET)
PatentsExpirationPatented Use
Pat. No. 7608605 Pharmaceutical composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608606 Pharmaceutical composition
Claim Types: Method of adminstration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608607 Pharmaceutical composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608608 Pharmaceutical composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608609 Pharmaceutical composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-1009: Method for administration of testosterone
Pat. No. 7608610 Pharmaceutical composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 21, 2023U-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, 2023U-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, 2023U-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, 2025U-843: Method for administration of testosterone

DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI); HIV integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME      NDA No.: 206510  Prod. No.: 001 DISC (150MG;EQ 300MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-1663: Treatment of HIV-1 infection

ISENTRESS (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022145  Prod. No.: 001 RX (EQ 400MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 22, 2021 PED 

ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: HIV 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 22, 2021 PED 

ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME      NDA No.: 205786  Prod. No.: 001 RX (EQ 100MG BASE/PACKET)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 22, 2021 PED 

ISENTRESS HD (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI)
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022145  Prod. No.: 002 RX (EQ 600MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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, 2032U-1663: Treatment of HIV-1 infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 22, 2021 PED 

CLINDESSE (CREAM) (VAGINAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: PERRIGO PHARMA INTL      NDA No.: 050793  Prod. No.: 001 RX (EQ 2% BASE)
PatentsExpirationPatented Use
Pat. No. 6899890 DP* Bioadhesive drug delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 27, 2023U-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, 2026U-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))
PatentsExpirationPatented 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, 2023U-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 (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
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))
PatentsExpirationPatented 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, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

STENDRA (TABLET) (ORAL) AVANAFIL
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS      NDA No.: 202276  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
PatentsExpirationPatented 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, 2025U-155: Treatment of erectile dysfunction

BONIVA (TABLET) (ORAL) IBANDRONATE SODIUM [GENERIC AB]
NDA Applicant: HOFFMANN LA ROCHE      NDA No.: 021455  Prod. No.: 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
May 6, 2023U-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, 2023U-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, 2023U-642: Treatment and prevention of osteoporosis

NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator; vasopressin analog
NDA Applicant: ROIVANT      NDA No.: 201656  Prod. No.: 001 DISC (0.00083MG/SPRAY)
PatentsExpirationPatented 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, 2023U-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, 2023U-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: factor VIII activator; vasopressin analog
NDA Applicant: ROIVANT      NDA No.: 201656  Prod. No.: 002 DISC (0.00166MG/SPRAY)
PatentsExpirationPatented 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, 2023U-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, 2023U-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 

NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator; vasopressin analog
NDA Applicant: FERRING PHARMS INC      NDA No.: 022517  Prod. No.: 001 RX (0.0277MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2024U-2326: Treatment of nocturia due to nocturnal polyuria in adults
Pat. No. 9974826 Methods comprising desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2018
Apr 13, 2030U-2326: Treatment of nocturia due to nocturnal polyuria in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 21, 2021 

NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator; vasopressin analog
NDA Applicant: FERRING PHARMS INC      NDA No.: 022517  Prod. No.: 002 RX (0.0553MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2024U-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, 2029U-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, 2030U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 21, 2021 

CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS      NDA No.: 021669  Prod. No.: 001 OTC (2%)
PatentsExpirationPatented Use
Pat. No. 7595021 DP* Method of providing alcohol-free disinfection
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
May 12, 2023U-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, 2024U-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, 2025U-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, 2027U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection

BANZEL (TABLET) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC      NDA No.: 021911  Prod. No.: 002 RX (200MG); 003 RX (400MG) NDA No.: 021911  Prod. No.: 001 DISC (100MG**)
PatentsExpirationPatented Use
Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)]
Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: None
May 14, 2023 *PED 

BANZEL (SUSPENSION) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC      NDA No.: 201367  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented 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 

EXFORGE HCT (TABLET) (ORAL) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 022314  Prod. No.: 001 RX (EQ 5MG BASE;12.5MG;160MG); 002 RX (EQ 5MG BASE;25MG;160MG); 003 RX (EQ 10MG BASE;12.5MG;160MG); 004 RX (EQ 10MG BASE;25MG;160MG); 005 RX (EQ 10MG BASE;25MG;320MG)
PatentsExpirationPatented 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))
PatentsExpirationPatented 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 

MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
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)
PatentsExpirationPatented 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, 2023U-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, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 13, 2023 PEDM-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

DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; corticosteroid
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 202236  Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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: estrogen; progestin; 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)
PatentsExpirationPatented 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, 2023U-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, 2028U-1: Prevention of pregnancy

SEASONIQUE (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB]
Drug Classes: estrogen; progestin; 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)
PatentsExpirationPatented 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, 2023U-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, 2024U-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, 2028U-1: Prevention of pregnancy

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2027U-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, 2027U-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, 2027U-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. 8894987 DP* Tamper resistant dosage forms
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Mar 29, 2030 

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 004 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 9675610 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 004: Jul 12, 2017
Jun 16, 2023 
Pat. No. 10369109 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 004: Aug 9, 2019
Jun 16, 2023 
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 004: Nov 14, 2012
Nov 20, 2023U-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): 004: Nov 27, 2018
Nov 20, 2023U-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): 004: Jun 10, 2020
Nov 20, 2023 
Pat. No. 7674799 DP* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Formulation
Pat. Sub. Date(s): 004: None
Mar 30, 2025 
Pat. No. 7674800 DS* DLR* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 004: None
Mar 30, 2025 
Pat. No. 7683072 DS* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Compound
Pat. Sub. Date(s): 004: None
Mar 30, 2025 
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): 004: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 004: 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): 004: 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): 004: Jun 30, 2020
Mar 30, 2025 
Pat. No. 7776314 DP* DLR* Abuse-proofed dosage system
Claim Types: Formulation
Pat. Sub. Date(s): 004: None
Apr 19, 2025 
Pat. No. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 004: Aug 19, 2014
Aug 24, 2027U-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): 004: Nov 25, 2014
Aug 24, 2027 
Pat. No. 9492389 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): 004: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 004: Nov 16, 2016
Aug 24, 2027U-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): 004: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 004: Nov 16, 2016
Aug 24, 2027U-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): 004: Sep 19, 2017
Aug 24, 2027 
Pat. No. 9770416 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 004: Sep 27, 2017
Aug 24, 2027 
Pat. No. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 004: Oct 4, 2017
Aug 24, 2027 
Pat. No. 8894987 DP* Tamper resistant dosage forms
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 004: Nov 25, 2014
Mar 29, 2030 

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 005 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 9675610 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 12, 2017
Jun 16, 2023 
Pat. No. 10369109 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 005: Aug 9, 2019
Jun 16, 2023 
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: Nov 14, 2012
Nov 20, 2023U-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): 005: Nov 27, 2018
Nov 20, 2023U-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): 005: Jun 10, 2020
Nov 20, 2023 
Pat. No. 7674799 DP* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Formulation
Pat. Sub. Date(s): 005: None
Mar 30, 2025 
Pat. No. 7674800 DS* DLR* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 005: None
Mar 30, 2025 
Pat. No. 7683072 DS* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Compound
Pat. Sub. Date(s): 005: None
Mar 30, 2025 
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): 005: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 005: 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): 005: 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): 005: Jun 30, 2020
Mar 30, 2025 
Pat. No. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 005: Aug 19, 2014
Aug 24, 2027U-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): 005: Nov 25, 2014
Aug 24, 2027 
Pat. No. 9492389 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): 005: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 005: Nov 16, 2016
Aug 24, 2027U-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): 005: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 005: Nov 16, 2016
Aug 24, 2027U-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): 005: Sep 19, 2017
Aug 24, 2027 
Pat. No. 9770416 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 005: Sep 27, 2017
Aug 24, 2027 
Pat. No. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 005: Oct 4, 2017
Aug 24, 2027 

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 006 RX (60MG); 007 RX (80MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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. 7674799 DP* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Mar 30, 2025 
Pat. No. 7674800 DS* DLR* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Mar 30, 2025 
Pat. No. 7683072 DS* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 30, 2025 
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. 7776314 DP* DLR* Abuse-proofed dosage system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 19, 2025 
Pat. No. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
Aug 24, 2027U-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, 2027U-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, 2027U-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 

NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 203340  Prod. No.: 002 RX (6MG/ML)
PatentsExpirationPatented 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, 2038U-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, 2038U-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)
PatentsExpirationPatented 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, 2023U-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, 2029U-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, 2030U-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, 2033U-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
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, 2035U-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))
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 2, 2021I-767: Treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron

ONZETRA XSAIL (POWDER) (NASAL) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX      NDA No.: 206099  Prod. No.: 001 RX (EQ 11MG BASE)
PatentsExpirationPatented 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, 2023U-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, 2025U-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, 2025U-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, 2027U-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, 2028U-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, 2029U-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, 2030U-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, 2033U-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 [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 021400  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 021400  Prod. No.: 003 DISC (EQ 2.5MG BASE**)
PatentsExpirationPatented 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, 2027U-1288: Treatement [sic, Treatment] of erectiile [sic, erectile] dysfunction by administering a film-coated tablet

XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 208090  Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2025U-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, 2030U-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, 2030U-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, 2030U-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, 2036U-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, 2036U-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, 2036U-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, 2036U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

VISTOGARD (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite; nucleoside analog antiviral; nucleoside metabolic inhibitor; pyrimidine analog
NDA Applicant: WELLSTAT THERAP      NDA No.: 208159  Prod. No.: 001 RX (10GM/PACKET)
PatentsExpirationPatented 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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 11, 2022ODE-104: Emergency tx of pts following a FU or capecitabine OD, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac system or CNS, and/or early-onset, unusually severe ar w/in 96 hrs following the end of FU or capecitabine admin.

XURIDEN (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite; nucleoside analog antiviral; nucleoside metabolic inhibitor; pyrimidine analog
NDA Applicant: WELLSTAT THERAP      NDA No.: 208169  Prod. No.: 001 RX (2GM/PACKET)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 4, 2022ODE-98: Treatment of hereditary orotic aciduria

AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO      NDA No.: 022504  Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)
PatentsExpirationPatented 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, 2023U-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, 2026U-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, 2026U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof

ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: neprilysin inhibitor; 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)
PatentsExpirationPatented Use
Pat. No. 8101659 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. 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 *PEDU-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. 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 *PEDU-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, 2033U-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, 2033U-3084: Treatment of heart failure with preserved ejection fraction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 16, 2024M-82: Labeling revisions related to clinical studies
Exclusivity Code: NCE - New chemical entityJan 7, 2021 PED 
Exclusivity Code: NPP - New patient populationApr 1, 2023 PED 

NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: sigma-1 agonist; uncompetitive NMDA receptor antagonist; antiarrhythmic; CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS      NDA No.: 021879  Prod. No.: 001 RX (20MG;10MG)
PatentsExpirationPatented 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, 2023U-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, 2026U-1093: Treatment of pseudobulbar affect

TOLAK (CREAM) (TOPICAL) FLUOROURACIL
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: HILL DERMACEUTICALS      NDA No.: 022259  Prod. No.: 001 RX (4%)
PatentsExpirationPatented Use
Pat. No. 7169401 DP* Topical skin care composition containing refined peanut oil
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Nov 4, 2015
Jul 18, 2023 

MOZOBIL (SOLUTION) (SUBCUTANEOUS) PLERIXAFOR
Drug Classes: hematopoietic stem cell mobilizer
NDA Applicant: GENZYME      NDA No.: 022311  Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 6987102 Methods to mobilize progenitor/stem cells
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 22, 2023U-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, 2023U-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

CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE      NDA No.: 020866  Prod. No.: 001 RX (EQ 0.8MG BASE)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2032U-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, 2032U-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, 2032U-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, 2032U-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, 2032U-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, 2032U-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, 2032U-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

TOLSURA (CAPSULE) (ORAL) ITRACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MAYNE PHARMA INTL      NDA No.: 208901  Prod. No.: 001 RX (65MG)
PatentsExpirationPatented 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, 2033U-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, 2033U-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
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 022288  Prod. No.: 001 RX (1.5%)
PatentsExpirationPatented Use
Pat. No. 8877168 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 25, 2014
Jul 30, 2023 
Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2014
Jan 13, 2025 

DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022287  Prod. No.: 001 RX (30MG); 002 RX (60MG)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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, 2032U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions

DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208056  Prod. No.: 001 DISC (30MG)
PatentsExpirationPatented 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 *PEDU-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: biguanide; 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)
PatentsExpirationPatented 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, 2023U-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: 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)
PatentsExpirationPatented 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, 2023U-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: 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)
PatentsExpirationPatented 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, 2023U-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, 2025U-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, 2027U-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, 2028U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 2, 2022I-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: 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)
PatentsExpirationPatented 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, 2023U-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, 2025U-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, 2027U-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, 2028U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthMay 2, 2022 

QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: 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)
PatentsExpirationPatented 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, 2023U-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, 2025U-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, 2027U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 2, 2022 

SIGNIFOR LAR KIT (FOR SUSPENSION) (INTRAMUSCULAR) PASIREOTIDE PAMOATE
Drug Classes: somatostatin analog
NDA Applicant: RECORDATI RARE      NDA No.: 203255  Prod. No.: 001 RX (EQ 20MG BASE/VIAL); 002 RX (EQ 40MG BASE/VIAL); 003 RX (EQ 60MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 8822637 Somatostatin analogues
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 13, 2015
Aug 6, 2023U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 29, 2021I-785: 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 exclusivityJun 29, 2025ODE-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 exclusivityDec 15, 2021ODE-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: 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)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2027U-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, 2027U-1772: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
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, 2029U-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, 2034U-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. 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, 2034U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 30, 2023M-252: Addition of information to clinical studies section regarding cardiovascular outcome
Exclusivity Code: M - MiscellaneousJul 3, 2022M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4

JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201281  Prod. No.: 001 RX (2.5MG;500MG); 002 RX (2.5MG;850MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2027U-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, 2029U-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: 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, 2030U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 30, 2023M-252: Addition of information to clinical studies section regarding cardiovascular outcome
Exclusivity Code: M - MiscellaneousJul 3, 2022M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4

JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201281  Prod. No.: 003 RX (2.5MG;1GM)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2027U-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, 2029U-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): 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, 2030U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 30, 2023M-252: Addition of information to clinical studies section regarding cardiovascular outcome
Exclusivity Code: M - MiscellaneousJul 3, 2022M-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: 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)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2027U-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, 2027U-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, 2029U-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, 2033U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 30, 2023M-252: Addition of information to clinical studies section regarding cardiovascular outcome
Exclusivity Code: M - MiscellaneousJul 3, 2022M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4

TRADJENTA (TABLET) (ORAL) LINAGLIPTIN
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201280  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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 
Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Claim Types: Compound; Process; Product-by-process
Pat. Sub. Date(s): 001: Dec 9, 2014
Nov 26, 2025 
Pat. No. 8673927 DLR* Uses of DPP-IV inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2014
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9486526 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Nov 18, 2016
Aug 5, 2029U-1915: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and who are ineligible for metformin therapy by administering linagliptin
Pat. No. 10034877 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 10, 2018
Aug 5, 2029U-2347: Treatment of Type 2 diabetes mellitus in a patient with renal impairment and for whom metformin therapy is inappropriate by administering linagliptin without dose adjustment
Pat. No. 8846695 DLR* Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 21, 2014
Jun 4, 2030U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 8853156 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2015
Mar 5, 2031U-1642: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and for whom metformin therapy is inappropriate by administering linagliptin
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 30, 2023M-252: Addition of information to clinical studies section regarding cardiovascular outcome
Exclusivity Code: M - MiscellaneousJul 3, 2022M-258: Information added to the labeling to describe carmelina trial to fulfill postmarketing commitment 1766-4

TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; dipeptidyl peptidase-4 (DPP-4) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 212614  Prod. No.: 001 RX (5MG;2.5MG;1GM); 002 RX (10MG;5MG;1GM); 003 RX (12.5MG;2.5MG;1GM); 004 RX (25MG;5MG;1GM)
PatentsExpirationPatented Use
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Aug 12, 2023U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Aug 12, 2023U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin
Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)]
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Feb 18, 2020
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 18, 2020
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 18, 2020
Apr 15, 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 18, 2020
Aug 1, 2028 
Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Apr 2, 2029 
Pat. No. 10022379 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Apr 2, 2029U-2732: Method of treating Type 2 diabetes using a pharmaceutical composition comprising linagliptin, metformin, empagliflozin and a basic amino acid
Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Claim Types: Composition; Method of use; Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Oct 14, 2029U-2730: Method of treating Type 2 diabetes mellitus using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin
Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Feb 18, 2020
May 21, 2030 
Pat. No. 10406172 DP* Pharmaceutical composition, methods for treating and uses thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Jun 15, 2030U-2733: Method of treating a Type 2 diabetes mellitus patient with insufficient glycemic control despite therapy with metformin using a pharmaceutical composition comprising empagliflozin, linagliptin and metformin
Pat. No. 10596120 DP* Pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 21, 2020
Mar 7, 2032U-2776: Treatment of a Type 2 diabetes mellitus patient with insufficient glycemic control despite metformin therapy using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin
U-2790: Treatment of a treatment-naive patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprisingmetformin and an outer coating comprising empagliflozin and linagliptin
Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Apr 3, 2034U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin
Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 18, 2020
Jun 11, 2034U-2731: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 M2<=egfr<60 ml/min/1.73 M2) by once daily administration of 10 mg or 25 mg of empagliflozin in combination with linagliptin and metformin

ZERIT XR (CAPSULE, EXTENDED RELEASE) (ORAL) STAVUDINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021453  Prod. No.: 001 DISC (37.5MG); 002 DISC (50MG); 003 DISC (75MG); 004 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 7135465 DP* Sustained release beadlets containing stavudine
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Aug 18, 2023 *PEDU-167: Method for treating HIV-1 infection

CUVPOSA (SOLUTION) (ORAL) GLYCOPYRROLATE
Drug Classes: anticholinergic
NDA Applicant: MERZ PHARMS      NDA No.: 022571  Prod. No.: 001 RX (1MG/5ML)
PatentsExpirationPatented Use
Pat. No. 7638552 Method for increasing the bioavailability of glycopyrrolate
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Aug 20, 2023U-1076: Reduce chronic severe drooling (i.e., sialorrhea) in patients with neurologic conditions associated with problem drooling
Pat. No. 7816396 Method for increasing the bioavailability of glycopyrrolate
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 20, 2023U-1076: Reduce chronic severe drooling (i.e., sialorrhea) in patients with neurologic conditions associated with problem drooling

SPINRAZA (SOLUTION) (INTRATHECAL) NUSINERSEN SODIUM
Drug Classes: survival motor neuron-2 (SMN2)-directed antisense oligonucleotide
NDA Applicant: BIOGEN IDEC      NDA No.: 209531  Prod. No.: 001 RX (EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 23, 2017
Sep 5, 2023 
Pat. No. 8110560 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2017
Dec 5, 2025U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site
Pat. No. 10266822 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Claim Types: Method of use; Method of initiating or enhancing a biochemical function in vivo
Pat. Sub. Date(s): 001: Jul 24, 2019
Dec 5, 2025U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site
Pat. No. 7838657 DS* Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 23, 2017
Jul 11, 2027 
Pat. No. 8361977 DS* DP* Compositions and methods for modulation of SMN2 splicing
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 23, 2017
May 27, 2030 
Pat. No. 9717750 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 31, 2017
Jun 17, 2030U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-2093: Treatment of type ii spinal muscular atrophy
U-2094: Treatment of type iii spinal muscular atrophy
Pat. No. 8980853 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2017
Nov 24, 2030U-1941: Treatment of infantile-onset spinal muscular atrophy
Pat. No. 9926559 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 24, 2018
Jan 9, 2034U-1943: Treatment of spinal muscular atrophy
Pat. No. 10436802 Methods for treating spinal muscular atrophy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2019
Sep 11, 2035U-1941: Treatment of infantile-onset spinal muscular atrophy
U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site
U-2093: Treatment of type ii spinal muscular atrophy
U-2094: Treatment of type iii spinal muscular atrophy
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 14, 2021M-226: Changes to the labeling based on results from a controlled clinical trial in patients with later-onset spinal muscular atrophy
Exclusivity Code: NCE - New chemical entityDec 23, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityDec 23, 2023ODE-127: Treatment of spinal muscular atrophy in pediatric and adult patients

TYZEKA (TABLET) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: NOVARTIS      NDA No.: 022011  Prod. No.: 001 DISC (600MG)
PatentsExpirationPatented Use
Pat. No. 7589079 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients

TYZEKA (SOLUTION) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: NOVARTIS      NDA No.: 022154  Prod. No.: 001 DISC (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients

PROAIR HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [GENERIC AB2]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7105152 DP* Suspension aerosol formulations
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: None
Sep 12, 2023 
Pat. No. 8132712 DP* Metered-dose inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2012
Sep 7, 2028 
Pat. No. 9463289 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 8, 2016
May 18, 2031 
Pat. No. 9808587 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 16, 2017
May 18, 2031 
Pat. No. 10022509 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10086156 DP* Dose counter for inhaler and method for counting doses
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Oct 17, 2018
May 18, 2031 
Pat. No. 10695512 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 30, 2020
May 18, 2031 
Pat. No. 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 

LAMICTAL XR (TABLET, EXTENDED RELEASE) (ORAL) LAMOTRIGINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED); mood stabilizer
NDA Applicant: GLAXOSMITHKLINE LLC      NDA No.: 022115  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG); 004 RX (200MG); 005 RX (300MG); 006 RX (250MG)
PatentsExpirationPatented Use
Pat. No. 9144547 DP* Oral dosage form for controlled drug release
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Oct 29, 2015
Sep 22, 2023 
Pat. No. 8637512 DP* Formulations and method of treatment
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 12, 2014
Jun 14, 2028 

REBETOL (SOLUTION) (ORAL) RIBAVIRIN
Drug Classes: nucleoside analog antiviral
NDA Applicant: SCHERING      NDA No.: 021546  Prod. No.: 001 DISC (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 6790837 DP* Ribavirin syrup formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 5, 2023 *PED 

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021379  Prod. No.: 001 RX (22.5MG)
PatentsExpirationPatented Use
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 31, 2017
Oct 15, 2023U-621: Method of treating cancer

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021488  Prod. No.: 001 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 31, 2017
Oct 15, 2023U-621: Method of treating cancer

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021731  Prod. No.: 001 RX (45MG)
PatentsExpirationPatented Use
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 31, 2017
Oct 15, 2023U-621: Method of treating cancer

FENSOLVI KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 213150  Prod. No.: 001 RX (45MG)
PatentsExpirationPatented Use
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 28, 2020
Oct 15, 2023U-2940: Method of treating pediatric patients 2 years of age and older with central precocious puberty
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 1, 2023I-829: Treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP)

ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
NDA Applicant: EIGER BIOPHARMS      NDA No.: 213969  Prod. No.: 001 RX (50MG); 002 RX (75MG)
PatentsExpirationPatented Use
Pat. No. 8828356 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 24, 2021
Oct 17, 2023U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)
Pat. No. 7838531 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 24, 2021
Jul 26, 2024U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 20, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2027ODE-324: Treatment of Hutchinson-Gilford progeria syndrome (HGPS) and progeroid laminopathies

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 18, 2016
Oct 20, 2023 
Pat. No. 10519252 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 17, 2020
Oct 20, 2023U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose
U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
U-2711: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron
U-2712: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron
U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 12, 2013
Feb 5, 2024 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 17, 2014
Jan 8, 2027U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 12, 2013
Feb 15, 2028U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex
U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Feb 2, 2021
Oct 20, 2023 
Pat. No. 10519252 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 2, 2021
Oct 20, 2023U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose
U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Feb 2, 2021
Feb 5, 2024 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Feb 2, 2021
Jan 8, 2027U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 2, 2021
Feb 15, 2028U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron

FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: LEO PHARMA AS      NDA No.: 207071  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 8722021 DP* Foamable carriers
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2015
Oct 24, 2023 
Pat. No. 8900554 DP* Foamable composition and uses thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 26, 2015
Oct 24, 2023 
Pat. No. 10322085 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 21, 2019
Oct 24, 2023 
Pat. No. 8435498 Penetrating pharmaceutical foam
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 26, 2015
Mar 1, 2024U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 7700076 DP* Penetrating pharmaceutical foam
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2015
Sep 18, 2027 
Pat. No. 10117812 DP* Foamable composition combining a polar solvent and a hydrophobic carrier
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2018
Oct 18, 2027U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 9265725 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 23, 2016
Dec 8, 2027 
Pat. No. 9211259 Antibiotic kit and composition and uses thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 14, 2016
Feb 28, 2029U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea

RECLAST (INJECTABLE) (INTRAVENOUS) ZOLEDRONIC ACID [GENERIC AP]
Drug Classes: bisphosphonate
NDA Applicant: NOVARTIS      NDA No.: 021817  Prod. No.: 001 RX (EQ 5MG BASE/100ML)
PatentsExpirationPatented Use
Pat. No. 8052987 Method of administering bisphosphonates
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 27, 2023U-1199: Treatment and prevention of postmenopausal or glucocorticoid-induced osteoporosis and treatment to increase bone mass in men with osteoporosis
Pat. No. 7932241 DP* Pharmaceutical products comprising bisphosphonates
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: May 25, 2011
Aug 5, 2028 *PED 

RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA      NDA No.: 021745  Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
PatentsExpirationPatented Use
Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None
Oct 27, 2023 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 005 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-662: Treatment of osteoporosis in postmenopausal women

XEPI (CREAM) (TOPICAL) OZENOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: FERRER INTERNACIONAL      NDA No.: 208945  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6335447 DS* Quinolonecarboxylic acid derivatives or salts thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 19, 2018
Nov 9, 2023 
Pat. No. 9399014 Pharmaceutical topical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2018
Dec 15, 2029U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
Pat. No. 9180200 DP* Pharmaceutical topical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2018
Jan 29, 2032U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 11, 2022 

KYLEENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE      NDA No.: 208224  Prod. No.: 001 RX (19.5MG)
PatentsExpirationPatented Use
Pat. No. 7252839 DP* Delivery system and a manufacturing process of a delivery system
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 11, 2016
Nov 13, 2023 
Pat. No. 9615965 DP* Inserter
Claim Types: Device; Kit; Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 9, 2017
Sep 16, 2029U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system
Pat. No. 10561524 Inserter
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 28, 2020
Sep 16, 2029U-2948: A method of positioning an intrauterine system (IUS) by determining a depth of the uterus, holding an inserter handle with one hand, inserting the IUS into the uterus, and retracting a slider on the handle to release the IUS into the uterus
Pat. No. 9668912 DP* Inserter
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 28, 2017
Apr 1, 2031 

SKYLA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE      NDA No.: 203159  Prod. No.: 001 RX (13.5MG)
PatentsExpirationPatented Use
Pat. No. 7252839 DP* Delivery system and a manufacturing process of a delivery system
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Feb 5, 2013
Nov 13, 2023 
Pat. No. 9615965 DP* Inserter
Claim Types: Device; Kit; Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 9, 2017
Sep 16, 2029U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system
Pat. No. 10561524 Inserter
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 28, 2020
Sep 16, 2029U-2948: A method of positioning an intrauterine system (IUS) by determining a depth of the uterus, holding an inserter handle with one hand, inserting the IUS into the uterus, and retracting a slider on the handle to release the IUS into the uterus
Pat. No. 9668912 DP* Inserter
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 28, 2017
Apr 1, 2031 

AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: muscle relaxant
NDA Applicant: TEVA PHARMS INTL      NDA No.: 021777  Prod. No.: 001 RX (15MG); 002 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7544372 Modified release dosage forms of skeletal muscle relaxants
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023U-979: Relief of muscle spasm
Pat. No. 7790199 DP* Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023 
Pat. No.