Patent Expiration View
Products whose next patent expiration is in 2024

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.


TASIGNA (CAPSULE) (ORAL) NILOTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
022068  Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 7169791 DS* DP* Inhibitors of tyrosine kinases
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: None; 002: Sep 23, 2011; 003: Apr 12, 2018
Jan 4, 2024 *PEDU-836: A method for the treatment of leukemias
Pat. No. 8389537 Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 29, 2013; 002: None; 003: Apr 12, 2018
Jan 18, 2027 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
Pat. No. 8415363 DS* DP* Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 13, 2013; 002: None; 003: Apr 12, 2018
Jan 18, 2027 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
U-1407: Treatment of newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (PH + CML)
Pat. No. 8501760 DP* Pharmaceutical compositions comprising nilotinib or its salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2013; 002: Aug 9, 2013; 003: Apr 12, 2018
Jan 18, 2027 *PED 
Pat. No. 8293756 DP* Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Oct 8, 2014; 002: Oct 8, 2014; 003: Apr 12, 2018
Mar 25, 2028 *PED 
Pat. No. 8163904 DS* DP* Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: Apr 12, 2018
Feb 23, 2029 *PED 
Pat. No. 9061029 DS* Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2016; 002: Dec 1, 2016; 003: Apr 12, 2018
Oct 7, 2032 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
U-3231: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) by administering nilotinib dispersed in a fruit preparation
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 22, 2025 PEDODE-171: Treatment of pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
Exclusivity Code: ODE - Orphan drug exclusivitySep 22, 2025 PEDODE-172: Treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia with resistance or intolerance to prior tyrosine-kinase inhibitor therapy
Exclusivity Code: ODE - Orphan drug exclusivityMar 23, 2029 PEDODE-380: Treatment of pediatric patients greater than or equal to 1 year of age with accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy

LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 001 DISC (EQ 0.1MG BASE**); 002 DISC (EQ 0.4MG BASE**)
PatentsExpirationPatented Use
Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Aug 11, 2015
Jan 8, 2024 
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 13, 2017
Jan 8, 2024 
Pat. No. 8889176 Method of managing or treating pain
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 12, 2014
Jan 16, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8216604 Method of managing or treating pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None
Oct 3, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): All strengths: Sep 1, 2017
Jan 26, 2032 

LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 003 DISC (EQ 0.3MG BASE**)
PatentsExpirationPatented Use
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 13, 2017
Jan 8, 2024 
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): 003: Sep 1, 2017
Jan 26, 2032 

TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
201688  Prod. No.: 001 RX (28MG)
PatentsExpirationPatented Use
Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Jan 11, 2024 
Pat. No. RE47526 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 1, 2020
Apr 9, 2024 
Pat. No. 11484671 DP* Aerosolization apparatus with capsule puncture alignment guide
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 18, 2022
Nov 7, 2024U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 8664187 Methods of treatment of endobronchial infections
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Jun 20, 2025U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Oct 27, 2025 
Pat. No. 8869794 DP* Aerosolization apparatus with capsule puncturing member
Claim Types: Device; Process; Part of a dosage form; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Sep 12, 2028U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 10207066 DP* Aerosolization apparatus with capsule puncture alignment guide
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 4, 2030U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.:
021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9018192 Unitary pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2015
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 9545414 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Method of use; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Feb 13, 2017
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8598185 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 28, 2029 

COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
202123  Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 6, 2011
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 8841310 DP* Combinations of a pyrimidine containing NNRTI with RT inhibitors
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Oct 20, 2014
Dec 9, 2025U-257: Treatment of HIV infection
Pat. No. 10857102 DP* Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 6, 2021
Jan 14, 2033 

STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: CYP3A inhibitor == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
203100  Prod. No.: 001 RX (150MG;150MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 2, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 7176220 DS* DP* [Extended 1011 days (2.8 years)]
4-oxoquinoline compound and use thereof as pharmaceutical agent
Claim Types: Method of use; Compound; Composition
Pat. Sub. Date(s): 001: None
Feb 27, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 14, 2015
Apr 26, 2027 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2030 *PEDU-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Mar 3, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 24, 2014
Oct 30, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 4, 2018
Apr 6, 2033 *PED 

TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD      NDA No.:
021752  Prod. No.: 001 RX (200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-248: Treatment of HIV
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 18, 2017
Jan 13, 2024U-257: Treatment of HIV infection

NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.:
207318  Prod. No.: 001 DISC (EQ 17MG BASE)
PatentsExpirationPatented Use
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2017
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 25, 2016
Sep 26, 2025 
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 25, 2016
Aug 24, 2026U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: May 25, 2016
Jun 3, 2028 
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 25, 2016
Apr 29, 2030 

NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.:
207318  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Jul 25, 2018
Sep 26, 2025 
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 24, 2026U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 002: Jul 25, 2018
Jun 3, 2028 
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Jul 25, 2018
Apr 29, 2030 
Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 10, 2020
Mar 23, 2037U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 30, 2021
Mar 23, 2037U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.:
210793  Prod. No.: 001 RX (EQ 34MG BASE)
PatentsExpirationPatented Use
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 25, 2018
Sep 26, 2025 
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 24, 2026U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: Jul 25, 2018
Jun 3, 2028 
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jul 25, 2018
Apr 29, 2030 
Pat. No. 10449185 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2019
Aug 27, 2038 
Pat. No. 10646480 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 15, 2020
Aug 27, 2038 
Pat. No. 10849891 DP* Formulations of pimavanserin
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 11, 2020
Aug 27, 2038U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 11452721 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 27, 2022
Aug 27, 2038 

DIFICID (TABLET) (ORAL) FIDAXOMICIN [GENERIC AB]
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.:
201699  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 6, 2013
Jan 15, 2024 *PED 
Pat. No. 7906489 18-membered macrocycles and analogs thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2011
Sep 4, 2027 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
U-319: Treatment of microbial infections
Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B
Claim Types: New polymorph, salt or hydrate; Formulation; Composition
Pat. Sub. Date(s): 001: Aug 29, 2011
Jan 31, 2028 *PED 
Pat. No. 7863249 DS* DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Aug 29, 2011
Jan 31, 2028 *PED 
Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 5, 2014
Jan 31, 2028 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
U-319: Treatment of microbial infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 24, 2027ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD)

DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.:
213138  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 15, 2024 *PED 
Pat. No. 7906489 18-membered macrocycles and analogs thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2020
Sep 4, 2027 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B
Claim Types: New polymorph, salt or hydrate; Formulation; Composition
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PED 
Pat. No. 7863249 DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PED 
Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
Pat. No. 9808530 DP* Composition of tiacumicin compounds
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2020
Nov 28, 2034 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 24, 2027ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD)

PROLENSA (SOLUTION/DROPS) (OPHTHALMIC) BROMFENAC SODIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUSCH AND LOMB      NDA No.:
203168  Prod. No.: 001 RX (EQ 0.07% ACID)
PatentsExpirationPatented Use
Pat. No. 8669290 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2014
Jan 16, 2024 
Pat. No. 8754131 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 30, 2014
Jan 16, 2024 
Pat. No. 8871813 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 29, 2014
Jan 16, 2024 
Pat. No. 8927606 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenyl acetic acid
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 12, 2015
Jan 16, 2024U-100: Method of treating ocular inflammation
U-1095: Method of treating ocular inflammation
U-810: Method of treatment to alleviate inflammation of the eye
Pat. No. 9144609 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 4, 2015
Jan 16, 2024 
Pat. No. 9561277 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 7, 2017
Jan 16, 2024U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery
Pat. No. 8129431 DS* DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 6, 2013
Sep 11, 2025 
Pat. No. 10085958 DP* Bromfenac bioavailability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2018
Nov 19, 2032 
Pat. No. 9517220 Bromfenac bioavailability
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2017
Nov 11, 2033U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE [GENERIC AP]
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.:
201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)]
Macrocyclic analogs and methods of their use and preparation
Claim Types: Compound; Process
Pat. Sub. Date(s): 001: Nov 30, 2010
Jan 20, 2024 *PED 
Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 7, 2018
Jul 8, 2027 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 13, 2026 PEDM-280: Revisions to the pediatric use subsection of labeling to include the results from clinical studies E7389-G000-223 and E7389-G000-213, conducted to fulfill a pediatric written request

ZAVZPRET (SPRAY, METERED) (NASAL) ZAVEGEPANT HYDROCHLORIDE
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: PFIZER      NDA No.:
216386  Prod. No.: 001 RX (EQ 10MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 7220862 DS* DP* Calcitonin gene related peptide receptor antagonists
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 6, 2023
Jan 21, 2024 
Pat. No. 8481546 DS* DP* CGRP receptor antagonist
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 6, 2023
Oct 7, 2031U-3555: Administration of zavegepant for acute treatment of migraine with or without aura
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 9, 2028 

RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: vasoconstrictor
NDA Applicant: MAYNE PHARMA      NDA No.:
208552  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 8815929 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2018
Jan 22, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8420688 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
Aug 2, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 7812049 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
May 2, 2028U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8883838 DP* Pharmaceutical cream compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 9, 2017
Dec 1, 2031 
Pat. No. 9974773 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 22, 2018
Jun 11, 2035U-2306: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 10335391 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2019
Jun 11, 2035U-2567: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream, where the patient experiences no rebound or worsening of facial erythema post-treatment
Pat. No. 10751325 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 26, 2020
Jun 11, 2035U-2921: Once daily topical treatment of persistent facial erythema associated with rosacea in adults
Pat. No. 11517560 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2022
Jun 11, 2035U-3494: Once daily topical treatment of persistent facial erythema associated with rosacea in female adults

EVOCLIN (AEROSOL, FOAM) (TOPICAL) CLINDAMYCIN PHOSPHATE
Drug Classes: lincosamide antibacterial
NDA Applicant: MYLAN      NDA No.:
050801  Prod. No.: 001 DISC (1%**)
PatentsExpirationPatented Use
Pat. No. 7374747 DP* Pharmaceutical foam
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 23, 2024U-921: Treatment of acne vulgaris
Pat. No. 7141237 DP* Pharmaceutical foam
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: None
Feb 3, 2024 

TORISEL (SOLUTION) (INTRAVENOUS) TEMSIROLIMUS [GENERIC AP]
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.:
022088  Prod. No.: 001 RX (25MG/ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8299116 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 20, 2012
Jan 25, 2024 *PED 
Pat. No. 8455539 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 18, 2013
Jan 25, 2024 *PED 
Pat. No. 8722700 DP* CCI-779 formulations for parenteral administration
Claim Types: Method of administration; Formulation; Process
Pat. Sub. Date(s): 001: Jun 5, 2014
Jan 25, 2024 *PED 
Pat. No. 8026276 DP* Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 20, 2026 *PED 
Pat. No. 8791097 Anti-tumor activity of CCI-779 in papillary renal cell cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2014
Nov 10, 2032 *PEDU-1550: Method of treating metastatic papillary renal cell carcinoma with temsirolimus.
U-1551: Method of treating papillary renal cell carcinoma with temsirolimus, in the absence of interferon alpha.

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 001 RX (145MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024U-1278: Method of treating irritable bowel syndrome with constipation in adults
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Aug 30, 2026U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 6, 2015
Feb 17, 2031 
Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 11, 2014
Oct 30, 2031U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2014
Oct 30, 2031 
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 10, 2017
Aug 16, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 12, 2026I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 002 RX (290MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jan 28, 2024U-1278: Method of treating irritable bowel syndrome with constipation in adults
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 002: None
Aug 30, 2026U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 6, 2015
Feb 17, 2031 
Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 11, 2014
Oct 30, 2031U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 19, 2014
Oct 30, 2031 
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Aug 10, 2017
Aug 16, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 003 RX (72MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024U-1516: Method of treating chronic idiopathic constipation in adult patients.
U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Aug 30, 2026U-1516: Method of treating chronic idiopathic constipation in adult patients.
U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Feb 24, 2017
Feb 17, 2031U-1516: Method of treating chronic idiopathic constipation in adult patients.
U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 10675325 DP* Stable formulations of linaclotide
Claim Types: Composition
Pat. Sub. Date(s): 003: Jun 22, 2020
Aug 11, 2031 
Pat. No. 10702576 Stable formulations of linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 003: Aug 4, 2020
Aug 11, 2031U-1516: Method of treating chronic idiopathic constipation in adult patients.
U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Aug 10, 2017
Aug 16, 2033U-1516: Method of treating chronic idiopathic constipation in adult patients.
U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 12, 2026I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age

SEASONIQUE (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
021840  Prod. No.: 001 RX (0.03MG,0.01MG;0.15MG,N/A)
PatentsExpirationPatented Use
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

OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL      NDA No.:
205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
PatentsExpirationPatented Use
Pat. No. 8173707 Ophthalmologic irrigation solutions and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 13, 2014
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014
Jan 30, 2024 *PED 
Pat. No. 9278101 Ophthalmologic irrigation solutions and method
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 9, 2016
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 28, 2016
Jan 30, 2024 *PED 
Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 5, 2018
Oct 23, 2033 
Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2015
Apr 23, 2034 *PED 
Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 9, 2016
Apr 23, 2034 *PED 

CHLORAPREP ONE-STEP (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.:
020832  Prod. No.: 006 OTC (2%;70% (26ML))
PatentsExpirationPatented Use
Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules
Claim Types: Device; Process
Pat. Sub. Date(s): 006: None
Jan 31, 2024 

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. 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

NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC      NDA No.:
022517  Prod. No.: 001 DISC (0.0277MG)
PatentsExpirationPatented Use
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. 11020448 Methods comprising desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2021
May 21, 2029U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration
Pat. No. 11963995 Methods comprising desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 21, 2024
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): 001: Jul 19, 2018
Apr 13, 2030U-2326: Treatment of nocturia due to nocturnal polyuria in adults

NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC      NDA No.:
022517  Prod. No.: 002 DISC (0.0553MG)
PatentsExpirationPatented Use
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. 11963995 Methods comprising desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 21, 2024
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

NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ACERUS      NDA No.:
205488  Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8574622 DP* Controlled release delivery system for nasal applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 26, 2014
Feb 4, 2024 
Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
Feb 4, 2024 
Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
Feb 4, 2024U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.
Pat. No. 8877230 Controlled release delivery system for nasal applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2014
Feb 4, 2024U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone
Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2021
Mar 17, 2034U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA      NDA No.:
214621  Prod. No.: 001 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 8735401 Thienopyrimidine compounds and use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2021
Feb 4, 2024U-3019: Treatment of adult patients with advanced prostate cancer that is sex-hormone-dependent
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 14, 2021
Jan 28, 2025 
Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Jan 14, 2021
Jan 28, 2025 
Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 25, 2023
Sep 27, 2033 
Pat. No. 10350170 DP* Solid preparation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 14, 2021
Feb 25, 2036 
Pat. No. 10449191 Treatment of prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2021
Sep 29, 2037U-3020: Treatment of adult patients with advanced prostate cancer
Pat. No. 10786501 Treatment of prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2021
Sep 29, 2037U-3020: Treatment of adult patients with advanced prostate cancer
Pat. No. 11583526 Treatment of prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2023
Sep 29, 2037U-3020: Treatment of adult patients with advanced prostate cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 18, 2025 

OSPHENA (TABLET) (ORAL) OSPEMIFENE [GENERIC AB]
Drug Classes: estrogen agonist/antagonist
NDA Applicant: DUCHESNAY      NDA No.:
203505  Prod. No.: 001 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 8470890 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 8772353 Method for enhancing the bioavalability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2014
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 9241915 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Feb 10, 2016
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 9855224 Method for enhancing the bioavailability of ospemifene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2018
Feb 13, 2024U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 6245819 [Extended 5 years]
Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 25, 2013
Jul 21, 2025U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 8236861 Method for enhancing the bioavailablity of ospemifene
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 25, 2013
Aug 11, 2026U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene
U-1370: Treatment of dyspareunia associated with menopause
U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause
Pat. No. 8642079 DP* Solid formulations of ospemifene
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 20, 2014
Jul 9, 2028 

ZMAX (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV      NDA No.:
050797  Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
PatentsExpirationPatented Use
Pat. No. 6984403 DP* Azithromycin dosage forms with reduced side effects
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 14, 2024U-282: Method of treating bacterial infections
Pat. No. 7887844 DP* Multiparticulate crystalline drug compositions having controlled release profiles
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 15, 2011
Feb 14, 2024 

SYMTUZA (TABLET) (ORAL) COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: CYP3A inhibitor == human immunodeficiency virus (HIV-1) protease inhibitor == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: JANSSEN PRODS      NDA No.:
210455  Prod. No.: 001 RX (150MG;800MG;200MG;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 15, 2018
Feb 16, 2024 
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 15, 2018
Apr 17, 2025 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Aug 15, 2018
Dec 26, 2026 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Aug 15, 2018
Sep 3, 2029U-2353: Tx of HIV-1 infection using a composition containing a PK enhancer that inhibits cytochrome P450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2364: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase in adults who have no prior antiretroviral treatment history
U-2365: Treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2766: Tx of HIV1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults & pediatric patients at least 40kg having no prior ARV tx history or are virologically suppressed on a stable ARV regimen for at least 6 mo
U-2767: Treatment of HIV-1 infection using a composition containing a pk enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who have no prior ARV treatment history
U-2768: Treatment of HIV-1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who are virologically suppressed on a stable ARV regimen for at least 6 months
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Aug 15, 2018
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 15, 2018
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 5, 2018
Oct 6, 2032 
Pat. No. 10786518 Compositions and methods of treating HIV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 28, 2020
Jul 19, 2038U-2978: Treatment of HIV-1 infection in adult or pediatric patients (>=40 kg) with <50 copies/ml HIV-1 RNA after >= 6 months on prior antiretroviral regimen and no known darunavir or tenofovir resistance-associated substitutions

CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS      NDA No.:
021669  Prod. No.: 001 OTC (2%)
PatentsExpirationPatented Use
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

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: estrogen == progestin == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.:
214846  Prod. No.: 001 RX (1MG;0.5MG;40MG)
PatentsExpirationPatented Use
Pat. No. 9346822 Thienopyrimidine compounds and use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 21, 2021
Feb 17, 2024U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 21, 2021
Jan 28, 2025 
Pat. No. 8058280 DS* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Jun 21, 2021
Jan 28, 2025 
Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 25, 2023
Sep 27, 2033 
Pat. No. 11033551 Methods of treating uterine fibroids
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 21, 2021
Sep 29, 2037U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
Pat. No. 11957684 Treatment of heavy menstrual bleeding associated with uterine fibroids
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2024
Sep 29, 2037U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
Pat. No. 11793812 Methods of treating endometriosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2023
May 3, 2038U-2360: Management of moderate to severe pain associated with endometriosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 5, 2025I-898: For the management of moderate to severe pain associated with endometriosis
Exclusivity Code: M - MiscellaneousJan 27, 2026M-289: Information added to the labeling to describe the results of MVT-601-035
Exclusivity Code: NCE - New chemical entityDec 18, 2025 
Exclusivity Code: NP - New productMay 26, 2024 

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS      NDA No.:
205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 9, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 30, 2016
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2017
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Apr 21, 2026U-1577: Control of serum phosphorous levels
Pat. No. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
Pat. No. 10300039 Ferric citrate dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 21, 2030U-2549: Control of serum phosphorus levels

EXSERVAN (FILM) (ORAL) RILUZOLE
Drug Classes: benzothiazole
NDA Applicant: AQUESTIVE      NDA No.:
212640  Prod. No.: 001 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 2, 2020
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2020
Apr 3, 2024 

KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: dopaminergic agonist
NDA Applicant: SUMITOMO PHARMA AM      NDA No.:
210875  Prod. No.: 001 DISC (10MG); 002 DISC (15MG); 003 DISC (20MG); 004 DISC (25MG); 005 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 3, 2024 
Pat. No. 10821074 DP* Sublingual and buccal film compositions
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 12, 2020
Aug 7, 2029 
Pat. No. 9044475 DP* Sublingual apomorphine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030 
Pat. No. 9283219 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9326981 Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669019 DP* Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669021 Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10420763 DP* Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 8414922 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 8846074 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 11419769 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2022
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10449146 Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10959943 Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 2, 2021
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease

LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC      NDA No.:
200603  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (20MG); 004 RX (120MG); 005 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 9815827 Agent for treatment of schizophrenia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Feb 20, 2024U-2166: Treatment of major depressive episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9174975 Remedy for integration dysfunction syndrome
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 23, 2015
Aug 20, 2024 *PEDU-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia
Pat. No. RE45573 DS* Process for producing imide compound
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jun 24, 2015
Dec 23, 2025 *PED 
Pat. No. 9555027 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Mar 1, 2017
May 26, 2026U-543: Treatment of schizophrenia
Pat. No. 8729085 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 29, 2014
Nov 26, 2026 *PED 
Pat. No. 8883794 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 12, 2014
Nov 26, 2026 *PED 
Pat. No. 9907794 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 19, 2018
Nov 26, 2026 *PED 
Pat. No. 9827242 Method of treatment for mental disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 19, 2017
May 23, 2031U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia
U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder
Pat. No. 9259423 Method of treatment for mental disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
Nov 23, 2031 *PEDU-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder

SYMPAZAN (FILM) (ORAL) CLOBAZAM
Drug Classes: benzodiazepine
NDA Applicant: OTTER PHARMS      NDA No.:
210833  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 30, 2018
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 30, 2018
Apr 3, 2024 
Pat. No. 11541002 DP* Oral film compositions and dosage forms having precise active dissolution profiles
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 4, 2023
Jan 31, 2040U-724: Method of treating seizures

OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
205832  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7119093 DS* DP* 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an-ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulpho- nate and the use thereof as a pharmaceutical composition
Claim Types: New polymorph, salt or hydrate; Composition; Intermediate
Pat. Sub. Date(s): All strengths: Oct 22, 2014
Feb 21, 2024 
Pat. No. 6762180 DS* DP* [Extended 1824 days (5 years)]
Substituted indolines which inhibit receptor tyrosine kinases
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 22, 2014
Apr 1, 2026 *PED 
Pat. No. 10154990 Medicaments for the treatment or prevention of fibrotic diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 18, 2019
Jul 8, 2026 *PEDU-2620: Use of nintedanib for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD)
Pat. No. 10105323 DP* Pharmaceutical dosage form for immediate release of an indolinone derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 6, 2018
Dec 4, 2029 *PED 
Pat. No. 9907756 DP* Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2018
Dec 7, 2029 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 6, 2027 PEDODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD)

ZOLINZA (CAPSULE) (ORAL) VORINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: MSD SUB MERCK      NDA No.:
021991  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
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 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 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 with cutaneous T-cell lymphoma (CTCL)

INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: ACORDA      NDA No.:
209184  Prod. No.: 001 RX (42MG)
PatentsExpirationPatented Use
Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 22, 2024 
Pat. No. RE43711 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 3, 2029U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 
Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032 

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX      NDA No.:
210583  Prod. No.: 001 DISC (30MG/ML (30MG/ML)**)
PatentsExpirationPatented Use
Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 6, 2020
May 26, 2030 
Pat. No. 10709713 Nanoparticulate meloxicam formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2020
May 26, 2030U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 11253478 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Mar 4, 2022
May 26, 2030U-3318: Management of moderate-to-severe pain by injection
Pat. No. 10881663 Method of treating pain in elderly patients with mild renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2021
Mar 8, 2039U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment
Pat. No. 11458145 Methods of administering intravenous meloxicam in a bolus dose
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2022
Mar 8, 2039U-3318: Management of moderate-to-severe pain by injection

GRALISE (TABLET) (ORAL) GABAPENTIN [GENERIC AB2]
NDA Applicant: ALMATICA      NDA No.:
022544  Prod. No.: 001 RX (300MG); 002 RX (600MG)
PatentsExpirationPatented Use
Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None
Feb 26, 2024U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia

NASCOBAL (SPRAY, METERED) (NASAL) CYANOCOBALAMIN [GENERIC AB]
Drug Classes: vitamin B12
NDA Applicant: ENDO OPERATIONS      NDA No.:
021642  Prod. No.: 001 RX (0.5MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8940714 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 5, 2015
Feb 26, 2024U-1152: Cyanocobalamin administration through nasal infusion
Pat. No. 7404489 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Kit
Pat. Sub. Date(s): 001: None
Mar 12, 2024 
Pat. No. 9415007 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 15, 2016
Jul 28, 2024U-1896: Supplement for vitamin B12 deficiencies
Pat. No. 7229636 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: None
Aug 1, 2024U-817: Nasal administration of cyanocobalamin
Pat. No. 7879349 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Jun 10, 2011
Aug 1, 2024U-1152: Cyanocobalamin administration through nasal infusion
Pat. No. 8003353 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 9, 2014
Aug 1, 2024U-817: Nasal administration of cyanocobalamin

DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
202236  Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
PatentsExpirationPatented Use
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 

FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: LEO PHARMA AS      NDA No.:
207071  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
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

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: ABBVIE      NDA No.:
021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014
Mar 2, 2024 *PED 

PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
NDA Applicant: EVOFEM INC      NDA No.:
208352  Prod. No.: 001 RX (1%;1.8%;0.4%)
PatentsExpirationPatented Use
Pat. No. 6706276 DP* Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 3, 2020
Mar 6, 2024 
Pat. No. 10568855 Compositions and methods for enhancing the efficacy of contraceptive microbicides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 3, 2020
Mar 15, 2033U-1: Prevention of pregnancy
Pat. No. 11337989 Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2022
Mar 15, 2033U-1: Prevention of pregnancy
Pat. No. 11439610 DS* DP* Compositions and methods for enhancing the efficacy of contraceptive microbicides
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 15, 2022
Mar 15, 2033 

DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
022522  Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
PatentsExpirationPatented Use
Pat. No. 8536206 Process for the preparation of roflumilast
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018
Mar 8, 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; 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): 001: Jan 30, 2014; 002: Mar 14, 2018
Mar 8, 2024 

GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: aminolevulinate synthase 1-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
212194  Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 11530408 DS* DP* Therapeutic compositions
Claim Types: Composition
Pat. Sub. Date(s): 001: Jan 6, 2023
May 18, 2024 
Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 28, 2025 
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 24, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 4, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 12, 2029U-2672: Treatment of acute hepatic porphyria
Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 9133461 DS* DP* [Extended 190 days (0.5 years)]
Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Nov 30, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2019
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2022
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 20, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2026ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP)

LEQVIO (SOLUTION) (SUBCUTANEOUS) INCLISIRAN SODIUM
NDA Applicant: NOVARTIS      NDA No.:
214012  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 10669544 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 11530408 DS* Therapeutic compositions
Claim Types: Composition
Pat. Sub. Date(s): 001: Jan 18, 2023
May 18, 2024 
Pat. No. 8809292 DS* DP* Compositions and methods for inhibiting expression of the PCSK9 gene
Claim Types: Compound; Composition; Cell; Vector; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
May 10, 2027U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 8222222 Compositions and methods for inhibiting expression of the PCSK9 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 29, 2027U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 24, 2028U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 9370582 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028 
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 12, 2029U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 10125369 DS* DP* PCSK9 iRNA compositions and methods of use thereof
Claim Types: Compound; Composition; Cell; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 18, 2034U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
Pat. No. 10851377 Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 25, 2036U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 22, 2026 

ULORIC (TABLET) (ORAL) FEBUXOSTAT [GENERIC AB]
Drug Classes: xanthine oxidase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
021856  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7361676 DP* Solid preparation containing single crystal form
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Mar 8, 2024 
Pat. No. 8372872 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 26, 2013; 002: None
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline
Pat. No. 9107912 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2015
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline

LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
206162  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Mar 12, 2024U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 7449464 DS* DP* [Extended 1275 days (3.5 years)]
Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 12, 2027U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 8247416 DS* Phthalazinone derivative
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 24, 2028 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 4, 2031U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Mar 12, 2024U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 9169235 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Mar 12, 2024U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
Pat. No. 9566276 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 22, 2020
Mar 12, 2024U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Oct 11, 2024 
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Aug 12, 2027U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 12, 2027U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 7449464 DS* DP* [Extended 1275 days (3.5 years)]
Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Sep 8, 2027 
Pat. No. 11633396 DP* Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 19, 2023
Oct 7, 2029 
Pat. No. 11975001 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 3, 2024
Oct 7, 2029 
Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Dec 31, 2029 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 4, 2031U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Pat. No. 11970530 Methods of treating homologous recombination deficient cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 28, 2024
Oct 25, 2041U-3929: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of advanced epithelial ovarian cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
U-3930: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of fallopian tube cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
U-3931: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 11, 2025I-885: For the adjuvant treatment of adult patients with deleterious or suspected deleterious GBRCA mutated HER2-negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy
Exclusivity Code: I - New IndicationMay 31, 2026I-914: In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAM) metastatic castration-resistant prostate cancer (MCRPC)
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2025ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 27, 2026ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic
Exclusivity Code: ODE - Orphan drug exclusivityMay 8, 2027ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability

SINUVA (IMPLANT) (IMPLANTATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: INTERSECT ENT INC      NDA No.:
209310  Prod. No.: 001 RX (1.35MG)
PatentsExpirationPatented Use
Pat. No. 7662141 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 7713255 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 7951130 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 7951131 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 7951133 Sinus delivery of sustained release therapeutics
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 8109918 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 9585681 Device and methods for treating paranasal sinus conditions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Apr 4, 2026U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 7544192 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Nov 29, 2026U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 8025635 DP* Device and methods for treating paranasal sinus conditions
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Apr 26, 2018
Jun 12, 2027U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 10357640 Expandable devices and methods for treating a nasal or sinus condition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 6, 2019
Oct 3, 2031U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant
Pat. No. 8763222 DP* Methods and devices for crimping self-expanding devices
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 26, 2018
Feb 8, 2032 
Pat. No. 10406332 DP* Systems, devices, and method for treating a sinus condition
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 6, 2019
Mar 13, 2034 
Pat. No. 10232152 DP* Systems, devices, and method for treating a sinus condition
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2019
Nov 24, 2034U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant

TIROSINT (CAPSULE) (ORAL) LEVOTHYROXINE SODIUM
Drug Classes: L-thyroxine (T4)
NDA Applicant: IBSA      NDA No.:
021924  Prod. No.: 002 RX (0.025MG); 003 RX (0.05MG); 004 RX (0.075MG); 005 RX (0.1MG); 006 RX (0.125MG); 007 RX (0.15MG); 008 RX (0.112MG); 009 RX (0.137MG); 010 RX (0.088MG); 011 RX (0.175MG); 012 RX (0.2MG); 013 RX (0.013MG)
PatentsExpirationPatented Use
Pat. No. 7691411 DP* Pharmaceutical formulae for thyroid hormones and procedures for obtaining them
Claim Types: Formulation
Pat. Sub. Date(s): 002: Sep 15, 2016; 003: Sep 15, 2016; 004: Sep 15, 2016; 005: Sep 15, 2016; 006: Sep 15, 2016; 007: Sep 15, 2016; 008: Sep 15, 2016; 009: Sep 15, 2016; 010: Sep 15, 2016; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: Sep 15, 2016
Mar 14, 2024 
Pat. No. 7723390 DP* Pharmaceutical formulations for thyroid hormones
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 27, 2010; 003: May 27, 2010; 004: May 27, 2010; 005: May 27, 2010; 006: May 27, 2010; 007: May 27, 2010; 008: May 27, 2010; 009: May 27, 2010; 010: May 27, 2010; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: May 27, 2010
Mar 14, 2024 

VELTASSA (POWDER) (ORAL) PATIROMER SORBITEX CALCIUM
Drug Classes: potassium binder
NDA Applicant: VIFOR PHARMA      NDA No.:
205739  Prod. No.: 001 RX (EQ 8.4GM BASE/PACKET); 002 RX (EQ 16.8GM BASE/PACKET); 003 RX (EQ 25.2GM BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 8287847 Ion binding polymers and uses thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8475780 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8778324 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8889115 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 10485821 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2019
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 7556799 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Feb 27, 2025U-1766: Treatment of hyperkalemia
Pat. No. 8216560 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 14, 2027U-1766: Treatment of hyperkalemia
Pat. No. 8282913 DP* Ion binding polymers and uses thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2015
May 29, 2027 
Pat. No. 8147873 DP* [Extended 832 days (2.3 years)]
Methods and compositions for treatment of ion imbalances
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Jun 20, 2028 
Pat. No. 8337824 DS* Linear polyol stabilized polyfluoroacrylate compositions
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 18, 2015
May 29, 2030U-1766: Treatment of hyperkalemia
Pat. No. 9492476 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2016
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 9925212 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 20, 2018
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 11123363 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 21, 2021
Oct 8, 2033U-1766: Treatment of hyperkalemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationOct 2, 2026 

VELTASSA (POWDER) (ORAL) PATIROMER SORBITEX CALCIUM
Drug Classes: potassium binder
NDA Applicant: VIFOR PHARMA      NDA No.:
205739  Prod. No.: 004 DISC (EQ 1GM BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 8287847 Ion binding polymers and uses thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8475780 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8778324 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8889115 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 10485821 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 7556799 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Feb 27, 2025U-1766: Treatment of hyperkalemia
Pat. No. 8216560 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Mar 14, 2027U-1766: Treatment of hyperkalemia
Pat. No. 8282913 DP* Ion binding polymers and uses thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 004: Oct 31, 2023
May 29, 2027 
Pat. No. 8147873 DP* [Extended 832 days (2.3 years)]
Methods and compositions for treatment of ion imbalances
Claim Types: Formulation
Pat. Sub. Date(s): 004: Oct 31, 2023
Jun 20, 2028 
Pat. No. 8337824 DS* Linear polyol stabilized polyfluoroacrylate compositions
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 004: Oct 31, 2023
May 29, 2030U-1766: Treatment of hyperkalemia
Pat. No. 9492476 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 9925212 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 11123363 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 31, 2023
Oct 8, 2033U-1766: Treatment of hyperkalemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthOct 2, 2026 

IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: THE MEDICINES CO      NDA No.:
021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
PatentsExpirationPatented Use
Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 1, 2024 
Pat. No. 8301238 DP* Two-part electrotransport device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Sep 30, 2031 
Pat. No. 9364656 Method of storing an electrotransport drug delivery device
Claim Types: Process
Pat. Sub. Date(s): 001: Jun 21, 2016
Sep 30, 2031U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9731121 DP* Switch validation circuit and method
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 12, 2017
Oct 17, 2031 
Pat. No. 8781571 DP* Switch validation circuit and method
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 001: May 28, 2015
Mar 31, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428708 Self-test for analgesic product
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: None
May 21, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428709 DP* Current control for electrotransport drug delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: May 28, 2015
Jun 11, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9095706 DP* Self-test for analgesic product
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 3, 2033 

SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist == opioid antagonist
NDA Applicant: INDIVIOR      NDA No.:
022410  Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
PatentsExpirationPatented Use
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 3, 2024U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 9687454 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 14, 2017
Aug 7, 2029U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 11135216 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Aug 7, 2029U-3111: Treating opioid use disorder
Pat. No. 8475832 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None
Mar 26, 2030U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence

DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse tr == human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MERCK SHARP DOHME      NDA No.:
206510  Prod. No.: 001 DISC (150MG;EQ 300MG BASE)
PatentsExpirationPatented Use
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: human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MSD SUB MERCK      NDA No.:
022145  Prod. No.: 001 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
Apr 3, 2024 *PED 
Pat. No. 8852632 DS* DP* Pharmaceutical formulation containing a release rate controlling composition
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2023
Jan 28, 2028U-257: Treatment of HIV infection
Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Sep 11, 2029 *PEDU-257: Treatment of HIV infection
Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent
Claim Types: Formulation; Process; Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 27, 2023
Jun 2, 2030U-257: Treatment of HIV infection

ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MSD SUB MERCK      NDA No.:
203045  Prod. No.: 001 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 20, 2012
Apr 3, 2024 *PED 
Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Jan 20, 2012
Sep 11, 2029 *PEDU-257: Treatment of HIV infection

ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MSD SUB MERCK      NDA No.:
203045  Prod. No.: 002 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Apr 3, 2024 *PED 
Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 002: None
Sep 11, 2029 *PEDU-257: Treatment of HIV infection
Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent
Claim Types: Formulation; Process; Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 27, 2023
Jun 2, 2030U-257: Treatment of HIV infection

ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MSD SUB MERCK      NDA No.:
205786  Prod. No.: 001 RX (EQ 100MG BASE/PACKET)
PatentsExpirationPatented Use
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

ISENTRESS HD (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibit
NDA Applicant: MSD SUB MERCK      NDA No.:
022145  Prod. No.: 002 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
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. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent
Claim Types: Formulation; Process; Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 27, 2023
Jun 2, 2030U-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

ORACEA (CAPSULE) (ORAL) DOXYCYCLINE [GENERIC AB]
NDA Applicant: GALDERMA LABS LP      NDA No.:
050805  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 8394405 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 25, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8394406 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 25, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8470364 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 26, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8709478 Once daily formulations of tetracyclines
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 30, 2014
Apr 7, 2024U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8206740 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Dec 24, 2025U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 7749532 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Dec 19, 2027U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.:
207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationPatented Use
Pat. No. 8802137 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9827317 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 7718189 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 9566234 DP* Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2022
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

RELISTOR (SOLUTION) (SUBCUTANEOUS) METHYLNALTREXONE BROMIDE
Drug Classes: opioid antagonist
NDA Applicant: SALIX PHARMS      NDA No.:
021964  Prod. No.: 001 RX (12MG/0.6ML (12MG/0.6ML)); 002 RX (8MG/0.4ML (8MG/0.4ML)); 003 RX (12MG/0.6ML (12MG/0.6ML))
PatentsExpirationPatented Use
Pat. No. 8552025 DP* Stable methylnaltrexone preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 22, 2013
Apr 8, 2024 
Pat. No. 9669096 DP* Stable pharmaceutical formulations of methylnaltrexone
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jun 9, 2017
Apr 8, 2024 
Pat. No. 10376584 DP* Stable pharmaceutical formulations of methylnaltrexone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Apr 8, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 8420663 Peripheral opioid receptor antagonists and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 24, 2013; 002: None; 003: None
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 8822490 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Sep 22, 2014
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 9180125 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 20, 2015
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 9492445 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 8247425 Peripheral opioid receptor antagonists and uses thereof
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Sep 13, 2012; 002: None; 003: None
Dec 31, 2030U-1185: Treatment of opioid-induced constipation

MAVENCLAD (TABLET) (ORAL) CLADRIBINE
Drug Classes: purine antimetabolite
NDA Applicant: EMD SERONO INC      NDA No.:
022561  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7888328 DP* Oral formulations of cladribine
Claim Types: Formulation; Product-by-process; Method of improving a treatment; Method of use; Process
Pat. Sub. Date(s): 001: May 28, 2019
Apr 11, 2024U-2521: Treatment of MS with a tablet with an admixture of (a) an amorphous inclusion complex of cladribine and hydroxypropyl-b-cyclodextrin and (b) amorphous free cladribine and cyclodextrin as a non-inclusion complex, cladribine/cyclodextrin 1:10-1:16 w/w
Pat. No. 8785415 DP* Oral formulations of cladribine
Claim Types: Formulation; Process; Product-by-process; Method of use
Pat. Sub. Date(s): 001: May 28, 2019
Apr 11, 2024U-2523: Treatment of MS with an admixture of (a) an amorphous inclusion complex of cladribine (2CDA) and cyclodextrin and (b) amorphous free 2CDA and cyclodextrin as a non-inclusion complex, formulated as a solid oral form, w/o sign. amounts of cryst. 2CDA
Pat. No. 8377903 Cladribine regimen for treating multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2019
May 31, 2026U-2522: Treating RRMS or SPMS with oral cladribine: (i) 2-4 months induction with 1.7 mg/kg - 3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) 2-4 months maintenance with about 1.7 mg/kg cladribine; (iv) cladribine-free period
Pat. No. 7713947 Cladribine regimen for treating multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2019
Oct 16, 2026U-2520: Treating MS with oral cladribine acc. to the steps (i) induction period with about 1.7 mg/kg-3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) maintenance period with about 1.7 mg/kg cladribine; (iv) cladribine-free period
Pat. No. 10849919 Cladribine regimen for treating progressive forms of multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 9, 2022
Nov 23, 2038U-3411: Treating non-early SPMS by administering oral cladribine at a fixed dose per patient, per body weight and per treatment year, which fixed dose is 1.75 +/- 0.2 mg/kg, to be administered within months 1 and 2 in each of 2 adjacent treatment years

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
202293  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 9238076 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8431685 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Oct 13, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Oct 13, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7456254 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Dec 30, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Apr 4, 2026 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Feb 18, 2027 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Feb 18, 2027 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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: Feb 5, 2014
Dec 20, 2027 *PEDU-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: Feb 5, 2014
Sep 21, 2028 *PED 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Sep 21, 2028 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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: Jun 2, 2014
Sep 21, 2028 *PED 
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2014
Feb 19, 2029 *PED 
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: Feb 5, 2014
Jun 16, 2030 *PED 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 15, 2017
Jul 18, 2030 *PED 
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 25, 2014
Nov 26, 2030 *PEDU-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousNov 8, 2026 PEDM-298: Labeling revisions related to study D1699CC00001

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
202293  Prod. No.: 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 9238076 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8431685 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Oct 13, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Oct 13, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7456254 Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Dec 30, 2025 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Apr 4, 2026 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Feb 18, 2027 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Feb 18, 2027 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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: Feb 5, 2014
Dec 20, 2027 *PEDU-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: Feb 5, 2014
Sep 21, 2028 *PED 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Sep 21, 2028 *PEDU-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 2, 2014
Sep 21, 2028 *PED 
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 5, 2014
Feb 19, 2029 *PED 
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: Feb 5, 2014
Jun 16, 2030 *PED 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jul 18, 2030 *PED 
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 25, 2014
Nov 26, 2030 *PEDU-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 19, 2023
Jan 18, 2040 *PEDU-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes
Pat. No. 10973836 Methods of treating heart failure with reduced ejection fraction
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Apr 21, 2021
Sep 9, 2040 *PEDU-3127: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without Type II diabetes
Pat. No. 11903955 Methods of treating heart failure with reduced ejection fraction
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 13, 2024
Sep 9, 2040 *PEDU-3825: Reduce the risk of cardiovascular death and worsening heart failure in adults with heart failure with reduced ejection fraction, without type ii diabetes, and having an HBA1C of < 5.7%
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousNov 8, 2026 PEDM-298: Labeling revisions related to study D1699CC00001

DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022287  Prod. No.: 001 RX (30MG); 002 RX (60MG)
PatentsExpirationPatented Use
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 (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
208056  Prod. No.: 001 DISC (30MG)
PatentsExpirationPatented Use
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 

EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant == central nervous system (CNS) stimulant == adrenergic agonist == amphetamine anorectic
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 31, 2019
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 15, 2019
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 
Pat. No. 11896562 Oral amphetamine composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2024
Mar 10, 2037U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients

EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant == central nervous system (CNS) stimulant == adrenergic agonist == amphetamine anorectic
NDA Applicant: AZURITY      NDA No.:
209905  Prod. No.: 005 DISC (2.5MG**)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 005: Dec 9, 2021
Mar 10, 2037 

XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC      NDA No.:
209022  Prod. No.: 001 RX (0.093MG)
PatentsExpirationPatented Use
Pat. No. 8522778 DP* Nasal devices
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 20, 2024 
Pat. No. 7975690 Nasal devices
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2017
Dec 29, 2025U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10124132 DP* Nasal delivery
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Dec 6, 2018
Mar 6, 2027U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 11602603 DP* Nasal delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 5, 2023
Oct 27, 2028U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10076615 Nasal delivery
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Oct 12, 2018
Jul 30, 2029U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 8550073 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Oct 22, 2029 
Pat. No. 8978647 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Dec 6, 2030 
Pat. No. 10252010 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: May 8, 2019
Feb 7, 2031 
Pat. No. 11033696 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 6, 2021
May 20, 2033 
Pat. No. 10179216 DP* Nasal delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Feb 8, 2019
Jul 8, 2033U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10478574 Nasal administration
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 10, 2019
Nov 4, 2033U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10076614 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 12, 2018
Oct 20, 2034 
Pat. No. 10300229 DP* Nasal delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 18, 2019
Jul 7, 2035U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 11554229 Nasal administration
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 8, 2023
Feb 23, 2036U-2133: Method of delivering fluticasone propionate to a nasal airway
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 15, 2027I-940: Treatment of chronic rhinosinusitis without nasal polyps (CRSSNP) in adults

CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone == opioid antagonist
NDA Applicant: NALPROPION      NDA No.:
200063  Prod. No.: 001 RX (90MG;8MG)
PatentsExpirationPatented Use
Pat. No. 11278544 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2022
Apr 21, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 7462626 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1586: For effect on blood glucose parameters in patients with insulin resistance
Pat. No. 7375111 DP* Compositions for affecting weight loss
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Mar 26, 2025 
Pat. No. 9107837 Sustained release formulation of naltrexone
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 3, 2015
Jun 4, 2027U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 8318788 Layered pharmaceutical formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss
Pat. No. 8722085 Methods for administering weight loss medications
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 9125868 Methods for administering weight loss medications
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 15, 2015
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 10307376 Methods for administering weight loss medications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 8088786 DP* Layered pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Feb 3, 2029 
Pat. No. 11324741 Methods for treating visceral fat conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2022
May 29, 2029U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8916195 Sustained release formulation of naltrexone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 20, 2015
Feb 2, 2030U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 22, 2021
Jan 10, 2031U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 17, 2016
Jan 13, 2032U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder
Pat. No. 10403170 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11139056 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 9633575 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 25, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2019
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity

MEGACE ES (SUSPENSION) (ORAL) MEGESTROL ACETATE [GENERIC AB]
Drug Classes: progestin
NDA Applicant: ENDO OPERATIONS      NDA No.:
021778  Prod. No.: 001 RX (125MG/ML)
PatentsExpirationPatented Use
Pat. No. 7101576 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9040088 Nanoparticulate megestrol formulations
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 11, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101540 DP* Nanoparticulate megestrol formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101549 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9107827 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)

SOOLANTRA (CREAM) (TOPICAL) IVERMECTIN [GENERIC AB]
Drug Classes: antiparasitic == pediculicide
NDA Applicant: GALDERMA LABS LP      NDA No.:
206255  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 7550440 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8080530 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8093219 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8415311 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8470788 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8815816 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 11033565 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 22, 2021
Apr 22, 2024 
Pat. No. 9089587 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2015
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233117 Treatment of inflammatory lesions of rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2016
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233118 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2016
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9782425 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2018
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 10206939 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2019
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.

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. 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. 11571531 Powder delivery devices
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 19, 2023
Feb 23, 2026U-1809: Method of drug delivery via the nasal cavity
Pat. No. 10124132 DP* Nasal delivery
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Dec 10, 2018
Mar 6, 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 

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON      NDA No.:
202020  Prod. No.: 001 RX (1MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 13, 2012
Apr 23, 2024U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 12, 2013
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON      NDA No.:
202020  Prod. No.: 002 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Apr 23, 2024 
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 002: None
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON      NDA No.:
202020  Prod. No.: 003 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 003: None
Apr 23, 2024U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 003: None
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 8168218 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Aug 22, 2012
Jan 7, 2028U-1269: Treatment of rheumatologic, allergic, pulmonary, gastrointestinal, dermatologic diseases or conditions by the use of a delayed release 5mg prednisone tablet

PROBUPHINE (IMPLANT) (IMPLANTATION) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: partial opioid agonist
NDA Applicant: REACX PHARMS      NDA No.:
204442  Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
PatentsExpirationPatented Use
Pat. No. 7736665 Implantable polymeric device for sustained release of buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2016
Apr 25, 2024U-1878: For opioid dependence

DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.:
211911  Prod. No.: 001 RX (10MCG)
PatentsExpirationPatented Use
Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 30, 2024U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Feb 19, 2025U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020
Dec 19, 2026 
Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020
Dec 19, 2026 
Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 7, 2027U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Device; Product-by-process
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 24, 2029 
Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Mar 24, 2020
Jul 15, 2031 
Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Device; Method of use; Process
Pat. Sub. Date(s): 001: Mar 24, 2020
Oct 31, 2034 
Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Oct 31, 2034U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant

MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.:
202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationPatented Use
Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 16, 2014
May 4, 2024 *PEDU-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
May 4, 2024 *PED 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
May 4, 2024 *PED 
Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
May 4, 2024 *PEDU-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 17, 2018
Apr 30, 2029 *PEDU-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 10842780 DP* Pharmaceutical composition for modified release
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 11, 2020
Mar 28, 2030 *PEDU-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more
Pat. No. 11707451 Pharmaceutical composition for modified release
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 21, 2023
Mar 28, 2030 *PEDU-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 25, 2024 PEDI-855: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kilograms or more

MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.:
213801  Prod. No.: 001 RX (8MG/ML)
PatentsExpirationPatented Use
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 22, 2021
May 4, 2024 *PED 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 22, 2021
May 4, 2024 *PED 
Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 22, 2021
Oct 1, 2036 *PEDU-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 25, 2024 PED 

DUAVEE (TABLET) (ORAL) BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Drug Classes: estrogen agonist/antagonist
NDA Applicant: WYETH PHARMS      NDA No.:
022247  Prod. No.: 001 RX (EQ 20MG BASE;0.45MG)
PatentsExpirationPatented Use
Pat. No. 6479535 DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 31, 2013
May 6, 2024U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
Pat. No. 7683051 DS* DP* Crystalline polymorph of bazedoxifene acetate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process; Product-by-process
Pat. Sub. Date(s): 001: Oct 31, 2013
Mar 10, 2027U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause

OMONTYS PRESERVATIVE FREE (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) PEGINESATIDE ACETATE
Drug Classes: erythropoiesis-stimulating agent (ESA)
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
202799  Prod. No.: 001 DISC (EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)); 002 DISC (EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)); 003 DISC (EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)); 004 DISC (EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)); 005 DISC (EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)); 006 DISC (EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)); 007 DISC (EQ 10MG BASE/ML (EQ 10MG BASE/ML)); 008 DISC (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 7084245 DS* DP* Peptides that bind to the erythropoietin receptor
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024U-1238: Treatment of anemia due to chronic kidney disease
Pat. No. 7414105 DS* DP* [Extended 684 days (1.9 years)]
Peptides that bind to the erythropoietin receptor
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024U-1238: Treatment of anemia due to chronic kidney disease
Pat. No. 7528104 DS* DP* Peptides that bind to the erythropoietin receptor
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024 
Pat. No. 7919118 DS* DP* Spacer moiety for poly (ethylene glycol) modified peptide based compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024 
Pat. No. 7550433 Erythropoietin receptor peptide formulations and uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
Jun 2, 2026U-1238: Treatment of anemia due to chronic kidney disease
Pat. No. 7919461 Erythropoietin receptor peptide formulations and uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
Jun 2, 2026U-1238: Treatment of anemia due to chronic kidney disease

ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.:
209936  Prod. No.: 001 DISC (60MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7511041 DS* DP* Fused azole-pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2017
May 13, 2024 
Pat. No. RE46856 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Claim Types: Compound; Composition; Kit; Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Oct 22, 2029U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 9636344 Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2017
Mar 29, 2032U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 10383876 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts
Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2019
Mar 29, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 14, 2024ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies

NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.:
203340  Prod. No.: 002 RX (6MG/ML)
PatentsExpirationPatented Use
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
Pat. No. 11207306 Non-aqueous liquid nimodipine compositions
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 26, 2022
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. 11413277 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment
Pat. Sub. Date(s): 002: Aug 25, 2022
Apr 16, 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. 11806338 DP* Non-aqueous liquid nimodipine compositions
Claim Types: Formulation claimed by its inherent performace characteristics; Device
Pat. Sub. Date(s): 002: Nov 17, 2023
Apr 16, 2038 

EQUETRO (CAPSULE, EXTENDED RELEASE) (ORAL) CARBAMAZEPINE [Has competitive generic]
Drug Classes: mood stabilizer
NDA Applicant: VALIDUS PHARMS      NDA No.:
021710  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 6977253 Methods for the treatment of bipolar disorder using carbamazepine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 19, 2024U-693: The recommended initial dose of EQUETRO is 400mg/day given in divided doses, twice daily. The dose should be adjusted in 200mg daily increments to achieve optimal clinical response.

ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
NDA Applicant: SHIONOGI INC      NDA No.:
022129  Prod. No.: 001 DISC (5%**)
PatentsExpirationPatented Use
Pat. No. 7294342 Ectoparasite asphyxiator compositions and methods for their application
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 19, 2024U-970: Topical treatment of lice infestations

ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS      NDA No.:
022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 7, 2016
May 20, 2024 
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Apr 29, 2015
May 21, 2024 
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Aug 18, 2024 
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 28, 2024 
Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 23, 2026 

VIZAMYL (INJECTABLE) (INTRAVENOUS) FLUTEMETAMOL F-18
NDA Applicant: GE HEALTHCARE      NDA No.:
203137  Prod. No.: 002 RX (121.5mCi/30ML (4.05mCi/ML)) NDA No.: 203137  Prod. No.: 001 DISC (40.5mCi/10ML (4.05mCi/ML))
PatentsExpirationPatented Use
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 

PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.:
209939  Prod. No.: 001 RX (240MG); 002 RX (480MG)
PatentsExpirationPatented Use
Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 7, 2017
May 22, 2024 
Pat. No. RE46791 DS* DP* [Extended 1702 days (4.7 years)]
Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 21, 2020
Jan 18, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAug 2, 2026D-189: Extension of letermovir dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease
Exclusivity Code: I - New IndicationJun 5, 2026I-916: Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])
Exclusivity Code: ODE - Orphan drug exclusivityNov 8, 2024ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
Exclusivity Code: ODE - Orphan drug exclusivityJun 5, 2030ODE-423: For prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])

PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.:
209940  Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 7, 2017
May 22, 2024 
Pat. No. RE46791 DS* DP* [Extended 1702 days (4.7 years)]
Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Jan 18, 2029 
Pat. No. 10603384 DP* Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative
Claim Types: Formulation; Product-by-process; Process; Method of use
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Feb 28, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAug 2, 2026D-189: Extension of letermovir dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease
Exclusivity Code: I - New IndicationJun 5, 2026I-916: Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])
Exclusivity Code: ODE - Orphan drug exclusivityNov 8, 2024ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
Exclusivity Code: ODE - Orphan drug exclusivityJun 5, 2030ODE-423: For prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])

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. 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 

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.:
209637  Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
PatentsExpirationPatented Use
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 20, 2017
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Oct 20, 2025 
Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 7, 2022
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2018
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2018
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 8, 2019
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 13, 2019
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: May 20, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Mar 20, 2026U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2019
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 21, 2021
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate.
Sep 27, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Dec 5, 2031U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Feb 1, 2032 
Pat. No. 10335462 Use of long-acting GLP-1 peptides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Jun 21, 2033U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.:
209637  Prod. No.: 002 RX (4MG/3ML (1.34MG/ML))
PatentsExpirationPatented Use
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Sep 24, 2020
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Oct 20, 2025 
Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 7, 2022
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: May 20, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Mar 20, 2026U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Sep 21, 2021
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: Dec 21, 2020
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate.
Sep 29, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Dec 5, 2031U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Feb 1, 2032 
Pat. No. 10335462 Use of long-acting GLP-1 peptides
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Jun 21, 2033U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.:
209637  Prod. No.: 003 RX (8MG/3ML (2.68MG/ML))
PatentsExpirationPatented Use
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Apr 29, 2022
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Oct 20, 2025 
Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 003: Oct 7, 2022
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: May 20, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Apr 29, 2022
Mar 20, 2026U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Apr 29, 2022
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate.
Sep 29, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Apr 29, 2022
Dec 5, 2031U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 29, 2022
Feb 1, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMar 28, 2025D-185: Addition of a 3rd maintenance dose of semaglutide

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.:
209637  Prod. No.: 004 RX (2MG/3ML (0.68MG/ML))
PatentsExpirationPatented Use
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 004: Nov 14, 2022
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Oct 20, 2025 
Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Nov 14, 2022
Mar 20, 2026U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Nov 14, 2022
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate.
Sep 29, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Nov 14, 2022
Dec 5, 2031U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 004: Nov 14, 2022
Feb 1, 2032 
Pat. No. 10335462 DP* Use of long-acting GLP-1 peptides
Claim Types: Method of use
Pat. Sub. Date(s): 004: Nov 14, 2022
Jun 21, 2033U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof

ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
203496  Prod. No.: 001 RX (EQ 0.125MG BASE); 005 RX (EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jan 13, 2014; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jun 17, 2015; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 8, 2016; 005: Feb 9, 2017
May 24, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 23, 2016; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017
Jul 14, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9393203 DP* Osmotic drug delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2016; 005: Feb 9, 2017
Apr 27, 2026U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil
Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017
Jul 30, 2026 
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Mar 14, 2017
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Mar 28, 2017
Dec 15, 2028 
Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin®
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 15, 2023
Dec 15, 2028 
Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Formulation; Method of use; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017
Feb 13, 2030 
Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs
Claim Types: Drug in a container; Process
Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017
Jan 22, 2031 
Pat. No. 8747897 DP* Osmotic drug delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 13, 2014; 005: Feb 9, 2017
Aug 11, 2031U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form
U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2026ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression

ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
203496  Prod. No.: 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 13, 2014
May 24, 2024 
Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jun 17, 2015
May 24, 2024 
Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2016
May 24, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Aug 23, 2016
May 24, 2024 
Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Jul 14, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9393203 DP* Osmotic drug delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2016
Apr 27, 2026U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil
Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Jul 30, 2026 
Pat. No. 8497393 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Dec 15, 2028 
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Mar 14, 2017
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Mar 28, 2017
Dec 15, 2028 
Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin®
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 15, 2023
Dec 15, 2028 
Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Formulation; Method of use; Composition
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Feb 13, 2030 
Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs
Claim Types: Drug in a container; Process
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Jan 22, 2031 
Pat. No. 8747897 DP* Osmotic drug delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2014
Aug 11, 2031U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form
U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2026ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression

REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
021272  Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML)
PatentsExpirationPatented Use
Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 2, 2015; 002: Dec 2, 2015; 003: Dec 2, 2015; 004: Dec 2, 2015; 005: Aug 24, 2021
May 24, 2024U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration
Pat. No. 9713599 Parenteral formulations of treprostinil
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 25, 2017; 002: Jul 25, 2017; 003: Jul 25, 2017; 004: Jul 25, 2017; 005: Aug 24, 2021
Dec 16, 2024U-2036: A method of treating pulmonary hypertension comprising parenterally administering a formulation comprising a) 0.1 to 5% w/v of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer
Pat. No. 10076505 DP* Inhalation formulations of Treprostinil
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 1, 2018; 002: Oct 1, 2018; 003: Oct 1, 2018; 004: Oct 1, 2018; 005: Aug 24, 2021
Dec 16, 2024 
Pat. No. 10695308 Inhalation formulations of treprostinil
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2020; 002: Jul 8, 2020; 003: Jul 8, 2020; 004: Jul 8, 2020; 005: Aug 24, 2021
Dec 16, 2024U-2845: A method of treating a human patient suffering from pulmonary hypertension
Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 18, 2014; 002: Feb 18, 2014; 003: Feb 18, 2014; 004: Feb 18, 2014; 005: Aug 24, 2021
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2014; 002: Feb 25, 2014; 003: Feb 25, 2014; 004: Feb 25, 2014; 005: Aug 24, 2021
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 14, 2017; 002: Mar 14, 2017; 003: Mar 14, 2017; 004: Mar 14, 2017; 005: Aug 24, 2021
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 28, 2017; 002: Mar 28, 2017; 003: Mar 28, 2017; 004: Mar 28, 2017; 005: Aug 24, 2021
Dec 15, 2028 
Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin®
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 15, 2023
Dec 15, 2028 
Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Aug 23, 2011; 002: None; 003: None; 004: None; 005: Aug 24, 2021
Mar 29, 2029U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration

REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
021272  Prod. No.: 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)
PatentsExpirationPatented Use
Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 20, 2023
May 24, 2024U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration
Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Dec 15, 2028 
Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin®
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Dec 15, 2028 
Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Oct 20, 2023
Mar 29, 2029U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration

ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HALEON US HOLDINGS      NDA No.:
020589  Prod. No.: 002 OTC (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 24, 2019
May 25, 2024 

ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS      NDA No.:
021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.:
022369  Prod. No.: 001 RX (0.03%)
PatentsExpirationPatented Use
Pat. No. 8101161 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012
May 25, 2024U-1217: Method of increasing hair growth
U-1218: Method of stimulating hair growth

MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: GALDERMA LABS LP      NDA No.:
204708  Prod. No.: 001 RX (EQ 0.33% BASE)
PatentsExpirationPatented Use
Pat. No. 8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 27, 2014
May 25, 2024U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025 
Pat. No. 8410102 Methods and compositions for treating or preventing erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 7439241 Compounds, formulations, and methods for treating or preventing rosacea
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Aug 25, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513247 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513249 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861631 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861632 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8053427 DP* Brimonidine gel composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8163725 DP* Gel compositions and methods of use
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031 
Pat. No. 10201517 DP* Brimonidine gel compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 13, 2019
Jun 13, 2031 

OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ZYLA      NDA No.:
202080  Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG)
PatentsExpirationPatented Use
Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2016
May 26, 2024 
Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 14, 2011
Mar 16, 2025 

ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
207620  Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
PatentsExpirationPatented Use
Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition
Claim Types: Formulation; Kit
Pat. Sub. Date(s): All strengths: Aug 6, 2015
May 27, 2024 *PED 
Pat. No. 8101659 DP* [Extended 732 days (2 years)]
Methods of treatment and pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 6, 2015
Jul 15, 2025 *PED 
Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 7, 2016
May 8, 2027 *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
Pat. No. 11135192 Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 18, 2021
Aug 22, 2033U-3084: Treatment of heart failure with preserved ejection fraction
Pat. No. 11058667 Sacubitril-valsartan dosage regimen for treating heart failure
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Jul 13, 2021
May 9, 2036U-3170: Treating chronic heart failure with reduced ejection fraction in patients not taking an ACE inhibitor or an ARB or previously taking low doses of these agents, by titrating up from half the usually recommended starting dose
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 16, 2024M-82: Labeling revisions related to clinical studies

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE      NDA No.:
021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented Use
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 4, 2014
May 28, 2024 
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2015
May 28, 2024U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 4, 2015
May 28, 2024U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
May 28, 2024U-1800: A method of treating ocular pain and/or enhancing ocular comfort
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2012
Nov 28, 2024 *PEDU-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013
Nov 28, 2024 *PEDU-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Nov 28, 2024 *PEDU-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 23, 2011
Nov 24, 2027 *PEDU-1181: A method of treating or preventing ocular pain in a patient

NUVIGIL (TABLET) (ORAL) ARMODAFINIL [GENERIC AB]
NDA Applicant: CEPHALON      NDA No.:
021875  Prod. No.: 001 RX (50MG); 003 RX (150MG); 004 RX (250MG); 005 RX (200MG) NDA No.: 021875  Prod. No.: 002 DISC (100MG**)
PatentsExpirationPatented Use
Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 29, 2024 *PED 
Pat. No. 7132570 DS* DP* Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: None
Jun 18, 2024 *PED 

PROVIGIL (TABLET) (ORAL) MODAFINIL [GENERIC AB]
Drug Classes: sympathomimetic-like agent
NDA Applicant: CEPHALON      NDA No.:
020717  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 29, 2024 *PED 

ZONTIVITY (TABLET) (ORAL) VORAPAXAR SULFATE
Drug Classes: protease-activated receptor-1 (PAR-1) antagonist
NDA Applicant: KEY THERAP      NDA No.:
204886  Prod. No.: 001 DISC (EQ 2.08MG BASE)
PatentsExpirationPatented Use
Pat. No. 7713999 DS* DP* Thrombin receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 14, 2018
May 30, 2024U-2291: Reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)
Pat. No. 7304078 DS* DP* [Extended 1356 days (3.7 years)]
Thrombin receptor antagonists
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 5, 2014
Dec 23, 2027U-1512: Reduction of thrombotic cardiovascular events

ILEVRO (SUSPENSION/DROPS) (OPHTHALMIC) NEPAFENAC
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HARROW EYE      NDA No.:
203491  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 7947295 DP* Ophthalmic compositions containing a synergistic combination of two polymers
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 15, 2013
Jun 8, 2024 
Pat. No. 9662398 DP* Carboxylvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2017
Dec 1, 2030 
Pat. No. 8921337 DP* Carboxyvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 8, 2015
Mar 31, 2032 

ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: BRISTOL-MYERS      NDA No.:
021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Jun 9, 2024 *PEDU-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012
Jun 9, 2024 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012
Jun 9, 2024 *PEDU-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010
Apr 27, 2025 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 21, 2026 *PEDU-1290: Treatment of lung cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Feb 13, 2027 *PEDU-1290: Treatment of lung cancer
Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016
Jul 12, 2034 *PEDU-1434: Treatment of pancreatic cancer

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 16, 2024 
Pat. No. 11476952 DP* Pharma-informatics system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Apr 28, 2026 
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 7978064 DP* Communication system with partial power source
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 14, 2026 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9444503 DP* Active signal processing personal health signal receivers
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 19, 2027U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9119554 DP* Pharma-informatics system
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 16, 2028 
Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 8674825 DP* Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 9, 2029U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 8956288 DP* In-body power source having high surface area electrode
Claim Types: Device; Method-of-use; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 6, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 10441194 DP* Ingestible event marker systems
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 1, 2019
Jul 26, 2029 
Pat. No. 8945005 DP* Controlled activation ingestible identifier
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Aug 19, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 15, 2029 
Pat. No. 8718193 DP* Active signal processing personal health signal receivers
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 5, 2029 
Pat. No. 9149577 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2029 
Pat. No. 8847766 DP* Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 29, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 27, 2030 
Pat. No. 8114021 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 21, 2030 
Pat. No. 11464423 DP* In-body power source having high surface area electrode
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Sep 15, 2030 
Pat. No. 9941931 DP* System for supply chain management
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 7, 2018
Nov 4, 2030 
Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 17, 2030 
Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 25, 2030 
Pat. No. 8547248 DP* Implantable zero-wire communications system
Claim Types: Device; Method of use; Kit
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 18, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Feb 18, 2022
Jul 11, 2031 
Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2031 
Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 23, 2020
Jun 13, 2032 
Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Oct 15, 2033U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver

TPOXX (CAPSULE) (ORAL) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.:
208627  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Aug 9, 2018
Jun 18, 2024 
Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2018
Jul 23, 2027 
Pat. No. 9339466 DS* DP* Polymorphic forms of ST-246 and methods of preparation
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: Aug 9, 2018
Mar 23, 2031 
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2018
Sep 4, 2031U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg
Pat. No. 11890270 Polymorphic forms of ST-246 and methods of preparation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 27, 2024
Aug 8, 2032U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 13, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJul 13, 2025ODE-200: Indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg

TPOXX (SOLUTION) (INTRAVENOUS) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.:
214518  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024 
Pat. No. 8530509 DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024 
Pat. No. 8802714 Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Jul 23, 2027 
Pat. No. 9233097 DP* ST-246 liquid formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031 
Pat. No. 9907859 ST-246 liquid formulations and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Pat. No. 10576165 DP* ST-246 liquid formulations and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031 
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Sep 4, 2031U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 13, 2023 

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: rifamycin antibacterial
NDA Applicant: SALIX PHARMS      NDA No.:
021361  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7045620 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Jun 19, 2024 
Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Jun 19, 2024 
Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 7, 2011
Jun 19, 2024 
Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 8, 2012
Jun 19, 2024 
Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 8, 2012
Jun 19, 2024 
Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 1, 2014
Jun 19, 2024 
Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition
Pat. Sub. Date(s): 001: Nov 5, 2014
Jun 19, 2024 
Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Apr 7, 2011
Jun 1, 2025 
Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2013
Feb 27, 2026 
Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jul 11, 2014
Feb 27, 2026U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Jun 8, 2016
Feb 27, 2026 
Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2020
Feb 27, 2026U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults
U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older
Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jun 18, 2012
Sep 2, 2027 
Pat. No. 7928115 Methods of treating travelers diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 21, 2011
Jul 24, 2029U-1121: Method of treating travelers' diarrhea

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: rifamycin antibacterial
NDA Applicant: SALIX PHARMS      NDA No.:
021361  Prod. No.: 002 RX (550MG)
PatentsExpirationPatented Use
Pat. No. 7045620 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: None
Jun 19, 2024 
Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 19, 2024 
Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 19, 2024 
Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: May 9, 2012
Jun 19, 2024 
Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: May 8, 2012
Jun 19, 2024 
Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 002: Oct 1, 2014
Jun 19, 2024 
Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition
Pat. Sub. Date(s): 002: Nov 5, 2014
Jun 19, 2024 
Pat. No. 7915275 Use of polymorphic forms of rifaximin for medical preparations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 18, 2015
Feb 23, 2025U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 1, 2025 
Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 002: Sep 16, 2013
Feb 27, 2026 
Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 002: Jul 11, 2014
Feb 27, 2026U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence
U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 002: Jun 8, 2016
Feb 27, 2026 
Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 14, 2020
Feb 27, 2026U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults
U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older
Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: Jun 18, 2012
Sep 2, 2027U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 10456384 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 12, 2019
Feb 26, 2029U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof
U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older
Pat. No. 10765667 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 19, 2020
Feb 26, 2029U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof
U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older
Pat. No. 11564912 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 2, 2023
Feb 26, 2029U-3511: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult female subjects and symptoms thereof
U-3512: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult female subjects
Pat. No. 11779571 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 23, 2023
Feb 26, 2029U-3706: Treatment of bloating associated with diarrhea-predominant irritable bowel syndrome (IBS-D) in adult female subjects
Pat. No. 8309569 Methods for treating diarrhea-associated irritable bowel syndrome
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 18, 2015
Jul 18, 2029U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 8829017 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 9, 2014
Jul 24, 2029U-1562: Treatment of patients with hepatic encephalopathy (he)
Pat. No. 8946252 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 3, 2015
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9421195 Methods of treating hepatic encephalopathy
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Oct 11, 2016
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9629828 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 27, 2017
Jul 24, 2029U-1994: Reduction in risk of overt hepatic encephalopathy (HE) in adults
Pat. No. 10314828 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 1, 2019
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 10335397 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 24, 2019
Jul 24, 2029U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode
Pat. No. 10709694 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 23, 2020
Jul 24, 2029U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode
Pat. No. 8642573 Methods of treating hepatic encephalopathy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 8969398 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 4, 2015
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence

MOVANTIK (TABLET) (ORAL) NALOXEGOL OXALATE
Drug Classes: opioid antagonist
NDA Applicant: VALINOR      NDA No.:
204760  Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7056500 DP* Polymer conjugates of opioid antagonists
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 5, 2015
Jun 29, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 8067431 Chemically modified small molecules
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Dec 16, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 7786133 DS* DP* [Extended 272 days (0.7 years)]
Chemically modified small molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Sep 16, 2028 
Pat. No. 9012469 DS* DP* Crystalline naloxol-peg conjugate
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: May 15, 2015
Apr 2, 2032 

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE      NDA No.:
210450  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 20, 2018
Sep 10, 2024 
Pat. No. 7419983 DS* DP* [Extended 5 years]
Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018
Jul 6, 2029U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 11707464 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 23, 2023
Mar 14, 2034U-3672: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix for up to 24 months
Pat. No. 10537572 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2020
Sep 1, 2036U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin
Pat. No. 10682351 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 15, 2020
Sep 1, 2036U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole
Pat. No. 11690854 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2023
Apr 19, 2038U-3653: Management of moderate to severe pain associated with endometriosis in a patient with moderate hepatic impairment
Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Feb 6, 2023
Jul 23, 2039 
Pat. No. 11690845 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 2, 2023
Aug 27, 2040U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE      NDA No.:
210450  Prod. No.: 002 RX (EQ 200MG BASE)
PatentsExpirationPatented Use
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Aug 20, 2018
Sep 10, 2024 
Pat. No. 7419983 DS* DP* [Extended 5 years]
Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018
Jul 6, 2029U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 11344551 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 27, 2022
Mar 14, 2034U-3388: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women to reduce dysmenorrhea and non-menstrual pelvic pain
U-3389: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women having dyspareunia associated with endometriosis
Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 002: Feb 6, 2023
Jul 23, 2039 
Pat. No. 11690845 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 2, 2023
Aug 27, 2040U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

XEGLYZE (LOTION) (TOPICAL) ABAMETAPIR
NDA Applicant: HATCHTECH      NDA No.:
206966  Prod. No.: 001 DISC (0.74%)
PatentsExpirationPatented Use
Pat. No. 8212038 DP* Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 9357783 DP* Methods and compositions for controlling ectoparasites
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024 
Pat. No. 9839631 DS* DP* Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 7812163 DP* [Extended 5 years]
Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Oct 28, 2026U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 10292389 DP* Pediculicidal composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Dec 17, 2034U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 24, 2025 

RUBRACA (TABLET) (ORAL) RUCAPARIB CAMSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ZR PHARMA      NDA No.:
209115  Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 7351701 Therapeutic compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Jul 23, 2024U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 7531530 Therapeutic compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Jul 23, 2024U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 12, 2027U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 12, 2027U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8754072 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Feb 10, 2031 
Pat. No. 9045487 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Feb 10, 2031 
Pat. No. 9861638 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 6, 2018
Feb 10, 2031U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
Pat. No. 10278974 DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jun 4, 2019
Feb 10, 2031 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017
Aug 4, 2031U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 9987285 DP* High dosage strength tablets of rucaparib
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 28, 2018
Aug 17, 2035 
Pat. No. 10130636 High dosage strength tablets of rucaparib
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 17, 2018
Aug 17, 2035U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation
U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation
U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 6, 2025ODE-168: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
Drug Classes: farnesyltransferase inhibitor
NDA Applicant: SENTYNL THERAPS INC      NDA No.:
213969  Prod. No.: 001 RX (50MG); 002 RX (75MG)
PatentsExpirationPatented Use
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)
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, 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

INVOKAMET (TABLET) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS      NDA No.:
204353  Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
PatentsExpirationPatented Use
Pat. No. 8785403 DP* Glucopyranoside compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Jul 30, 2024 
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 11576894 DP* Combination therapy for the treatment of diabetes
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 13, 2023
Jul 6, 2030 

INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS      NDA No.:
205879  Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
PatentsExpirationPatented Use
Pat. No. 8785403 DP* Glucopyranoside compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 30, 2024 
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.:
021372  Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 27, 2011
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8598219 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8729094 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 21, 2014
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9066980 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2015
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9125905 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Process; Drug in a container
Pat. Sub. Date(s): 001: Sep 9, 2015
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 
Pat. No. 9457021 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.:
021372  Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonose