Orange Book Companion
Tradenames starting with "A"

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.


ABACAVIR SULFATE (SOLUTION) (ORAL) ABACAVIR SULFATE [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: HETERO LABS LTD III      NDA No.: 201107  Prod. No.: 001 RX (EQ 20MG BASE/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 14, 2018 

ABELCET (INJECTABLE, LIPID COMPLEX) (INJECTION) AMPHOTERICIN B
Drug Classes: lipid-based polyene antifungal
NDA Applicant: LEADIANT BIOSCI INC      NDA No.: 050724  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6406713 DS* Methods of preparing low-toxicity drug-lipid complexes
Claim Types: Process
Pat. Sub. Date(s): 001: None
Jun 18, 2019 

ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021436  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2015
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6977257 DP* Aripiprazole oral solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 24, 2022 *PED 
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 26, 2013
Jul 24, 2021 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2015
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Apr 12, 2020 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 8518421 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 26, 2013
Jul 24, 2021 *PED 
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9358207 DP* Flashmelt oral dosage formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Apr 12, 2020 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (INJECTABLE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 7115587 DP* Aripiprazole complex formulation and method
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PEDU-764: Treatment of schizophrenia
Pat. No. 7550445 DP* Aripiprazole complex formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 19, 2024U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338427 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338428 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Aug 6, 2023U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014
Jun 29, 2025 
Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 8759351 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Aug 6, 2023U-1530: Use of aripiprazole in extended release injectable suspension
U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
Pat. No. 8993761 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Apr 28, 2015
Sep 25, 2022 
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      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. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
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. 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. 8114021 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 2, 2026 
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. 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. 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. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
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. 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. 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. 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. 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. 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. 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. 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. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-543: Treatment of schizophrenia
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. 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. 9149577 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 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. 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
Pat. No. 9270503 DP* Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 19, 2034U-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. 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. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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. 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. 9577864 DP* Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Oct 3, 2033U-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. 9787511 DP* Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping
Claim Types: Method of use; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 19, 2034U-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. 9941931 DP* System for supply chain management
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 7, 2018
Nov 4, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ABLAVAR (SOLUTION) (INTRAVENOUS) GADOFOSVESET TRISODIUM
Drug Classes: paramagnetic contrast agent
NDA Applicant: LANTHEUS MEDCL      NDA No.: 021711  Prod. No.: 001 DISC (2440MG/10ML (244MG/ML)); 002 DISC (3660MG/15ML (244MG/ML))
PatentsExpirationPatented Use
Pat. No. 6676929 DP* [Extended 1805 days (4.9 years)]
Diagnostic imaging contrast agents with extended blood retention
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: None
May 4, 2020 

ABLYSINOL (SOLUTION) (INTRA-ARTERIAL) ALCOHOL
Drug Classes: pediculicide
NDA Applicant: BELCHER PHARMS LLC      NDA No.: 207987  Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 21, 2025ODE-192: Indicated to induce controlled cardiac septal infraction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy

ABRAXANE (FOR SUSPENSION) (IV (INFUSION)) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
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
Feb 21, 2026U-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
Oct 27, 2024U-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Dec 9, 2023U-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-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
Aug 13, 2026U-1290: Treatment of lung 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
Dec 9, 2023U-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-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
Feb 21, 2026U-1290: Treatment of lung 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
Dec 9, 2023U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8853260 DP* Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014
Oct 10, 2020U-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic 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
Feb 21, 2026U-1434: Treatment of pancreatic cancer
Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Mar 4, 2032U-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
Jan 12, 2034U-1434: Treatment of pancreatic cancer
Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Mar 4, 2032U-1290: Treatment of lung cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2020ODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

ABSORICA (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: retinoid
NDA Applicant: SUN PHARM INDS INC      NDA No.: 021951  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG); 004 RX (40MG); 005 RX (25MG); 006 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 7435427 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation; Method of administration; Product-by-process
Pat. Sub. Date(s): 001: Jun 7, 2012; 002: Jun 7, 2012; 003: Jun 7, 2012; 004: Jun 7, 2012; 005: Apr 6, 2015; 006: Apr 6, 2015
Sep 21, 2021 
Pat. No. 8367102 Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 27, 2013; 002: None; 003: None; 004: None; 005: Apr 6, 2015; 006: Apr 6, 2015
Sep 21, 2021U-1347: Treatment of a skin disorder
Pat. No. 8952064 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 23, 2015
Sep 21, 2021 
Pat. No. 9078925 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 17, 2015
Sep 21, 2021 
Pat. No. 9089534 DP* Pharmaceutical semi-solid composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 17, 2015
Sep 21, 2021 

ABSTRAL (TABLET) (SUBLINGUAL) FENTANYL CITRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: SENTYNL THERAPS INC      NDA No.: 022510  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.3MG BASE); 004 RX (EQ 0.4MG BASE); 005 RX (EQ 0.6MG BASE); 006 RX (EQ 0.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 6759059 DP* Fentanyl composition for the treatment of acute pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 6761910 DP* Pharmaceutical composition for the treatment of acute disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 7910132 DP* Pharmaceutical composition for the treatment of acute disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2011; 002: None; 003: None; 004: None; 005: None; 006: None
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer

ACANYA (GEL) (TOPICAL) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE [GENERIC AB]
Drug Classes: lincosamide antibacterial
NDA Applicant: DOW PHARM      NDA No.: 050819  Prod. No.: 001 RX (2.5%;EQ 1.2% BASE)
PatentsExpirationPatented Use
Pat. No. 8288434 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 19, 2012
Aug 5, 2029U-124: Treatment of acne
Pat. No. 8663699 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2014
Jun 3, 2029U-124: Treatment of acne
Pat. No. 8895070 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2015
Jun 3, 2029U-124: Treatment of acne
Pat. No. 9078870 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 13, 2015
Jun 3, 2029 

ACCUNEB (SOLUTION) (INHALATION) ALBUTEROL SULFATE [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 020949  Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)
PatentsExpirationPatented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Dec 28, 2021U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease)

ACETADOTE (INJECTABLE) (INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
Drug Classes: antidote; antidote for acetaminophen overdose; mucolytic
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 8148356 DP* Acetylcysteine composition and uses therefor
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Apr 4, 2012
May 21, 2026 
Pat. No. 8399445 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2013
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8653061 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 24, 2014
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8722738 Acetycysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 27, 2014
Apr 6, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9327028 Acetylcysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 18, 2016
Jul 21, 2031U-1839: Composition and method for providing a reduction in side effects for human patients in need of acetylcysteine therapy

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 001 RX (30MG); 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6165513 Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 10, 2018 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 003 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Pat. Sub. Date(s): 003: None
Dec 10, 2018 *PED 
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women
Pat. No. 6465443 DP* Method for inhibiting bone resorption
Claim Types: Composition; Kit
Pat. Sub. Date(s): 003: None
Feb 14, 2019 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 004 DISC (75MG**)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Pat. Sub. Date(s): 004: None
Dec 10, 2018 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 005 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Pat. Sub. Date(s): 005: None
Dec 10, 2018 *PED 
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-662: Treatment of osteoporosis in postmenopausal women

ACTONEL WITH CALCIUM (COPACKAGED) (TABLET, TABLET) (ORAL) CALCIUM CARBONATE; RISEDRONATE SODIUM
NDA Applicant: WARNER CHILCOTT      NDA No.: 021823  Prod. No.: 001 DISC (EQ 500MG BASE,N/A;N/A,35MG**)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Dec 10, 2018 *PED 
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 17, 2019 *PEDU-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women
Pat. No. 6465443 DP* Method for inhibiting bone resorption
Claim Types: Composition; Kit
Pat. Sub. Date(s): 001: None
Feb 14, 2019 *PED 

ACTOPLUS MET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021842  Prod. No.: 001 RX (500MG;EQ 15MG BASE); 002 RX (850MG;EQ 15MG BASE)
PatentsExpirationPatented Use
Pat. No. 9101660 DP* Solid preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 10, 2015
Jan 22, 2027 
Pat. No. 9320714 DP* Tablet
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 20, 2016
Feb 3, 2029 

ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022024  Prod. No.: 001 RX (1GM;EQ 15MG BASE); 002 RX (1GM;EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 6099859 DP* Controlled release oral tablet having a unitary core
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Mar 20, 2018 
Pat. No. 6495162 DP* Controlled release oral tablet having a unitary core
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Mar 20, 2018 
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021U-974: Adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes who are already treated with a pioglitazone and metformin
Pat. No. 6866866 DP* Controlled release metformin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021 
Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 31, 2026 
Pat. No. 7919116 Controlled release metformin formulations
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 20, 2011; 002: None
Mar 20, 2018U-1120: To reduce gastrointestinal side effects administer with a meal; as starting dose administer once daily with evening meal
U-973: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone or metformin alone
Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None
Jul 31, 2026 
Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None
Sep 19, 2023 
Pat. No. 8475841 Controlled release metformin formulations
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 20, 2018U-973: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone or metformin alone
Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Sep 19, 2023 
Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 21, 2015
Sep 19, 2023 

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented Use
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
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. 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

ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: ALLERGAN      NDA No.: 022427  Prod. No.: 001 RX (0.45%)
PatentsExpirationPatented Use
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010
Aug 15, 2029 
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 19, 2013
Mar 7, 2028 
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 10, 2015
Aug 5, 2024 
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Mar 7, 2028 

ACZONE (GEL) (TOPICAL) DAPSONE
Drug Classes: sulfone
NDA Applicant: AQUA PHARMS LLC      NDA No.: 207154  Prod. No.: 001 RX (7.5%)
PatentsExpirationPatented Use
Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2016
Nov 18, 2033 
Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 16, 2016
Nov 18, 2033U-1033: Topical treatment of acne vulgaris
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthFeb 24, 2019 

ADAPALENE AND BENZOYL PEROXIDE (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: ACTAVIS MID ATLANTIC      NDA No.: 203790  Prod. No.: 001 RX (0.1%;2.5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJan 23, 2018 

ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: GALEN UK       NDA No.: 022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
May 20, 2022 
Pat. No. 7052679 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 7078020 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021U-1375: ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
Pat. No. 7090830 DP* Drug condensation aerosols and kits
Claim Types: Kit; Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
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. 7585493 DP* Thin-film drug delivery article and method of use
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 7601337 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Jul 25, 2022 
Pat. No. 8173107 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
Pat. No. 8235037 DP* Drug condensation aerosols and kits
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 26, 2021 
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 
Pat. No. 8955512 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 18, 2015
Oct 26, 2021 
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. 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. 9439907 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 13, 2016
Oct 26, 2021 
Pat. No. 9440034 DP* Drug condensation aerosols and kits
Claim Types: Formulation; Kit; Method of administration
Pat. Sub. Date(s): 001: Oct 13, 2016
Oct 26, 2021 
Pat. No. 9687487 DS* DP* Aerosol forming device for use in inhalation therapy
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 14, 2017
Oct 26, 2021 

ADCIRCA (TABLET) (ORAL) TADALAFIL [GENERIC AB2]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: ELI LILLY CO      NDA No.: 022332  Prod. No.: 001 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 5859006 DS* DP* [Extended 679 days (1.9 years)]
Tetracyclic derivatives; process of preparation and use
Claim Types: Compound; Method of use; Composition; Process
Pat. Sub. Date(s): 001: None
May 21, 2018 *PEDU-975: Treatment of pulmonary hypertension
Pat. No. 6821975 DS* DP* Beta-carboline drug products
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
May 19, 2021 *PED 
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 26, 2020 *PED 

ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS      NDA No.: 011522  Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
PatentsExpirationPatented Use
Pat. No. 6384020 Rapid immediate release oral dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jan 6, 2021 *PED 

ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE      NDA No.: 021303  Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 21, 2019 *PED 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 21, 2019 *PED 
Pat. No. 6322819 Oral pulsed dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 21, 2019 *PED 
Pat. No. 6605300 Oral pulsed dose drug delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 21, 2019 *PED 

ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS      NDA No.: 022526  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7151103 Method of treating female hypoactive sexual desire disorder with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2015
May 9, 2023U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 7420057 DS* DP* Stable polymorph of flibanserin
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 14, 2015
Aug 1, 2022 
Pat. No. 8227471 Treating sexual desire disorders with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2015
May 9, 2023U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 9468639 Treating sexual desire disorders with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 8, 2016
Oct 16, 2022U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 18, 2020 

ADEMPAS (TABLET) (ORAL) RIOCIGUAT
Drug Classes: soluble guanylate cyclase (sGC) stimulator
NDA Applicant: BAYER HLTHCARE      NDA No.: 204819  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 6743798 DS* DP* Substituted pyrazole derivatives condensed with six-membered heterocyclic rings
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Nov 6, 2013
Jul 16, 2019 
Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)]
Carbamate-substituted pyrazolopyridines
Claim Types: Compound; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 6, 2013
Dec 4, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 8, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityOct 8, 2020ODE-53: Treatment of adults with pulmonary arterial hypertension (PAH) who group 1, to improve exercise capacity, who functional class and to delay clinical worsening.

ADLYXIN (SOLUTION) (SUBCUTANEOUS) LIXISENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US      NDA No.: 208471  Prod. No.: 001 RX (0.15MG/3ML (0.05MG/ML)); 002 RX (0.3MG/3ML (0.1MG/ML))
PatentsExpirationPatented Use
Pat. No. RE45313 DS* DP* Exendin variant peptides
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jul 12, 2020 
Pat. No. 8475414 DP* Medication delivery device and method for operating a medication delivery device
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Dec 28, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 8882721 DP* Drive assembly suitable for use in a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jun 28, 2031 
Pat. No. 8915888 DP* Dosing and drive mechanism for drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jun 8, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9072836 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Mar 15, 2032 
Pat. No. 9084853 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Oct 5, 2031 
Pat. No. 9308329 DP* Medication delivery device and method for operating a medication delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Dec 28, 2030U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9408893 Pharmaceutical combination for use in glycemic control in diabetes type 2 patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 9, 2016
Aug 27, 2032U-1894: Combination treatment with a glitazone for improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 9440029 DP* Drive mechanism for a drug delivery device and drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 29, 2016
Jan 30, 2032 
Pat. No. 9511193 DP* Assembly and indicator for a drug delivery device
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 29, 2016
Jan 19, 2032 
Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 3, 2017
Nov 11, 2030 
Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 19, 2017
May 9, 2032U-2200: Combination treatment with insulin glargine with or without metformin for improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 9855388 DP* Dosing and drive mechanism for drug delivery device
Claim Types: Device; Process; Method of administration
Pat. Sub. Date(s): All strengths: Jan 12, 2018
Apr 24, 2029U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9981013 Use of AVE0010 for the treatment of diabetes mellitus type 2
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 8, 2018
Aug 30, 2030U-2297: Improvement of glycemic control in Type 2 diabetes patients by administering a starting dose of 10 mcg for 14 days and increasing to a maintenance dose of 20 mcg on day 15
Pat. No. 10028910 DP* Pharmaceutical composition comprising a GLP-1-agonist and methionine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 30, 2018
Nov 11, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 27, 2021 

ADMELOG (SOLUTION) (IV (INFUSION), SUBCUTANEOUS) INSULIN LISPRO
Drug Classes: insulin analog
NDA Applicant: SANOFI-AVENTIS US      NDA No.: 209196  Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 11, 2020 

ADMELOG SOLOSTAR (SOLUTION) (IV (INFUSION), SUBCUTANEOUS) INSULIN LISPRO
Drug Classes: insulin analog
NDA Applicant: SANOFI-AVENTIS US      NDA No.: 209196  Prod. No.: 002 RX (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Sep 23, 2027 
Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Sep 15, 2024 
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 3, 2024 
Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Apr 12, 2025 
Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Jun 5, 2024 
Pat. No. 9011391 DP* Pen-type injector
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 26, 2024U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve
Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Aug 17, 2024 
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Aug 28, 2024 
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Aug 16, 2024 
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Aug 19, 2024 
Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 11, 2018
Apr 8, 2033 
Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 2, 2024 
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 30, 2018
Mar 4, 2024U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 11, 2020 

ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: IMPAX      NDA No.: 020800  Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7905352 DP* Kits containing medicine injection devices and containers
Claim Types: Kit; Device
Pat. Sub. Date(s): All strengths: Jun 2, 2017
Apr 12, 2027 

ADRENALIN (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204200  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 14, 2016
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (type I), including anaphylaxis

ADRENALIN (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204640  Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2015
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (type I), including anaphylaxis

ADVAIR DISKUS 100/50; ADVAIR DISKUS 250/50; ADVAIR DISKUS 500/50 (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021077  Prod. No.: 001 RX (0.1MG/INH;EQ 0.05MG BASE/INH); 002 RX (0.25MG/INH;EQ 0.05MG BASE/INH); 003 RX (0.5MG/INH;EQ 0.05MG BASE/INH)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021254  Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6161724 DP* Indicating device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jul 16, 2018 *PED 
Pat. No. 6170717 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jun 23, 2018 *PED 
Pat. No. 6315173 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jun 23, 2018 *PED 
Pat. No. 6431168 DP* Dispenser with doses' counter
Claim Types: Device; Method of administration; Drug in a container
Pat. Sub. Date(s): 001: None
Dec 8, 2018 *PED 
Pat. No. 6435372 DP* Delivery system for a medicament and method for the assembly thereof
Claim Types: Device; Process
Pat. Sub. Date(s): 001: None
Jul 16, 2018 *PED 
Pat. No. 6510969 Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jun 23, 2018 *PED 
Pat. No. 6938796 DP* Indicating device
Claim Types: Device; Process; Method of administration
Pat. Sub. Date(s): 001: None
Jul 16, 2018 *PED 
Pat. No. 6966467 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jun 23, 2018 *PED 
Pat. No. 6997349 DP* Indicating device
Claim Types: Device; Kit; Process
Pat. Sub. Date(s): 001: None
Jul 16, 2018 *PED 
Pat. No. 7107986 DP* Dispenser with doses' counter
Claim Types: Device
Pat. Sub. Date(s): 001: None
Dec 8, 2018 *PED 
Pat. No. 7143908 DP* Indicating device
Claim Types: Device; Process
Pat. Sub. Date(s): 001: None
Jul 16, 2018 *PED 
Pat. No. 7350676 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: None
Feb 24, 2019 *PED 
Pat. No. 7500444 DP* Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Aug 26, 2026 *PED 
Pat. No. 7832351 DP* Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2012
Dec 19, 2023 *PED 
Pat. No. 9861771 DP* Device housing for an aerosol container
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 22, 2018
Oct 11, 2020 

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021254  Prod. No.: 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6161724 DP* Indicating device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jul 16, 2018 *PED 
Pat. No. 6170717 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jun 23, 2018 *PED 
Pat. No. 6315173 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jun 23, 2018 *PED 
Pat. No. 6431168 DP* Dispenser with doses' counter
Claim Types: Device; Method of administration; Drug in a container
Pat. Sub. Date(s): All strengths: None
Dec 8, 2018 *PED 
Pat. No. 6435372 DP* Delivery system for a medicament and method for the assembly thereof
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: None
Jul 16, 2018 *PED 
Pat. No. 6510969 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jun 23, 2018 *PED 
Pat. No. 6938796 DP* Indicating device
Claim Types: Device; Process; Method of administration
Pat. Sub. Date(s): All strengths: None
Jul 16, 2018 *PED 
Pat. No. 6966467 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jun 23, 2018 *PED 
Pat. No. 6997349 DP* Indicating device
Claim Types: Device; Kit; Process
Pat. Sub. Date(s): All strengths: None
Jul 16, 2018 *PED 
Pat. No. 7107986 DP* Dispenser with doses' counter
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Dec 8, 2018 *PED 
Pat. No. 7143908 DP* Indicating device
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: None
Jul 16, 2018 *PED 
Pat. No. 7350676 DP* Valve for aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Feb 24, 2019 *PED 
Pat. No. 7500444 DP* Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Aug 26, 2026 *PED 
Pat. No. 7832351 DP* Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Dec 19, 2023 *PED 
Pat. No. 9861771 DP* Device housing for an aerosol container
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 22, 2018
Oct 11, 2020 

ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: PFIZER      NDA No.: 021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
PatentsExpirationPatented Use
Pat. No. 7863287 DP* Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 6, 2011
Feb 28, 2027 

ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
NDA Applicant: PFIZER      NDA No.: 021393  Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
PatentsExpirationPatented Use
Pat. No. 8883849 Treatment of sleep disturbances
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2014
Jan 17, 2022U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient
Pat. No. 9155718 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2015
Jan 17, 2022 

ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
NDA Applicant: PFIZER      NDA No.: 021394  Prod. No.: 001 OTC (38MG;200MG)
PatentsExpirationPatented Use
Pat. No. 8263647 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 30, 2022 

ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC      NDA No.: 204325  Prod. No.: 001 RX (EQ 1.25MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 

ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS      NDA No.: 204326  Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2016
Apr 9, 2026 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 

AFINITOR (TABLET) (ORAL) EVEROLIMUS
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS      NDA No.: 022334  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004 RX (7.5MG)
PatentsExpirationPatented Use
Pat. No. 5665772 DS* DP* [Extended 5 years]
O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: May 11, 2012
Mar 9, 2020 *PED 
Pat. No. 7297703 DP* Macrolides
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: May 11, 2012; 004: May 11, 2012
Jun 6, 2020 *PED 
Pat. No. 7741338 DP* Macrolides
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 12, 2014
Dec 6, 2019 
Pat. No. 8410131 Cancer treatment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 2, 2013
May 1, 2026 *PEDU-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib
Pat. No. 8436010 Treatment of solid tumors with rapamycin derivatives
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Jun 3, 2013
Aug 22, 2022 *PEDU-1396: Treatment of advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole
Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2014
Aug 18, 2022 *PEDU-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
Pat. No. 9006224 Neuroendocrine tumor treatment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 20, 2015
Jul 1, 2028U-1681: Treatment of patients with progessive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 26, 2019I-724: Treatment of adult patients with progressive, well differentiated, non-functional neuroendocrine tumors (NET) of GI or lung origin with unresectable, locally advanced or metastatic disease
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2023ODE-108: Treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, (excluding pancreatic) with unresectable, locally advanced or metastatic disease
Exclusivity Code: ODE - Orphan drug exclusivityNov 5, 2018 PEDODE-11: Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease
Exclusivity Code: ODE - Orphan drug exclusivityOct 26, 2019 PEDODE-24: Treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2018 PEDODE-4: Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection

AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM      NDA No.: 203985  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 5665772 DS* DP* [Extended 5 years]
O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None
Mar 9, 2020 *PED 
Pat. No. 7297703 DP* Macrolides
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None
Jun 6, 2020 *PED 
Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Mar 27, 2014
Mar 27, 2023 *PED 
Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2014
Aug 18, 2022 *PEDU-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
U-2280: Adjunctive treatment of patients with TSC-associated partial-onset seizures
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 10, 2021I-773: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2025ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2018 PEDODE-4: Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection

AFREZZA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: MANNKIND      NDA No.: 022472  Prod. No.: 001 RX (4 UNITS/INH); 002 RX (8 UNITS/INH); 003 RX (12 UNITS/INH)
PatentsExpirationPatented Use
Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1534: Administration of a composition comprising insulin complexed with a diketopiperazine.
Pat. No. 6652885 Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7305986 DP* Unit dose capsules for use in a dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jan 16, 2023 
Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Mar 2, 2023 
Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7943178 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Product-by-process
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7943572 Superior control of blood glucose in diabetes treatment
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 10, 2026U-1539: Pulmonary administration of an insulin composition comprising FDKP at the beginning of a meal to a patient also being treated with a long-acting insulin.
Pat. No. 8119593 Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8146588 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Apr 24, 2023 
Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jan 16, 2023 
Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Nov 24, 2022 
Pat. No. 8258095 Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8389470 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8424518 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Oct 17, 2031 
Pat. No. 8485180 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Mar 25, 2030 
Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Feb 19, 2032 
Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jun 11, 2030 
Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Sep 18, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8636001 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jul 12, 2032 
Pat. No. 8729019 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 14, 2014; 003: May 15, 2015
Dec 26, 2028 
Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015
Jun 11, 2030 
Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014
Jun 11, 2030U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8889099 DP* Methods and compositions for delivering peptides
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): All strengths: Dec 17, 2014
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8912193 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Method of use; Product-by-process; Method of administration
Pat. Sub. Date(s): All strengths: Aug 18, 2015
Jun 12, 2029U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 25, 2016
Jul 20, 2021 
Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Dec 23, 2015
Jun 12, 2029U-1788: Treatment of patient having diabetes mellitus via oral inhalation of fdkp microparticles comprising insulin
Pat. No. 9283193 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 12, 2016
Sep 14, 2026 
Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 31, 2016
Oct 20, 2029 
Pat. No. 9358352 DP* Dry powder drug delivery system and methods
Claim Types: Device; Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Feb 15, 2031U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9393372 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016
Jul 4, 2029 
Pat. No. 9446133 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Oct 19, 2016
Jun 12, 2029U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9511198 Dry powder inhaler and system for drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 5, 2017
Feb 16, 2030U-1929: Treatment of diabetes mellitus with an inhaled insulin to improve glycemic control using a dry powder inhalation system comprising an inhaler, a cartridge and a dry powder medicament comprising insulin in a single inhalation
U-1930: Method of aerosolizing/deagglomerating an insulin dry powder for use in treating diabetes mellitus via oral inhalation using an inhaler with a cartridge containing the insulin dry powder.
Pat. No. 9597374 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 11, 2017
Oct 8, 2031U-1987: Method of controlling glycemia in diabetics by administering an initial dose of insulin-FDKP with a meal; determining blood glucose level 1-2 hrs after and administering a supplemental dose of insulin-FDKP if postprandial glucose level is >140 mg/dl
Pat. No. 9662461 DP* Dry powder drug delivery system and methods
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 26, 2017
Jun 12, 2029U-2019: Method of delivering to a patient with diabetes mellitus in a single inhalation, greater than 75% of a dry powder dose comprising insulin and fumaryl diketopiperazine using a high resistance to flow dry powder inhaler.
Pat. No. 9717689 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 28, 2017
Sep 14, 2026 
Pat. No. 9943571 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 15, 2018
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 10046031 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 12, 2018
Aug 11, 2029U-2383: Method of controlling glycemia in a diabetic patient with delayed or prolonged food absorpbtion by administering 50 to 75% of a predetermined dose of insulin-FDKP at mealtime, and administering remainder of dose 30-120 minutes after beginning of meal

AGGRASTAT (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020912  Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 29, 2019 
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Nov 7, 2013
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020912  Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 29, 2016
Jan 29, 2019U-1898: Method of inhibiting platelet aggregation with AGGRASTAT (tirofiban hydrochloride)
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 002: Sep 29, 2016
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020913  Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913  Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 29, 2019 
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 7, 2013
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
May 6, 2023 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Mar 26, 2028 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Feb 25, 2032 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jan 13, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jun 28, 2031 
Pat. No. 9415008 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
May 19, 2025 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Sep 1, 2024 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
May 18, 2031 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jul 3, 2018
Sep 1, 2024 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
May 18, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 6, 2023 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Mar 26, 2028 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Feb 25, 2032 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jan 13, 2032 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Oct 6, 2034U-645: Treatment of asthma
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 28, 2031 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 19, 2025 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Sep 1, 2024 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
May 18, 2031 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Sep 1, 2024 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
May 18, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN      NDA No.: 022221  Prod. No.: 001 RX (3.5%)
PatentsExpirationPatented Use
Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 30, 2014
Jul 24, 2026U-1523: Method of inducing topical anesthesia in the eye

AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist; serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6297375 DS* 4-phenyl-pyridine derivatives
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 6, 2014
Feb 22, 2020 
Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2014
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 6, 2015
Nov 18, 2030 
Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 2, 2015
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 14, 2016
Sep 9, 2031U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2018
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 16, 2018
Sep 25, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 10, 2019 

AKYNZEO (POWDER) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 210493  Prod. No.: 001 RX (EQ 235MG BASE;EQ 0.25MG BASE)
PatentsExpirationPatented Use
Pat. No. 8426450 DS* DP* Substituted 4-phenyl pyridines having anti-emetic effect
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018
May 23, 2032 
Pat. No. 8895586 Methods of treating emesis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 17, 2018
May 23, 2032U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 17, 2018
Nov 18, 2030U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9403772 DS* 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol- yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator
Claim Types: New polymorph, salt or hydrate; Method of use; Process; Compound
Pat. Sub. Date(s): 001: May 17, 2018
May 23, 2032U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9908907 DS* DP* Substituted piperaziniums for the treatment of emesis
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018
May 23, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 19, 2023 

ALDARA (CREAM) (TOPICAL) IMIQUIMOD [GENERIC AB]
NDA Applicant: MEDICIS      NDA No.: 020723  Prod. No.: 001 RX (5%)
PatentsExpirationPatented Use
Pat. No. 7696159 DS* Treatment for basal cell carcinoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 12, 2010
Oct 1, 2024 *PEDU-1047: Treatment of biopsy-confirmed, primary superficial basal cell carcinoma (SBCC)
U-1048: Works through the induction of interferon and other cytokines

ALECENSA (CAPSULE) (ORAL) ALECTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.: 208434  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 9126931 DS* Tetracyclic compound
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 22, 2015
May 29, 2031 
Pat. No. 9365514 DP* Composition comprising tetracyclic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 11, 2016
Mar 4, 2032 
Pat. No. 9440922 DP* Tetracyclic compound
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 12, 2016
Jun 9, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 6, 2020I-756: Expanded the approved indication by removing the restriction for use only in patients who have progressed on or are intolerant to crizotinib
Exclusivity Code: NCE - New chemical entityDec 11, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityDec 11, 2022ODE-105: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib
Exclusivity Code: ODE - Orphan drug exclusivityNov 6, 2024ODE-159: For treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA approved test, excluding patients who have progressed on or are intolerant to crizotinib

ALIMTA (POWDER) (INTRAVENOUS) PEMETREXED DISODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: LILLY      NDA No.: 021462  Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 7772209 Antifolate combination therapies
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
May 24, 2022 *PEDU-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration

ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.: 209936  Prod. No.: 001 RX (60MG/VIAL)
PatentsExpirationPatented Use
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. 7511041 DS* DP* Fused azole-pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2017
May 13, 2024 
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 14, 2022 
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

ALLEGRA, CHILDREN'S ALLERGY (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021909  Prod. No.: 002 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 18, 2013
Nov 26, 2021U-1466: Relief of symptoms associated with respiratory allergies adults and children 6 years of age and older

ALLEGRA, CHILDREN'S ALLERGY; ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 201373  Prod. No.: 001 OTC (30MG/5ML) NDA No.: 201373  Prod. No.: 002 DISC (30MG/5ML)
PatentsExpirationPatented Use
Pat. No. 8933097 DP* Fexofenadine suspension formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 19, 2015
Aug 16, 2032 

ALLEGRA, CHILDREN'S HIVES (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021909  Prod. No.: 003 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 18, 2013
Nov 26, 2021 

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) (ORAL) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 020786  Prod. No.: 002 OTC (60MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6039974 DP* Pharmaceutical composition for combination of piperidinoalkanol-decongestant
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jul 1, 2011
Jul 31, 2018 

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) (ORAL) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021704  Prod. No.: 002 OTC (180MG;240MG)
PatentsExpirationPatented Use
Pat. No. RE39069 DP* Multi-layered osmotic device
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 1, 2011
May 29, 2018 
Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: Jul 1, 2011
Dec 25, 2020U-1159: Relief of symptoms associated with respiratory allergies, swelling of the nasal passages and sinus congestion and pressure in adults and children 12 years of age and older

ALLI (CAPSULE) (ORAL) ORLISTAT
Drug Classes: intestinal lipase inhibitor
NDA Applicant: GLAXOSMITHKLINE CONS      NDA No.: 021887  Prod. No.: 001 OTC (60MG)
PatentsExpirationPatented Use
Pat. No. 6004996 DP* Tetrahydrolipstatin containing compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 6, 2018 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE [GENERIC AP]
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 001 RX (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 [GENERIC AP]
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 002 RX (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 palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Oct 25, 2016
Jul 30, 2024 *PED 

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
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 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2017
Jan 10, 2022 *PED 

ALSUMA (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: MERIDIAN MEDCL      NDA No.: 022377  Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 7811254 DP* Autoinjector with needle depth adapter
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Oct 13, 2010
Aug 26, 2027U-1083: Acute treatment of migraine attacks, with or without aura, and the treatment of cluster headache episodes

ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: AQUA PHARMS LLC      NDA No.: 022055  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. RE43390 DS* DP* Pleuromutilin derivatives as antimicrobials
Claim Types: Compound; Process; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 9, 2012
Apr 12, 2021U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
Pat. No. 7875630 DS* Process salts compositions and use
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Feb 10, 2011
Feb 14, 2027 
Pat. No. 8207191 Process, salts, composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2016
Aug 30, 2024U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes

ALTACE (CAPSULE) (ORAL) RAMIPRIL [GENERIC AB]
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PHARMS LLC      NDA No.: 019901  Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

ALTACE (TABLET) (ORAL) RAMIPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PFIZER      NDA No.: 022021  Prod. No.: 001 DISC (1.25MG**); 002 DISC (2.5MG**); 003 DISC (5MG**); 004 DISC (10MG**)
PatentsExpirationPatented Use
Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 30, 2020U-871: Method of reducing risk of myocardial infarction, stroke and death

ALTOPREV (TABLET, EXTENDED RELEASE) (ORAL) LOVASTATIN
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: COVIS PHARMA BV      NDA No.: 021316  Prod. No.: 002 RX (20MG); 003 RX (40MG); 004 RX (60MG) NDA No.: 021316  Prod. No.: 001 DISC (10MG)
PatentsExpirationPatented Use
Pat. No. 5916595 HMG co-reductase inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 12, 2017 
Pat. No. 6080778 Methods for decreasing beta amyloid protein
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 23, 2018U-456: Method of decreasing the production of a-beta using a composition which decreases blood cholesterol in patients at risk of or exhibiting symptoms of Alzheimer's Disease

ALTRENO (LOTION) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: DOW PHARM      NDA No.: 209353  Prod. No.: 001 RX (0.05%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formAug 23, 2021 

ALUNBRIG (TABLET) (ORAL) BRIGATINIB
Drug Classes: kinase inhibitor
NDA Applicant: ARIAD      NDA No.: 208772  Prod. No.: 001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
PatentsExpirationPatented Use
Pat. No. 9012462 DS* Phosphorous derivatives as kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
Feb 6, 2031 
Pat. No. 9273077 Phosphorus derivatives as kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
May 21, 2029U-1927: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Pat. No. 9611283 Methods for inhibiting cell proliferation in ALK-driven cancers
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
Apr 10, 2034U-1927: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 28, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityApr 28, 2024ODE-142: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib

ALVESCO (AEROSOL, METERED) (INHALATION) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 021658  Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
PatentsExpirationPatented Use
Pat. No. 6120752 DP* Medicinal aerosol products containing formulations of ciclesonide and related steroids
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: None
May 13, 2018 
Pat. No. 6264923 DP* Medicinal aerosol formulation of ciclesonide and related compounds
Claim Types: Composition; Formulation; Drug in a container
Pat. Sub. Date(s): All strengths: None
May 13, 2018 
Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 1, 2028U-1355: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. patent claims method for treating a respiratory disease in a child

AMBIEN CR (TABLET, EXTENDED RELEASE) (ORAL) ZOLPIDEM TARTRATE [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA) A agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021774  Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)
PatentsExpirationPatented Use
Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 1, 2020 *PED 

AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
Drug Classes: porphyrin precursor
NDA Applicant: BIOFRONTERA      NDA No.: 208081  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 6559183 DP* Nano-emulsion of 5-aminolevulinic acid
Claim Types: Formulation; Kit; Process; Method of use; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Oct 7, 2016
Nov 12, 2019U-804: Treatment of actinic keratoses by photodynamic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 10, 2019 

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 001 RX (24MCG)
PatentsExpirationPatented Use
Pat. No. 6414016 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 5, 2020U-1392: Method of relieving or preventing constipation in a human patient with opioid-induced constipation
U-717: Method of relieving or preventing constipation in a human constipated patient
Pat. No. 6583174 DP* Composition and method for stabilizing the same
Claim Types: Composition; Formulation; Process
Pat. Sub. Date(s): 001: None
Oct 16, 2020 
Pat. No. 6982283 Method for treating drug-induced constipation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 9, 2013
Dec 4, 2022U-1391: Method for treating opioid-induced constipation
Pat. No. 7064148 Chloride channel opener
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Aug 30, 2022U-1404: Method for treating constipation in a patient with opioid-induced constipation by opening CIC channels
U-739: Method for treating constipation by opening CIC channels in a mammalian subject
Pat. No. 7417067 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 16, 2020 
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 26, 2011
Oct 25, 2027 
Pat. No. 8071613 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2011
Sep 5, 2020U-1203: Method for relieving or treating constipation in a human constipated patient
U-1393: Method for relieving or treating constipation in a patient with opioid-induced constipation
Pat. No. 8088934 DS* Composition and method for stabilizing the same
Claim Types: Compound
Pat. Sub. Date(s): 001: None
May 18, 2021 
Pat. No. 8097649 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2012
Oct 16, 2020 
Pat. No. 8097653 Dosage unit comprising a prostaglandin analog for treating constipation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2012
Nov 14, 2022U-1214: Method for relieving constipation in a human patient that comprises administering to the patient a dosage unit comprising (i) 24mcg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient
U-1394: Method for relieving constipation in a patient with opioid-induced constipation that comprises administering to the patient a dosage unit comprising(i)24microg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient
Pat. No. 8114890 DP* Anti-constipation composition
Claim Types: Formulation5558083
Pat. Sub. Date(s): 001: Feb 14, 2012
Comments: A
Sep 5, 2020 
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 20, 2012
Jan 23, 2027 
Pat. No. 8389542 DP* Dosage unit comprising a prostaglandin analog for treating constipation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 14, 2022U-1345: Use in relieving or preventing constipation in a human patient with a dosage unit comprising 24microg+/- 10% of a drug substance and a pharmaceutically suitable excipient
U-1395: Use in relieving or preventing constipation in a patient with opioid-induced constipation with a dosage unit comprising 24microg +/- 10% of a drug substance and a pharmaceutically suitable excipient
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 20, 2014
Sep 1, 2025U-1520: Method for the long term treatment of chronic constipation in a human subject
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 7, 2014
Jul 23, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 26, 2021M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 002 RX (8MCG)
PatentsExpirationPatented Use
Pat. No. 6414016 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 5, 2020U-874: Method of treating constipation in a patient with irritable bowel syndrome
Pat. No. 6583174 DP* Composition and method for stabilizing the same
Claim Types: Composition; Formulation; Process
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 7064148 Chloride channel opener
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Aug 30, 2022U-739: Method for treating constipation by opening CIC channels in a mammalian subject
U-873: Method of treating constipation in a patient with irritable bowel syndrome by opening chloride channels (CIC)
Pat. No. 7417067 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 7795312 Method for treating abdominal discomfort
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 17, 2024U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Oct 25, 2027 
Pat. No. 8071613 Anti-constipation composition
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 5, 2020U-1202: Method for relieving or treating constipation in a patient with irritable bowel syndrome
Pat. No. 8088934 DS* Composition and method for stabilizing the same
Claim Types: Compound
Pat. Sub. Date(s): 002: None
May 18, 2021 
Pat. No. 8097649 DP* Composition and method for stabilizing the same
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Oct 16, 2020 
Pat. No. 8114890 DP* Anti-constipation composition
Claim Types: Formulation5558083
Pat. Sub. Date(s): 002: None
Comments: A
Sep 5, 2020 
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jan 23, 2027 
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 20, 2014
Sep 1, 2025U-1519: Method for the long term treatment of chronic constipation in a human subject with irritable bowel syndrome
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Aug 7, 2014
Jan 23, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 26, 2021M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation

AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS      NDA No.: 022026  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them
Claim Types: New polymorph, salt or hydrate; Formulation
Pat. Sub. Date(s): All strengths: None
Nov 20, 2022 

AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS      NDA No.: 211139  Prod. No.: 001 RX (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 26, 2019 

AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS      NDA No.: 211139  Prod. No.: 002 RX (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 30, 2019 

AMPYRA (TABLET, EXTENDED RELEASE) (ORAL) DALFAMPRIDINE [GENERIC AB]
Drug Classes: potassium channel blocker
NDA Applicant: ACORDA      NDA No.: 022250  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 5540938 [Extended 5 years]
Formulations and their use in the treatment of neurological diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 30, 2018U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8007826 Sustained release aminopyridine composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 28, 2011
May 26, 2027U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8354437 Method of using sustained release aminopyridine compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 13, 2013
Dec 22, 2026U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8440703 Methods of using sustained release aminopyridine compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 12, 2013
Apr 8, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8663685 Sustained release aminopyridine composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 2, 2014
Jan 18, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 9918973 Sustained release aminopyridine composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2018
Dec 13, 2024U-1030: Improvement of walking in patients with multiple sclerosis (MS)

AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: muscle relaxant
NDA Applicant: TEVA PHARMS INTL      NDA No.: 021777  Prod. No.: 001 RX (15MG); 002 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7387793 DP* Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 26, 2025 
Pat. No. 7544372 Modified release dosage forms of skeletal muscle relaxants
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023U-979: Relief of muscle spasm
Pat. No. 7790199 DP* Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023 
Pat. No. 7820203 DP* Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023 
Pat. No. 7829121 Modified release dosage forms of skeletal muscle relaxants
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023U-1088: Relief of muscle spasm
Pat. No. 8877245 Modified release dosage forms of skeletal muscle relaxants
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 1, 2018
Nov 14, 2023U-979: Relief of muscle spasm
Pat. No. 9375410 Modified release dosage forms of skeletal muscle relaxants
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 12, 2016
Nov 14, 2023U-1088: Relief of muscle spasm
Pat. No. 9399025 DP* Modified release dosage forms of skeletal muscle relaxants
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 4, 2016
Nov 14, 2023U-979: Relief of muscle spasm

AMTURNIDE (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS      NDA No.: 200045  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2011; 002: None; 003: None; 004: None; 005: None
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None
May 16, 2023 
Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Nov 15, 2021 

AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: AVID RADIOPHARMS INC      NDA No.: 202008  Prod. No.: 002 RX (10-30ML (13.5-51mCi/ML)); 003 RX (10-50ML (13.5-51mCi/ML)) NDA No.: 202008  Prod. No.: 001 DISC (10ML (13.5-51mCi/ML))
PatentsExpirationPatented Use
Pat. No. 7687052 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Formulation; Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None
Apr 30, 2027 
Pat. No. 8506929 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None
Apr 30, 2027U-1423: Amyvid is a radioactive diagnostic agent for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment

AN-SULFUR COLLOID (SOLUTION) (INJECTION, ORAL) TECHNETIUM TC-99M SULFUR COLLOID KIT
NDA Applicant: PHARMALUCENCE      NDA No.: 017858  Prod. No.: 001 RX (N/A)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 13, 2019ODE-29: Localization of lymph nodes draining a primary tumor in patients with melanoma when used with a hand-held gamma counter

ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 021015  Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 1, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026 
Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466138 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8486925 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2013
Oct 12, 2026 
Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014
Oct 12, 2026 
Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8754070 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Oct 12, 2026 
Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014
Oct 12, 2026 
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ANGELIQ (TABLET) (ORAL) DROSPIRENONE; ESTRADIOL
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.: 021355  Prod. No.: 001 RX (0.25MG;0.5MG)
PatentsExpirationPatented Use
Pat. No. 8906890 DP* Very low-dosed solid oral dosage forms for HRT
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 8, 2015
Oct 22, 2031 

ANGIOMAX (INJECTABLE) (INTRAVENOUS) BIVALIRUDIN [GENERIC AP]
Drug Classes: anti-coagulant; direct thrombin inhibitor
NDA Applicant: SANDOZ INC      NDA No.: 020873  Prod. No.: 001 RX (250MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7582727 DP* Pharmaceutical formulations of bivalirudin and processes of making the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2029 *PED 
Pat. No. 7598343 DP* Pharmaceutical formulations of bivalirudin and processes of making the same
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: None
Jan 27, 2029 *PED 

ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: estrogen
NDA Applicant: THERAPEUTICSMD INC      NDA No.: 209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: May 14, 2014
Mar 23, 2023U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
May 21, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Jan 9, 2014
Dec 18, 2027 
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025 
Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Sep 11, 2022 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Feb 5, 2028 
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
Jun 14, 2027U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Oct 11, 2030 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Oct 2, 2027 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Nov 29, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 18, 2018 
Exclusivity Code: NCE - New chemical entityMay 10, 2018 

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS      NDA No.: 021695  Prod. No.: 001 RX (43MG); 003 RX (130MG)
PatentsExpirationPatented Use
Pat. No. 7101574 DS* DP* Pharmaceutical composition containing fenofibrate and the preparation method
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Aug 20, 2020 
Pat. No. 7863331 Pharmaceutical composition containing fenofibrate and method for the preparation thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 8, 2020U-1106: Treating hypertriglyceridemias with reduction of food effect
U-1107: Treating hypercholesterolemias with reduction of food effect

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS      NDA No.: 021695  Prod. No.: 004 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 8026281 Treating metabolic syndrome with fenofibrate
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Apr 22, 2025U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS      NDA No.: 021695  Prod. No.: 005 RX (90MG)
PatentsExpirationPatented Use
Pat. No. 8026281 Treating metabolic syndrome with fenofibrate
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Apr 22, 2025U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia
Pat. No. 9314447 DP* Reduced dose pharmaceutical compositions of fenofibrate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: May 2, 2016
May 31, 2033U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia

ANTIZOL (INJECTABLE) (INJECTION) FOMEPIZOLE [GENERIC AP]
Drug Classes: mucolytic antidote for acetaminophen overdose
NDA Applicant: PAR PHARM INC      NDA No.: 020696  Prod. No.: 001 RX (1.5GM/1.5ML (1GM/ML))
PatentsExpirationPatented Use
Pat. No. 7553863 DS* DP* Ultrapure 4-methylpyrazole
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Jun 30, 2027 

APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose
NDA Applicant: KEMPHARM      NDA No.: 208653  Prod. No.: 001 RX (325MG;EQ 6.12MG BASE)
PatentsExpirationPatented Use
Pat. No. 8461137 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Mar 22, 2018
Feb 22, 2031 
Pat. No. 8748413 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 8828978 DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 9132125 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 9549923 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 

APIDRA (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021629  Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML)) NDA No.: 021629  Prod. No.: 002 DISC (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Pat. Sub. Date(s): All strengths: None
Jun 18, 2018U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jan 25, 2023U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Mar 22, 2022 
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Mar 22, 2022U-471: Method of treating a patient suffering from diabetes mellitus

APIDRA SOLOSTAR (INJECTABLE) (SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021629  Prod. No.: 003 RX (300 UNITS/3ML)
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Pat. Sub. Date(s): 003: None
Jun 18, 2018U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: None
Jan 25, 2023U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Pat. Sub. Date(s): 003: None
Mar 22, 2022 
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: None
Mar 22, 2022U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: None
Sep 23, 2027 
Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 21, 2013
Sep 15, 2024 
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Nov 6, 2013
Mar 3, 2024 
Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 6, 2014
Mar 2, 2024 
Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 25, 2014
Apr 12, 2025 
Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 9, 2015
Jun 5, 2024 
Pat. No. 9011391 Pen-type injector
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 1, 2015
Mar 26, 2024U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve
Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 13, 2016
Mar 2, 2024 
Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Sep 15, 2016
Mar 2, 2024 
Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 27, 2016
Mar 2, 2024 
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 3, 2017
Aug 17, 2024 
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Feb 7, 2017
Aug 28, 2024 
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 28, 2017
Mar 2, 2024 
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 28, 2017
Aug 16, 2024 
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 4, 2017
Mar 2, 2024 
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 18, 2017
Aug 19, 2024 
Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 11, 2018
Apr 8, 2033 
Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Oct 3, 2017
Mar 2, 2024 
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Nov 28, 2017
Mar 2, 2024U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve

APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: VALEANT PHARMS NORTH      NDA No.: 022108  Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
PatentsExpirationPatented Use
Pat. No. 7241805 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7569610 Modified release formulations of a bupropion salt
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours
Pat. No. 7572935 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7585897 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7649019 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7662407 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 

APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.: 022301  Prod. No.: 001 RX (375MG)
PatentsExpirationPatented Use
Pat. No. 6551620 DS* DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 20, 2018U-907: For the maintenance of remission of ulcerative colitis in subjects 18 years of age and older
Pat. No. 8337886 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 26, 2012
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8496965 DP* Pellet formulation for the treatment of the intenstinal tract
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 31, 2013
Apr 20, 2018 
Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2014
May 1, 2030U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8911778 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2014
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8940328 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 4, 2015
Apr 20, 2018 
Pat. No. 8956647 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 19, 2015
Apr 20, 2018 

APTENSIO XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes: central nervous system stimulant
NDA Applicant: RHODES PHARMS      NDA No.: 205831  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (50MG); 007 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 6419960 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: May 18, 2015
Dec 16, 2019 
Pat. No. 7083808 DP* Controlled/modified release oral methylphenidate formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 18, 2015
Dec 16, 2019 
Pat. No. 7247318 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 18, 2015
Dec 16, 2019 
Pat. No. 7438930 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 18, 2015
Dec 16, 2019 
Pat. No. 8580310 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 18, 2015
Dec 16, 2019 
Pat. No. 9066869 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 27, 2015
Dec 16, 2019 
Pat. No. 9801823 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 29, 2017
Dec 16, 2019 
Pat. No. 10039719 Methods of treating attention deficit hyperactivity disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2018
Dec 16, 2019U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productApr 17, 2018 

APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 022416  Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 5753646 DS* DP* [Extended 5 years]
Substituted dihydrodibenzo/b,f/azepines, method of their preparation, their use in the treatment of some central nervous system disorders, and pharmaceutical compositions containing them
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Jun 27, 2021U-2041: Treatment of partial-onset seizures
Pat. No. 8372431 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 17, 2030 
Pat. No. 9206135 DS* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Compound; Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 20, 2016
Apr 21, 2026 
Pat. No. 9566244 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2017
Oct 23, 2028 
Pat. No. 9643929 DP* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 8, 2017
Apr 21, 2026 
Pat. No. 9750747 Treatments involving eslicarbazepine acetate or eslicarbazepine
Claim Types: Method of use; Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2017
Aug 24, 2032U-2041: Treatment of partial-onset seizures
U-2121: Treatment of partial-onset seizures in a patient suffering from or susceptible to absence seizures
Pat. No. 9763954 Therapeutical uses of eslicarbazepine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 10, 2017
Sep 13, 2028U-2123: Treatment of partial-onset seizures in patients with epilepsy who have been previously treated with oxcarbazepine
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAug 27, 2018D-150: 1600mg daily for patients on adjunctive therapy who did not achieve a satisfactory response on 1200mg daily dose
Exclusivity Code: I - New IndicationAug 27, 2018I-715: For the addition of the indication for monotherapy treatment in partial-onset seizures in adults.
Exclusivity Code: NCE - New chemical entityNov 8, 2018 

APTIVUS (CAPSULE) (ORAL) TIPRANAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021814  Prod. No.: 001 RX (250MG)
PatentsExpirationPatented Use
Pat. No. 5852195 DS* [Extended 1278 days (3.5 years)]
Pyranone compounds useful to treat retroviral infections
Claim Types: Compound
Pat. Sub. Date(s): 001: None
Dec 22, 2019 *PED 
Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 29, 2020 *PEDU-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir.
Pat. No. 6231887 DP* Pharmaceutical composition for acidic lipophilic compounds in a form of a self-emulsifying formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2019 *PED 

APTIVUS (SOLUTION) (ORAL) TIPRANAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 022292  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationPatented Use
Pat. No. 5852195 DS* [Extended 1278 days (3.5 years)]
Pyranone compounds useful to treat retroviral infections
Claim Types: Compound
Pat. Sub. Date(s): 001: None
Dec 22, 2019 *PED 
Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 29, 2020 *PEDU-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir.

ARAKODA (TABLET) (ORAL) TAFENOQUINE SUCCINATE
NDA Applicant: 60 DEGREES PHARMS      NDA No.: 210607  Prod. No.: 001 RX (EQ 100MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 20, 2023 
Exclusivity Code: NP - New productAug 8, 2021 

ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta2-adrenergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 022383  Prod. No.: 001 RX (EQ 75MCG BASE)
PatentsExpirationPatented Use
Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
Beta2-adrenoceptor agonists
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Feb 25, 2025U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8067437 Beta-2-adrenoreceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 26, 2013
Jun 2, 2020U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8479730 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2013
Oct 11, 2028 
Pat. No. 8658673 DS* DP* BETA2-adrenoreceptor agonists
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 28, 2015
Jun 2, 2020U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8796307 DS* DP* Beta2-adrenoreceptor agonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 9, 2015
Jun 2, 2020 

ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: ORAPHARMA      NDA No.: 050781  Prod. No.: 001 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 6682348 DP* Dispensing apparatus and cartridge
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 24, 2012
Mar 29, 2022 
Pat. No. 7699609 DP* Dispensing apparatus and cartridge with deformable tip
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 26, 2015
Mar 29, 2022 

ARGATROBAN IN SODIUM CHLORIDE (INJECTABLE) (INTRAVENOUS) ARGATROBAN
Drug Classes: anticoagulant; direct thrombin inhibitor
NDA Applicant: EAGLE PHARMS      NDA No.: 022434  Prod. No.: 001 RX (50MG/50ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 7589106 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1163: Method of treating thrombosis
Pat. No. 7687516 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1164: Method of treating an argatroban treatable condition

ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: cholinesterase inhibitor
NDA Applicant: EISAI INC      NDA No.: 022568  Prod. No.: 001 RX (23MG)
PatentsExpirationPatented Use
Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 9, 2013
Oct 4, 2026 

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): All strengths: Jan 19, 2017
Mar 19, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 209830  Prod. No.: 001 RX (675MG/2.4ML)
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 18, 2018
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 18, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018
Sep 8, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 RX (0.055MG/INH); 002 RX (0.113MG/INH); 003 RX (0.232MG/INH)
PatentsExpirationPatented Use
Pat. No. 6701917 DP* Dose counter for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6718972 DP* Dose metering system for medicament inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 6, 2023 
Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 23, 2021 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Mar 26, 2028 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Feb 25, 2032 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jan 13, 2032 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jun 28, 2031 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
May 19, 2025 
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Sep 1, 2024 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
May 18, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 27, 2020 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 001 RX (0.1MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: Aug 28, 2014
Aug 3, 2021U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Aug 3, 2021 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Oct 11, 2030 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 18, 2016
Oct 2, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 17, 2021 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 002 RX (0.2MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 002: Aug 28, 2014
Aug 3, 2021U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Aug 3, 2021 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Oct 11, 2030 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: May 18, 2016
Oct 2, 2027 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 003 RX (0.05MG/INH)
PatentsExpirationPatented Use
Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 003: Jun 13, 2018
Aug 3, 2021U-2349: For once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older
Pat. No. 7629335 DP* Anti-inflammatory androstane derivative
Claim Types: Formulation; Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Aug 3, 2021 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 23, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Feb 5, 2028 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 11, 2030 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 003: Jun 13, 2018
Oct 2, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthMay 17, 2021 

ARYMO ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: dopaminergic agonist; opioid agonist
NDA Applicant: EGALET      NDA No.: 208603  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
PatentsExpirationPatented Use
Pat. No. 9044402 DP* Abuse-deterrent pharmaceutical compositions for controlled release
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 8, 2017
Jul 1, 2033U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9549899 DP* Abuse deterrent pharmaceutical compositions for controlled release
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 21, 2017
Jul 1, 2033U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

ASACOL HD (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.: 021830  Prod. No.: 001 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 15, 2021U-141: Treatment of ulcerative colitis
Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2013
Nov 15, 2021 
Pat. No. 9089492 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 22, 2015
Nov 15, 2021 

ASCOR (SOLUTION) (INTRAVENOUS) ASCORBIC ACID
Drug Classes: vitamin C
NDA Applicant: MCGUFF      NDA No.: 209112  Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 2, 2024ODE-160: For treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated

ASMANEX TWISTHALER (POWDER) (INHALATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021067  Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH)
PatentsExpirationPatented Use
Pat. No. 6503537 DP* Preparation of powder agglomerates
Claim Types: Composition; Product-by-process; Device; Process
Pat. Sub. Date(s): All strengths: None
Sep 17, 2018 *PED 
Pat. No. 8173172 DP* Preparation of powder agglomerates
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 6, 2012
Sep 17, 2018 *PED 

ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.: 204096  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6440458 DP* Sustained release preparations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 29, 2013
Mar 25, 2019 
Pat. No. 6576259 DP* Sustained release formulation containing tacrolimus
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): All strengths: Jul 29, 2013
Mar 25, 2019U-1420: Method of once a day administration
Pat. No. 6884433 DP* Sustained release formulations containing tacrolimus
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 29, 2013
Mar 25, 2019U-1420: Method of once a day administration
Pat. No. 8551522 DP* Sustained-release formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 6, 2013
Mar 25, 2019 

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: histamine-1 receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 001 DISC (EQ 0.125MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationFeb 20, 2018 

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: histamine-1 receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 002 RX (EQ 0.1876MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
Pat. No. 9919050 DP* Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 29, 2018
Nov 22, 2025 

ATAZANAVIR SULFATE (CAPSULE) (ORAL) ATAZANAVIR SULFATE [GENERIC AB]
Drug Classes: HIV protease inhibitor
NDA Applicant: TEVA PHARMS USA      NDA No.: 091673  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE); 004 RX (EQ 300MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeJun 25, 2018 

ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 022560  Prod. No.: 001 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 7645459 DP* Dosage forms of bisphosphonates
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 7645460 DP* Dosage forms of risedronate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 8246989 DP* Dosage forms of bisphosphonates
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 28, 2012
Jan 16, 2026 

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.: 021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)]
Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
Jan 2, 2018 *PED 
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Claim Types: Compound; Method of use; Process
Pat. Sub. Date(s): 001: None
Jan 25, 2018 *PEDU-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. 5935946 DS* DP* Nucleotide analog composition and synthesis method
Claim Types: Compound; Composition; Product-by-process; Method of use; Process
Pat. Sub. Date(s): 001: None
Jan 25, 2018 *PEDU-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. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Jan 25, 2018 *PEDU-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. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 25, 2018 *PEDU-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. 6639071 DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4- trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Aug 14, 2018 *PED 
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 4, 2021 *PEDU-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. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: None
Sep 9, 2021 *PED 
Pat. No. 6939964 DS* Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Jul 20, 2018 *PED 
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. 8598185 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 28, 2029 
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. 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. 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. 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. 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

ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021527  Prod. No.: 001 RX (0.021MG/INH)
PatentsExpirationPatented Use
Pat. No. 6739333 DP* Stainless steel canister for propellant-driven metering aerosols
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 6983743 DP* Stainless steel canister for propellant-driven metering aerosols
Claim Types: Device
Pat. Sub. Date(s): 001: None
May 26, 2020 
Pat. No. 8474447 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: May 28, 2015
Jan 17, 2030 

AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 202992  Prod. No.: 001 RX (7MG); 002 RX (14MG)
PatentsExpirationPatented Use
Pat. No. 6794410 [Extended 1625 days (4.5 years)]
Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2013
Sep 12, 2026U-1285: Treatment of patients with relapsing forms of multiple sclerosis
Pat. No. 8802735 DP* (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Claim Types: Formulation; Composition
Pat. Sub. Date(s): All strengths: Sep 11, 2014
Sep 14, 2030 
Pat. No. 9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 15, 2015
Feb 4, 2034U-1786: Treatment of patients with relapsing forms of multiple sclerosis while managing the risk of teriflunomide and rosuvastatin interaction by limiting the rosuvastatin dose to no more than 10mg and/or administering about half the normal dose

AUGMENTIN XR (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN; CLAVULANATE POTASSIUM [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: DR REDDYS LABS INC      NDA No.: 050785  Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 4, 2020 
Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 4, 2020 
Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)
Pat. No. 7250176 Method of treating a bacterial infection
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 4, 2020U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml)

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 5753706 DP* Methods for treating renal failure
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 3, 2019U-1577: Control of serum phosphorous levels
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. 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. 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. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
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

AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
PatentsExpirationPatented Use
Pat. No. 8524733 DS* DP* Benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 27, 2031 
Pat. No. 9233959 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Sep 18, 2033 
Pat. No. 9296739 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Sep 18, 2033 
Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Sep 18, 2033U-1846: Treatment of a neurodegenerative disease or a symptom thereof
U-1995: Treatment of tardive dyskinesia
Pat. No. 9814708 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2017
Sep 18, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 30, 2020I-751: Treatment of tardive dyskinesia
Exclusivity Code: NCE - New chemical entityApr 3, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityApr 3, 2024ODE-134: Treatment of chorea associated with Huntington's disease

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013; 002: None
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012; 002: None
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012; 002: None
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012; 002: None
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013; 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 15, 2014
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 29, 2015
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 5, 2015
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 18, 2016
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 11, 2016
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Nov 23, 2024 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)

AVANDAMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021410  Prod. No.: 001 DISC (500MG;EQ 1MG BASE**); 002 DISC (500MG;EQ 2MG BASE**); 003 DISC (500MG;EQ 4MG BASE**); 004 DISC (1GM;EQ 2MG BASE**); 005 DISC (1GM;EQ 4MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8236345 DP* Composition and use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None
Oct 7, 2022 

AVANDARYL (TABLET) (ORAL) GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Drug Classes: sulfonylurea; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021700  Prod. No.: 001 DISC (1MG;4MG**); 002 DISC (2MG;4MG**); 003 DISC (4MG;4MG**); 004 DISC (2MG;8MG**); 005 DISC (4MG;8MG**)
PatentsExpirationPatented Use
Pat. No. 7358366 DS* Thiazolidinedione derivative and its use as antidiabetic
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Oct 19, 2020 *PED 

AVANDIA (TABLET) (ORAL) ROSIGLITAZONE MALEATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021071  Prod. No.: 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE) NDA No.: 021071  Prod. No.: 004 DISC (EQ 8MG BASE)
PatentsExpirationPatented Use
Pat. No. 7358366 DS* Thiazolidinedione derivative and its use as antidiabetic
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Oct 19, 2020 *PED 

AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: ENDO PHARMS INC      NDA No.: 022219  Prod. No.: 001 RX (750MG/3ML (250MG/ML))
PatentsExpirationPatented Use
Pat. No. 7718640 DP* Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Mar 14, 2027 
Pat. No. 8338395 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: None
Feb 27, 2026U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired).

AVELOX (TABLET) (ORAL) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE      NDA No.: 021085  Prod. No.: 001 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 6610327 DP* Pharmaceutical moxifloxacin preparation
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Oct 29, 2019U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 27, 2019M-185: Updates to the labeling to include results of a trial to evaluate the safety of moxifloxacin in pediatric patients with complicated intra-abdominal infections

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (SOLUTION) (INTRAVENOUS) MOXIFLOXACIN HYDROCHLORIDE [Has competitive generic]
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE      NDA No.: 021277  Prod. No.: 001 DISC (400MG/250ML (1.6MG/ML))
PatentsExpirationPatented Use
Pat. No. 6548079 DP* Moxifloxacin formulation containing common salt
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Jul 25, 2020U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 27, 2019M-185: Updates to the labeling to include results of a trial to evaluate the safety of moxifloxacin in pediatric patients with complicated intra-abdominal infections

AVYCAZ (POWDER) (IV (INFUSION)) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented Use
Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Feb 24, 2022U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Nov 12, 2026 
Pat. No. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jul 24, 2021U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 17, 2015
Aug 12, 2031 
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Oct 8, 2030 
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 17, 2015
Jun 15, 2032 
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Feb 24, 2017
Jun 15, 2032 
Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Pat. Sub. Date(s): 001: Aug 8, 2017
Jun 15, 2032 

AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE      NDA No.: 021494  Prod. No.: 001 DISC (15MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6930119 DP* Liquid pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 17, 2022 

AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE [Has competitive generic]
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO      NDA No.: 022504  Prod. No.: 001 DISC (30MG/1.5ML ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8419307 Spreading implement
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 30, 2013
Feb 26, 2027U-1386: A method of increasing the testosterone blood level of a person in need thereof
Pat. No. 8435944 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 27, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 7, 2014
Jul 13, 2023U-1545: A method of transdermally delivering testosterone
Pat. No. 8807861 DP* Spreading implement
Claim Types: Device; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Sep 10, 2014
Feb 26, 2027U-1563: A method of transdermal administration of a physiologically active agent to a subject.
Pat. No. 8993520 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 9, 2015
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9180194 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2015
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9289586 Spreading implement
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2016
Feb 26, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof

AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: BLUE EARTH      NDA No.: 208054  Prod. No.: 001 RX (9-221mCi/ML)
PatentsExpirationPatented Use
Pat. No. 5808146 DS* Amino acid analogs for tumor imaging
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 23, 2016
Nov 9, 2018 
Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Jul 28, 2016
Nov 28, 2026U-1879: Method of diagnosing tumors using positron emission tomography
Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2018
Nov 28, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 27, 2021 

AZASITE (SOLUTION/DROPS) (OPHTHALMIC) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: OAK PHARMS INC      NDA No.: 050810  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6239113 Topical treatment or prevention of ocular infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 6569443 DP* Topical treatment or prevention of ocular infections
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 6861411 Method of treating eye infections with azithromycin
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Nov 25, 2018U-709: Method of combating bacteria in a patient
Pat. No. 7056893 DP* Topical treatment for prevention of ocular infections
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Mar 31, 2019U-709: Method of combating bacteria in a patient

AZEDRA (SOLUTION) (INTRAVENOUS) IOBENGUANE I-131
Drug Classes: radioactive diagnostic agent
NDA Applicant: PROGENICS PHARMS INC      NDA No.: 209607  Prod. No.: 001 RX (15mCi/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 30, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityJul 30, 2025ODE-204: Treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy

AZILECT (TABLET) (ORAL) RASAGILINE MESYLATE [GENERIC AB]
Drug Classes: monoamine oxidase inhibitor (MAOI)
NDA Applicant: TEVA      NDA No.: 021641  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 7572834 DP* Rasagiline formulations and processes for their preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 5, 2026 
Pat. No. 7815942 DS* DP* Rasagiline formulations of improved content uniformity
Claim Types: Formulation; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Nov 8, 2010; 002: None
Aug 27, 2027U-219: Treatment of Parkinson's disease

AZITHROMYCIN (FOR SUSPENSION) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: LUPIN LTD      NDA No.: 065488  Prod. No.: 001 RX (EQ 100MG BASE/5ML); 002 RX (EQ 200MG BASE/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 26, 2018 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Last edited: 31 October 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide