Orange Book Companion
Tradenames starting with "A"
Patents Organized by Family

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.


ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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)
10 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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. 8642600 (Family Id: 26734754) 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. 9089567 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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 (Family Id: 32716306) 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)
Pat. No. 9125939 (Family Id: 33490596) 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. 8759350 (Family Id: 41212155) 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
5 Patents--4 FamiliesExpirationPatented Use
Pat. No. 6977257 DP* (Family Id: 23099862) Aripiprazole oral solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 24, 2022 *PED 
Pat. No. 7053092 (Family Id: 26734754) 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 (Family Id: 26734754) 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. 9387182 (Family Id: 32716306) 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)
Pat. No. 8759350 (Family Id: 41212155) 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)
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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
10 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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. 8642600 (Family Id: 26734754) 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. 9089567 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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 (Family Id: 32716306) 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)
Pat. No. 9125939 (Family Id: 33490596) 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. 8759350 (Family Id: 41212155) 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)
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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
7 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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. 8642600 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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* (Family Id: 27171631) Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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 (Family Id: 32716306) 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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7115587 DP* (Family Id: 31946748) 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* (Family Id: 31946748) 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: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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)
12 Patents--5 FamiliesExpirationPatented Use
Pat. No. 9089567 (Family Id: 26734754) 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. 8399469 DS* (Family Id: 27171631) 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. 8993761 DS* (Family Id: 27171631) 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. 8338427 DP* (Family Id: 34116189) 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* (Family Id: 34116189) 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. 8759351 DP* (Family Id: 34116189) 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. 7807680 DP* (Family Id: 34549292) 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 (Family Id: 34549292) 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. 8722679 DP* (Family Id: 34549292) 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. 10525057 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 31, 2020
Mar 8, 2034U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder
U-543: Treatment of schizophrenia
Pat. No. 10980803 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 19, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 11154553 (Family Id: 52691475) Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 17, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
32 Patents--18 FamiliesExpirationPatented Use
Pat. No. 7053092 (Family Id: 26734754) 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. 9089567 (Family Id: 26734754) 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. 8017615 DP* (Family Id: 27171631) 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* (Family Id: 27171631) Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 21, 2030 
Pat. No. 8580796 DS* (Family Id: 27171631) 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* (Family Id: 27171631) 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. 9359302 DS* DP* (Family Id: 27171631) 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 (Family Id: 32716306) 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. 9125939 (Family Id: 33490596) Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 7978064 DP* (Family Id: 37215570) Communication system with partial power source
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 14, 2026 
Pat. No. 8674825 DP* (Family Id: 37215570) 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. 8847766 DP* (Family Id: 37215570) 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. 9119554 DP* (Family Id: 37215570) Pharma-informatics system
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 16, 2028 
Pat. No. 8547248 DP* (Family Id: 37809585) 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. 8945005 DP* (Family Id: 39325440) 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. 8718193 DP* (Family Id: 39430365) Active signal processing personal health signal receivers
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 5, 2029 
Pat. No. 9444503 DP* (Family Id: 39430365) 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. 10441194 DP* (Family Id: 39674818) Ingestible event marker systems
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 1, 2019
Jul 26, 2029 
Pat. No. 8956288 DP* (Family Id: 39690523) 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* (Family Id: 40472459) 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. 9433371 DP* (Family Id: 40472459) 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. 8258962 DP* (Family Id: 41056656) 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. 9060708 DP* (Family Id: 41056656) Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 9258035 DP* (Family Id: 41056656) 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. 8759350 (Family Id: 41212155) 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. 9149577 DP* (Family Id: 42288378) Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2029 
Pat. No. 8545402 DP* (Family Id: 43050733) 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. 9320455 DP* (Family Id: 43050733) 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. 9941931 DP* (Family Id: 43970768) System for supply chain management
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 7, 2018
Nov 4, 2030 
Pat. No. 10517507 DP* (Family Id: 47506868) Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 23, 2020
Jun 13, 2032 
Pat. No. 11229378 DP* (Family Id: 47506868) Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Feb 18, 2022
Jul 11, 2031 
Pat. No. 9268909 DP* (Family Id: 50488695) 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

ABLYSINOL (SOLUTION) (INTRA-ARTERIAL) ALCOHOL
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving
NDA Applicant: BELCHER      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 [sic, "infarction"] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy

ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)
11 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7820788 DP* (Family Id: 34891317) Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010
Apr 27, 2025 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 (Family Id: 34891317) Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Jun 9, 2024 *PEDU-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8138229 DP* (Family Id: 34891317) Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012
Jun 9, 2024 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8314156 (Family Id: 34891317) Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012
Jun 9, 2024 *PEDU-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7758891 (Family Id: 36593193) Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8034375 (Family Id: 36593193) Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Feb 13, 2027 *PEDU-1290: Treatment of lung cancer
Pat. No. 8268348 (Family Id: 36593193) Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 21, 2026 *PEDU-1290: Treatment of lung cancer
Pat. No. 9101543 (Family Id: 36593193) Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 9393318 (Family Id: 44712580) Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9597409 (Family Id: 44712580) Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9511046 (Family Id: 51165317) Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016
Jul 12, 2034 *PEDU-1434: Treatment of pancreatic cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 6, 2023 PEDM-14: Additional clinical trial information added to pediatric use subsection

ABSORICA LD (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid
NDA Applicant: SUN PHARM      NDA No.: 211913  Prod. No.: 001 RX (8MG); 002 RX (16MG); 004 RX (24MG); 006 RX (32MG) NDA No.: 211913  Prod. No.: 003 DISC (20MG); 005 DISC (28MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9700535 DP* (Family Id: 55216820) Oral pharmaceutical composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2019
Aug 4, 2035 
Pat. No. 9750711 DP* (Family Id: 59018802) Low dose oral pharmaceutical composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2019
May 29, 2035 

ACANYA (GEL) (TOPICAL) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE [GENERIC AB]
Drug Classes: Dermatological Agents:Topical Anti-infectives == Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == lincosamide antibacterial
NDA Applicant: BAUSCH      NDA No.: 050819  Prod. No.: 001 RX (2.5%;EQ 1.2% BASE)
6 Patents--1 FamilyExpirationPatented Use
Pat. No. 8288434 DP* (Family Id: 41398394) 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 (Family Id: 41398394) 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 (Family Id: 41398394) 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* (Family Id: 41398394) 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 
Pat. No. 10220049 DP* (Family Id: 41398394) 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: Mar 8, 2019
Jun 3, 2029U-916: Topical treatment of acne vulgaris in patients 12 years or older
Pat. No. 10624918 (Family Id: 41398394) 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 11, 2020
Jun 3, 2029U-916: Topical treatment of acne vulgaris in patients 12 years or older

ACCRUFER (CAPSULE) (ORAL) FERRIC MALTOL
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: SHIELD TX      NDA No.: 212320  Prod. No.: 001 RX (30MG IRON)
3 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9248148 (Family Id: 39571409) Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Mar 29, 2031U-2603: Method of treating iron deficiency
Pat. No. 9802973 DS* DP* (Family Id: 52103522) Crystalline forms of ferric maltol
Claim Types: New polymorph, salt or hydrate; Process; Composition; Product-by-process; Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Oct 23, 2035U-2603: Method of treating iron deficiency
Pat. No. 10179120 (Family Id: 52432872) Dosage regimen of ferric trimaltol
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Jan 6, 2035U-2603: Method of treating iron deficiency
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 25, 2024 

ACETADOTE (INJECTABLE) (INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))
5 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8148356 DP* (Family Id: 36933421) 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 (Family Id: 36933421) 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 (Family Id: 36933421) 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 (Family Id: 45494138) 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 (Family Id: 45494138) 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

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN [Has competitive generic]
NDA Applicant: FRESENIUS KABI USA      NDA No.: 204767  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8741959 DP* (Family Id: 41066778) Paracetamol for parenteral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 24, 2019
Apr 19, 2030 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 005 RX (150MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7192938 (Family Id: 29414669) 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 (Family Id: 29414669) 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

ACTOPLUS MET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == 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.: 002 RX (850MG;EQ 15MG BASE) NDA No.: 021842  Prod. No.: 001 DISC (500MG;EQ 15MG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9101660 DP* (Family Id: 32064024) Solid preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 10, 2015
Jan 22, 2027 
Pat. No. 9320714 DP* (Family Id: 37073371) 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: Blood Glucose Regulators:Antidiabetic Agents == biguanide == Blood Glucose Regulators:Antidiabetic Combinations == 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 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
5 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7785627 DP* (Family Id: 34520446) Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 31, 2026 
Pat. No. 7959946 DP* (Family Id: 35060820) 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* (Family Id: 35060820) 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. 8668931 DP* (Family Id: 35060820) 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* (Family Id: 37073782) 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: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)
8 Patents--1 FamilyExpirationPatented Use
Pat. No. 8008338 DS* DP* (Family Id: 33563745) 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 (Family Id: 33563745) 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 (Family Id: 33563745) 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 (Family Id: 33563745) 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* (Family Id: 33563745) 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 (Family Id: 33563745) 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 (Family Id: 33563745) 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 (Family Id: 33563745) 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: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 022427  Prod. No.: 001 RX (0.45%)
4 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8512717 DP* (Family Id: 34138742) 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* (Family Id: 34138742) 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. 7842714 DS* DP* (Family Id: 40852460) Ketorolac tromethamine compositions for treating ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010
Aug 15, 2029 
Pat. No. 9192571 DP* (Family Id: 42938234) Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Mar 7, 2028 

ACUVUE THERAVISION WITH KETOTIFEN (DRUG-ELUTING CONTACT LENS) (OPHTHALMIC) KETOTIFEN FUMARATE
Drug Classes: histamine-1 (H1) receptor inhibitor
NDA Applicant: JOHNSON JOHNSON VISN      NDA No.: 022388  Prod. No.: 001 RX (EQ 19MCG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9474746 DP* (Family Id: 38421691) Methods for stabilizing oxidatively unstable compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 23, 2022
Mar 27, 2028 
Pat. No. 9962376 DP* (Family Id: 38739915) Methods and ophthalmic devices used in the treatment of ocular allergies
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 23, 2022
Jun 27, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 25, 2025 

ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: Antimycobacterials:Antimycobacterials, Other == Dermatological Agents:Topical Anti-infectives == sulfone
NDA Applicant: ALMIRALL      NDA No.: 207154  Prod. No.: 001 RX (7.5%)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9161926 DP* (Family Id: 49667632) 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 (Family Id: 49667632) 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
Pat. No. 11273132 DP* (Family Id: 49667632) Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2022
Nov 18, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationSep 10, 2022 

ADAPALENE AND BENZOYL PEROXIDE (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid == Dermatological Agents:Topical Anti-infectives
NDA Applicant: TARO      NDA No.: 209148  Prod. No.: 001 RX (0.3%;2.5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMay 30, 2022 

ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS      NDA No.: 022549  Prod. No.: 001 RX (10MG)
7 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7537009 DP* (Family Id: 27369190) Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 28, 2024 
Pat. No. 8074644 DP* (Family Id: 27369190) Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Jul 25, 2022 
Pat. No. 7458374 DP* (Family Id: 29400465) Method and apparatus for vaporizing a compound
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Aug 18, 2024 
Pat. No. 6716416 DP* (Family Id: 30772632) 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. 8387612 DP* (Family Id: 33476972) 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. 8991387 DP* (Family Id: 33476972) 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* (Family Id: 33476972) Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 7, 2016
May 20, 2024 

ADDYI (TABLET) (ORAL) FLIBANSERIN
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Female)
NDA Applicant: SPROUT PHARMS      NDA No.: 022526  Prod. No.: 001 RX (100MG)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7420057 DS* DP* (Family Id: 27440133) 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. 7151103 (Family Id: 8179028) 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. 8227471 (Family Id: 8179028) 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 (Family Id: 8179028) 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)

ADEMPAS (TABLET) (ORAL) RIOCIGUAT
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == 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)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)]
(Family Id: 29265155) Carbamate-substituted pyrazolopyridines
Claim Types: Compound; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 6, 2013
Dec 4, 2026 
Pat. No. 10662188 DS* DP* (Family Id: 50137643) Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Jun 23, 2020
Feb 18, 2034U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening
Pat. No. 11203593 DS* DP* (Family Id: 50137643) Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 14, 2022
Feb 18, 2034U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening

ADHANSIA XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines == central nervous system stimulant
NDA Applicant: PURDUE PHARMA LP      NDA No.: 212038  Prod. No.: 001 RX (25MG); 002 RX (35MG); 003 RX (45MG); 004 RX (55MG); 005 RX (70MG); 006 RX (85MG)
12 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9974752 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2019
Oct 30, 2035 
Pat. No. 10111839 (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10292938 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 22, 2019
Oct 30, 2035 
Pat. No. 10292939 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: May 22, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10449159 (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 22, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10500162 (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 11, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10507186 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 18, 2019
Oct 30, 2035 
Pat. No. 10512612 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 2, 2020
Oct 30, 2035 
Pat. No. 10512613 (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 2, 2020
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10568841 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2020
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10688060 DP* (Family Id: 55809326) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 23, 2020
Oct 30, 2035 
Pat. No. 10722473 (Family Id: 70728856) Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2020
Nov 19, 2038U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 28, 2024M-82: Labeling revisions related to clinical studies
Exclusivity Code: NP - New productFeb 27, 2022 

ADLARITY (SYSTEM) (TRANSDERMAL) DONEPEZIL HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == acetylcholinesterase inhibitor
NDA Applicant: CORIUM      NDA No.: 212304  Prod. No.: 001 RX (5MG/DAY); 002 RX (10MG/DAY)
7 Patents--3 FamiliesExpirationPatented Use
Pat. No. 10835499 DP* (Family Id: 57861282) Systems and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
May 20, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10966936 DP* (Family Id: 57861282) Systems comprising a composite backing and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Aug 11, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 9993466 DP* (Family Id: 59523314) Donepezil transdermal delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10300025 DP* (Family Id: 59523314) Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10307379 DP* (Family Id: 59523314) Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 11103463 (Family Id: 59523314) Methods for treating Alzheimer's disease with donepezil transdermal system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10016372 (Family Id: 59593165) Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type

ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: IMPAX      NDA No.: 020800  Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10166334 DP* (Family Id: 36578410) Medicine injection apparatuses
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 11, 2020
Jan 21, 2025 
Pat. No. 7905352 DP* (Family Id: 36578509) 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, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204200  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 9119876 DP* (Family Id: 53938725) Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 14, 2016
Mar 13, 2035 
Pat. No. 9295657 (Family Id: 53938725) 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, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204640  Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 9119876 DP* (Family Id: 53938725) Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2015
Mar 13, 2035 
Pat. No. 9295657 (Family Id: 53938725) 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
Pat. No. 10130592 DP* (Family Id: 53938725) Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 26, 2018
Mar 13, 2035 

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021254  Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7500444 DP* (Family Id: 30001969) Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Aug 26, 2026 *PED 
Pat. No. 7832351 DP* (Family Id: 30001969) Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2012; 002: None; 003: None
Dec 19, 2023 *PED 

ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7863287 DP* (Family Id: 32682029) 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 ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 10238640 DP* (Family Id: 35425554) Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

ADVIL DUAL ACTION WITH ACETAMINOPHEN (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 211733  Prod. No.: 001 OTC (250MG;125MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 28, 2023 

ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021393  Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8883849 (Family Id: 22997281) 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* (Family Id: 22997281) 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: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021394  Prod. No.: 001 OTC (38MG;200MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8263647 DP* (Family Id: 22997281) Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 30, 2022 

ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020589  Prod. No.: 002 OTC (100MG/5ML)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 10238640 DP* (Family Id: 35425554) Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 24, 2019
May 25, 2024 

ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC      NDA No.: 204325  Prod. No.: 001 DISC (EQ 1.25MG BASE/ML)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8709491 DP* (Family Id: 47424553) 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* (Family Id: 47424553) 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* (Family Id: 47424553) 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 Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
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)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8840924 DP* (Family Id: 37985648) 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. 8709491 DP* (Family Id: 47424553) 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. 9017731 DP* (Family Id: 47424553) 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* (Family Id: 47424553) 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 

AEMCOLO (TABLET, DELAYED RELEASE) (ORAL) RIFAMYCIN SODIUM
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == rifamycin antibacterial
NDA Applicant: REDHILL      NDA No.: 210910  Prod. No.: 001 RX (EQ 194MG BASE)
4 Patents--1 FamilyExpirationPatented Use
Pat. No. 8263120 DP* (Family Id: 34968899) Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8486446 DP* (Family Id: 34968899) Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8529945 DP* (Family Id: 34968899) Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8741948 DP* (Family Id: 34968899) Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025U-2448: Treatment of travelers' diarrhea caused by non-invasive strains of escherichia coli in adults

AFINITOR (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Immunological Agents:Immunosuppressants == 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)
4 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8410131 (Family Id: 26245731) 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 (Family Id: 26245731) 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 (Family Id: 26245731) 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 (Family Id: 37671355) 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: 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

AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Immunological Agents:Immunosuppressants == kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM      NDA No.: 203985  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8778962 (Family Id: 26245731) 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
Pat. No. 8617598 DP* (Family Id: 9922916) 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 
ExclusivityExpirationExclusivity Description
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

AGGRASTAT (INJECTABLE; SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE      NDA No.: 020912  Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)) NDA No.: 020912  Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 6770660 (Family Id: 29401623) Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (SOLUTION) (INTRAVENOUS) TIROFIBAN HYDROCHLORIDE [GENERIC AP]
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE      NDA No.: 020913  Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913  Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 6770660 (Family Id: 29401623) 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 DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
23 Patents--11 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 004: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 004: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9066957 DP* (Family Id: 51743574) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 9415008 DP* (Family Id: 55443303) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 004: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Apr 7, 2022
Aug 22, 2041 *PED 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 004: Dec 8, 2021
Jan 6, 2041 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 9, 2025 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
22 Patents--10 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9066957 DP* (Family Id: 51743574) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 7, 2022
Aug 22, 2041 *PED 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Jan 6, 2041 *PED 

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
16 Patents--7 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jul 3, 2018
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9066957 DP* (Family Id: 51743574) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9415008 DP* (Family Id: 55443303) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 9, 2025 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == 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/INH;EQ 0.014MG BASE/INH)
15 Patents--6 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9066957 DP* (Family Id: 51743574) Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma

AKLIEF (CREAM) (TOPICAL) TRIFAROTENE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: GALDERMA LABS LP      NDA No.: 211527  Prod. No.: 001 RX (0.005%)
5 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7807708 DS* DP* (Family Id: 34952934) Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 31, 2019
Oct 1, 2026 
Pat. No. 8227507 (Family Id: 34952934) Ligands that modulate RAR receptors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 31, 2019
Dec 21, 2025U-818: Topical treatment of acne vulgaris
Pat. No. 8470871 (Family Id: 34952934) Ligands that modulate RAR receptors
Claim Types: Method of use defined by mechanism of action
Pat. Sub. Date(s): 001: Oct 31, 2019
Dec 21, 2025U-2639: Method of activating rargamma receptor
Pat. No. 9498465 DP* (Family Id: 46889196) Topical compositions in the form of a gel containing a particular solubilized retinoid
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2021
May 30, 2033U-1033: Topical treatment of acne vulgaris
Pat. No. 9084778 DP* (Family Id: 49715798) Topical compositions containing a retinoid of the oil-in-water emulsion type
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 31, 2019
May 30, 2033U-134: Treatment of acne vulgaris
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 4, 2024 

AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: THEA PHARMA      NDA No.: 022221  Prod. No.: 001 RX (3.5%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8759401 DP* (Family Id: 38535570) 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: Antiemetics:Emetogenic Therapy Adjuncts == substance P/neurokinin-1 (NK-1) receptor antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
11 Patents--3 FamiliesExpirationPatented Use
Pat. No. 6297375 DS* (Family Id: 26152908) 4-phenyl-pyridine derivatives
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 6, 2014
Mar 17, 2023 
Pat. No. 8623826 (Family Id: 45806930) 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* (Family Id: 45806930) 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 (Family Id: 45806930) 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 (Family Id: 45806930) 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 (Family Id: 45806930) Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2018
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 10828297 (Family Id: 45806930) Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2020
Dec 17, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9951016 DS* DP* (Family Id: 54601836) Crystalline forms of an NK-1 antagonist
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 16, 2018
Sep 25, 2035 
Pat. No. 10233154 DS* (Family Id: 54601836) Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Mar 28, 2019
Sep 25, 2035 
Pat. No. 10676440 DS* DP* (Family Id: 54601836) Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jul 8, 2020
Sep 25, 2035 
Pat. No. 10961195 DS* DP* (Family Id: 54601836) Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 15, 2021
Sep 25, 2035 

AKYNZEO (POWDER; SOLUTION) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 210493  Prod. No.: 001 RX (EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL); 002 RX (EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML))
10 Patents--4 FamiliesExpirationPatented Use
Pat. No. 9186357 (Family Id: 45806930) 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; 002: Jun 24, 2020
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. 10828297 (Family Id: 45806930) Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2020
Dec 17, 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. 8426450 DS* DP* (Family Id: 48094815) Substituted 4-phenyl pyridines having anti-emetic effect
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032 
Pat. No. 8895586 (Family Id: 48094815) Methods of treating emesis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
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* (Family Id: 48094815) Substituted piperaziniums for the treatment of emesis
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032 
Pat. No. 10208073 (Family Id: 48094815) Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-to- lyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnet- upitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 8, 2019; 002: Jun 24, 2020
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. 10717721 DS* (Family Id: 48094815) Substituted piperaziniums for the treatment of emesis
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Aug 19, 2020
May 23, 2032 
Pat. No. 11312698 DS* DP* (Family Id: 48094815) Fosnetupitant chloride hydrochloride having improved stability
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 13, 2022
May 23, 2032 
Pat. No. 9403772 DS* (Family Id: 52133223) 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; 002: Jun 24, 2020
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. 10624911 DP* (Family Id: 59055193) Physiologically balanced injectable formulations of fosnetupitant
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: May 26, 2020; 002: Jun 24, 2020
Jun 2, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 19, 2023 

ALDARA (CREAM) (TOPICAL) IMIQUIMOD [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: BAUSCH      NDA No.: 020723  Prod. No.: 001 RX (5%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7696159 DS* (Family Id: 32994823) 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: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.: 208434  Prod. No.: 001 RX (EQ 150MG BASE)
4 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9126931 DS* (Family Id: 43308919) Tetracyclic compound
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 22, 2015
May 29, 2031 
Pat. No. 9440922 DP* (Family Id: 43308919) Tetracyclic compound
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 12, 2016
Jun 9, 2030 
Pat. No. 9365514 DP* (Family Id: 45605249) Composition comprising tetracyclic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 11, 2016
Mar 4, 2032 
Pat. No. 10350214 DP* (Family Id: 54332608) Preparation containing tetracyclic compound at high dose
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 9, 2020
Apr 24, 2035 
ExclusivityExpirationExclusivity Description
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 [GENERIC AP]
Drug Classes: Antineoplastics:Antineoplastics, Other == folate analog metabolic inhibitor
NDA Applicant: LILLY      NDA No.: 021462  Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7772209 (Family Id: 27396105) 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: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.: 209936  Prod. No.: 001 RX (60MG/VIAL)
4 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7511041 DS* DP* (Family Id: 32039115) Fused azole-pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2017
May 13, 2024 
Pat. No. RE46856 DS* DP* (Family Id: 39492563) Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Claim Types: Compound; Composition; Kit; Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Oct 22, 2029U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 9636344 (Family Id: 43984137) Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2017
Mar 29, 2032U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 10383876 DS* DP* (Family Id: 43984137) Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts
Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2019
Mar 29, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: 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

ALKINDI SPRINKLE (GRANULE) (ORAL) HYDROCORTISONE
NDA Applicant: ETON      NDA No.: 213876  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG); 004 RX (5MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 9675559 (Family Id: 45475414) Treatment of adrenal insufficiency
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
Jan 10, 2033U-3075: Treatment of adrenal insufficiency
Pat. No. 9717740 (Family Id: 45475414) Treatment of adrenal insufficiency
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
Nov 19, 2032U-3075: Treatment of adrenal insufficiency
Pat. No. 9649280 DP* (Family Id: 48746932) Composition comprising hydrocortisone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
May 12, 2034U-3075: Treatment of adrenal insufficiency

ALLEGRA, CHILDREN'S ALLERGY; ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: CHATTEM SANOFI      NDA No.: 201373  Prod. No.: 001 OTC (30MG/5ML) NDA No.: 201373  Prod. No.: 002 DISC (30MG/5ML**)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8933097 DP* (Family Id: 38120312) Fexofenadine suspension formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 19, 2015
Aug 2, 2030 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE [Has competitive generic]
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML))
13 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7947724 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 27, 2011
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* (Family Id: 32825409) 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* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* (Family Id: 32825409) 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. 8598219 DP* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8729094 DP* (Family Id: 49235852) 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* (Family Id: 49235852) 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* (Family Id: 49235852) 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* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457021 DP* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML))
8 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7947724 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* (Family Id: 32825409) 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* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* (Family Id: 32825409) Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Oct 25, 2016
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* (Family Id: 49235852) Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Sep 27, 2016
Jul 30, 2024 *PED 

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021262  Prod. No.: 001 RX (0.15%)
5 Patents--3 FamiliesExpirationPatented Use
Pat. No. 6627210 DP* (Family Id: 22814143) Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* (Family Id: 22814143) Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* (Family Id: 22814143) Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 6562873 (Family Id: 22814167) Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 9295641 (Family Id: 41415362) 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: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
7 Patents--3 FamiliesExpirationPatented Use
Pat. No. 6627210 DP* (Family Id: 22814143) Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* (Family Id: 22814143) Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* (Family Id: 22814143) Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 6562873 DP* (Family Id: 22814167) Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 8858961 DP* (Family Id: 41415362) 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 (Family Id: 41415362) 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* (Family Id: 41415362) 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: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == 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))
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7811254 DP* (Family Id: 39314714) 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: Dermatological Agents:Topical Anti-infectives == pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.: 022055  Prod. No.: 001 RX (1%)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7875630 DS* (Family Id: 34272868) 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 (Family Id: 34272868) 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

ALTRENO (LOTION) (TOPICAL) TRETINOIN
Drug Classes: Antineoplastics:Retinoids == Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: DOW PHARM      NDA No.: 209353  Prod. No.: 001 RX (0.05%)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 10653656 DP* (Family Id: 68099202) Topical pharmaceutical compositions for treating skin conditions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 28, 2020
Aug 22, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
Pat. No. 11324710 (Family Id: 68099202) Topical pharmaceutical compositions for treating skin conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 8, 2022
Aug 22, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formAug 23, 2021 

ALUNBRIG (TABLET) (ORAL) BRIGATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208772  Prod. No.: 001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
4 Patents--4 FamiliesExpirationPatented Use
Pat. No. 9012462 DS* (Family Id: 41340562) 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
Apr 28, 2031 
Pat. No. 9273077 (Family Id: 50188364) 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-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Pat. No. 10385078 DS* DP* (Family Id: 54365447) Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylp- iperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Nov 10, 2035U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Pat. No. 9611283 (Family Id: 58419365) 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-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 22, 2023I-847: Expanded indication of the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
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
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2027ODE-300: For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, not including patients who have progressed on or are intolerant to crizotinib

ALVESCO (AEROSOL, METERED) (INHALATION) CICLESONIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant: COVIS      NDA No.: 021658  Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8371292 (Family Id: 34312429) 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

AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
Drug Classes: porphyrin precursor
NDA Applicant: BIOFRONTERA      NDA No.: 208081  Prod. No.: 001 RX (10%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 11235169 (Family Id: 78087370) Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Feb 23, 2022
Oct 15, 2040U-3303: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 001 RX (24MCG)
8 Patents--5 FamiliesExpirationPatented Use
Pat. No. 6982283 (Family Id: 23104042) 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. 8097653 (Family Id: 23293447) 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. 8389542 DP* (Family Id: 23293447) 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. 7064148 (Family Id: 26980134) 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. 8748481 (Family Id: 35229739) 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. 8026393 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 26, 2011
Oct 25, 2027 
Pat. No. 8338639 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 20, 2012
Jan 23, 2027 
Pat. No. 8779187 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 7, 2014
Jan 23, 2027 

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 002 RX (8MCG)
6 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7064148 (Family Id: 26980134) 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. 7795312 (Family Id: 32717850) 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. 8748481 (Family Id: 35229739) 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. 8026393 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Oct 25, 2027 
Pat. No. 8338639 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jan 23, 2027 
Pat. No. 8779187 DP* (Family Id: 38169220) Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Aug 7, 2014
Jan 23, 2027 

AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == 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)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 6828339 DS* (Family Id: 23295188) 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 

AMONDYS 45 (SOLUTION) (INTRAVENOUS) CASIMERSEN
Drug Classes: antisense oligonucleotide
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 213026  Prod. No.: 001 RX (100MG/2ML (50MG/ML))
6 Patents--3 FamiliesExpirationPatented Use
Pat. No. 9447415 DS* DP* (Family Id: 35781530) Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Jun 28, 2025 
Pat. No. 9228187 DS* DP* (Family Id: 43991096) Antisense molecules and methods for treating pathologies
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030 
Pat. No. 9758783 (Family Id: 43991096) Antisense molecules and methods for treating pathologies
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping
U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production
Pat. No. 10287586 DS* DP* (Family Id: 43991096) Antisense molecules and methods for treating pathologies
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030 
Pat. No. 10781450 (Family Id: 43991096) Antisense molecules and methods for treating pathologies
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production
Pat. No. RE48960 DS* DP* (Family Id: 80444515) Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Method of use; Formulation
Pat. Sub. Date(s): 001: Mar 31, 2022
Jun 28, 2025U-3087: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by inducing exon-skipping of exon 45
U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 25, 2028ODE-347: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping

AMPHOTERICIN B (INJECTABLE, LIPOSOMAL) (INJECTION) AMPHOTERICIN B [GENERIC AB]
Drug Classes: Antifungals == lipid-based polyene antifungal
NDA Applicant: SPIL      NDA No.: 212514  Prod. No.: 001 RX (50MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyAug 14, 2022 

AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Skeletal Muscle Relaxants
NDA Applicant: TEVA PHARMS INTL      NDA No.: 021777  Prod. No.: 001 RX (15MG); 002 RX (30MG)
8 Patents--1 FamilyExpirationPatented Use
Pat. No. 7387793 DP* (Family Id: 34573847) Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 26, 2025 
Pat. No. 7544372 (Family Id: 34573847) 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* (Family Id: 34573847) 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* (Family Id: 34573847) Modified release dosage forms of skeletal muscle relaxants
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 14, 2023 
Pat. No. 7829121 (Family Id: 34573847) 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 (Family Id: 34573847) 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 (Family Id: 34573847) 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* (Family Id: 34573847) 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: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine calcium channel blocker == Cardiovascular Agents:Diuretics, Thiazide == thiazide diuretic
NDA Applicant: NOVARTIS      NDA No.: 200045  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8183295 DP* (Family Id: 29550141) 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 

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))
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7687052 DS* DP* (Family Id: 38326579) 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* (Family Id: 38326579) 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

AMZEEQ (AEROSOL, FOAM) (TOPICAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents == tetracycline-class drug
NDA Applicant: JOURNEY      NDA No.: 212379  Prod. No.: 001 RX (EQ 4% BASE)
12 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8865139 DP* (Family Id: 43826720) Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 8945516 DP* (Family Id: 43826720) Surfactant-free water-free foamable compositions, breakable foams and gels and their uses
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030 
Pat. No. 8992896 DP* (Family Id: 43826720) Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 9675700 DP* (Family Id: 43826720) Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10086080 (Family Id: 43826720) Topical tetracycline compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10137200 (Family Id: 43826720) Surfactant-free water-free foamable compositions, breakable foams and gels and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10213512 DP* (Family Id: 43826720) Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10265404 DP* (Family Id: 43826720) Compositions, gels and foams with rheology modulators and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030 
Pat. No. 10821187 (Family Id: 43826720) Compositions, gels and foams with rheology modulators and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2020
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10517882 (Family Id: 49003540) Method for healing of an infected acne lesion without scarring
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2020
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10398641 (Family Id: 61281858) Compositions and methods for treating rosacea and acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Sep 8, 2037U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10849847 (Family Id: 61281858) Compositions and methods for treating rosacea and acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Sep 8, 2037U-2647: Treatment of non-nodular acne vulgaris

ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ABBVIE      NDA No.: 022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309  Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)); 003 DISC (1.62% (40.5MG/2.5GM PACKET))
8 Patents--1 FamilyExpirationPatented Use
Pat. No. 8466136 DP* (Family Id: 37943593) Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026 
Pat. No. 8466137 (Family Id: 37943593) 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 (Family Id: 37943593) 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* (Family Id: 37943593) 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* (Family Id: 37943593) 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 (Family Id: 37943593) 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* (Family Id: 37943593) 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* (Family Id: 37943593) Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014
Oct 12, 2026 

ANGELIQ (TABLET) (ORAL) DROSPIRENONE; ESTRADIOL
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant: BAYER HLTHCARE      NDA No.: 021355  Prod. No.: 001 RX (0.25MG;0.5MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8906890 DP* (Family Id: 44260074) 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: anticoagulant == direct thrombin inhibitor
NDA Applicant: SANDOZ INC      NDA No.: 020873  Prod. No.: 001 RX (250MG/VIAL)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7582727 DP* (Family Id: 41009179) 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* (Family Id: 41128407) 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 

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX      NDA No.: 210583  Prod. No.: 001 RX (30MG/ML (30MG/ML))
7 Patents--4 FamiliesExpirationPatented Use
Pat. No. 8512727 DP* (Family Id: 33563669) Nanoparticulate meloxicam formulations
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2020
Dec 25, 2022U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 9974746 DP* (Family Id: 42352727) Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 6, 2020
May 26, 2030 
Pat. No. 11253478 DP* (Family Id: 42352727) Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Mar 4, 2022
May 26, 2030U-3318: Management of moderate-to-severe pain by injection
Pat. No. 10463673 DP* (Family Id: 43124706) Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10471067 DP* (Family Id: 43124706) Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10709713 (Family Id: 43124706) Nanoparticulate meloxicam formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2020
May 26, 2030U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10881663 (Family Id: 67842838) Method of treating pain in elderly patients with mild renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2021
Mar 8, 2039U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 20, 2023 

ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Contraceptives, Other == progestin/estrogen CHC
NDA Applicant: THERAPEUTICSMD INC      NDA No.: 209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)
6 Patents--2 FamiliesExpirationPatented Use
Pat. No. 10632066 (Family Id: 70332435) Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 29, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10765628 (Family Id: 70332435) Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10780047 (Family Id: 70332435) Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10918649 DP* (Family Id: 71528001) System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 17, 2021
Jun 21, 2039 
Pat. No. 10925882 DP* (Family Id: 71528001) System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 24, 2021
Jun 21, 2039 
Pat. No. 10940157 DP* (Family Id: 71528001) System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 11, 2021
Jun 21, 2039 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
15 Patents--9 FamiliesExpirationPatented Use
Pat. No. RE44874 DS* DP* (Family Id: 26246542) 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)]
(Family Id: 26246542) 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. 7776895 DP* (Family Id: 26246542) 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. 8161968 DP* (Family Id: 27772613) Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Feb 5, 2028 
Pat. No. 9333310 DP* (Family Id: 33017600) Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* (Family Id: 34889131) Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Oct 23, 2027 
Pat. No. 8746242 DP* (Family Id: 34983693) Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Oct 11, 2030 
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
(Family Id: 35242158) 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* (Family Id: 35242158) Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025 
Pat. No. 8183257 (Family Id: 35242158) 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 (Family Id: 35242158) 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. 8534281 DP* (Family Id: 37663259) Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Mar 8, 2030 
Pat. No. 9750726 DP* (Family Id: 41573013) Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Nov 29, 2030 
Pat. No. 11090294 (Family Id: 41573013) Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2021
Nov 29, 2030U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8511304 DP* (Family Id: 9929711) 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.
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 9, 2022M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN      NDA No.: 021695  Prod. No.: 004 RX (30MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8026281 (Family Id: 36181048) 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: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN      NDA No.: 021695  Prod. No.: 005 RX (90MG)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8026281 (Family Id: 36181048) 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* (Family Id: 48142027) 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
Drug Classes: antidote
NDA Applicant: PAR PHARM INC      NDA No.: 020696  Prod. No.: 001 DISC (1.5GM/1.5ML (1GM/ML)**)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 7553863 DS* DP* (Family Id: 36977317) Ultrapure 4-methylpyrazole
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Jun 30, 2027 

APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant: KVK TECH INC      NDA No.: 208653  Prod. No.: 001 RX (325MG;EQ 6.12MG BASE)
5 Patents--1 FamilyExpirationPatented Use
Pat. No. 8461137 DS* DP* (Family Id: 43411452) 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* (Family Id: 43411452) 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* (Family Id: 43411452) 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* (Family Id: 43411452) 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* (Family Id: 43411452) 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 

APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant: KVK TECH INC      NDA No.: 208653  Prod. No.: 002 RX (325MG;EQ 4.08MG BASE); 003 RX (325MG;EQ 8.16MG BASE)
5 Patents--1 FamilyExpirationPatented Use
Pat. No. 8461137 DS* DP* (Family Id: 43411452) 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): All strengths: Jan 25, 2019
Feb 22, 2031 
Pat. No. 8748413 DS* DP* (Family Id: 43411452) 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): All strengths: Jan 25, 2019
Jul 10, 2030 
Pat. No. 8828978 DP* (Family Id: 43411452) 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): All strengths: Jan 25, 2019
Jul 1, 2030 
Pat. No. 9132125 DS* DP* (Family Id: 43411452) 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): All strengths: Jan 25, 2019
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* (Family Id: 43411452) 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): All strengths: Jan 25, 2019
Jul 1, 2030 

APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: BAUSCH      NDA No.: 022108  Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
8 Patents--3 FamiliesExpirationPatented Use
Pat. No. 7241805 DP* (Family Id: 37595948) 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 (Family Id: 37595948) 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* (Family Id: 37595948) Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7585897 DP* (Family Id: 37595948) Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7649019 DP* (Family Id: 37595948) Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7662407 DP* (Family Id: 37595948) Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7671094 DP* (Family Id: 39225245) Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7645802 DP* (Family Id: 40521541) Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 

APOMORPHINE HYDROCHLORIDE (INJECTABLE) (SUBCUTANEOUS) APOMORPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SAGE CHEMS      NDA No.: 212025  Prod. No.: 001 RX (30MG/3ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyAug 24, 2022 

APRETUDE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 215499  Prod. No.: 001 RX (600MG/3ML (200MG/ML))
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8410103 DS* DP* (Family Id: 37215098) (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 14, 2022
Apr 28, 2026 
Pat. No. 10927129 DS* DP* (Family Id: 37215098) N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 14, 2022
Apr 28, 2026 
Pat. No. 11224597 DP* (Family Id: 45832235) Pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 10, 2022
Sep 15, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 21, 2026 

APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: Inflammatory Bowel Disease Agents:Aminosalicylates and/ or Prodrugs
NDA Applicant: VALEANT PHARMS INTL      NDA No.: 022301  Prod. No.: 001 RX (375MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8865688 (Family Id: 42073898) 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

APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE [GENERIC AB]
Drug Classes: Anticonvulsants:Sodium Channel Agents
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 022416  Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
10 Patents--5 FamiliesExpirationPatented Use
Pat. No. 9206135 DS* (Family Id: 34983785) 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. 9643929 DP* (Family Id: 34983785) Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 8, 2017
Apr 21, 2026 
Pat. No. 10675287 (Family Id: 37394802) Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2020
May 6, 2025U-2041: Treatment of partial-onset seizures
U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures
Pat. No. 10695354 (Family Id: 37394802) Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 30, 2020
May 6, 2025U-2501: Treatment of partial-onset seizures
U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures
Pat. No. 10702536 (Family Id: 37394802) Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2020
May 6, 2025U-2501: Treatment of partial-onset seizures
Pat. No. 9763954 (Family Id: 37809995) 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
Pat. No. 8372431 DP* (Family Id: 40254311) Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 17, 2030 
Pat. No. 9566244 DP* (Family Id: 40254311) Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2017
Oct 23, 2028 
Pat. No. 10912781 DP* (Family Id: 40254311) Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Oct 23, 2028 
Pat. No. 9750747 (Family Id: 46889403) 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

ARAKODA (TABLET) (ORAL) TAFENOQUINE SUCCINATE
Drug Classes: Antiparasitics:Antiprotozoals
NDA Applicant: 60 DEGREES PHARMS      NDA No.: 210607  Prod. No.: 001 RX (EQ 100MG BASE)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 10342791 (Family Id: 56092389) Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Claim Types: Method of use (dosaage regimen); Kit
Pat. Sub. Date(s): 001: Jul 31, 2019
Dec 2, 2035U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose
Pat. No. 10888558 (Family Id: 56092389) Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Feb 10, 2021
Dec 2, 2035U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 20, 2023 
Exclusivity Code: NP - New productAug 8, 2021 

ARAZLO (LOTION) (TOPICAL) TAZAROTENE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == retinoid
NDA Applicant: BAUSCH      NDA No.: 211882  Prod. No.: 001 RX (0.045%)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 11311482 (Family Id: 66328069) Topical compositions and methods for treating skin diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 5, 2022
May 11, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 18, 2022 

ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.: 022383  Prod. No.: 001 DISC (EQ 75MCG BASE)
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
(Family Id: 10854788) 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. 8479730 DP* (Family Id: 32526997) Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2013
Oct 11, 2028 

ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents == tetracycline-class drug
NDA Applicant: ORAPHARMA      NDA No.: 050781  Prod. No.: 001 RX (EQ 1MG BASE)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 6682348 DP* (Family Id: 28453332) 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* (Family Id: 28453332) 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: CIPLA      NDA No.: 022434  Prod. No.: 001 DISC (50MG/50ML (1MG/ML))
2 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7589106 DP* (Family Id: 39230808) Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1163: Method of treating thrombosis
Pat. No. 7687516 DP* (Family Id: 46329449) 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: Antidementia Agents:Cholinesterase Inhibitors == acetylcholinesterase inhibitor
NDA Applicant: EISAI INC      NDA No.: 022568  Prod. No.: 001 RX (23MG)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8481565 DP* (Family Id: 36615033) Method for stabilizing anti-dementia drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 9, 2013
Oct 4, 2026 

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
11 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7718189 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8802137 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9827317 DP* (Family Id: 37669512) Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 8632804 (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 (Family Id: 38123420) Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9566234 DP* (Family Id: 49624305) Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 (Family Id: 54480776) Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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))
11 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) 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 (Family Id: 43386893) 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. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) 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. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) 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. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) 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
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
12 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 002: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 002: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
12 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 003: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 10226458 (Family Id: 45929620) Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 11097006 DP* (Family Id: 50339464) Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 9452131 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 003: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10238651 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 (Family Id: 54141031) Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 10, 2020
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 209830  Prod. No.: 001 RX (675MG/2.4ML)
8 Patents--3 FamiliesExpirationPatented Use
Pat. No. 8431576 DS* (Family Id: 43386893) 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 (Family Id: 43386893) 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. 10112903 DS* (Family Id: 43386893) Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* (Family Id: 55301322) Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018
Sep 8, 2035 
Pat. No. 10688091 DP* (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 8, 2020
Aug 17, 2035 
Pat. No. 10849894 (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Aug 17, 2035U-543: Treatment of schizophrenia
Pat. No. 11154552 DP* (Family Id: 55301322) Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2021
Aug 17, 2035 
Pat. No. 11273158 (Family Id: 65818625) Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 004 RX (0.055MG/INH)
20 Patents--9 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 004: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 004: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Apr 7, 2022
Aug 22, 2041 *PED 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 004: Dec 8, 2021
Jan 6, 2041 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 9, 2025 PED 

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
20 Patents--9 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 7, 2022
Aug 22, 2041 *PED 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Jan 6, 2041 *PED 

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 008 DISC (0.03MG/INH)
20 Patents--9 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 008: May 5, 2022
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
May 8, 2031 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 008: May 5, 2022
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 008: May 5, 2022
Jul 1, 2032 *PED 
Pat. No. 9782550 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Feb 28, 2036 *PED 
Pat. No. 10569034 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Feb 16, 2037 *PED 
Pat. No. 10918816 DP* (Family Id: 54072809) Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Jun 14, 2036 *PED 
Pat. No. 11000653 DP* (Family Id: 60452683) Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 008: May 5, 2022
Jun 18, 2039 *PED 
Pat. No. 11266796 DP* (Family Id: 60627623) Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Aug 22, 2041 *PED 
Pat. No. 11173259 DP* (Family Id: 71522990) Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Jan 6, 2041 *PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH)
13 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jul 1, 2032 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 9, 2025 PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
13 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 007 DISC (0.03MG/INH)
13 Patents--5 FamiliesExpirationPatented Use
Pat. No. 7540282 DP* (Family Id: 26908022) Reservoir pressure system for medicament inhaler
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 6, 2023 *PED 
Pat. No. 8651103 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Sep 26, 2028 *PED 
Pat. No. 9463288 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* (Family Id: 29415374) Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
Pat. No. 9616024 DP* (Family Id: 34272843) Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Mar 1, 2025 *PED 
Pat. No. 8714149 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Aug 25, 2032 *PED 
Pat. No. 10195375 DP* (Family Id: 41501996) Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Aug 14, 2031 *PED 
Pat. No. 8978966 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Jul 13, 2032 *PED 
Pat. No. 9216260 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Dec 28, 2031 *PED 
Pat. No. 9731087 DP* (Family Id: 44971401) Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* (Family Id: 44971401) Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 10561808 DP* (Family Id: 44971401) Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 007: Aug 5, 2021
Jul 1, 2032 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 9, 2025 PED 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 001 RX (0.1MG/INH); 002 RX (0.2MG/INH); 003 RX (0.05MG/INH)
6 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8161968 DP* (Family Id: 27772613) Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018
Feb 5, 2028 
Pat. No. 8201556 DP* (Family Id: 33017600) Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018
Feb 5, 2029 
Pat. No. 9333310 DP* (Family Id: 33017600) Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 18, 2016; 002: May 18, 2016; 003: Jun 13, 2018
Oct 2, 2027 
Pat. No. 8113199 DP* (Family Id: 34889131) Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018
Oct 23, 2027 
Pat. No. 8746242 DP* (Family Id: 34983693) Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018
Oct 11, 2030 
Pat. No. 8534281 DP* (Family Id: 37663259) Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018
Mar 8, 2030 

ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS      NDA No.: 213036  Prod. No.: 001 RX (110MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 26, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityMay 26, 2027ODE-290: Indicated for the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen

ARYMO ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ZYLA      NDA No.: 208603  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 9044402 DP* (Family Id: 48703579) Abuse-deterrent pharmaceutical compositions for controlled release
Claim Types: Formulation; Method of use
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* (Family Id: 48703579) 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.

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 HFA (AEROSOL, METERED) (INHALATION) MOMETASONE FUROATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: ORGANON      NDA No.: 205641  Prod. No.: 003 RX (0.05MG/INH)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthFeb 12, 2023 PED 

ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE) (ORAL) RANOLAZINE
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == antianginal
NDA Applicant: SPIL      NDA No.: 216018  Prod. No.: 002 RX (1GM)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 10898444 DP* (Family Id: 62486518) Extended release multiparticulates of ranolazine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 3, 2022
Jan 24, 2038 

ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Immunological Agents:Immunosuppressants == 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)May 24, 2025 

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 001 DISC (0.137MG/SPRAY)
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) 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 (Family Id: 36498307) 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

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 002 DISC (0.2055MG/SPRAY)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) 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 (Family Id: 36498307) 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* (Family Id: 36498307) Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 29, 2018
Nov 22, 2025 

ASTEPRO ALLERGY; ASTEPRO ALLERGY, CHILDREN'S (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist
NDA Applicant: BAYER HLTHCARE      NDA No.: 213872  Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
3 Patents--1 FamilyExpirationPatented Use
Pat. No. 8071073 DP* (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Jun 4, 2028 
Pat. No. 8518919 (Family Id: 36498307) Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025U-3166: OTC use: allergy symptom reliever; temporary relief of these symptoms due to hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing and itchy nose
Pat. No. 9919050 DP* (Family Id: 36498307) Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025 

ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: APIL      NDA No.: 022560  Prod. No.: 001 RX (35MG)
3 Patents--2 FamiliesExpirationPatented Use
Pat. No. 7645459 DP* (Family Id: 36190430) 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. 8246989 DP* (Family Id: 36190430) Dosage forms of bisphosphonates
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 28, 2012
Jan 16, 2026 
Pat. No. 7645460 DP* (Family Id: 46123939) 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

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-HIV Combinations == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.: 021937  Prod. No.: 001 RX (600MG;200MG;300MG)
7 Patents--2 FamiliesExpirationPatented Use
Pat. No. 8592397 DP* (Family Id: 32776014) Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8716264 DP* (Family Id: 32776014) Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* (Family Id: 32776014) Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* (Family Id: 32776014) Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 8598185 DP* (Family Id: 37532913) Unitary pharmaceutical dosage form
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 28, 2029 
Pat. No. 9018192 (Family Id: 37532913) Unitary pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2015
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 9545414 DP* (Family Id: 37532913) 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

ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE      NDA No.: 212868  Prod. No.: 001 RX (0.25MG/5ML (0.05MG/ML)); 002 RX (0.5MG/5ML (0.1MG/ML)); 003 RX (1MG/10ML (0.1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJan 26, 2022 

ATROPINE SULFATE (SOLUTION) (INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE      NDA No.: 213424  Prod. No.: 001 RX (8MG/20ML (0.4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapySep 21, 2021 

ATROPINE SULFATE (SOLUTION/DROPS) (OPHTHALMIC) ATROPINE SULFATE [GENERIC AT]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: APOTEX INC      NDA No.: 215624  Prod. No.: 001 RX (1%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMay 25, 2022 

ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021527  Prod. No.: 001 RX (0.021MG/INH)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8474447 DP* (Family Id: 40083622) Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: May 28, 2015
Jan 17, 2030 

AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 202992  Prod. No.: 001 RX (7MG); 002 RX (14MG)
3 Patents--3 FamiliesExpirationPatented Use
Pat. No. 6794410 [Extended 1625 days (4.5 years)]
(Family Id: 23078354) 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
Mar 12, 2027 *PEDU-1285: Treatment of patients with relapsing forms of multiple sclerosis
Pat. No. 8802735 DP* (Family Id: 41510564) (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
Mar 14, 2031 *PED 
Pat. No. 9186346 (Family Id: 47710071) 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
Aug 4, 2034 *PEDU-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 30, 2024 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)
15 Patents--4 FamiliesExpirationPatented Use
Pat. No. 5753706 DP* (Family Id: 26708838) Methods for treating renal failure
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 3, 2022U-1577: Control of serum phosphorous levels
Pat. No. 7767851 DS* DP* (Family Id: 32912273) 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. 8338642 DS* DP* (Family Id: 32912273) 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* (Family Id: 32912273) 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* (Family Id: 32912273) 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 (Family Id: 32912273) 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 (Family Id: 32912273) 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. 9328133 DS* DP* (Family Id: 32912273) 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* (Family Id: 42738229) Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
Pat. No. 10300039 (Family Id: 42738229) Ferric citrate dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 21, 2030U-2549: Control of serum phosphorus levels
Pat. No. 8093423 (Family Id: 46328327) 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* (Family Id: 46328327) 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. 8754257 DP* (Family Id: 46328327) 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. 9050316 (Family Id: 46328327) 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. 9757416 DS* DP* (Family Id: 46328327) 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
Drug Classes: Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
7 Patents--5 FamiliesExpirationPatented Use
Pat. No. 8524733 DS* DP* (Family Id: 42107127) Benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Oct 3, 2031 *PED 
Pat. No. 9233959 DP* (Family Id: 50341905) Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 18, 2034 *PED 
Pat. No. 9296739 DP* (Family Id: 50341905) Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 18, 2034 *PED 
Pat. No. 9814708 DP* (Family Id: 50341905) Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2017
Mar 18, 2034 *PED 
Pat. No. 10959996 (Family Id: 55590145) Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Mar 31, 2021
Sep 7, 2036 *PEDU-3055: A method of treating Huntington's chorea
Pat. No. 9550780 DS* DP* (Family Id: 56553858) 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
Mar 18, 2034 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11179386 DP* (Family Id: 61873991) Analogs of deutetrabenazine, their preparation and use
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2021
Sep 15, 2038 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 24, 2024 PEDM-54: Information from pediatric studies added to label
Exclusivity Code: NCE - New chemical entityOct 3, 2022 PED 
Exclusivity Code: ODE - Orphan drug exclusivityOct 3, 2024 PEDODE-134: Treatment of chorea associated with Huntington's disease

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
27 Patents--11 FamiliesExpirationPatented Use
Pat. No. 7749194 DP* (Family Id: 36777846) Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Oct 30, 2028 
Pat. No. 9724471 DP* (Family Id: 36777846) Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 8206360 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013
Feb 27, 2027 
Pat. No. 8926594 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 5, 2015
Mar 31, 2026 
Pat. No. 9259539 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 11, 2016
Feb 1, 2026 
Pat. No. 10960155 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 22, 2021
Jun 25, 2026 
Pat. No. 8226610 DP* (Family Id: 39362498) Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012
Apr 10, 2029 
Pat. No. 8231573 DP* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012
Nov 25, 2028 
Pat. No. 9238108 DP* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 18, 2016
Feb 20, 2027 
Pat. No. 8021344 DP* (Family Id: 41569299) Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8016788 DP* (Family Id: 46326653) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 21, 2025 
Pat. No. 8313466 DP* (Family Id: 46326653) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012
Nov 23, 2024 
Pat. No. 7947017 DP* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 12, 2028 
Pat. No. 8361029 DP* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 9149579 (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 7731690 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jan 15, 2025 
Pat. No. 8425462 DP* (Family Id: 47075270) Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013
Nov 23, 2024 
Pat. No. 8920377 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 29, 2015
Nov 23, 2024 
Pat. No. 10314977 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 7918823 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8608698 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9056170 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9737669 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10335549 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 7731686 DP* (Family Id: 56195833) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jun 1, 2026 
Pat. No. 10737028 DP* (Family Id: 67844882) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
29 Patents--12 FamiliesExpirationPatented Use
Pat. No. 7749194 DP* (Family Id: 36777846) Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Oct 30, 2028 
Pat. No. 9724471 DP* (Family Id: 36777846) Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 8206360 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 27, 2027 
Pat. No. 8926594 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 5, 2015
Mar 31, 2026 
Pat. No. 9259539 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 11, 2016
Feb 1, 2026 
Pat. No. 10960155 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 22, 2021
Jun 25, 2026 
Pat. No. 8226610 DP* (Family Id: 39362498) Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Apr 10, 2029 
Pat. No. 8231573 DP* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 25, 2028 
Pat. No. 9238108 DP* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 18, 2016
Feb 20, 2027 
Pat. No. 8021344 DP* (Family Id: 41569299) Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8016788 DP* (Family Id: 46326653) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 21, 2025 
Pat. No. 8313466 DP* (Family Id: 46326653) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 7947017 DP* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 12, 2028 
Pat. No. 8361029 DP* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 9149579 (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 7731690 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jan 15, 2025 
Pat. No. 8425462 DP* (Family Id: 47075270) Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8920377 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 29, 2015
Nov 23, 2024 
Pat. No. 10314977 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 11, 2019
Nov 23, 2024 
Pat. No. 7918823 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9056170 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9737669 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10335549 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 2, 2019
Apr 30, 2025 
Pat. No. 7731686 DP* (Family Id: 56195833) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jun 1, 2026 
Pat. No. 10688244 DP* (Family Id: 62627607) Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10842938 DP* (Family Id: 62627607) Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* (Family Id: 67844882) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 25, 2020
Nov 23, 2024 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
30 Patents--12 FamiliesExpirationPatented Use
Pat. No. 7749194 DP* (Family Id: 36777846) Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Oct 30, 2028 
Pat. No. 9724471 DP* (Family Id: 36777846) 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. 8206360 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 8926594 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 31, 2026 
Pat. No. 9259539 DP* (Family Id: 39030179) 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* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 10960155 DP* (Family Id: 39030179) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 22, 2021
Jun 25, 2026 
Pat. No. 8226610 DP* (Family Id: 39362498) 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* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 9238108 DP* (Family Id: 39887852) Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 20, 2027 
Pat. No. 8021344 DP* (Family Id: 41569299) 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. 8016788 DP* (Family Id: 46326653) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 21, 2025 
Pat. No. 8313466 DP* (Family Id: 46326653) 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* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 8361029 DP* (Family Id: 46328420) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9149579 (Family Id: 46328420) 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. 7731690 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jan 15, 2025 
Pat. No. 8425462 DP* (Family Id: 47075270) 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. 8920377 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 (Family Id: 47075270) 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)
Pat. No. 10314977 DP* (Family Id: 47075270) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 11, 2019
Nov 23, 2024 
Pat. No. 7918823 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9056170 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9737669 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 10335549 DP* (Family Id: 55073988) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 2, 2019
Apr 30, 2025 
Pat. No. 7731686 DP* (Family Id: 56195833) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jun 1, 2026 
Pat. No. 10688244 DP* (Family Id: 62627607) Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10842938 DP* (Family Id: 62627607) Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* (Family Id: 67844882) Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 25, 2020
Nov 23, 2024 

AVACLYR (OINTMENT) (OPHTHALMIC) ACYCLOVIR
Drug Classes: Antivirals:Antiherpetic Agents == Dermatological Agents:Topical Anti-infectives == Dermatological Agents:Dermatological Agents, Other == nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: FERA PHARMS LLC      NDA No.: 202408  Prod. No.: 001 DISC (3%**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 29, 2026ODE-235: Indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus

AVANDAMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == 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**)
1 Patent--1 FamilyExpirationPatented Use
Pat. No. 8236345 DP* (Family Id: 27447849) 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 

AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ENDO PHARMS INC      NDA No.: 022219  Prod. No.: 001 RX (750MG/3ML (250MG/ML))
2 Patents--1 FamilyExpirationPatented Use
Pat. No. 7718640 DP* (Family Id: 32748728) 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 (Family Id: 32748728) 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
May 8, 2027U-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).

AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
7 Patents--4 FamiliesExpirationPatented Use
Pat. No. 7612087 DP* (Family Id: 27619669) Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Nov 12, 2026 
Pat. No. 8471025 DS* (Family Id: 42154208) 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* (Family Id: 42154208) 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* (Family Id: 46317443) 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* (Family Id: 46317443) 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* (Family Id: 46317443) 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 
Pat. No. 7112592 DS* DP* (Family Id: 8853181) 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
Jan 7, 2026U-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-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2025 GAIN 

AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE      NDA No.: 021494