ABILIFY (SOLUTION) (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.: 021713  Prod. No.: 001 DISC (1MG/ML)

Patents	Expiration	Patented Use
Pat. No. 6977257 DP* Aripiprazole oral solution Claim Types: Formulation Pat. Sub. Date(s): 001: None	Oct 24, 2022 *PED
Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): 001: None	Jan 28, 2022	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 5, 2014	Jul 28, 2022 *PED	U-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014	Mar 2, 2027	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016	Dec 25, 2023	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 12, 2021	ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (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.: 021729  Prod. No.: 002 DISC (10MG); 003 DISC (15MG)

Patents	Expiration	Patented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Jan 28, 2022	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None	Dec 16, 2024 *PED
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None	Mar 25, 2023 *PED
Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014	Jul 28, 2022 *PED	U-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014	Mar 25, 2023 *PED
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014	Mar 2, 2027	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015	Jan 28, 2022	U-543: Treatment of schizophrenia
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015	Jul 28, 2026	U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016	Sep 25, 2022	U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016	Dec 25, 2023	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 12, 2021	ODE-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**)

Patents	Expiration	Patented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Jan 28, 2022	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None	Dec 16, 2024 *PED
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None	Mar 25, 2023 *PED
Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014	Jul 28, 2022 *PED	U-1492: Treatment of irritability associated with autistic disorder
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014	Mar 25, 2023 *PED
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016	Sep 25, 2022	U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016	Dec 25, 2023	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 12, 2021	ODE-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))

Patents	Expiration	Patented Use
Pat. No. 7115587 DP* Aripiprazole complex formulation and method Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None	Jan 21, 2025 *PED	U-764: Treatment of schizophrenia
Pat. No. 7550445 DP* Aripiprazole complex formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 21, 2025 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 12, 2021	ODE-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)

Patents	Expiration	Patented Use
Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014	Oct 19, 2024
Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Oct 19, 2024	U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia
Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None	Mar 15, 2025	U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia
Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None	Aug 6, 2023	U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia
Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014	Jun 29, 2025
Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014	Oct 19, 2024
Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014	Aug 6, 2023	U-1530: Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
Pat. No. 8993761 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 28, 2015	Sep 25, 2022
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015	Jan 28, 2022	U-543: Treatment of schizophrenia
Pat. No. 10525057 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, 2034	U-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 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, 2033	U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia
Pat. No. 11154553 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, 2033	U-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)

Patents	Expiration	Patented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jan 28, 2022	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017	Sep 14, 2026
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jun 16, 2024
Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jun 21, 2030
Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Nov 25, 2030
Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Apr 27, 2030
Pat. No. 8547248 DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 18, 2030	U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Dec 12, 2017	Sep 25, 2022
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 12, 2017	Sep 25, 2022
Pat. No. 8674825 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Apr 9, 2029	U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 5, 2029
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Mar 2, 2027	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8847766 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Mar 29, 2030	U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8945005 DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Aug 19, 2029	U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8956288 DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jul 6, 2029	U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Nov 17, 2030
Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Mar 5, 2029
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jan 28, 2022	U-543: Treatment of schizophrenia
Pat. No. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 16, 2028
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Jul 28, 2026	U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 15, 2029
Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Mar 5, 2029
Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Oct 15, 2033	U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver
Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 15, 2031
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Dec 12, 2017	Sep 25, 2022	U-1529: Adjunctive treatment of major depressive disorder (MDD) U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder U-543: Treatment of schizophrenia
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Dec 25, 2023	U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017	Sep 15, 2029
Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Nov 19, 2027	U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018	Nov 4, 2030
Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019	Jul 26, 2029
Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020	Jun 13, 2032
Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 18, 2022	Jul 11, 2031

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))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Jun 21, 2025	ODE-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)

Patents	Expiration	Patented Use
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013	Aug 21, 2026 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010	Apr 27, 2025 *PED	U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011	Jun 9, 2024 *PED	U-1117: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012	Feb 13, 2027 *PED	U-1290: Treatment of lung cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012	Jun 9, 2024 *PED	U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012	Aug 21, 2026 *PED	U-1290: Treatment of lung cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012	Jun 9, 2024 *PED	U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015	Aug 21, 2026 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 9393318 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016	Sep 4, 2032 *PED	U-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016	Jul 12, 2034 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 9597409 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017	Sep 4, 2032 *PED	U-1290: Treatment of lung cancer
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 6, 2023 PED	M-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)

Patents	Expiration	Patented Use
Pat. No. 9700535 DP* Oral pharmaceutical composition of isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2019	Aug 4, 2035
Pat. No. 9750711 DP* 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)

Patents	Expiration	Patented Use
Pat. No. 8288434 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 19, 2012	Aug 5, 2029	U-124: Treatment of acne
Pat. No. 8663699 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2014	Jun 3, 2029	U-124: Treatment of acne
Pat. No. 8895070 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2015	Jun 3, 2029	U-124: Treatment of acne
Pat. No. 9078870 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 13, 2015	Jun 3, 2029
Pat. No. 10220049 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 8, 2019	Jun 3, 2029	U-916: Topical treatment of acne vulgaris in patients 12 years or older
Pat. No. 10624918 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, 2029	U-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)

Patents	Expiration	Patented Use
Pat. No. 9248148 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, 2031	U-2603: Method of treating iron deficiency
Pat. No. 9802973 DS* DP* 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, 2035	U-2603: Method of treating iron deficiency
Pat. No. 10179120 Dosage regimen of ferric trimaltol Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2019	Jan 6, 2035	U-2603: Method of treating iron deficiency
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 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))

Patents	Expiration	Patented Use
Pat. No. 8148356 DP* Acetylcysteine composition and uses therefor Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Apr 4, 2012	May 21, 2026
Pat. No. 8399445 Acetylcysteine composition and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2013	Aug 24, 2025	U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8653061 Acetylcysteine composition and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 24, 2014	Aug 24, 2025	U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8722738 Acetycysteine compositions and methods of use thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 27, 2014	Apr 6, 2032	U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9327028 Acetylcysteine compositions and methods of use thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 18, 2016	Jul 21, 2031	U-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))

Patents	Expiration	Patented Use
Pat. No. 8741959 DP* 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)

Patents	Expiration	Patented Use
Pat. No. 7192938 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None	Nov 6, 2023 *PED	U-353: Prevention and treatment of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None	Nov 6, 2023 *PED	U-662: Treatment of osteoporosis in postmenopausal women

ACTOPLUS MET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE [GENERIC AB]
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.: 001 RX (500MG;EQ 15MG BASE); 002 RX (850MG;EQ 15MG BASE)

Patents	Expiration	Patented Use
Pat. No. 9101660 DP* Solid preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 10, 2015	Jan 22, 2027
Pat. No. 9320714 DP* Tablet Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 20, 2016	Feb 3, 2029

ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: 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)

Patents	Expiration	Patented Use
Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Jul 31, 2026
Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None	Jul 31, 2026
Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None	Sep 19, 2023
Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Sep 19, 2023
Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015	Sep 19, 2023

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)

Patents	Expiration	Patented Use
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011	Nov 24, 2027 *PED	U-1181: A method of treating or preventing ocular pain in a patient
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012	Nov 28, 2024 *PED	U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013	Nov 28, 2024 *PED	U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013	Nov 28, 2024 *PED	U-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014	May 28, 2024
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015	May 28, 2024	U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015	May 28, 2024	U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016	May 28, 2024	U-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%)

Patents	Expiration	Patented Use
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010	Aug 15, 2029
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013	Mar 7, 2028
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015	Aug 5, 2024
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015	Mar 7, 2028

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)

Patents	Expiration	Patented Use
Pat. No. 9474746 DP* Methods for stabilizing oxidatively unstable compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2022	Mar 27, 2028
Pat. No. 9962376 DP* 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 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%)

Patents	Expiration	Patented Use
Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016	Nov 18, 2033
Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016	Nov 18, 2033	U-1033: Topical treatment of acne vulgaris
Pat. No. 11273132 DP* 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Sep 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%)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: PC - Patent challenge	May 30, 2022

ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS      NDA No.: 022549  Prod. No.: 001 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013	May 20, 2022
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013	Aug 18, 2024
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013	Oct 28, 2024
Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013	Jul 25, 2022
Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013	Oct 23, 2026
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015	May 21, 2024
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016	May 20, 2024

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)

Patents	Expiration	Patented Use
Pat. No. 7151103 Method of treating female hypoactive sexual desire disorder with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015	May 9, 2023	U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 7420057 DS* DP* Stable polymorph of flibanserin Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 14, 2015	Aug 1, 2022
Pat. No. 8227471 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015	May 9, 2023	U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 9468639 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 8, 2016	Oct 16, 2022	U-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)

Patents	Expiration	Patented Use
Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)] Carbamate-substituted pyrazolopyridines Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 6, 2013	Dec 4, 2026
Pat. No. 10662188 DS* DP* 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, 2034	U-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* 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, 2034	U-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)

Patents	Expiration	Patented Use
Pat. No. 9974752 DP* 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 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10292938 DP* 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* 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10449159 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10500162 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10507186 DP* 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* 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 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10568841 DP* 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, 2035	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10688060 DP* 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 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, 2038	U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 28, 2024	M-82: Labeling revisions related to clinical studies
Exclusivity Code: NP - New product	Feb 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)

Patents	Expiration	Patented Use
Pat. No. 9993466 DP* Donepezil transdermal delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 6, 2022	Jul 26, 2037
Pat. No. 10016372 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, 2037	U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10300025 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022	Jul 26, 2037
Pat. No. 10307379 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022	Jul 26, 2037
Pat. No. 10835499 DP* 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, 2038	U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10966936 DP* 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, 2038	U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11103463 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, 2037	U-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)

Patents	Expiration	Patented Use
Pat. No. 7905352 DP* Kits containing medicine injection devices and containers Claim Types: Kit; Device Pat. Sub. Date(s): All strengths: Jun 2, 2017	Apr 12, 2027
Pat. No. 10166334 DP* Medicine injection apparatuses Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 11, 2020	Jan 21, 2025

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))

Patents	Expiration	Patented Use
Pat. No. 9119876 DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 14, 2016	Mar 13, 2035
Pat. No. 9295657 Epinephrine formulations Claim Types: Method Pat. Sub. Date(s): 001: Apr 12, 2016	Mar 13, 2035	U-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))

Patents	Expiration	Patented Use
Pat. No. 9119876 DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2015	Mar 13, 2035
Pat. No. 9295657 Epinephrine formulations Claim Types: Method Pat. Sub. Date(s): 001: Apr 12, 2016	Mar 13, 2035	U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis
Pat. No. 10130592 DP* 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)

Patents	Expiration	Patented Use
Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None	Aug 26, 2026 *PED
Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 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)

Patents	Expiration	Patented Use
Pat. No. 7863287 DP* Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines Claim Types: Formulation Pat. Sub. Date(s): 001: May 6, 2011	Feb 28, 2027

ADVIL 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)

Patents	Expiration	Patented Use
Pat. No. 10238640 DP* 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)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 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)

Patents	Expiration	Patented Use
Pat. No. 8883849 Treatment of sleep disturbances Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014	Jan 17, 2022	U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient
Pat. No. 9155718 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2015	Jan 17, 2022

ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: 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)

Patents	Expiration	Patented Use
Pat. No. 8263647 DP* 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)

Patents	Expiration	Patented Use
Pat. No. 10238640 DP* 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)

Patents	Expiration	Patented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017	Jun 28, 2032
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017	Jun 28, 2032
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017	Jun 28, 2032

ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: Central Nervous System 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)

Patents	Expiration	Patented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None	Jun 28, 2032
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 26, 2016	Apr 9, 2026
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None	Jun 28, 2032
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None	Jun 28, 2032

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)

Patents	Expiration	Patented Use
Pat. No. 8263120 DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018	May 3, 2025
Pat. No. 8486446 DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018	May 3, 2025
Pat. No. 8529945 DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018	May 3, 2025
Pat. No. 8741948 DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 6, 2018	May 3, 2025	U-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)

Patents	Expiration	Patented Use
Pat. No. 8410131 Cancer treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2013	May 1, 2026 *PED	U-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib
Pat. No. 8436010 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jun 3, 2013	Aug 22, 2022 *PED	U-1396: Treatment of advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole
Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014	Aug 18, 2022 *PED	U-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
Pat. No. 9006224 Neuroendocrine tumor treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 20, 2015	Jul 1, 2028	U-1681: Treatment of patients with progessive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Feb 26, 2023	ODE-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)

Patents	Expiration	Patented Use
Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014	Mar 27, 2023 *PED
Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014	Aug 18, 2022 *PED	U-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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Apr 10, 2025	ODE-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))

Patents	Expiration	Patented Use
Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016	May 1, 2023	U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (SOLUTION) (INTRAVENOUS) TIROFIBAN HYDROCHLORIDE [GENERIC AP]
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE      NDA No.: 020913  Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913  Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))

Patents	Expiration	Patented Use
Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 7, 2013	May 1, 2023	U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

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)

Patents	Expiration	Patented Use
Pat. No. 7540282 DP* 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* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Sep 26, 2028 *PED
Pat. No. 8714149 DP* 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. 8978966 DP* 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. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Dec 28, 2031 *PED
Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Nov 19, 2025 *PED
Pat. No. 9616024 DP* 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. 9731087 DP* 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. 9782550 DP* 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* 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. 9987229 DP* 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. 10022510 DP* 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* 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. 10195375 DP* 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. 10561808 DP* 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. 10569034 DP* 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. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020	Nov 19, 2025 *PED
Pat. No. 10918816 DP* 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* 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. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021	Jan 6, 2041 *PED
Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022	Aug 22, 2041 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jan 9, 2025 PED	M-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)

Patents	Expiration	Patented Use
Pat. No. 7540282 DP* 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* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Sep 26, 2028 *PED
Pat. No. 8714149 DP* 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. 8978966 DP* 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. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Dec 28, 2031 *PED
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Nov 19, 2025 *PED
Pat. No. 9616024 DP* 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. 9731087 DP* 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. 9782550 DP* 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* 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. 9987229 DP* 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. 10022510 DP* 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* 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. 10195375 DP* 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. 10561808 DP* 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. 10569034 DP* 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. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020	Nov 19, 2025 *PED
Pat. No. 10918816 DP* 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* 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. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021	Jan 6, 2041 *PED
Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022	Aug 22, 2041 *PED