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.
| 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 (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: 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
Drug Classes: 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. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *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. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 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: 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. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *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. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 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: 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: 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
ABLAVAR (SOLUTION) (INTRAVENOUS) GADOFOSVESET TRISODIUM
Drug Classes: paramagnetic contrast agent
NDA Applicant: LANTHEUS MEDCL NDA No.: 021711 Prod. No.: 001 DISC (2440MG/10ML (244MG/ML)); 002 DISC (3660MG/15ML (244MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6676929 DP* [Extended 1805 days (4.9 years)] Diagnostic imaging contrast agents with extended blood retention Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: None | May 4, 2020 |
ABLYSINOL (SOLUTION) (INTRA-ARTERIAL) ALCOHOL
Drug Classes: pediculicide
NDA Applicant: BELCHER 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 (FOR SUSPENSION) (IV (INFUSION)) 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. 8853260 DP* Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2014 | Apr 10, 2021 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015 | 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: ODE - Orphan drug exclusivity | Mar 6, 2021 PED | ODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. |
ABSORICA (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: retinoid
NDA Applicant: SUN PHARM INDS INC NDA No.: 021951 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG); 004 RX (40MG); 005 RX (25MG); 006 RX (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7435427 DP* Pharmaceutical semi-solid composition of isotretinoin Claim Types: Formulation; Method of administration; Product-by-process Pat. Sub. Date(s): 001: Jun 7, 2012; 002: Jun 7, 2012; 003: Jun 7, 2012; 004: Jun 7, 2012; 005: Apr 6, 2015; 006: Apr 6, 2015 | Sep 21, 2021 | |
| Pat. No. 8367102 Pharmaceutical semi-solid composition of isotretinoin Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 27, 2013; 002: None; 003: None; 004: None; 005: Apr 6, 2015; 006: Apr 6, 2015 | Sep 21, 2021 | U-1347: Treatment of a skin disorder |
| Pat. No. 8952064 DP* Pharmaceutical semi-solid composition of isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 23, 2015 | Sep 21, 2021 | |
| Pat. No. 9078925 DP* Pharmaceutical semi-solid composition of isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 17, 2015 | Sep 21, 2021 | |
| Pat. No. 9089534 DP* Pharmaceutical semi-solid composition of isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 17, 2015 | Sep 21, 2021 |
ABSORICA LD (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: 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: 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: iron replacement product; phosphate binder; decorporation agent
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 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 |
ACCUNEB (SOLUTION) (INHALATION) ALBUTEROL SULFATE [GENERIC AN]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 020949 Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Dec 28, 2021 | U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease) |
ACETADOTE (INJECTABLE) (INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
Drug Classes: antidote; antidote for acetaminophen overdose; mucolytic
NDA Applicant: CUMBERLAND PHARMS NDA No.: 021539 Prod. No.: 001 RX (6GM/30ML (200MG/ML))
| 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]
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: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021842 Prod. No.: 001 RX (500MG;EQ 15MG BASE); 002 RX (850MG;EQ 15MG BASE)
| 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: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022024 Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Mar 17, 2021 | U-974: Adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes who are already treated with a pioglitazone and metformin |
| Pat. No. 6866866 DP* Controlled release metformin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: None | Mar 17, 2021 | |
| Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 31, 2026 | |
| Pat. No. 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: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
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: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
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 |
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Sep 10, 2022 |
ADASUVE (POWDER) (INHALATION) LOXAPINE
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. 7052679 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7078020 DP* Delivery of antipsychotics through an inhalation route Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | U-1375: ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults |
| Pat. No. 7090830 DP* Drug condensation aerosols and kits Claim Types: Kit; Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Aug 18, 2024 | |
| Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 28, 2024 | |
| Pat. No. 7585493 DP* Thin-film drug delivery article and method of use Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7601337 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Jul 25, 2022 | |
| Pat. No. 8173107 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8235037 DP* Drug condensation aerosols and kits Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 | |
| Pat. No. 8955512 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 18, 2015 | Oct 26, 2021 | |
| Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015 | May 21, 2024 | |
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 | |
| Pat. No. 9439907 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9440034 DP* Drug condensation aerosols and kits Claim Types: Formulation; Kit; Method of administration Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9687487 DS* DP* Aerosol forming device for use in inhalation therapy Claim Types: Device Pat. Sub. Date(s): 001: Jul 14, 2017 | Oct 26, 2021 |
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: TEVA WOMENS NDA No.: 011522 Prod. No.: 007 DISC (2.5MG;2.5MG;2.5MG;2.5MG**); 008 DISC (5MG;5MG;5MG;5MG**); 009 DISC (1.25MG;1.25MG;1.25MG;1.25MG**); 010 DISC (7.5MG;7.5MG;7.5MG;7.5MG**); 011 DISC (1.875MG;1.875MG;1.875MG;1.875MG**); 012 DISC (3.125MG;3.125MG;3.125MG;3.125MG**); 013 DISC (3.75MG;3.75MG;3.75MG;3.75MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 6, 2021 *PED |
ADDYI (TABLET) (ORAL) FLIBANSERIN
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) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 18, 2020 |
ADEMPAS (TABLET) (ORAL) RIOCIGUAT
Drug Classes: soluble guanylate cyclase (sGC) stimulator
NDA Applicant: BAYER HLTHCARE NDA No.: 204819 Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 8, 2020 | ODE-53: Treatment of adults with pulmonary arterial 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 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 27, 2022 |
ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: IMPAX NDA No.: 020800 Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
| 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: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 204200 Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
| 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: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 204640 Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
| 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 DISKUS 100/50; ADVAIR DISKUS 250/50; ADVAIR DISKUS 500/50 (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE [GENERIC AB]
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 021077 Prod. No.: 001 RX (0.1MG/INH;EQ 0.05MG BASE/INH); 002 RX (0.25MG/INH;EQ 0.05MG BASE/INH); 003 RX (0.5MG/INH;EQ 0.05MG BASE/INH)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Dec 20, 2020 | M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events |
ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 021254 Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 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 | |
| Pat. No. 9861771 DP* Device housing for an aerosol container Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 22, 2018 | Oct 11, 2020 |
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: 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; nonsteroidal anti-inflammatory drug; 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: nonsteroidal anti-inflammatory drug
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: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
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: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
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: nonsteroidal anti-inflammatory drug
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 stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 RX (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 stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: NEOS THERAPS NDA No.: 204326 Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
| 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: rifamycin antimycobacterial; 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: 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. 5665772 DS* DP* [Extended 5 years] O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: May 11, 2012 | Mar 9, 2020 *PED | |
| Pat. No. 7297703 DP* Macrolides Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: May 11, 2012; 004: May 11, 2012 | Jun 6, 2020 *PED | |
| Pat. No. 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
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM NDA No.: 203985 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5665772 DS* DP* [Extended 5 years] O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None | Mar 9, 2020 *PED | |
| Pat. No. 7297703 DP* Macrolides Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None | Jun 6, 2020 *PED | |
| Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 | Mar 27, 2023 *PED | |
| Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 | Aug 18, 2022 *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: I - New Indication | Apr 10, 2021 | I-773: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
| Exclusivity Code: ODE - Orphan drug 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 (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: anti-platelet agent
NDA Applicant: MEDICURE NDA No.: 020913 Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913 Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
| 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: corticosteroid; 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. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): 004: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): 004: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Feb 25, 2032 | |
| 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 | Jan 13, 2032 | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Oct 6, 2034 | 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 | Jun 28, 2031 | |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Oct 6, 2034 | U-645: Treatment of asthma |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Sep 1, 2024 | |
| 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 | May 18, 2031 | |
| 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 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Aug 28, 2035 | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 004: Aug 2, 2019 | Sep 1, 2024 | |
| 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 | May 18, 2031 | |
| 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 | May 18, 2031 | |
| 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 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 | Jan 1, 2032 | |
| 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 | Aug 16, 2036 |
AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; 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. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Feb 25, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jan 13, 2032 | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Oct 6, 2034 | 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 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Sep 1, 2024 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | May 18, 2031 | |
| 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 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Aug 28, 2035 | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Sep 1, 2024 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | May 18, 2031 | |
| 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 | May 18, 2031 | |
| 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 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jan 1, 2032 | |
| 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 | Aug 16, 2036 |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): 001: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Feb 25, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jan 13, 2032 | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Oct 6, 2034 | 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): 001: Jan 30, 2017 | Jun 28, 2031 | |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Oct 6, 2034 | U-645: Treatment of asthma |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 | Sep 1, 2024 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Jul 3, 2018 | Sep 1, 2024 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 | May 18, 2031 | |
| 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): 001: Dec 12, 2018 | May 18, 2031 | |
| 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): 001: Mar 5, 2019 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jan 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 27, 2020 |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Feb 25, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jan 13, 2032 | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Oct 6, 2034 | 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: Jan 30, 2017 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Sep 1, 2024 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Sep 1, 2024 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | May 18, 2031 | |
| 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: Dec 12, 2018 | May 18, 2031 | |
| 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: Mar 5, 2019 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jan 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 27, 2020 |
AKLIEF (CREAM) (TOPICAL) TRIFAROTENE
NDA Applicant: GALDERMA LABS LP NDA No.: 211527 Prod. No.: 001 RX (0.005%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807708 DS* DP* 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 Ligands that modulate RAR receptors Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2019 | Dec 21, 2025 | U-818: Topical treatment of acne vulgaris |
| Pat. No. 8470871 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, 2025 | U-2639: Method of activating rargamma receptor |
| Pat. No. 9084778 DP* 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, 2033 | U-134: Treatment of acne vulgaris |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 4, 2024 |
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN NDA No.: 022221 Prod. No.: 001 RX (3.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2014 | Jul 24, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist; serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 205718 Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6297375 DS* 4-phenyl-pyridine derivatives Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2014 | Mar 17, 2023 | |
| Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2014 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 6, 2015 | Nov 18, 2030 | |
| Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 2, 2015 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 14, 2016 | Sep 9, 2031 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2018 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 16, 2018 | Sep 25, 2035 | |
| Pat. No. 10233154 DS* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 28, 2019 | Sep 25, 2035 |
AKYNZEO (POWDER) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 210493 Prod. No.: 001 RX (EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8426450 DS* DP* Substituted 4-phenyl pyridines having anti-emetic effect Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 17, 2018 | May 23, 2032 | |
| Pat. No. 8895586 Methods of treating emesis Claim Types: Method of use Pat. Sub. Date(s): 001: May 17, 2018 | May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 17, 2018 | Nov 18, 2030 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9403772 DS* 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol- yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator Claim Types: New polymorph, salt or hydrate; Method of use; Process; Compound Pat. Sub. Date(s): 001: May 17, 2018 | May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9908907 DS* DP* Substituted piperaziniums for the treatment of emesis Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 17, 2018 | May 23, 2032 | |
| Pat. No. 10208073 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 | May 23, 2032 | U-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* Physiologically balanced injectable formulations of fosnetupitant Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 26, 2020 | Jun 2, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 19, 2023 |
AKYNZEO (SOLUTION) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 210493 Prod. No.: 002 RX (EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8426450 DS* DP* Substituted 4-phenyl pyridines having anti-emetic effect Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jun 24, 2020 | May 23, 2032 | |
| Pat. No. 8895586 Methods of treating emesis Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2020 | May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jun 24, 2020 | Nov 18, 2030 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9403772 DS* 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol- yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator Claim Types: New polymorph, salt or hydrate; Method of use; Process; Compound Pat. Sub. Date(s): 002: Jun 24, 2020 | May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Pat. No. 9908907 DS* DP* Substituted piperaziniums for the treatment of emesis Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jun 24, 2020 | May 23, 2032 | |
| Pat. No. 10208073 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): 002: Jun 24, 2020 | May 23, 2032 | U-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* Physiologically balanced injectable formulations of fosnetupitant Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 002: Jun 24, 2020 | Jun 2, 2037 |
ALDARA (CREAM) (TOPICAL) IMIQUIMOD [GENERIC AB]
NDA Applicant: BAUSCH NDA No.: 020723 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7696159 DS* Treatment for basal cell carcinoma Claim Types: Method of use Pat. Sub. Date(s): 001: May 12, 2010 | Oct 1, 2024 *PED | U-1047: Treatment of biopsy-confirmed, primary superficial basal cell carcinoma (SBCC) U-1048: Works through the induction of interferon and other cytokines |
ALECENSA (CAPSULE) (ORAL) ALECTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE NDA No.: 208434 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9126931 DS* Tetracyclic compound Claim Types: Compound Pat. Sub. Date(s): 001: Dec 22, 2015 | May 29, 2031 | |
| Pat. No. 9365514 DP* Composition comprising tetracyclic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 11, 2016 | Mar 4, 2032 | |
| Pat. No. 9440922 DP* Tetracyclic compound Claim Types: Composition Pat. Sub. Date(s): 001: Oct 12, 2016 | Jun 9, 2030 | |
| Pat. No. 10350214 DP* Preparation containing tetracyclic compound at high dose Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 9, 2020 | Apr 24, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 6, 2020 | I-756: Expanded the approved indication by removing the restriction for use only in patients who have progressed on or are intolerant to crizotinib |
| Exclusivity Code: NCE - New chemical entity | Dec 11, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 11, 2022 | ODE-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 exclusivity | Nov 6, 2024 | ODE-159: For treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA approved test, excluding patients who have progressed on or are intolerant to crizotinib |
ALIMTA (POWDER) (INTRAVENOUS) PEMETREXED DISODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: LILLY NDA No.: 021462 Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7772209 Antifolate combination therapies Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | May 24, 2022 *PED | U-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration |
ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE NDA No.: 209936 Prod. No.: 001 RX (60MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46856 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis Claim Types: Compound; Composition; Kit; Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 | Oct 22, 2029 | U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
| Pat. No. 7511041 DS* DP* Fused azole-pyrimidine derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Oct 10, 2017 | May 13, 2024 | |
| Pat. No. 9636344 Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 10, 2017 | Mar 29, 2032 | U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
| Pat. No. 10383876 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2019 | Mar 29, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 14, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 14, 2024 | ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
ALLEGRA, CHILDREN'S ALLERGY (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021909 Prod. No.: 002 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 18, 2013 | Nov 26, 2021 | U-1466: Relief of symptoms associated with respiratory allergies adults and children 6 years of age and older |
ALLEGRA, CHILDREN'S ALLERGY; ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 201373 Prod. No.: 001 OTC (30MG/5ML) NDA No.: 201373 Prod. No.: 002 DISC (30MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8933097 DP* Fexofenadine suspension formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 19, 2015 | Aug 2, 2030 |
ALLEGRA, CHILDREN'S HIVES (TABLET, ORALLY DISINTEGRATING) (ORAL) FEXOFENADINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021909 Prod. No.: 003 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723348 DP* Orodispersible tablets containing fexofenadine Claim Types: Formulation Pat. Sub. Date(s): 003: Dec 18, 2013 | Nov 26, 2021 |
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) (ORAL) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021704 Prod. No.: 002 OTC (180MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Jul 1, 2011 | Dec 25, 2020 | U-1159: Relief of symptoms associated with respiratory allergies, swelling of the nasal passages and sinus congestion and pressure in adults and children 12 years of age and older |
ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE [GENERIC AP]
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 001 RX (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: May 27, 2011 | Jul 30, 2024 *PED | |
| Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 3, 2013 | Jul 30, 2024 *PED | |
| Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8598219 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8729094 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 21, 2014 | Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
| Pat. No. 9066980 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
| Pat. No. 9125905 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Process; Drug in a container Pat. Sub. Date(s): 001: Sep 9, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 5, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Sep 27, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Oct 25, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457021 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 25, 2016 | Jul 30, 2024 *PED |
ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE [GENERIC AP]
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 002 RX (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Sep 3, 2013 | Jul 30, 2024 *PED | |
| Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 5, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Sep 27, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Oct 25, 2016 | Jul 30, 2024 *PED |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014 | Mar 2, 2024 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017 | Jan 10, 2022 *PED | |
| Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 10, 2021 |
ALSUMA (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: MERIDIAN MEDCL NDA No.: 022377 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7811254 DP* Autoinjector with needle depth adapter Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Oct 13, 2010 | Aug 26, 2027 | U-1083: Acute treatment of migraine attacks, with or without aura, and the treatment of cluster headache episodes |
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43390 DS* DP* Pleuromutilin derivatives as antimicrobials Claim Types: Compound; Process; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 9, 2012 | Apr 12, 2021 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Pat. No. 7875630 DS* Process salts compositions and use Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Feb 10, 2011 | Feb 14, 2027 | |
| Pat. No. 8207191 Process, salts, composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2016 | Aug 30, 2024 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
ALTACE (CAPSULE) (ORAL) RAMIPRIL [GENERIC AB]
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PHARMS LLC NDA No.: 019901 Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 30, 2020 | U-871: Method of reducing risk of myocardial infarction, stroke and death |
ALTACE (TABLET) (ORAL) RAMIPRIL
Drug Classes: angiotensin converting enzyme inhibitor
NDA Applicant: KING PFIZER NDA No.: 022021 Prod. No.: 001 DISC (1.25MG**); 002 DISC (2.5MG**); 003 DISC (5MG**); 004 DISC (10MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7368469 Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 30, 2020 | U-871: Method of reducing risk of myocardial infarction, stroke and death |
ALTRENO (LOTION) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: DOW PHARM NDA No.: 209353 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6517847 DP* Topical gel delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Aug 30, 2018 | Aug 3, 2020 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
| Pat. No. 10653656 DP* Topical pharmaceutical compositions for treating skin conditions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 28, 2020 | Aug 22, 2038 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | Aug 23, 2021 |
ALUNBRIG (TABLET) (ORAL) BRIGATINIB
Drug Classes: kinase inhibitor
NDA Applicant: ARIAD NDA No.: 208772 Prod. No.: 001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9012462 DS* Phosphorous derivatives as kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 | Jul 31, 2030 | |
| Pat. No. 9273077 Phosphorus derivatives as kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 | May 21, 2029 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
| Pat. No. 9611283 Methods for inhibiting cell proliferation in ALK-driven cancers Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 | Apr 10, 2034 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
| Pat. No. 10385078 DS* DP* 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, 2035 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 28, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-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 exclusivity | May 22, 2027 | ODE-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
NDA Applicant: COVIS PHARMA BV NDA No.: 021658 Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Feb 1, 2028 | U-1355: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. patent claims method for treating a respiratory disease in a child |
AMBIEN CR (TABLET, EXTENDED RELEASE) (ORAL) ZOLPIDEM TARTRATE [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021774 Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 1, 2020 *PED |
AMINOCAPROIC ACID (TABLET) (ORAL) AMINOCAPROIC ACID [GENERIC AB]
Drug Classes: antifibrinolytic
NDA Applicant: AMNEAL NDA No.: 212492 Prod. No.: 001 RX (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | May 30, 2020 |
AMINOCAPROIC ACID (SYRUP) (ORAL) AMINOCAPROIC ACID [GENERIC AA]
Drug Classes: antifibrinolytic
NDA Applicant: AMNEAL PHARMS LLC NDA No.: 212780 Prod. No.: 001 RX (1.25GM/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Feb 26, 2020 |
AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC NDA No.: 021908 Prod. No.: 001 RX (24MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6414016 Anti-constipation composition Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 5, 2020 | U-1392: Method of relieving or preventing constipation in a human patient with opioid-induced constipation U-717: Method of relieving or preventing constipation in a human constipated patient |
| Pat. No. 6583174 DP* Composition and method for stabilizing the same Claim Types: Composition; Formulation; Process Pat. Sub. Date(s): 001: None | Oct 16, 2020 | |
| Pat. No. 6982283 Method for treating drug-induced constipation Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2013 | Dec 4, 2022 | U-1391: Method for treating opioid-induced constipation |
| Pat. No. 7064148 Chloride channel opener Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 30, 2022 | U-1404: Method for treating constipation in a patient with opioid-induced constipation by opening CIC channels U-739: Method for treating constipation by opening CIC channels in a mammalian subject |
| Pat. No. 7417067 DP* Composition and method for stabilizing the same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 16, 2020 | |
| Pat. No. 8026393 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 26, 2011 | Oct 25, 2027 | |
| Pat. No. 8071613 Anti-constipation composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2011 | Sep 5, 2020 | U-1203: Method for relieving or treating constipation in a human constipated patient U-1393: Method for relieving or treating constipation in a patient with opioid-induced constipation |
| Pat. No. 8088934 DS* Composition and method for stabilizing the same Claim Types: Compound Pat. Sub. Date(s): 001: None | May 18, 2021 | |
| Pat. No. 8097649 DP* Composition and method for stabilizing the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2012 | Oct 16, 2020 | |
| Pat. No. 8097653 Dosage unit comprising a prostaglandin analog for treating constipation Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2012 | Nov 14, 2022 | U-1214: Method for relieving constipation in a human patient that comprises administering to the patient a dosage unit comprising (i) 24mcg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient U-1394: Method for relieving constipation in a patient with opioid-induced constipation that comprises administering to the patient a dosage unit comprising(i)24microg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient |
| Pat. No. 8114890 DP* Anti-constipation composition Claim Types: Formulation5558083 Pat. Sub. Date(s): 001: Feb 14, 2012 Comments: A | Sep 5, 2020 | |
| Pat. No. 8338639 DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 20, 2012 | Jan 23, 2027 | |
| Pat. No. 8389542 DP* Dosage unit comprising a prostaglandin analog for treating constipation Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 22, 2013 | Nov 14, 2022 | U-1345: Use in relieving or preventing constipation in a human patient with a dosage unit comprising 24microg+/- 10% of a drug substance and a pharmaceutically suitable excipient U-1395: Use in relieving or preventing constipation in a patient with opioid-induced constipation with a dosage unit comprising 24microg +/- 10% of a drug substance and a pharmaceutically suitable excipient |
| Pat. No. 8748481 Method for treating gastrointestinal disorder Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 20, 2014 | Sep 1, 2025 | U-1520: Method for the long term treatment of chronic constipation in a human subject |
| Pat. No. 8779187 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Aug 7, 2014 | Jan 23, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 26, 2021 | M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation |
AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC NDA No.: 021908 Prod. No.: 002 RX (8MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6414016 Anti-constipation composition Claim Types: Method of use Pat. Sub. Date(s): 002: None | Sep 5, 2020 | U-874: Method of treating constipation in a patient with irritable bowel syndrome |
| Pat. No. 6583174 DP* Composition and method for stabilizing the same Claim Types: Composition; Formulation; Process Pat. Sub. Date(s): 002: None | Oct 16, 2020 | |
| Pat. No. 7064148 Chloride channel opener Claim Types: Method of use Pat. Sub. Date(s): 002: None | Aug 30, 2022 | U-739: Method for treating constipation by opening CIC channels in a mammalian subject U-873: Method of treating constipation in a patient with irritable bowel syndrome by opening chloride channels (CIC) |
| Pat. No. 7417067 DP* Composition and method for stabilizing the same Claim Types: Formulation Pat. Sub. Date(s): 002: None | Oct 16, 2020 | |
| Pat. No. 7795312 Method for treating abdominal discomfort Claim Types: Method of use Pat. Sub. Date(s): 002: None | Sep 17, 2024 | U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome |
| Pat. No. 8026393 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Oct 25, 2027 | |
| Pat. No. 8071613 Anti-constipation composition Claim Types: Method of use Pat. Sub. Date(s): 002: None | Sep 5, 2020 | U-1202: Method for relieving or treating constipation in a patient with irritable bowel syndrome |
| Pat. No. 8088934 DS* Composition and method for stabilizing the same Claim Types: Compound Pat. Sub. Date(s): 002: None | May 18, 2021 | |
| Pat. No. 8097649 DP* Composition and method for stabilizing the same Claim Types: Formulation Pat. Sub. Date(s): 002: None | Oct 16, 2020 | |
| Pat. No. 8114890 DP* Anti-constipation composition Claim Types: Formulation5558083 Pat. Sub. Date(s): 002: None Comments: A | Sep 5, 2020 | |
| Pat. No. 8338639 DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jan 23, 2027 | |
| Pat. No. 8748481 Method for treating gastrointestinal disorder Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 20, 2014 | Sep 1, 2025 | U-1519: Method for the long term treatment of chronic constipation in a human subject with irritable bowel syndrome |
| Pat. No. 8779187 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Aug 7, 2014 | Jan 23, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 26, 2021 | M-225: Revisions to section 8.4 of the prescribing information to include a safety and efficacy study in pediatric patients ages >=6 years to <18 years with chronic idiopathic constipation |
AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS NDA No.: 022026 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them Claim Types: New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): All strengths: None | Nov 20, 2022 |
AMPYRA (TABLET, EXTENDED RELEASE) (ORAL) DALFAMPRIDINE [GENERIC AB]
Drug Classes: potassium channel blocker
NDA Applicant: ACORDA NDA No.: 022250 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8007826 DLR* Sustained release aminopyridine composition Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 28, 2011 | May 26, 2027 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
| Pat. No. 8354437 DLR* Method of using sustained release aminopyridine compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2013 | Dec 22, 2026 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
| Pat. No. 8440703 DLR* Methods of using sustained release aminopyridine compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 12, 2013 | Apr 8, 2025 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: muscle relaxant
NDA Applicant: TEVA PHARMS INTL NDA No.: 021777 Prod. No.: 001 RX (15MG); 002 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7387793 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 26, 2025 | |
| Pat. No. 7544372 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | U-979: Relief of muscle spasm |
| Pat. No. 7790199 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | |
| Pat. No. 7820203 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | |
| Pat. No. 7829121 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Nov 14, 2023 | U-1088: Relief of muscle spasm |
| Pat. No. 8877245 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 1, 2018 | Nov 14, 2023 | U-979: Relief of muscle spasm |
| Pat. No. 9375410 Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 12, 2016 | Nov 14, 2023 | U-1088: Relief of muscle spasm |
| Pat. No. 9399025 DP* Modified release dosage forms of skeletal muscle relaxants Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2016 | Nov 14, 2023 | U-979: Relief of muscle spasm |
AMTURNIDE (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS NDA No.: 200045 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None | May 16, 2023 | |
| Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: None | Nov 15, 2021 |
AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: AVID RADIOPHARMS INC NDA No.: 202008 Prod. No.: 002 RX (10-30ML (13.5-51mCi/ML)); 003 RX (10-50ML (13.5-51mCi/ML)) NDA No.: 202008 Prod. No.: 001 DISC (10ML (13.5-51mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7687052 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques Claim Types: Compound; Formulation; Diagnostic or surgical method Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None | Apr 30, 2027 | |
| Pat. No. 8506929 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None | Apr 30, 2027 | U-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: tetracycline-class drug
NDA Applicant: FOAMIX NDA No.: 212379 Prod. No.: 001 RX (EQ 4% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8865139 DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 8945516 DP* 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* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 9675700 DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10086080 Topical tetracycline compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10137200 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, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10213512 DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10265404 DP* 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. 10398641 Compositions and methods for treating rosacea and acne Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 | Sep 8, 2037 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10517882 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, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE NDA No.: 021015 Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET) NDA No.: 021015 Prod. No.: 003 DISC (12.5MG/1.25GM ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 1, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466136 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | |
| Pat. No. 8466137 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466138 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8486925 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013 | Oct 12, 2026 | |
| Pat. No. 8729057 DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 | Oct 12, 2026 | |
| Pat. No. 8741881 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8754070 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014 | Oct 12, 2026 | |
| Pat. No. 8759329 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014 | Oct 12, 2026 | |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ANGELIQ (TABLET) (ORAL) DROSPIRENONE; ESTRADIOL
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE NDA No.: 021355 Prod. No.: 001 RX (0.25MG;0.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8906890 DP* Very low-dosed solid oral dosage forms for HRT Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jan 8, 2015 | Oct 22, 2031 |
ANGIOMAX (INJECTABLE) (INTRAVENOUS) BIVALIRUDIN [GENERIC AP]
Drug Classes: anticoagulant; direct thrombin inhibitor
NDA Applicant: SANDOZ INC NDA No.: 020873 Prod. No.: 001 RX (250MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7582727 DP* Pharmaceutical formulations of bivalirudin and processes of making the same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 27, 2029 *PED | |
| Pat. No. 7598343 DP* Pharmaceutical formulations of bivalirudin and processes of making the same Claim Types: Product-by-process Pat. Sub. Date(s): 001: None | Jan 27, 2029 *PED |
ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX NDA No.: 210583 Prod. No.: 001 RX (30MG/ML (30MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8512727 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 | Dec 25, 2022 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 6, 2020 | May 26, 2030 | |
| Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020 | Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 6, 2020 | Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 20, 2023 |
ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: estrogen
NDA Applicant: THERAPEUTICSMD INC NDA No.: 209627 Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10632066 Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 29, 2020 | Feb 1, 2039 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 203975 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: May 14, 2014 | Mar 23, 2023 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | May 21, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 9, 2014 | Dec 18, 2027 | |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | |
| Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Sep 11, 2022 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Feb 5, 2028 | |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Jun 14, 2027 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 | Oct 11, 2030 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Nov 29, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 9, 2022 | M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial |
ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS NDA No.: 021695 Prod. No.: 001 RX (43MG); 003 RX (130MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101574 DS* DP* Pharmaceutical composition containing fenofibrate and the preparation method Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Aug 20, 2020 | |
| Pat. No. 7863331 Pharmaceutical composition containing fenofibrate and method for the preparation thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 8, 2020 | U-1106: Treating hypertriglyceridemias with reduction of food effect U-1107: Treating hypercholesterolemias with reduction of food effect |
ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS NDA No.: 021695 Prod. No.: 004 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8026281 Treating metabolic syndrome with fenofibrate Claim Types: Method of use Pat. Sub. Date(s): 004: None | Apr 22, 2025 | U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS NDA No.: 021695 Prod. No.: 005 RX (90MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8026281 Treating metabolic syndrome with fenofibrate Claim Types: Method of use Pat. Sub. Date(s): 005: None | Apr 22, 2025 | U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
| Pat. No. 9314447 DP* Reduced dose pharmaceutical compositions of fenofibrate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: May 2, 2016 | May 31, 2033 | U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
ANTIZOL (INJECTABLE) (INJECTION) FOMEPIZOLE [Has competitive generic]
Drug Classes: antidote
NDA Applicant: PAR PHARM INC NDA No.: 020696 Prod. No.: 001 DISC (1.5GM/1.5ML (1GM/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7553863 DS* DP* Ultrapure 4-methylpyrazole Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Jun 30, 2027 |
APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant: KVK TECH INC NDA No.: 208653 Prod. No.: 001 RX (325MG;EQ 6.12MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8461137 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition Pat. Sub. Date(s): 001: Mar 22, 2018 | Feb 22, 2031 | |
| Pat. No. 8748413 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 | Jul 1, 2030 | |
| Pat. No. 8828978 DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 | Jul 1, 2030 | |
| Pat. No. 9132125 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2018 | Jul 1, 2030 | U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| Pat. No. 9549923 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 | Jul 1, 2030 |
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8461137 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition Pat. Sub. Date(s): All strengths: Jan 25, 2019 | Feb 22, 2031 | |
| Pat. No. 8748413 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 | Jul 10, 2030 | |
| Pat. No. 8828978 DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 | Jul 1, 2030 | |
| Pat. No. 9132125 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 25, 2019 | Jul 1, 2030 | U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| Pat. No. 9549923 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 | Jul 1, 2030 |
APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: VALEANT PHARMS NORTH NDA No.: 022108 Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7241805 DP* Modified release formulations of a bupropion salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7569610 Modified release formulations of a bupropion salt Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours |
| Pat. No. 7572935 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7585897 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7649019 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7662407 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 |
APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL NDA No.: 022301 Prod. No.: 001 RX (375MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2014 | May 1, 2030 | U-1310: For the maintenance of remission of ulcerative colitis |
APTENSIO XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AB3]
Drug Classes: central nervous system stimulant
NDA Applicant: RHODES PHARMS NDA No.: 205831 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (50MG); 007 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6419960 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7083808 DP* Controlled/modified release oral methylphenidate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7247318 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7438930 DP* DLR* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 8580310 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 9066869 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 27, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 9801823 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 29, 2017 | Jun 16, 2020 *PED | |
| Pat. No. 10039719 Methods of treating attention deficit hyperactivity disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2018 | Jun 16, 2020 *PED | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE
NDA Applicant: SUNOVION PHARMS INC NDA No.: 022416 Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753646 DS* DP* [Extended 5 years] Substituted dihydrodibenzo/b,f/azepines, method of their preparation, their use in the treatment of some central nervous system disorders, and pharmaceutical compositions containing them Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Jun 27, 2021 | U-2041: Treatment of partial-onset seizures |
| Pat. No. 8372431 DP* Pharmaceutical composition comprising licarbazepine acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 17, 2030 | |
| Pat. No. 9206135 DS* Asymmetric catalytic reduction of oxcarbazepine Claim Types: Compound; Product-by-process; Method of use Pat. Sub. Date(s): All strengths: May 20, 2016 | Apr 21, 2026 | |
| Pat. No. 9566244 DP* Pharmaceutical composition comprising licarbazepine acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 8, 2017 | Oct 23, 2028 | |
| Pat. No. 9643929 DP* Asymmetric catalytic reduction of oxcarbazepine Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 8, 2017 | Apr 21, 2026 | |
| Pat. No. 9750747 Treatments involving eslicarbazepine acetate or eslicarbazepine Claim Types: Method of use; Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2017 | Aug 24, 2032 | U-2041: Treatment of partial-onset seizures U-2121: Treatment of partial-onset seizures in a patient suffering from or susceptible to absence seizures |
| Pat. No. 9763954 Therapeutical uses of eslicarbazepine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 10, 2017 | Sep 13, 2028 | U-2123: Treatment of partial-onset seizures in patients with epilepsy who have been previously treated with oxcarbazepine |
| Pat. No. 10675287 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, 2025 | U-2041: Treatment of partial-onset seizures U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures |
| Pat. No. 10695354 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, 2025 | U-2501: Treatment of partial-onset seizures U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures |
APTIVUS (CAPSULE) (ORAL) TIPRANAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021814 Prod. No.: 001 RX (250MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 29, 2020 *PED | U-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir. |
APTIVUS (SOLUTION) (ORAL) TIPRANAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 022292 Prod. No.: 001 RX (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 29, 2020 *PED | U-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir. |
ARAKODA (TABLET) (ORAL) TAFENOQUINE SUCCINATE
NDA Applicant: 60 DEGREES PHARMS NDA No.: 210607 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10342791 Regimens of tafenoquine for prevention of malaria in malaria-naive subjects Claim Types: Dosaage regimen; Kit Pat. Sub. Date(s): 001: Jul 31, 2019 | Dec 2, 2035 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 20, 2023 | |
| Exclusivity Code: NP - New product | Aug 8, 2021 |
ARAZLO (LOTION) (TOPICAL) TAZAROTENE
Drug Classes: retinoid
NDA Applicant: BAUSCH NDA No.: 211882 Prod. No.: 001 RX (0.045%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6517847 DP* Topical gel delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jan 8, 2020 | Aug 3, 2020 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 18, 2022 |
ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: NOVARTIS NDA No.: 022383 Prod. No.: 001 DISC (EQ 75MCG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)] Beta2-adrenoceptor agonists Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | Feb 25, 2025 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8067437 Beta-2-adrenoreceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 26, 2013 | Jun 2, 2020 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8479730 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2013 | Oct 11, 2028 | |
| Pat. No. 8658673 DS* DP* BETA2-adrenoreceptor agonists Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 28, 2015 | Jun 2, 2020 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8796307 DS* DP* Beta2-adrenoreceptor agonists Claim Types: Composition Pat. Sub. Date(s): 001: Dec 9, 2015 | Jun 2, 2020 |
ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline-class drug
NDA Applicant: ORAPHARMA NDA No.: 050781 Prod. No.: 001 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6682348 DP* Dispensing apparatus and cartridge Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 24, 2012 | Mar 29, 2022 | |
| Pat. No. 7699609 DP* Dispensing apparatus and cartridge with deformable tip Claim Types: Device Pat. Sub. Date(s): 001: Mar 26, 2015 | Mar 29, 2022 |
ARGATROBAN IN SODIUM CHLORIDE (INJECTABLE) (INTRAVENOUS) ARGATROBAN
Drug Classes: anticoagulant; direct thrombin inhibitor
NDA Applicant: EAGLE PHARMS NDA No.: 022434 Prod. No.: 001 RX (50MG/50ML (1MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7589106 DP* Alcohol free formulation of argatroban Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jul 20, 2011 | Sep 26, 2027 | U-1163: Method of treating thrombosis |
| Pat. No. 7687516 DP* Alcohol free formulation of argatroban Claim Types: Formulation; Drug in a container; Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 20, 2011 | Sep 26, 2027 | U-1164: Method of treating an argatroban treatable condition |
ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: cholinesterase inhibitor
NDA Applicant: EISAI INC NDA No.: 022568 Prod. No.: 001 RX (23MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2013 | Oct 4, 2026 |
ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC NDA No.: 207356 Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7718189 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Jun 6, 2025 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Aug 15, 2028 | |
| Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen |
| Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | |
| Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Dec 5, 2026 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 8802137 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Apr 8, 2024 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 9566234 DP* Systems for treating pulmonary infections Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Jan 18, 2034 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 9827317 DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Apr 8, 2024 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
| Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | May 15, 2035 | U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen |
| Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2019 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | Sep 28, 2030 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2025 | ODE-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: 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10112903 DS* 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, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): All strengths: Oct 14, 2015 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2015 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): All strengths: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* 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, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jul 18, 2018 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 18, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10016415 DP* Aripiprazole prodrug compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 18, 2018 | Sep 8, 2035 | |
| Pat. No. 10112903 DS* 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, 2030 | U-543: Treatment of schizophrenia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2020 |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 004 RX (0.055MG/INH); 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Feb 25, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jan 13, 2032 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Sep 1, 2024 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | May 18, 2031 | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 28, 2035 | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 28, 2035 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | May 18, 2031 | |
| 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: Mar 20, 2020 | May 18, 2031 | |
| 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: Mar 20, 2020 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jan 1, 2032 | |
| 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 | Aug 16, 2036 |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6701917 DP* Dose counter for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6718972 DP* Dose metering system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6748947 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 6871646 DP* De-agglomerator for breath-actuated dry powder inhaler Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | May 6, 2023 | |
| Pat. No. 8006690 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 23, 2021 | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Mar 26, 2028 | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Feb 25, 2032 | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jan 13, 2032 | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jun 28, 2031 | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | May 19, 2025 | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Sep 1, 2024 | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | May 18, 2031 | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | May 18, 2031 | |
| 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: Dec 12, 2018 | May 18, 2031 | |
| 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: Mar 5, 2019 | Feb 14, 2031 | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jan 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 27, 2020 |
ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE NDA No.: 205625 Prod. No.: 001 RX (0.1MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: Aug 28, 2014 | Aug 3, 2021 | U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older |
| Pat. No. 7629335 DP* Anti-inflammatory androstane derivative Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Aug 3, 2021 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Feb 5, 2028 | |
| Pat. No. 8201556 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Feb 5, 2029 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014 | Oct 11, 2030 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 18, 2016 | Oct 2, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | May 17, 2021 |
ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE NDA No.: 205625 Prod. No.: 002 RX (0.2MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 002: Aug 28, 2014 | Aug 3, 2021 | U-1559: Indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years of age and older |
| Pat. No. 7629335 DP* Anti-inflammatory androstane derivative Claim Types: Formulation; Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Aug 3, 2021 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Feb 5, 2028 | |
| Pat. No. 8201556 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Feb 5, 2029 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 002: Aug 28, 2014 | Oct 11, 2030 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: May 18, 2016 | Oct 2, 2027 |
ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE NDA No.: 205625 Prod. No.: 003 RX (0.05MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101866 DS* DP* Anti-inflammatory androstane derivative Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 003: Jun 13, 2018 | Aug 3, 2021 | U-2349: For once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older |
| Pat. No. 7629335 DP* Anti-inflammatory androstane derivative Claim Types: Formulation; Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Aug 3, 2021 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Oct 23, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Feb 5, 2028 | |
| Pat. No. 8201556 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Feb 5, 2029 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Oct 11, 2030 | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 003: Jun 13, 2018 | Oct 2, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | May 17, 2021 |
ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS NDA No.: 213036 Prod. No.: 001 RX (110MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | May 26, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 26, 2027 | ODE-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: dopaminergic agonist; opioid agonist
NDA Applicant: ZYLA NDA No.: 208603 Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9044402 DP* Abuse-deterrent pharmaceutical compositions for controlled release Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 8, 2017 | Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9549899 DP* Abuse deterrent pharmaceutical compositions for controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2017 | Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
ASACOL HD (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL NDA No.: 021830 Prod. No.: 001 RX (800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation Pat. Sub. Date(s): 001: None | Nov 15, 2021 | U-141: Treatment of ulcerative colitis |
| Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 13, 2013 | Nov 15, 2021 | |
| Pat. No. 9089492 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 22, 2015 | Nov 15, 2021 |
ASCOR (SOLUTION) (INTRAVENOUS) ASCORBIC ACID
Drug Classes: vitamin C
NDA Applicant: MCGUFF NDA No.: 209112 Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 2, 2024 | ODE-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 |
ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 001 DISC (EQ 0.125MG BASE/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2011 | Jun 4, 2028 | |
| Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2013 | Nov 22, 2025 | U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis |
ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 002 RX (EQ 0.1876MG BASE/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 15, 2011 | Jun 4, 2028 | |
| Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 18, 2013 | Nov 22, 2025 | U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis |
| Pat. No. 9919050 DP* Compositions comprising azelastine Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 29, 2018 | Nov 22, 2025 |
ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL NDA No.: 022560 Prod. No.: 001 RX (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7645459 DP* Dosage forms of bisphosphonates Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
| Pat. No. 7645460 DP* Dosage forms of risedronate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
| Pat. No. 8246989 DP* Dosage forms of bisphosphonates Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 28, 2012 | Jan 16, 2026 |
ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 RX (600MG;200MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use Pat. Sub. Date(s): 001: None | May 4, 2021 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: None | Sep 9, 2021 *PED | |
| Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 13, 2024 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 8598185 DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Apr 28, 2029 | |
| Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2014 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 9018192 Unitary pharmaceutical dosage form Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2015 | Jun 13, 2026 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 10, 2016 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| Pat. No. 9545414 DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Method of use; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Feb 13, 2017 | Jun 13, 2026 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 19, 2017 | Jan 13, 2024 | U-257: Treatment of HIV infection |
ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021527 Prod. No.: 001 RX (0.021MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6739333 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 6983743 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 8474447 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: May 28, 2015 | Jan 17, 2030 |
AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US NDA No.: 202992 Prod. No.: 001 RX (7MG); 002 RX (14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6794410 [Extended 1625 days (4.5 years)] Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2013 | Sep 12, 2026 | U-1285: Treatment of patients with relapsing forms of multiple sclerosis |
| Pat. No. 8802735 DP* (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Claim Types: Formulation; Composition Pat. Sub. Date(s): All strengths: Sep 11, 2014 | Sep 14, 2030 | |
| Pat. No. 9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 15, 2015 | Feb 4, 2034 | U-1786: Treatment of patients with relapsing forms of multiple sclerosis while managing the risk of teriflunomide and rosuvastatin interaction by limiting the rosuvastatin dose to no more than 10mg and/or administering about half the normal dose |
AUGMENTIN XR (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN; CLAVULANATE POTASSIUM [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: NEOPHARMA NDA No.: 050785 Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7250176 Method of treating a bacterial infection Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: KERYX BIOPHARMS NDA No.: 205874 Prod. No.: 001 RX (EQ 210MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753706 DP* Methods for treating renal failure Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 3, 2021 | U-1577: Control of serum phosphorous levels |
| Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Apr 21, 2026 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Dec 30, 2016 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9387191 DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 | Jul 21, 2030 | |
| Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2017 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 10300039 Ferric citrate dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 21, 2030 | U-2549: Control of serum phosphorus levels |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 6, 2020 | I-790: Use of ferric citrate for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis |
AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA BRANDED PHARM NDA No.: 208082 Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8524733 DS* DP* Benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Mar 27, 2031 | |
| Pat. No. 9233959 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Sep 18, 2033 | |
| Pat. No. 9296739 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Sep 18, 2033 | |
| Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Sep 18, 2033 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof U-1995: Treatment of tardive dyskinesia |
| Pat. No. 9814708 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2017 | Sep 18, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 30, 2020 | I-751: Treatment of tardive dyskinesia |
| Exclusivity Code: NCE - New chemical entity | Apr 3, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 3, 2024 | ODE-134: Treatment of chorea associated with Huntington's disease |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Nov 23, 2024 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Mar 12, 2028 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Mar 21, 2025 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 26, 2013 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 21, 2013; 002: None | Feb 27, 2027 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Aug 21, 2012; 002: None | Apr 10, 2029 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Aug 21, 2012; 002: None | Nov 25, 2028 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2012; 002: None | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013; 002: None | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 23, 2013; 002: None | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 16, 2015 | Nov 23, 2024 | |
| Pat. No. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Nov 6, 2015 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 18, 2016 | Feb 20, 2027 | |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 11, 2016 | Feb 1, 2026 | |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 23, 2017 | May 23, 2027 | U-2092: Method for confirming dose delivery |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 2, 2019 | Apr 30, 2025 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Mar 12, 2028 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Mar 21, 2025 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 27, 2027 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Dec 15, 2017 | Apr 10, 2029 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 25, 2028 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 20, 2027 | |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Feb 1, 2026 | |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | May 23, 2027 | U-2092: Method for confirming dose delivery |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | |
| Pat. No. 9833573 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 | Nov 23, 2024 | U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs) |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Jul 2, 2019 | Apr 30, 2025 |
AVACLYR (OINTMENT) (OPHTHALMIC) ACYCLOVIR
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: FERA PHARMS LLC NDA No.: 202408 Prod. No.: 001 DISC (3%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 29, 2026 | ODE-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: 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**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8236345 DP* Composition and use Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None | Oct 7, 2022 |
AVANDARYL (TABLET) (ORAL) GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Drug Classes: sulfonylurea; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO NDA No.: 021700 Prod. No.: 001 DISC (1MG;4MG**); 002 DISC (2MG;4MG**); 003 DISC (4MG;4MG**); 004 DISC (2MG;8MG**); 005 DISC (4MG;8MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7358366 DS* DLR* Thiazolidinedione derivative and its use as antidiabetic Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Oct 19, 2020 *PED |
AVANDIA (TABLET) (ORAL) ROSIGLITAZONE MALEATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO NDA No.: 021071 Prod. No.: 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE) NDA No.: 021071 Prod. No.: 004 DISC (EQ 8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7358366 DS* DLR* Thiazolidinedione derivative and its use as antidiabetic Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Oct 19, 2020 *PED |
AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: ENDO PHARMS INC NDA No.: 022219 Prod. No.: 001 RX (750MG/3ML (250MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7718640 DP* Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 14, 2027 | |
| Pat. No. 8338395 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: None | Feb 27, 2026 | U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired). |
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (SOLUTION) (INTRAVENOUS) MOXIFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE NDA No.: 021277 Prod. No.: 001 DISC (400MG/250ML (1.6MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6548079 DP* Moxifloxacin formulation containing common salt Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 25, 2020 | U-298: Method of combating bacteria in a patient |
AVYCAZ (POWDER) (IV (INFUSION)) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jan 7, 2026 | U-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 |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jul 24, 2021 | U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium U-2509: A method of treating a bacterial infection in complicated intra-abdominal infection (CIAI) and complicated urinary tract infection (CUTI), including pyelonephritis, patients comprising administering an effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015 | Aug 12, 2031 | |
| Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Oct 8, 2030 | |
| Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Jun 15, 2032 | |
| Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017 | Jun 15, 2032 | |
| Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017 | Jun 15, 2032 |
AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE NDA No.: 021494 Prod. No.: 001 DISC (15MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6930119 DP* Liquid pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 17, 2022 |
AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO NDA No.: 022504 Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8419307 Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 | Feb 26, 2027 | U-1386: A method of increasing the testosterone blood level of a person in need thereof |
| Pat. No. 8435944 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 27, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 7, 2014 | Jul 13, 2023 | U-1545: A method of transdermally delivering testosterone |
| Pat. No. 8807861 DP* Spreading implement Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Sep 10, 2014 | Feb 26, 2027 | U-1563: A method of transdermal administration of a physiologically active agent to a subject. |
| Pat. No. 8993520 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 9180194 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 9289586 Spreading implement Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 19, 2016 | Feb 26, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: BLUE EARTH NDA No.: 208054 Prod. No.: 001 RX (9-221mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5808146 DS* Amino acid analogs for tumor imaging Claim Types: Compound Pat. Sub. Date(s): 001: Jun 23, 2016 | Nov 9, 2020 | |
| Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Jul 28, 2016 | Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
| Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 27, 2018 | Nov 28, 2026 | |
| Pat. No. 10124079 Imaging of metastatic or recurrent cancer Claim Types: Method of administration; Diagnostic or surgical method Pat. Sub. Date(s): 001: Dec 12, 2018 | Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 27, 2021 |
AYVAKIT (TABLET) (ORAL) AVAPRITINIB
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9200002 DS* DP* Compositions useful for treating disorders related to KIT Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 | Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 | Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 | Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 |
AZEDRA (SOLUTION) (INTRAVENOUS) IOBENGUANE I-131
Drug Classes: radioactive diagnostic agent
NDA Applicant: PROGENICS PHARMS INC NDA No.: 209607 Prod. No.: 001 RX (15mCi/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Jul 30, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 30, 2025 | ODE-204: Treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy |
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; corticosteroid
NDA Applicant: APOTEX NDA No.: 207712 Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Aug 29, 2020 |
AZILECT (TABLET) (ORAL) RASAGILINE MESYLATE [GENERIC AB]
Drug Classes: monoamine oxidase inhibitor (MAOI)
NDA Applicant: TEVA NDA No.: 021641 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7572834 DP* Rasagiline formulations and processes for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Dec 5, 2026 | |
| Pat. No. 7815942 DS* DP* Rasagiline formulations of improved content uniformity Claim Types: Formulation; Composition; Method of use; Process Pat. Sub. Date(s): 001: Nov 8, 2010; 002: None | Aug 27, 2027 | U-219: Treatment of Parkinson's disease |