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. 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. 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. 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. 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) |
ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 DISC (1MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: 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. 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. 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. 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) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: 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. 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. 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) |
ABILIFY (INJECTABLE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
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 |
ABILIFY ASIMTUFII (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: OTSUKA NDA No.: 217006 Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 25, 2023 | Mar 15, 2025 | U-1530: Use of aripiprazole in extended release injectable suspension |
| Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 25, 2023 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension |
| 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): All strengths: May 25, 2023 | Jun 29, 2025 | |
| Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension |
| Pat. No. 10517951 DP* Injectable preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11097007 DP* Injectable preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11638757 DP* Injectable preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 25, 2023 | Apr 23, 2033 | U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other
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. 10525057 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 31, 2020 | Mar 8, 2034 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder U-543: Treatment of schizophrenia |
| Pat. No. 10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 11154553 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11344547 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2022 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11400087 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2022 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 11648347 DP* Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 15, 2023 | Apr 6, 2034 |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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. 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. 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. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 15, 2029 | |
| Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020 | Jun 13, 2032 | |
| Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 18, 2022 | Jul 11, 2031 | |
| Pat. No. 11464423 DP* In-body power source having high surface area electrode Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Sep 15, 2030 | |
| Pat. No. 11476952 DP* Pharma-informatics system Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Apr 28, 2026 |
ABLYSINOL (SOLUTION) (INTRA-ARTERIAL) ALCOHOL
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving
NDA Applicant: BPI LABS NDA No.: 207987 Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 21, 2025 | ODE-192: Indicated to induce controlled cardiac septal infraction [sic, "infarction"] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy |
ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
NDA Applicant: BRISTOL-MYERS NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010 | Apr 27, 2025 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011 | Jun 9, 2024 *PED | U-1117: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Feb 13, 2027 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012 | Jun 9, 2024 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 21, 2026 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012 | Jun 9, 2024 *PED | U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015 | Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9393318 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016 | Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 9511046 Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016 | Jul 12, 2034 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9597409 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017 | Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 6, 2023 PED | M-14: Additional clinical trial information added to pediatric use subsection |
ABSORICA LD (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
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: Antibacterials:Antibacterials, Other
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
NDA Applicant: SHIELD TX NDA No.: 212320 Prod. No.: 001 RX (30MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9248148 Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 | Mar 29, 2031 | U-2603: Method of treating iron deficiency |
| Pat. No. 9802973 DS* DP* Crystalline forms of ferric maltol Claim Types: New polymorph, salt or hydrate; Process; Composition; Product-by-process; Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 | Oct 23, 2035 | U-2603: Method of treating iron deficiency |
| Pat. No. 10179120 Dosage regimen of ferric trimaltol Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 | Jan 6, 2035 | U-2603: Method of treating iron deficiency |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 25, 2024 |
ACETADOTE (INJECTABLE) (INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
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 |
ACTHAR GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
NDA Applicant: MALLINCKRODT ARD NDA No.: 008372 Prod. No.: 008 RX (80 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11752199 Methods of modulating pericytes Claim Types: Method of use Pat. Sub. Date(s): 008: Sep 21, 2023 | Feb 25, 2041 | U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering |
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]
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021842 Prod. No.: 002 RX (850MG;EQ 15MG BASE) NDA No.: 021842 Prod. No.: 001 DISC (500MG;EQ 15MG BASE**)
| 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
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022024 Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 31, 2026 | |
| Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None | Jul 31, 2026 | |
| Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None | Sep 19, 2023 | |
| Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Sep 19, 2023 | |
| Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015 | Sep 19, 2023 |
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: ABBVIE NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011 | Nov 24, 2027 *PED | U-1181: A method of treating or preventing ocular pain in a patient |
| Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012 | Nov 28, 2024 *PED | U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient |
| Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013 | Nov 28, 2024 *PED | U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery |
| Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Nov 28, 2024 *PED | U-1441: A method of treating or reducing ocular pain and burning/stinging |
| Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014 | May 28, 2024 | |
| Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015 | May 28, 2024 | U-1626: A method of treating or preventing ocular pain and burning |
| Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015 | May 28, 2024 | U-1662: A method of treating ocular pain |
| Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | May 28, 2024 | U-1800: A method of treating ocular pain and/or enhancing ocular comfort |
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: ABBVIE NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Aug 15, 2029 | |
| Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013 | Mar 7, 2028 | |
| Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015 | Aug 5, 2024 | |
| Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Mar 7, 2028 |
ACUVUE THERAVISION WITH KETOTIFEN (DRUG-ELUTING CONTACT LENS) (OPHTHALMIC) KETOTIFEN FUMARATE
NDA Applicant: JOHNSON JOHNSON VISN NDA No.: 022388 Prod. No.: 001 DISC (EQ 19MCG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9474746 DP* Methods for stabilizing oxidatively unstable compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2022 | Mar 27, 2028 | |
| Pat. No. 9962376 DP* Methods and ophthalmic devices used in the treatment of ocular allergies Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 23, 2022 | Jun 27, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 25, 2025 |
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
NDA Applicant: ALMIRALL NDA No.: 207154 Prod. No.: 001 RX (7.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Nov 18, 2033 | |
| Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016 | Nov 18, 2033 | U-1033: Topical treatment of acne vulgaris |
| Pat. No. 11273132 DP* Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2022 | Nov 18, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Sep 10, 2022 |
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Aug 18, 2024 | |
| Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 28, 2024 | |
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 | |
| Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015 | May 21, 2024 | |
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 |
ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS NDA No.: 022526 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7151103 [Extended 5 years] 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, 2028 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| 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) |
ADEMPAS (TABLET) (ORAL) RIOCIGUAT [GENERIC AB]
NDA Applicant: BAYER HLTHCARE NDA No.: 204819 Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)] Carbamate-substituted pyrazolopyridines Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 6, 2013 | Dec 4, 2026 | |
| Pat. No. 10662188 DS* DP* Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Jun 23, 2020 | Feb 18, 2034 | U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
| Pat. No. 11203593 DS* DP* Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 14, 2022 | Feb 18, 2034 | U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
ADHANSIA XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
NDA Applicant: PURDUE PHARMA LP NDA No.: 212038 Prod. No.: 001 DISC (25MG); 002 DISC (35MG); 003 DISC (45MG); 004 DISC (55MG); 005 DISC (70MG); 006 DISC (85MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9974752 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 8, 2019 | Oct 30, 2035 | |
| Pat. No. 10111839 Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2019 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10292938 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 22, 2019 | Oct 30, 2035 | |
| Pat. No. 10292939 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: May 22, 2019 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10449159 Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 22, 2019 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10500162 Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2019 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10507186 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 18, 2019 | Oct 30, 2035 | |
| Pat. No. 10512612 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 2, 2020 | Oct 30, 2035 | |
| Pat. No. 10512613 Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 2, 2020 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10568841 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Feb 26, 2020 | Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Pat. No. 10688060 DP* Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 23, 2020 | Oct 30, 2035 | |
| Pat. No. 10722473 Methods and compositions particularly for treatment of attention deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2020 | Nov 19, 2038 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 28, 2024 | M-82: Labeling revisions related to clinical studies |
ADLARITY (SYSTEM) (TRANSDERMAL) DONEPEZIL HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors
NDA Applicant: CORIUM NDA No.: 212304 Prod. No.: 001 RX (5MG/DAY); 002 RX (10MG/DAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9993466 DP* Donepezil transdermal delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10016372 Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 10300025 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10307379 DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | |
| Pat. No. 10835499 DP* Systems and methods for long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | May 20, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 10966936 DP* Systems comprising a composite backing and methods for long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Aug 11, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 11103463 Methods for treating Alzheimer's disease with donepezil transdermal system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 6, 2022 | Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 11648214 DP* Systems and methods for long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 2, 2023 | Sep 23, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Pat. No. 11679086 Systems comprising a composite backing and methods for long term transdermal administration Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 3, 2023 | May 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 11, 2025 |
ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
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
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]
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 |
ADRENALIN (SOLUTION) (INTRAVENOUS) EPINEPHRINE
NDA Applicant: PAR STERILE PRODUCTS NDA No.: 215875 Prod. No.: 001 RX (2MG/250ML (8MCG/ML)); 002 RX (4MG/250ML (16MCG/ML)); 003 RX (5MG/250ML (20MCG/ML)); 004 RX (8MG/250ML (32MCG/ML)); 005 RX (10MG/250ML (40MCG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10653646 DP* Epinephrine compositions and containers Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 10, 2023 | Mar 21, 2039 | |
| Pat. No. 11083698 Epinephrine compositions and containers Claim Types: Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 10, 2023 | Mar 21, 2039 | U-3567: To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock |
| Pat. No. 11207280 DP* Epinephrine compositions and containers Claim Types: Process; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 10, 2023 | Mar 21, 2039 |
ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
NDA Applicant: GLAXO GRP LTD NDA No.: 021254 Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None | Aug 26, 2026 *PED | |
| Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2012; 002: None; 003: None | Dec 19, 2023 *PED |
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
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: Analgesics:Nonsteroidal Anti-inflammatory Drugs
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 [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 211733 Prod. No.: 001 OTC (250MG;125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 28, 2023 |
ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020589 Prod. No.: 002 OTC (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 24, 2019 | May 25, 2024 |
ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: NEOS THERAPS INC NDA No.: 204325 Prod. No.: 001 DISC (EQ 1.25MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Jun 28, 2032 | |
| Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Jun 28, 2032 | |
| Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Jun 28, 2032 |
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE [GENERIC AB]
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
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: Anticonvulsants:Sodium Channel Agents
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 16, 2028 GAIN |
AFINITOR (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
NDA Applicant: NOVARTIS NDA No.: 022334 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004 RX (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410131 Cancer treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2013 | May 1, 2026 *PED | U-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib |
| Pat. No. 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 progressive neuroendocrine tumors of pancreatic origin (pnet) that are unresectable, locally advanced or metastatic |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2023 | ODE-108: Treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, (excluding pancreatic) with unresectable, locally advanced or metastatic disease |
AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
NDA Applicant: NOVARTIS PHARM NDA No.: 203985 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 | Mar 27, 2023 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2025 | ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
AGGRASTAT (INJECTABLE; SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
NDA Applicant: MEDICURE NDA No.: 020912 Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)) NDA No.: 020912 Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770660 Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016 | May 1, 2023 | U-1444: a dosing regimen of aggrastat (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-st elevation ACS |
AGGRASTAT (SOLUTION) (INTRAVENOUS) TIROFIBAN HYDROCHLORIDE [GENERIC AP]
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
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Jul 13, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Dec 28, 2031 *PED | |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 004: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 004: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 004: Nov 10, 2022 | Jun 19, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Jul 13, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Feb 28, 2036 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Mar 1, 2025 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 13, 2022 | Sep 24, 2038 | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2022 | May 24, 2040 | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): All strengths: Nov 10, 2022 | Jun 19, 2040 |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
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. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Jul 3, 2018 | Mar 1, 2025 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 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 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
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. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Apr 6, 2035 *PED | U-645: Treatment of asthma |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Mar 1, 2025 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 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 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED |
AIRSUPRA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE; BUDESONIDE
NDA Applicant: ASTRAZENECA NDA No.: 214070 Prod. No.: 001 RX (EQ 90MCG BASE/INH;80MCG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 24, 2023 | May 28, 2030 | U-3509: As-needed treatment or prevention of bronchoconstriction and reduction of the risk of exacerbations in patients with asthma 18 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 10, 2026 |
AKEEGA (TABLET) (ORAL) ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
NDA Applicant: JANSSEN BIOTECH NDA No.: 216793 Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (500MG;EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Aug 12, 2027 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8071623 DS* DP* [Extended 702 days (1.9 years)] Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Mar 27, 2031 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Aug 12, 2027 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8436185 DS* DP* Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide Claim Types: Compound Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Apr 24, 2029 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Aug 4, 2031 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 11091459 DS* DP* Niraparib compositions Claim Types: Formulation; Process; Composition Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Mar 27, 2038 | |
| Pat. No. 11207311 Method of treating prostate cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Jul 28, 2037 | U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 11673877 DS* DP* Niraparib compositions Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2023 | Mar 27, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 11, 2026 |
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* [Extended 1752 days (4.8 years)] Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Oct 31, 2019 | Jul 19, 2031 | |
| 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 |
| Pat. No. 9498465 DP* Topical compositions in the form of a gel containing a particular solubilized retinoid Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): 001: Jun 17, 2021 | May 30, 2033 | U-1033: Topical treatment of acne vulgaris |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 4, 2024 |
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: THEA PHARMA 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: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HELSINN HLTHCARE NDA No.: 205718 Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6297375 DS* [Extended 1119 days (3.1 years)] 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 | |
| Pat. No. 10676440 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 8, 2020 | Sep 25, 2035 | |
| Pat. No. 10828297 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2020 | Dec 17, 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. 10961195 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 15, 2021 | Sep 25, 2035 | |
| Pat. No. 11559523 DP* Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Composition Pat. Sub. Date(s): 001: Feb 22, 2023 | Nov 18, 2030 | U-3522: Method of treating emesis |
AKYNZEO (POWDER; SOLUTION) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
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)) NDA No.: 210493 Prod. No.: 001 DISC (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; 002: Jun 24, 2020 | May 23, 2032 | |
| Pat. No. 8895586 Methods of treating emesis Claim Types: Method of use Pat. Sub. Date(s): 001: May 17, 2018; 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): 001: May 17, 2018; 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): 001: May 17, 2018; 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): 001: May 17, 2018; 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): 001: Mar 8, 2019; 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): 001: May 26, 2020; 002: Jun 24, 2020 | Jun 2, 2037 | |
| Pat. No. 10717721 DS* Substituted piperaziniums for the treatment of emesis Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 19, 2020 | May 23, 2032 | |
| Pat. No. 10828297 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 9, 2020 | Dec 17, 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. 11312698 DS* DP* Fosnetupitant chloride hydrochloride having improved stability Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 13, 2022 | May 23, 2032 | |
| Pat. No. 11529362 DP* Physiologically balanced injectable formulations of fosnetupitant Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 17, 2023 | Jun 2, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 19, 2023 |
ALDARA (CREAM) (TOPICAL) IMIQUIMOD [Has competitive generic]
NDA Applicant: BAUSCH NDA No.: 020723 Prod. No.: 001 DISC (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
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 | |
| Pat. No. 11433076 DP* Preparation containing tetracyclic compound at high dose Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 28, 2022 | Apr 24, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| 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 |
ALENDRONATE SODIUM (SOLUTION) (ORAL) ALENDRONATE SODIUM [GENERIC AA]
NDA Applicant: NOVITIUM PHARMA NDA No.: 214512 Prod. No.: 001 RX (EQ 70MG BASE/75ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Nov 20, 2023 |
ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
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 |
ALKINDI SPRINKLE (GRANULE) (ORAL) HYDROCORTISONE
NDA Applicant: ETON NDA No.: 213876 Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG); 004 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9649280 DP* Composition comprising hydrocortisone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 | May 12, 2034 | U-3075: Treatment of adrenal insufficiency |
| Pat. No. 9675559 Treatment of adrenal insufficiency Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 | Jan 10, 2033 | U-3075: Treatment of adrenal insufficiency |
| Pat. No. 9717740 Treatment of adrenal insufficiency Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 | Nov 19, 2032 | U-3075: Treatment of adrenal insufficiency |
ALLEGRA, CHILDREN'S ALLERGY; ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
NDA Applicant: CHATTEM SANOFI 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 |
ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 001 DISC (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
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 002 DISC (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 [GENERIC AB]
NDA Applicant: ABBVIE NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014 | Mar 2, 2024 *PED |
ALSUMA (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
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
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
ALTRENO (LOTION) (TOPICAL) TRETINOIN
NDA Applicant: DOW PHARM NDA No.: 209353 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
| Pat. No. 11324710 Topical pharmaceutical compositions for treating skin conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 8, 2022 | Aug 22, 2038 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
ALUNBRIG (TABLET) (ORAL) BRIGATINIB
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208772 Prod. No.: 001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9012462 DS* [Extended 491 days (1.3 years)] Phosphorous derivatives as kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 | Apr 28, 2031 | |
| Pat. No. 9273077 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: I - New Indication | May 22, 2023 | I-847: Expanded indication of the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test |
| Exclusivity Code: 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 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 |
AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
NDA Applicant: BIOFRONTERA NDA No.: 208081 Prod. No.: 001 RX (10%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11235169 Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 23, 2022 | Oct 15, 2040 | U-3303: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light |
| Pat. No. 11540981 DP* Nanoemulsion formulation with improved stability and cell penetration Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2023 | Feb 7, 2028 |
AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
NDA Applicant: SUCAMPO PHARMA LLC NDA No.: 021908 Prod. No.: 001 RX (24MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 8338639 DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 20, 2012 | Jan 23, 2027 | |
| 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 |
AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
NDA Applicant: SUCAMPO PHARMA LLC NDA No.: 021908 Prod. No.: 002 RX (8MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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 |
AMONDYS 45 (SOLUTION) (INTRAVENOUS) CASIMERSEN
Drug Classes: antisense oligonucleotide
NDA Applicant: SAREPTA THERAPS INC NDA No.: 213026 Prod. No.: 001 RX (100MG/2ML (50MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE48960 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof Claim Types: Compound; Method of use; Formulation Pat. Sub. Date(s): 001: Mar 31, 2022 | Jun 28, 2025 | U-3087: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by inducing exon-skipping of exon 45 U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping |
| Pat. No. 9228187 DS* DP* Antisense molecules and methods for treating pathologies Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 | Nov 12, 2030 | |
| Pat. No. 9447415 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 | Jun 28, 2025 | |
| Pat. No. 9758783 Antisense molecules and methods for treating pathologies Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2021 | Nov 12, 2030 | U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production |
| Pat. No. 10287586 DS* DP* Antisense molecules and methods for treating pathologies Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 | Nov 12, 2030 | |
| Pat. No. 10781450 Antisense molecules and methods for treating pathologies Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2021 | Nov 12, 2030 | U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 25, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 25, 2028 | ODE-347: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping |
AMPHOTERICIN B (INJECTABLE, LIPOSOMAL) (INJECTION) AMPHOTERICIN B [GENERIC AB]
NDA Applicant: SPIL NDA No.: 212514 Prod. No.: 001 RX (50MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 14, 2022 |
AMRIX (CAPSULE, EXTENDED RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE [GENERIC AB]
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
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 |
AMVUTTRA (SOLUTION) (SUBCUTANEOUS) VUTRISIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 215515 Prod. No.: 001 RX (EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 12, 2029 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 9370581 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 9399775 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases Claim Types: Compound; Composition; Cell; Method of use; Kit Pat. Sub. Date(s): 001: Jul 13, 2022 | Nov 16, 2032 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Aug 24, 2028 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10208307 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Compound; Cell; ; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10570391 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases Claim Types: Compound; Cell; ; Composition; Method of use; Kit Pat. Sub. Date(s): 001: Jul 13, 2022 | Nov 16, 2032 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Aug 14, 2035 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10683501 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Jul 13, 2022 | Dec 4, 2028 | |
| Pat. No. 11286486 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 13, 2022 | Jul 28, 2036 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Pat. No. 11401517 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 31, 2022 | Aug 14, 2035 | U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 13, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 13, 2029 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
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: Antibacterials:Tetracyclines
NDA Applicant: JOURNEY 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 |
| Pat. No. 10821187 Compositions, gels and foams with rheology modulators and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2020 | Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
| Pat. No. 10849847 Compositions and methods for treating rosacea and acne Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2020 | Sep 8, 2037 | U-2647: Treatment of non-nodular acne vulgaris |
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
NDA Applicant: BESINS HLTHCARE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309 Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)**); 003 DISC (1.62% (40.5MG/2.5GM PACKET)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
ANGELIQ (TABLET) (ORAL) DROSPIRENONE; ESTRADIOL
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]
NDA Applicant: SANDOZ 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: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX NDA No.: 210583 Prod. No.: 001 DISC (30MG/ML (30MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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; 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. 10709713 Nanoparticulate meloxicam formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2020 | May 26, 2030 | U-2750: Management of moderate-to-severe pain by intravenous injection |
| Pat. No. 10881663 Method of treating pain in elderly patients with mild renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2021 | Mar 8, 2039 | U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment |
| Pat. No. 11253478 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2022 | May 26, 2030 | U-3318: Management of moderate-to-severe pain by injection |
| Pat. No. 11458145 Methods of administering intravenous meloxicam in a bolus dose Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2022 | Mar 8, 2039 | U-3318: Management of moderate-to-severe pain by injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 20, 2023 |
ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
NDA Applicant: MAYNE PHARMA 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 |
| Pat. No. 10765628 Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 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 |
| Pat. No. 10780047 Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 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 |
| Pat. No. 10918649 DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Feb 17, 2021 | Jun 21, 2039 | |
| Pat. No. 10925882 DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Feb 24, 2021 | Jun 21, 2039 | |
| Pat. No. 10940157 DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Mar 11, 2021 | Jun 21, 2039 | |
| Pat. No. 11529308 DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Dec 21, 2022 | Jun 21, 2039 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
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. 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 | |
| Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2021 | Nov 29, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
NDA Applicant: LUPIN NDA No.: 021695 Prod. No.: 004 DISC (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
NDA Applicant: LUPIN NDA No.: 021695 Prod. No.: 005 DISC (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
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: ZEVRA THERAP NDA No.: 208653 Prod. No.: 001 DISC (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: ZEVRA THERAP NDA No.: 208653 Prod. No.: 002 DISC (325MG;EQ 4.08MG BASE); 003 DISC (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 |
APHEXDA (POWDER) (SUBCUTANEOUS) MOTIXAFORTIDE ACETATE
NDA Applicant: BIOLINERX LTD NDA No.: 217159 Prod. No.: 001 RX (EQ 62MG BASE/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 8, 2030 | ODE-442: To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma |
APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other
NDA Applicant: BAUSCH 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 |
APOMORPHINE HYDROCHLORIDE (INJECTABLE) (SUBCUTANEOUS) APOMORPHINE HYDROCHLORIDE [GENERIC AP]
NDA Applicant: SAGE CHEMS NDA No.: 212025 Prod. No.: 001 RX (30MG/3ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 24, 2022 |
APONVIE (EMULSION) (INTRAVENOUS) APREPITANT
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HERON THERAPS INC NDA No.: 216457 Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561229 DP* Emulsion formulations of aprepitant Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting |
| Pat. No. 9808465 Emulsion formulations of aprepitant Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting |
| Pat. No. 9974742 DP* Emulsion formulations of an NK-1 receptor antagonist and uses thereof Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 9974793 DP* Emulsion formulations of aprepitant Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 9974794 DP* Emulsion formulations of aprepitant Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting |
| Pat. No. 10500208 DP* Emulsion formulations of aprepitant Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 10624850 Emulsion formulations of an NK-1 receptor antagonist and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting |
| Pat. No. 10953018 Emulsion formulations of aprepitant Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting |
| Pat. No. 11173118 DP* Emulsion formulations of an NK-1 receptor antagonist and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 5, 2022 | Sep 18, 2035 | |
| Pat. No. 11744800 DP* Methods of use of emulsion formulations of an NK-1 receptor antagonist Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2023 | Sep 18, 2035 | U-3690: A method for preventing of post-operative nausea and vomiting |
APRETUDE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 215499 Prod. No.: 001 RX (600MG/3ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410103 DS* DP* (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 14, 2022 | Apr 28, 2026 | |
| Pat. No. 10927129 DS* DP* N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 14, 2022 | Apr 28, 2026 | |
| Pat. No. 11224597 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 10, 2022 | Sep 15, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 21, 2026 |
APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
NDA Applicant: SALIX 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 |
APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE [GENERIC AB]
Drug Classes: Anticonvulsants:Sodium Channel Agents
NDA Applicant: SUMITOMO PHARMA AM NDA No.: 022416 Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
| Pat. No. 10702536 Methods of treatment of partial onset seizures using eslicarbazepine acetate Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2020 | May 6, 2025 | U-2501: Treatment of partial-onset seizures |
| Pat. No. 10912781 DP* Pharmaceutical composition comprising licarbazepine acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Oct 23, 2028 | |
| Pat. No. 11364247 Methods of treatment of partial onset seizures using eslicarbazepine acetate Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 23, 2022 | 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 |
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: Method of use (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 |
| Pat. No. 10888558 Regimens of tafenoquine for prevention of malaria in malaria-naive subjects Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Feb 10, 2021 | Dec 2, 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 |
| Pat. No. 11744828 Regimens of tafenoquine for prevention of malaria in malaria-naïve subjects Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Oct 4, 2023 | 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 |
ARAZLO (LOTION) (TOPICAL) TAZAROTENE
NDA Applicant: BAUSCH NDA No.: 211882 Prod. No.: 001 RX (0.045%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11311482 Topical compositions and methods for treating skin diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 5, 2022 | May 11, 2038 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
| Pat. No. 11679116 DP* Topical compositions and methods for treating psoriasis Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2023 | Jun 6, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 18, 2022 |
ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
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. 8479730 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2013 | Oct 11, 2028 |
ARGATROBAN IN SODIUM CHLORIDE (INJECTABLE) (INTRAVENOUS) ARGATROBAN
NDA Applicant: CIPLA NDA No.: 022434 Prod. No.: 001 DISC (50MG/50ML (1MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7589106 DP* Alcohol free formulation of argatroban Claim Types: Formulation; Drug in a container; Method of use Pat. Sub. Date(s): 001: Jul 20, 2011 | Sep 26, 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: Antidementia Agents:Cholinesterase Inhibitors
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: Antibacterials:Aminoglycosides
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 |
| Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 24, 2020 | May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
| Pat. No. 11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2022 | May 15, 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: ODE - Orphan drug exclusivity | Sep 28, 2030 GAIN | 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: Antidepressants:Antidepressants, Other
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 |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: 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): 002: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 002: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 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): 003: 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): 003: 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): 003: 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): 003: 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): 003: 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): 003: 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): 003: 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): 003: 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): 003: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 10, 2020 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
| Pat. No. 11406632 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 003: Aug 19, 2022 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other
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 |
| Pat. No. 10688091 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 8, 2020 | Aug 17, 2035 | |
| Pat. No. 10849894 Aripiprazole prodrug composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2020 | Aug 17, 2035 | U-543: Treatment of schizophrenia |
| Pat. No. 11154552 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2021 | Aug 17, 2035 | |
| Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 13, 2022 | Apr 6, 2039 | U-543: Treatment of schizophrenia |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 004 RX (0.055MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Jul 13, 2032 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 004: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 004: Nov 10, 2022 | Dec 19, 2040 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Jul 13, 2032 *PED | |
| 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 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Feb 28, 2036 *PED | |
| 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 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 | Feb 16, 2037 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 | Jun 14, 2036 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 | Jun 18, 2039 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 | Aug 22, 2041 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): All strengths: Nov 10, 2022 | Dec 19, 2040 *PED |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 008 DISC (0.03MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | May 8, 2031 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Jul 13, 2032 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 008: May 5, 2022 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Feb 28, 2036 *PED | |
| Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Feb 28, 2036 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 008: May 5, 2022 | Jul 1, 2032 *PED | |
| Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Feb 16, 2037 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Nov 19, 2025 *PED | |
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Jun 14, 2036 *PED | |
| Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 008: May 5, 2022 | Jun 18, 2039 *PED | |
| Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 | Jan 6, 2041 *PED | |
| Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 | Aug 22, 2041 *PED | |
| Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: Jun 29, 2022 | Mar 26, 2040 *PED | |
| Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 008: Jun 29, 2022 | Aug 10, 2038 *PED | |
| Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 008: Jul 13, 2022 | Mar 24, 2039 *PED | |
| Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 008: Oct 6, 2022 | Nov 24, 2040 *PED | |
| Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 008: Nov 10, 2022 | Dec 19, 2040 *PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 001 DISC (0.055MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Jul 13, 2032 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 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 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | Nov 19, 2025 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Jul 13, 2032 *PED | |
| 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 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 5, 2019 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 | Jul 1, 2032 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 | Nov 19, 2025 *PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 007 DISC (0.03MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 6, 2023 *PED | |
| Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Sep 26, 2028 *PED | |
| Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Aug 25, 2032 *PED | |
| Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Jul 13, 2032 *PED | |
| Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Dec 28, 2031 *PED | |
| Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 19, 2025 *PED | |
| Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Mar 1, 2025 *PED | |
| Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 18, 2031 *PED | |
| Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Aug 14, 2031 *PED | |
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 007: Aug 5, 2021 | Jul 1, 2032 *PED | |
| Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 | Nov 19, 2025 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Jan 9, 2025 PED |
ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
NDA Applicant: GLAXOSMITHKLINE NDA No.: 205625 Prod. No.: 001 RX (0.1MG/INH); 002 RX (0.2MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 28, 2014 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 28, 2014 | Aug 5, 2028 *PED | |
| Pat. No. 8201556 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 28, 2014 | Feb 5, 2029 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 28, 2014 | Sep 8, 2030 *PED | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 28, 2014 | Apr 11, 2031 *PED | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): All strengths: May 18, 2016 | Apr 2, 2028 *PED |
ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
NDA Applicant: GLAXOSMITHKLINE NDA No.: 205625 Prod. No.: 003 RX (0.05MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Apr 23, 2028 *PED | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Aug 5, 2028 *PED | |
| 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 | Sep 8, 2030 *PED | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 003: Jun 13, 2018 | Apr 11, 2031 *PED | |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 003: Jun 13, 2018 | Apr 2, 2028 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 1, 2026 | M-290: Information added to section 8.4 of the labeling to include the result ofstudy HZA114971 |
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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; Method of use 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. |
ASCOR (SOLUTION) (INTRAVENOUS) ASCORBIC ACID
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 |
ASMANEX HFA (AEROSOL, METERED) (INHALATION) MOMETASONE FUROATE
NDA Applicant: ORGANON LLC NDA No.: 205641 Prod. No.: 003 RX (0.05MG/INH)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NS - New strength | Feb 12, 2023 PED |
ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE) (ORAL) RANOLAZINE
NDA Applicant: SPIL NDA No.: 216018 Prod. No.: 001 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11510878 DP* Extended release multiparticulates of ranolazine Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 1, 2022 | Jan 24, 2038 |
ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE) (ORAL) RANOLAZINE
NDA Applicant: SPIL NDA No.: 216018 Prod. No.: 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10898444 DP* Extended release multiparticulates of ranolazine Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 3, 2022 | Jan 24, 2038 | |
| Pat. No. 11510878 DP* Extended release multiparticulates of ranolazine Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 1, 2022 | Jan 24, 2038 |
ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS
NDA Applicant: ASTELLAS NDA No.: 204096 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | May 24, 2025 |
ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 001 DISC (0.137MG/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
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 022203 Prod. No.: 002 DISC (0.2055MG/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 |
ASTEPRO ALLERGY; ASTEPRO ALLERGY, CHILDREN'S (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE
NDA Applicant: BAYER HLTHCARE NDA No.: 213872 Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 8, 2021 | Jun 4, 2028 | |
| Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 8, 2021 | Nov 22, 2025 | U-3166: OTC use: allergy symptom reliever; temporary relief of these symptoms due to hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing and itchy nose |
| Pat. No. 9919050 DP* Compositions comprising azelastine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 8, 2021 | Nov 22, 2025 |
ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
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 |
ATORVALIQ (SUSPENSION) (ORAL) ATORVASTATIN CALCIUM
NDA Applicant: CMP DEV LLC NDA No.: 213260 Prod. No.: 001 RX (20MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11369567 DP* Aqueous suspension suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 7, 2023 | Jun 7, 2037 | |
| Pat. No. 11654106 DP* Aqueous suspension suitable for oral administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 1, 2023 | Jun 7, 2037 | U-3612: As an adjunct to diet to reduce low-density lipoprotein cholesterol in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia U-3613: As an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia |
ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 RX (600MG;200MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 13, 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 |
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
NDA Applicant: AM REGENT NDA No.: 216120 Prod. No.: 001 RX (0.4MG/ML (0.4MG/ML)); 002 RX (1MG/ML (1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jan 29, 2023 |
ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021527 Prod. No.: 001 RX (0.021MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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]
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 | Mar 12, 2027 *PED | 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 | Mar 14, 2031 *PED | |
| 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 | Aug 4, 2034 *PED | 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 30, 2024 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS NDA No.: 205874 Prod. No.: 001 RX (EQ 210MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 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 |
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* [Extended 562 days (1.5 years)] Benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Oct 3, 2031 *PED | |
| Pat. No. 9233959 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Mar 18, 2034 *PED | |
| Pat. No. 9296739 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 | Mar 18, 2034 *PED | |
| Pat. No. 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 | Mar 18, 2034 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| 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 | Mar 18, 2034 *PED | |
| Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Mar 31, 2021 | Sep 7, 2036 *PED | U-3055: A method of treating Huntington's chorea |
| Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2021 | Sep 15, 2038 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 27, 2022 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Oct 13, 2022 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
| Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 15, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
| Pat. No. 11648244 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
| Pat. No. 11666566 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 16, 2023 | Sep 18, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Dec 24, 2024 PED | M-54: Information from pediatric studies added to label |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 3, 2024 PED | ODE-134: Treatment of chorea associated with Huntington's disease |
AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA NDA No.: 216354 Prod. No.: 001 RX (6MG); 002 RX (12MG); 003 RX (24MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8524733 DS* DP* [Extended 562 days (1.5 years)] Benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Oct 3, 2031 *PED | |
| 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: Feb 27, 2023 | Mar 18, 2034 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Sep 7, 2036 *PED | U-3055: A method of treating Huntington's chorea |
| Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Sep 15, 2038 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 11311488 DP* Osmotic dosage forms comprising deutetrabenazine and methods of use thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Jun 10, 2041 | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
| Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
| Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 27, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
| Pat. No. 11648244 Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2023 | Sep 7, 2036 *PED | U-1995: Treatment of tardive dyskinesia |
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other
NDA Applicant: AXSOME NDA No.: 215430 Prod. No.: 001 RX (105MG;45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8569328 DP* Compositions and methods comprising tilidine or related compounds and dextromethorphan Claim Types: Composition; Method of use; Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Oct 29, 2033 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9168234 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9198905 Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 9205083 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Sep 16, 2022 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
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| Pat. No. 11617728 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 3, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11617747 Bupropion as a modulator of drug activity Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): 001: May 3, 2023 | Nov 5, 2034 | U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels |
| Pat. No. 11717518 Bupropion Dosage Forms With Reduced Food And Alcohol Dosing Effects Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2023 | Jan 20, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11730706 Treatment of depression in certain patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 28, 2023 | Jan 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11752144 Compounds and combinations thereof for treating neurological and psychiatric conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2023 | Feb 23, 2043 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Pat. No. 11779579 Bupropion as a modulator of drug activity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2023 | Nov 5, 2034 | U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 18, 2025 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/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 | 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 | 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 | 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 | 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 | 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 | Mar 21, 2025 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): 001: Jul 26, 2013 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 21, 2013 | 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 | 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 | 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 | 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 | 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 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: 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): 001: 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): 001: 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): 001: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: 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): 001: 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): 001: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 2, 2019 | Apr 30, 2025 | |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Apr 22, 2021 | Jun 25, 2026 | |
| Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2023 | Dec 12, 2026 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 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): 002: None | Jun 1, 2026 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Jan 15, 2025 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Oct 30, 2028 | |
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 12, 2028 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 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): 002: Jul 26, 2013 | Nov 2, 2029 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 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): 002: None | Apr 10, 2029 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 25, 2028 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 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): 002: None | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: 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): 002: 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): 002: 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): 002: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: 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): 002: 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): 002: Aug 30, 2017 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jun 11, 2019 | Nov 23, 2024 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jul 2, 2019 | Apr 30, 2025 | |
| Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Nov 4, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Dec 10, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 22, 2021 | Jun 25, 2026 | |
| Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Mar 29, 2023 | Dec 12, 2026 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
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 | |
| Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Nov 4, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Aug 25, 2020 | Nov 23, 2024 | |
| Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Dec 10, 2020 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Apr 22, 2021 | Jun 25, 2026 | |
| Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Mar 29, 2023 | Dec 12, 2026 |
AVACLYR (OINTMENT) (OPHTHALMIC) ACYCLOVIR
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 |
AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
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 [Extended 435 days (1.2 years)] Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: None | May 8, 2027 | 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). |
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins
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* [Extended 1413 days (3.9 years)] 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 pneumonia (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. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 25, 2025 GAIN | |
| Exclusivity Code: NPP - New patient population | Dec 20, 2025 |
AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
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; Method of administration 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
NDA Applicant: BLUE EARTH NDA No.: 208054 Prod. No.: 001 RX (9-221mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
| Pat. No. 10716868 Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 22, 2020 | 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 |
| Pat. No. 10933147 Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2021 | 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 |
| Pat. No. 10953112 Precursor compound of radioactive halogen-labeled organic compound Claim Types: Product-by-process Pat. Sub. Date(s): 001: Apr 20, 2021 | Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
| Pat. No. 10967077 Imaging of metastatic or recurrent cancer Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Apr 20, 2021 | 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 |
AYVAKIT (TABLET) (ORAL) AVAPRITINIB
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 001 RX (100MG); 002 RX (200MG)
| 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 U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| 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 U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| 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 U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN) |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 22, 2030 | ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
AYVAKIT (TABLET) (ORAL) AVAPRITINIB
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 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): 003: 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): 003: 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): 003: 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 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 22, 2030 | ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
AYVAKIT (TABLET) (ORAL) AVAPRITINIB
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 004 RX (25MG)
| 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): 004: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) U-3506: Treatment of indolent systemic mastocytosis (ISM) |
| Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) U-3506: Treatment of indolent systemic mastocytosis (ISM) |
| Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) U-3506: Treatment of indolent systemic mastocytosis (ISM) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN) |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: I - New Indication | May 22, 2026 | I-912: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 22, 2030 | ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
AYVAKIT (TABLET) (ORAL) AVAPRITINIB
NDA Applicant: BLUEPRINT MEDICINES NDA No.: 212608 Prod. No.: 005 RX (50MG)
| 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): 005: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 005: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 005: Jul 13, 2021 | Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN) |
| Exclusivity Code: I - New Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
| Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 22, 2030 | ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM) |
AZEDRA (SOLUTION) (INTRAVENOUS) IOBENGUANE I-131
NDA Applicant: PROGENICS PHARMS INC NDA No.: 209607 Prod. No.: 001 RX (15mCi/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| 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 |
AZILECT (TABLET) (ORAL) RASAGILINE MESYLATE [GENERIC AB]
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 |
AZSTARYS (CAPSULE) (ORAL) DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
NDA Applicant: COMMAVE THERAP NDA No.: 212994 Prod. No.: 001 RX (EQ 5.2MG BASE;EQ 26.1MG BASE); 002 RX (EQ 7.8MG BASE;EQ 39.2MG BASE); 003 RX (EQ 10.4MG BASE;EQ 52.3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9079928 DP* Methylphenidate-oxoacid conjugates, processes of making and using the same Claim Types: Composition Pat. Sub. Date(s): All strengths: May 17, 2021 | Jul 27, 2032 | |
| Pat. No. 10584112 DS* DP* Methylphenidate-prodrugs, processes of making and using the same Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 17, 2021 | Dec 9, 2037 | |
| Pat. No. 10584113 DP* Methylphenidate-prodrugs, processes of making and using the same Claim Types: Composition Pat. Sub. Date(s): All strengths: May 17, 2021 | Dec 9, 2037 | |
| Pat. No. 10759778 DP* Methylphenidate-prodrugs, processes of making and using the same Claim Types: Kit Pat. Sub. Date(s): All strengths: May 17, 2021 | Dec 9, 2037 | |
| Pat. No. 10858341 Compositions comprising methylphenidate-prodrugs, processes of making and using the same Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 17, 2021 | Dec 9, 2037 | U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate |
| Pat. No. 10954213 Compositions comprising methylphenidate-prodrugs, processes of making and using the same Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 17, 2021 | Dec 9, 2037 | U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 7, 2026 |