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. 7169791 DS* DP* Inhibitors of tyrosine kinases Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: None; 002: Sep 23, 2011; 003: Apr 12, 2018 | Jan 4, 2024 *PED | U-836: A method for the treatment of leukemias |
| Pat. No. 8389537 Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2013; 002: None; 003: Apr 12, 2018 | Jan 18, 2027 *PED | U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) |
| Pat. No. 8415363 DS* DP* Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Jun 13, 2013; 002: None; 003: Apr 12, 2018 | Jan 18, 2027 *PED | U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) U-1407: Treatment of newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (PH + CML) |
| Pat. No. 8501760 DP* Pharmaceutical compositions comprising nilotinib or its salt Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2013; 002: Aug 9, 2013; 003: Apr 12, 2018 | Jan 18, 2027 *PED | |
| Pat. No. 8293756 DP* Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Oct 8, 2014; 002: Oct 8, 2014; 003: Apr 12, 2018 | Mar 25, 2028 *PED | |
| Pat. No. 8163904 DS* DP* Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: Apr 12, 2018 | Feb 23, 2029 *PED | |
| Pat. No. 9061029 DS* Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Dec 1, 2016; 002: Dec 1, 2016; 003: Apr 12, 2018 | Oct 7, 2032 *PED | U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) U-3231: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) by administering nilotinib dispersed in a fruit preparation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 22, 2025 PED | ODE-171: Treatment of pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 22, 2025 PED | ODE-172: Treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia with resistance or intolerance to prior tyrosine-kinase inhibitor therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 23, 2029 PED | ODE-380: Treatment of pediatric patients greater than or equal to 1 year of age with accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy |
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 022569 Prod. No.: 001 DISC (EQ 0.1MG BASE**); 002 DISC (EQ 0.4MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Aug 11, 2015 | Jan 8, 2024 | |
| Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 13, 2017 | Jan 8, 2024 | |
| Pat. No. 8889176 Method of managing or treating pain Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 12, 2014 | Jan 16, 2024 | U-767: Management of breakthrough pain in patients with cancer |
| Pat. No. 8216604 Method of managing or treating pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None | Oct 3, 2024 | U-767: Management of breakthrough pain in patients with cancer |
| Pat. No. 9731869 DP* Container Claim Types: Packaging or device material Pat. Sub. Date(s): All strengths: Sep 1, 2017 | Jan 26, 2032 |
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BTCP PHARMA NDA No.: 022569 Prod. No.: 003 DISC (EQ 0.3MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition Claim Types: Device Pat. Sub. Date(s): 003: Dec 13, 2017 | Jan 8, 2024 | |
| Pat. No. 9731869 DP* Container Claim Types: Packaging or device material Pat. Sub. Date(s): 003: Sep 1, 2017 | Jan 26, 2032 |
TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 201688 Prod. No.: 001 RX (28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jan 11, 2024 | |
| Pat. No. RE47526 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Jun 1, 2020 | Apr 9, 2024 | |
| Pat. No. 11484671 DP* Aerosolization apparatus with capsule puncture alignment guide Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Nov 18, 2022 | Nov 7, 2024 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 8664187 Methods of treatment of endobronchial infections Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Jun 17, 2019 | Jun 20, 2025 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Oct 27, 2025 | |
| Pat. No. 8869794 DP* Aerosolization apparatus with capsule puncturing member Claim Types: Device; Process; Part of a dosage form; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Sep 12, 2028 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 10207066 DP* Aerosolization apparatus with capsule puncture alignment guide Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Nov 4, 2030 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [Has competitive generic]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 DISC (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. 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. 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. 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 |
| 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. 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. 8598185 DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Apr 28, 2029 |
COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 202123 Prod. No.: 001 RX (200MG;EQ 25MG BASE;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-257: Treatment of HIV infection |
| 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. 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. 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 |
| Pat. No. 7125879 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Sep 6, 2011 | Apr 21, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 8841310 DP* Combinations of a pyrimidine containing NNRTI with RT inhibitors Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Oct 20, 2014 | Dec 9, 2025 | U-257: Treatment of HIV infection |
| Pat. No. 10857102 DP* Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 6, 2021 | Jan 14, 2033 |
STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: CYP3A inhibitor == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 203100 Prod. No.: 001 RX (150MG;150MG;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-257: Treatment of HIV infection |
| Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 2, 2014 | Jan 13, 2024 | U-257: Treatment of HIV infection |
| 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. 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 |
| Pat. No. 7176220 DS* DP* 4-oxoquinoline compound and use thereof as pharmaceutical agent Claim Types: Method of use; Compound; Composition Pat. Sub. Date(s): 001: None | Feb 27, 2027 *PED | U-257: Treatment of HIV infection |
| Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 26, 2027 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Apr 14, 2015 | Apr 26, 2027 *PED | |
| Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: None | Mar 3, 2030 *PED | U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase |
| Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Mar 3, 2030 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8633219 DP* Combination therapy Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 24, 2014 | Oct 30, 2030 *PED | U-257: Treatment of HIV infection |
| Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 4, 2018 | Apr 6, 2033 *PED |
TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD NDA No.: 021752 Prod. No.: 001 RX (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-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
| 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. 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. 9744181 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 18, 2017 | Jan 13, 2024 | U-257: Treatment of HIV infection |
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 001 DISC (EQ 17MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2017 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 25, 2016 | Sep 26, 2025 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 25, 2016 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: May 25, 2016 | Jun 3, 2028 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2016 | Apr 29, 2030 |
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 002: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 10, 2020 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 30, 2021 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 210793 Prod. No.: 001 RX (EQ 34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 10449185 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2019 | Aug 27, 2038 | |
| Pat. No. 10646480 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2020 | Aug 27, 2038 | |
| Pat. No. 10849891 DP* Formulations of pimavanserin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2020 | Aug 27, 2038 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 11452721 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 27, 2022 | Aug 27, 2038 |
DIFICID (TABLET) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC NDA No.: 201699 Prod. No.: 001 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Dec 6, 2013 | Jan 15, 2024 *PED | |
| Pat. No. 7906489 18-membered macrocycles and analogs thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2011 | Sep 4, 2027 *PED | U-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older U-319: Treatment of microbial infections |
| Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B Claim Types: New polymorph, salt or hydrate; Formulation; Composition Pat. Sub. Date(s): 001: Aug 29, 2011 | Jan 31, 2028 *PED | |
| Pat. No. 7863249 DS* DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 29, 2011 | Jan 31, 2028 *PED | |
| Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 5, 2014 | Jan 31, 2028 *PED | U-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older U-319: Treatment of microbial infections |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 24, 2027 | ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD) |
DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC NDA No.: 213138 Prod. No.: 001 RX (40MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Feb 21, 2020 | Jan 15, 2024 *PED | |
| Pat. No. 7906489 18-membered macrocycles and analogs thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2020 | Sep 4, 2027 *PED | U-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older |
| Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B Claim Types: New polymorph, salt or hydrate; Formulation; Composition Pat. Sub. Date(s): 001: Feb 21, 2020 | Jan 31, 2028 *PED | |
| Pat. No. 7863249 DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Feb 21, 2020 | Jan 31, 2028 *PED | |
| Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2020 | Jan 31, 2028 *PED | U-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older |
| Pat. No. 9808530 DP* Composition of tiacumicin compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2020 | Nov 28, 2034 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 24, 2027 | ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD) |
PROLENSA (SOLUTION/DROPS) (OPHTHALMIC) BROMFENAC SODIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUSCH AND LOMB NDA No.: 203168 Prod. No.: 001 RX (EQ 0.07% ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8669290 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2014 | Jan 16, 2024 | |
| Pat. No. 8754131 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2014 | Jan 16, 2024 | |
| Pat. No. 8871813 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2014 | Jan 16, 2024 | |
| Pat. No. 8927606 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenyl acetic acid Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 12, 2015 | Jan 16, 2024 | U-100: Method of treating ocular inflammation U-1095: Method of treating ocular inflammation U-810: Method of treatment to alleviate inflammation of the eye |
| Pat. No. 9144609 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 4, 2015 | Jan 16, 2024 | |
| Pat. No. 9561277 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 7, 2017 | Jan 16, 2024 | U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery |
| Pat. No. 8129431 DS* DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Claim Types: Formulation Pat. Sub. Date(s): 001: May 6, 2013 | Sep 11, 2025 | |
| Pat. No. 10085958 DP* Bromfenac bioavailability Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 15, 2018 | Nov 19, 2032 | |
| Pat. No. 9517220 Bromfenac bioavailability Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2017 | Nov 11, 2033 | U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery |
HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE [GENERIC AP]
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC NDA No.: 201532 Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6214865 DS* Macrocyclic analogs and methods of their use and preparation Claim Types: Compound; Process Pat. Sub. Date(s): 001: Nov 30, 2010 | Jan 20, 2024 *PED | |
| Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 7, 2018 | Jul 8, 2027 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 13, 2026 PED | M-280: Revisions to the pediatric use subsection of labeling to include the results from clinical studies E7389-G000-223 and E7389-G000-213, conducted to fulfill a pediatric written request |
ZAVZPRET (SPRAY, METERED) (NASAL) ZAVEGEPANT HYDROCHLORIDE
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: PFIZER NDA No.: 216386 Prod. No.: 001 RX (EQ 10MG BASE/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7220862 DS* DP* Calcitonin gene related peptide receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Apr 6, 2023 | Jan 21, 2024 | |
| Pat. No. 8481546 DS* DP* CGRP receptor antagonist Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 6, 2023 | Oct 7, 2031 | U-3555: Administration of zavegepant for acute treatment of migraine with or without aura |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 9, 2028 |
RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: vasoconstrictor
NDA Applicant: MAYNE PHARMA NDA No.: 208552 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8815929 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2018 | Jan 22, 2024 | U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream |
| Pat. No. 8420688 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 9, 2017 | Aug 2, 2024 | U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream |
| Pat. No. 7812049 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 9, 2017 | May 2, 2028 | U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream |
| Pat. No. 8883838 DP* Pharmaceutical cream compositions and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 9, 2017 | Dec 1, 2031 | |
| Pat. No. 9974773 Stabilized oxymetazoline formulations and their uses Claim Types: Method of use Pat. Sub. Date(s): 001: May 22, 2018 | Jun 11, 2035 | U-2306: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream |
| Pat. No. 10335391 Stabilized oxymetazoline formulations and their uses Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2019 | Jun 11, 2035 | U-2567: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream, where the patient experiences no rebound or worsening of facial erythema post-treatment |
| Pat. No. 10751325 Stabilized oxymetazoline formulations and their uses Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 26, 2020 | Jun 11, 2035 | U-2921: Once daily topical treatment of persistent facial erythema associated with rosacea in adults |
| Pat. No. 11517560 Stabilized oxymetazoline formulations and their uses Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2022 | Jun 11, 2035 | U-3494: Once daily topical treatment of persistent facial erythema associated with rosacea in female adults |
EVOCLIN (AEROSOL, FOAM) (TOPICAL) CLINDAMYCIN PHOSPHATE
Drug Classes: lincosamide antibacterial
NDA Applicant: NORVIUM BIOSCIENCE NDA No.: 050801 Prod. No.: 001 DISC (1%**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7374747 DP* Pharmaceutical foam Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 23, 2024 | U-921: Treatment of acne vulgaris |
| Pat. No. 7141237 DP* Pharmaceutical foam Claim Types: Drug in a container Pat. Sub. Date(s): 001: None | Feb 3, 2024 |
TORISEL (SOLUTION) (INTRAVENOUS) TEMSIROLIMUS [GENERIC AP]
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 022088 Prod. No.: 001 RX (25MG/ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8299116 DP* CCI-779 concentrate formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 20, 2012 | Jan 25, 2024 *PED | |
| Pat. No. 8455539 DP* CCI-779 concentrate formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 18, 2013 | Jan 25, 2024 *PED | |
| Pat. No. 8722700 DP* CCI-779 formulations for parenteral administration Claim Types: Method of administration; Formulation; Process Pat. Sub. Date(s): 001: Jun 5, 2014 | Jan 25, 2024 *PED | |
| Pat. No. 8026276 DP* Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 20, 2026 *PED | |
| Pat. No. 8791097 Anti-tumor activity of CCI-779 in papillary renal cell cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2014 | Nov 10, 2032 *PED | U-1550: Method of treating metastatic papillary renal cell carcinoma with temsirolimus. U-1551: Method of treating papillary renal cell carcinoma with temsirolimus, in the absence of interferon alpha. |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 001 RX (145MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 002 RX (290MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 002: None | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 003 RX (72MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Aug 30, 2026 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Feb 17, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020 | Aug 11, 2031 | |
| Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020 | Aug 11, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017 | Aug 16, 2033 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
SEASONIQUE (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL [GENERIC AB]
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: TEVA BRANDED PHARM NDA No.: 021840 Prod. No.: 001 RX (0.03MG,0.01MG;0.15MG,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7320969 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 30, 2024 | U-828: Prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception |
| Pat. No. 7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2011 | Dec 5, 2028 | U-1: Prevention of pregnancy |
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL NDA No.: 205388 Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8173707 Ophthalmologic irrigation solutions and method Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Jan 30, 2024 *PED | |
| Pat. No. 9278101 Ophthalmologic irrigation solutions and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2016 | Jan 30, 2024 *PED | U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain |
| Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2016 | Jan 30, 2024 *PED | |
| Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 5, 2018 | Oct 23, 2033 | |
| Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2015 | Apr 23, 2034 *PED | |
| Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2016 | Apr 23, 2034 *PED |
CHLORAPREP ONE-STEP (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 006 OTC (2%;70% (26ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules Claim Types: Device; Process Pat. Sub. Date(s): 006: None | Jan 31, 2024 |
CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO NDA No.: 020832 Prod. No.: 002 OTC (2%;70% (26ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules Claim Types: Device; Process Pat. Sub. Date(s): 002: None | Jan 31, 2024 | |
| Pat. No. 7422388 DP* Applicator for coloring antiseptic Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: May 22, 2013 | Apr 25, 2027 | U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery |
NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 001 DISC (0.0277MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7560429 DP* Orodispersible dosage forms of desmopressin acetate Claim Types: Formulation; Process; Method of use; Kit Pat. Sub. Date(s): 001: Jul 19, 2018 | Feb 2, 2024 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 11020448 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 17, 2021 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 11963995 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: May 21, 2024 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 9974826 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 19, 2018 | Apr 13, 2030 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC NDA No.: 022517 Prod. No.: 002 DISC (0.0553MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7560429 DP* Orodispersible dosage forms of desmopressin acetate Claim Types: Formulation; Process; Method of use; Kit Pat. Sub. Date(s): 002: Jul 19, 2018 | Feb 2, 2024 | U-2326: Treatment of nocturia due to nocturnal polyuria in adults |
| Pat. No. 10137167 Methods comprising desmopressin Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Dec 12, 2018 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 11963995 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: May 21, 2024 | May 21, 2029 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
| Pat. No. 9974826 Methods comprising desmopressin Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 19, 2018 | Apr 13, 2030 | U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration |
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ACERUS NDA No.: 205488 Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8574622 DP* Controlled release delivery system for nasal applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2014 | Feb 4, 2024 | |
| Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | |
| Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation. |
| Pat. No. 8877230 Controlled release delivery system for nasal applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2014 | Feb 4, 2024 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 10, 2021 | Mar 17, 2034 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214621 Prod. No.: 001 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8735401 Thienopyrimidine compounds and use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2021 | Feb 4, 2024 | U-3019: Treatment of adult patients with advanced prostate cancer that is sex-hormone-dependent |
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 14, 2021 | Jan 28, 2025 | |
| Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jan 14, 2021 | Jan 28, 2025 | |
| Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 25, 2023 | Sep 27, 2033 | |
| Pat. No. 10350170 DP* Solid preparation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 14, 2021 | Feb 25, 2036 | |
| Pat. No. 10449191 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2021 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 10786501 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2021 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 11583526 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2023 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 12097198 Treatment of prostate cancer Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Sep 25, 2024 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2025 |
OSPHENA (TABLET) (ORAL) OSPEMIFENE [GENERIC AB]
Drug Classes: estrogen agonist/antagonist
NDA Applicant: DUCHESNAY NDA No.: 203505 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8470890 Method for enhancing the bioavailability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8772353 Method for enhancing the bioavalability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2014 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 9241915 Method for enhancing the bioavailability of ospemifene Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Feb 10, 2016 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 9855224 Method for enhancing the bioavailability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2018 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 6245819 Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 25, 2013 | Jul 21, 2025 | U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8236861 Method for enhancing the bioavailablity of ospemifene Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 25, 2013 | Aug 11, 2026 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8642079 DP* Solid formulations of ospemifene Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 20, 2014 | Jul 9, 2028 |
ZMAX (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV NDA No.: 050797 Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6984403 DP* Azithromycin dosage forms with reduced side effects Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 14, 2024 | U-282: Method of treating bacterial infections |
| Pat. No. 7887844 DP* Multiparticulate crystalline drug compositions having controlled release profiles Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 15, 2011 | Feb 14, 2024 |
SYMTUZA (TABLET) (ORAL) COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: CYP3A inhibitor == human immunodeficiency virus (HIV-1) protease inhibitor == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: JANSSEN PRODS NDA No.: 210455 Prod. No.: 001 RX (150MG;800MG;200MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Aug 15, 2018 | Feb 16, 2024 | |
| Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 15, 2018 | Apr 17, 2025 | |
| Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 15, 2018 | Dec 26, 2026 | |
| Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Aug 15, 2018 | Sep 3, 2029 | U-2353: Tx of HIV-1 infection using a composition containing a PK enhancer that inhibits cytochrome P450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months U-2364: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase in adults who have no prior antiretroviral treatment history U-2365: Treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months U-2766: Tx of HIV1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults & pediatric patients at least 40kg having no prior ARV tx history or are virologically suppressed on a stable ARV regimen for at least 6 mo U-2767: Treatment of HIV-1 infection using a composition containing a pk enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who have no prior ARV treatment history U-2768: Treatment of HIV-1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who are virologically suppressed on a stable ARV regimen for at least 6 months |
| Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 15, 2018 | Aug 15, 2032 | U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months |
| Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 15, 2018 | Aug 15, 2032 | U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months |
| Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 5, 2018 | Oct 6, 2032 | |
| Pat. No. 10786518 Compositions and methods of treating HIV Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 28, 2020 | Jul 19, 2038 | U-2978: Treatment of HIV-1 infection in adult or pediatric patients (>=40 kg) with <50 copies/ml HIV-1 RNA after >= 6 months on prior antiretroviral regimen and no known darunavir or tenofovir resistance-associated substitutions |
CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS NDA No.: 021669 Prod. No.: 001 OTC (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7066916 Disinfectant delivery system, and method of providing alcohol-free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2024 | U-737: Disinfection of patient skin prior to an invasive procedure |
| Pat. No. 7717889 DP* Disinfectant delivery system and method of providing alcohol free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2012 | Feb 27, 2025 | U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection |
| Pat. No. 7427574 DP* Non-woven wash cloth Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 25, 2026 | |
| Pat. No. 7935093 DP* Disinfectant delivery system and method of providing alcohol-free disinfection Claim Types: Method of use Pat. Sub. Date(s): 001: May 24, 2011 | Oct 2, 2027 | U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection |
MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: estrogen == progestin == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214846 Prod. No.: 001 RX (1MG;0.5MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9346822 Thienopyrimidine compounds and use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 21, 2021 | Feb 17, 2024 | U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women |
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jun 21, 2021 | Jan 28, 2025 | |
| Pat. No. 8058280 DS* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jun 21, 2021 | Jan 28, 2025 | |
| Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 25, 2023 | Sep 27, 2033 | |
| Pat. No. 11033551 Methods of treating uterine fibroids Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 21, 2021 | Sep 29, 2037 | U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women |
| Pat. No. 11957684 Treatment of heavy menstrual bleeding associated with uterine fibroids Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2024 | Sep 29, 2037 | U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women |
| Pat. No. 11793812 Methods of treating endometriosis Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2023 | May 3, 2038 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 5, 2025 | I-898: For the management of moderate to severe pain associated with endometriosis |
| Exclusivity Code: M - Miscellaneous | Jan 27, 2026 | M-289: Information added to the labeling to describe the results of MVT-601-035 |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2025 | |
| Exclusivity Code: NP - New product | May 26, 2024 |
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. 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. 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. 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. 9387191 DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 | Jul 21, 2030 | |
| 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 |
EXSERVAN (FILM) (ORAL) RILUZOLE
Drug Classes: benzothiazole
NDA Applicant: AQUESTIVE NDA No.: 212640 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 2, 2020 | Feb 20, 2024 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2020 | Apr 3, 2024 |
KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: dopaminergic agonist
NDA Applicant: SUMITOMO PHARMA AM NDA No.: 210875 Prod. No.: 001 DISC (10MG); 002 DISC (15MG); 003 DISC (20MG); 004 DISC (25MG); 005 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 20, 2024 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 3, 2024 | |
| Pat. No. 10821074 DP* Sublingual and buccal film compositions Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 12, 2020 | Aug 7, 2029 | |
| Pat. No. 9044475 DP* Sublingual apomorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | |
| Pat. No. 9283219 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9326981 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669019 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669021 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10420763 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8414922 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8846074 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 11419769 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2022 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10449146 Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10959943 Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2021 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC NDA No.: 200603 Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (20MG); 004 RX (120MG); 005 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9815827 Agent for treatment of schizophrenia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Feb 20, 2024 | U-2166: Treatment of major depressive episodes associated with bipolar I disorder U-543: Treatment of schizophrenia |
| Pat. No. 9174975 Remedy for integration dysfunction syndrome Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 23, 2015 | Aug 20, 2024 *PED | U-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia |
| Pat. No. RE45573 DS* Process for producing imide compound Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jun 24, 2015 | Dec 23, 2025 *PED | |
| Pat. No. 9555027 DP* Pharmaceutical composition Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Mar 1, 2017 | May 26, 2026 | U-543: Treatment of schizophrenia |
| Pat. No. 8729085 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 29, 2014 | Nov 26, 2026 *PED | |
| Pat. No. 8883794 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 12, 2014 | Nov 26, 2026 *PED | |
| Pat. No. 9907794 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 19, 2018 | Nov 26, 2026 *PED | |
| Pat. No. 9827242 Method of treatment for mental disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 19, 2017 | May 23, 2031 | U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder |
| Pat. No. 9259423 Method of treatment for mental disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | Nov 23, 2031 *PED | U-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder |
SYMPAZAN (FILM) (ORAL) CLOBAZAM
Drug Classes: benzodiazepine
NDA Applicant: OTTER PHARMS NDA No.: 210833 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 30, 2018 | Feb 20, 2024 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 30, 2018 | Apr 3, 2024 | |
| Pat. No. 11541002 DP* Oral film compositions and dosage forms having precise active dissolution profiles Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 4, 2023 | Jan 31, 2040 | U-724: Method of treating seizures |
OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 205832 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7119093 DS* DP* 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an-ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulpho- nate and the use thereof as a pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Intermediate Pat. Sub. Date(s): All strengths: Oct 22, 2014 | Feb 21, 2024 | |
| Pat. No. 6762180 DS* DP* Substituted indolines which inhibit receptor tyrosine kinases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 22, 2014 | Apr 1, 2026 *PED | |
| Pat. No. 10154990 Medicaments for the treatment or prevention of fibrotic diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 18, 2019 | Jul 8, 2026 *PED | U-2620: Use of nintedanib for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD) |
| Pat. No. 10105323 DP* Pharmaceutical dosage form for immediate release of an indolinone derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 6, 2018 | Dec 4, 2029 *PED | |
| Pat. No. 9907756 DP* Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2018 | Dec 7, 2029 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 6, 2027 PED | ODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD) |
ZOLINZA (CAPSULE) (ORAL) VORINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: MSD SUB MERCK NDA No.: 021991 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851509 DP* Polymorphs of suberoylanilide hydroxamic acid Claim Types: Formulation; Composition; Method of use Pat. Sub. Date(s): 001: Dec 15, 2010 | Feb 21, 2024 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 7399787 Methods of treating cancer with HDAC inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2025 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
| Pat. No. 8093295 DP* Formulations of suberoylanilide hydroxamic acid and methods for producing the same Claim Types: Formulation; Composition Pat. Sub. Date(s): 001: None | May 16, 2026 | |
| Pat. No. 7456219 DS* Polymorphs of suberoylanilide hydroxamic acid Claim Types: New polymorph, salt or hydrate; Product-by-process Pat. Sub. Date(s): 001: None | Mar 11, 2027 | |
| Pat. No. 8450372 Formulations of suberoylanilide hydroxamic acid and methods for producing same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 14, 2013 | Mar 18, 2028 | U-892: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) |
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: MERZ PHARMS NDA No.: 209184 Prod. No.: 001 RX (42MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 22, 2024 | |
| Pat. No. RE43711 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 3, 2029 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 |
ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX NDA No.: 210583 Prod. No.: 001 DISC (30MG/ML (30MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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. 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. 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. 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 |
GRALISE (TABLET) (ORAL) GABAPENTIN [GENERIC AB2]
NDA Applicant: ALMATICA NDA No.: 022544 Prod. No.: 001 RX (300MG); 002 RX (600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Feb 26, 2024 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
NASCOBAL (SPRAY, METERED) (NASAL) CYANOCOBALAMIN [Has competitive generic]
Drug Classes: vitamin B12
NDA Applicant: ENDO OPERATIONS NDA No.: 021642 Prod. No.: 001 DISC (0.5MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8940714 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 5, 2015 | Feb 26, 2024 | U-1152: Cyanocobalamin administration through nasal infusion |
| Pat. No. 7404489 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Kit Pat. Sub. Date(s): 001: None | Mar 12, 2024 | |
| Pat. No. 9415007 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 15, 2016 | Jul 28, 2024 | U-1896: Supplement for vitamin B12 deficiencies |
| Pat. No. 7229636 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: None | Aug 1, 2024 | U-817: Nasal administration of cyanocobalamin |
| Pat. No. 7879349 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Jun 10, 2011 | Aug 1, 2024 | U-1152: Cyanocobalamin administration through nasal infusion |
| Pat. No. 8003353 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 9, 2014 | Aug 1, 2024 | U-817: Nasal administration of cyanocobalamin |
DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 202236 Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8163723 Combination of azelastine and steroids Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2012 | Feb 29, 2024 *PED | U-1667: Treatment of allergic rhinitis, including seasonal allergic rhinitis U-644: Treatment of seasonal allergic rhinitis U-707: Allergic rhinitis U-77: Treatment of symptoms of seasonal allergic rhinitis U-81: Relief of symptoms associated with seasonal allergic rhinitis |
| Pat. No. 8168620 DP* Combination of azelastine and steroids Claim Types: Formulation; Process Pat. Sub. Date(s): 001: May 11, 2012 | Aug 24, 2026 *PED |
FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: LEO PHARMA AS NDA No.: 207071 Prod. No.: 001 RX (15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8435498 Penetrating pharmaceutical foam Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 26, 2015 | Mar 1, 2024 | U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
| Pat. No. 7700076 DP* Penetrating pharmaceutical foam Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 26, 2015 | Sep 18, 2027 | |
| Pat. No. 10117812 DP* Foamable composition combining a polar solvent and a hydrophobic carrier Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2018 | Oct 18, 2027 | U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
| Pat. No. 9265725 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2016 | Dec 8, 2027 | |
| Pat. No. 9211259 Antibiotic kit and composition and uses thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 14, 2016 | Feb 28, 2029 | U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
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 |
PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
NDA Applicant: EVOFEM INC NDA No.: 208352 Prod. No.: 001 RX (1%;1.8%;0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6706276 DP* Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 6, 2024 | |
| Pat. No. 10568855 Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 15, 2033 | U-1: Prevention of pregnancy |
| Pat. No. 11337989 Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2022 | Mar 15, 2033 | U-1: Prevention of pregnancy |
| Pat. No. 11439610 DS* DP* Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 15, 2022 | Mar 15, 2033 | |
| Pat. No. 11992472 Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2024 | Mar 15, 2033 | U-1: Prevention of pregnancy |
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 022522 Prod. No.: 001 RX (500MCG); 002 RX (250MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2014; 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2014; 002: Mar 14, 2018 | Mar 8, 2024 |
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: aminolevulinate synthase 1-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 11530408 DS* DP* Therapeutic compositions Claim Types: Composition Pat. Sub. Date(s): 001: Jan 6, 2023 | May 18, 2024 | |
| Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 28, 2025 | |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 24, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 4, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 12, 2029 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Nov 30, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 12, 2019 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 16, 2022 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP) |
LEQVIO (SOLUTION) (SUBCUTANEOUS) INCLISIRAN SODIUM
NDA Applicant: NOVARTIS NDA No.: 214012 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 10669544 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Mar 8, 2024 | |
| Pat. No. 11530408 DS* Therapeutic compositions Claim Types: Composition Pat. Sub. Date(s): 001: Jan 18, 2023 | May 18, 2024 | |
| Pat. No. 8809292 DS* DP* Compositions and methods for inhibiting expression of the PCSK9 gene Claim Types: Compound; Composition; Cell; Vector; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | May 10, 2027 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 8222222 Compositions and methods for inhibiting expression of the PCSK9 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 29, 2027 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 24, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 9370582 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 4, 2028 | |
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Dec 12, 2029 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10125369 DS* DP* PCSK9 iRNA compositions and methods of use thereof Claim Types: Compound; Composition; Cell; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 18, 2034 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Pat. No. 10851377 Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 25, 2036 | U-3652: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH), by inhibiting expression of the PCSK9 gene |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 22, 2026 |
ULORIC (TABLET) (ORAL) FEBUXOSTAT [GENERIC AB]
Drug Classes: xanthine oxidase inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021856 Prod. No.: 001 RX (40MG); 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7361676 DP* Solid preparation containing single crystal form Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 8, 2024 | |
| Pat. No. 8372872 Methods for concomitant treatment of theophylline and febuxostat Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 26, 2013; 002: None | Sep 8, 2031 | U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline |
| Pat. No. 9107912 Methods for concomitant treatment of theophylline and febuxostat Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2015 | Sep 8, 2031 | U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline |
LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 206162 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Mar 12, 2024 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 12, 2027 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 8247416 DS* Phthalazinone derivative Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 24, 2028 | |
| 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): 001: Jan 15, 2015 | Aug 4, 2031 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 208558 Prod. No.: 001 RX (100MG); 002 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 12, 2024 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 9169235 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Mar 12, 2024 | U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone |
| Pat. No. 9566276 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2020 | Mar 12, 2024 | U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Aug 12, 2027 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 12, 2027 | U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Sep 8, 2027 | |
| Pat. No. 11633396 DP* Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 19, 2023 | Oct 7, 2029 | |
| Pat. No. 11975001 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 3, 2024 | Oct 7, 2029 | |
| Pat. No. 12048695 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 23, 2024 | Oct 7, 2029 | |
| Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Dec 31, 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 15, 2017 | Aug 4, 2031 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Pat. No. 11970530 Methods of treating homologous recombination deficient cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 28, 2024 | Oct 25, 2041 | U-3929: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of advanced epithelial ovarian cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status U-3930: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of fallopian tube cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status U-3931: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 11, 2025 | I-885: For the adjuvant treatment of adult patients with deleterious or suspected deleterious GBRCA mutated HER2-negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy |
| Exclusivity Code: I - New Indication | May 31, 2026 | I-914: In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAM) metastatic castration-resistant prostate cancer (MCRPC) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2025 | ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 27, 2026 | ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 8, 2027 | ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability |
SINUVA (IMPLANT) (IMPLANTATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: INTERSECT ENT INC NDA No.: 209310 Prod. No.: 001 RX (1.35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7662141 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7713255 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7951130 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7951131 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7951133 Sinus delivery of sustained release therapeutics Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 8109918 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Mar 12, 2024 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 9585681 Device and methods for treating paranasal sinus conditions Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Apr 4, 2026 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7544192 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Nov 29, 2026 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 8025635 DP* Device and methods for treating paranasal sinus conditions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 26, 2018 | Jun 12, 2027 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 10357640 Expandable devices and methods for treating a nasal or sinus condition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2019 | Oct 3, 2031 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 8763222 DP* Methods and devices for crimping self-expanding devices Claim Types: Device Pat. Sub. Date(s): 001: Apr 26, 2018 | Feb 8, 2032 | |
| Pat. No. 10406332 DP* Systems, devices, and method for treating a sinus condition Claim Types: Device Pat. Sub. Date(s): 001: Dec 6, 2019 | Mar 13, 2034 | |
| Pat. No. 10232152 DP* Systems, devices, and method for treating a sinus condition Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 6, 2019 | Nov 24, 2034 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
TIROSINT (CAPSULE) (ORAL) LEVOTHYROXINE SODIUM
Drug Classes: L-thyroxine (T4)
NDA Applicant: IBSA NDA No.: 021924 Prod. No.: 002 RX (0.025MG); 003 RX (0.05MG); 004 RX (0.075MG); 005 RX (0.1MG); 006 RX (0.125MG); 007 RX (0.15MG); 008 RX (0.112MG); 009 RX (0.137MG); 010 RX (0.088MG); 011 RX (0.175MG); 012 RX (0.2MG); 013 RX (0.013MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7691411 DP* Pharmaceutical formulae for thyroid hormones and procedures for obtaining them Claim Types: Formulation Pat. Sub. Date(s): 002: Sep 15, 2016; 003: Sep 15, 2016; 004: Sep 15, 2016; 005: Sep 15, 2016; 006: Sep 15, 2016; 007: Sep 15, 2016; 008: Sep 15, 2016; 009: Sep 15, 2016; 010: Sep 15, 2016; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: Sep 15, 2016 | Mar 14, 2024 | |
| Pat. No. 7723390 DP* Pharmaceutical formulations for thyroid hormones Claim Types: Formulation Pat. Sub. Date(s): 002: May 27, 2010; 003: May 27, 2010; 004: May 27, 2010; 005: May 27, 2010; 006: May 27, 2010; 007: May 27, 2010; 008: May 27, 2010; 009: May 27, 2010; 010: May 27, 2010; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: May 27, 2010 | Mar 14, 2024 |
VELTASSA (POWDER) (ORAL) PATIROMER SORBITEX CALCIUM
Drug Classes: potassium binder
NDA Applicant: VIFOR PHARMA NDA No.: 205739 Prod. No.: 001 RX (EQ 8.4GM BASE/PACKET); 002 RX (EQ 16.8GM BASE/PACKET) NDA No.: 205739 Prod. No.: 003 DISC (EQ 25.2GM BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8287847 Ion binding polymers and uses thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8475780 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8778324 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8889115 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 10485821 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2019 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 7556799 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Feb 27, 2025 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8216560 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Mar 14, 2027 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8282913 DP* Ion binding polymers and uses thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Nov 18, 2015 | May 29, 2027 | |
| Pat. No. 8147873 DP* Methods and compositions for treatment of ion imbalances Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 18, 2015 | Jun 20, 2028 | |
| Pat. No. 8337824 DS* Linear polyol stabilized polyfluoroacrylate compositions Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: Nov 18, 2015 | May 29, 2030 | U-1766: Treatment of hyperkalemia |
| Pat. No. 9492476 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 13, 2016 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Pat. No. 9925212 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 20, 2018 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Pat. No. 11123363 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 21, 2021 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Oct 2, 2026 |
VELTASSA (POWDER) (ORAL) PATIROMER SORBITEX CALCIUM
Drug Classes: potassium binder
NDA Applicant: VIFOR PHARMA NDA No.: 205739 Prod. No.: 004 RX (EQ 1GM BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8287847 Ion binding polymers and uses thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8475780 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8778324 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8889115 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 10485821 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 30, 2024 | U-1766: Treatment of hyperkalemia |
| Pat. No. 7556799 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Feb 27, 2025 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8216560 Ion binding polymers and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Mar 14, 2027 | U-1766: Treatment of hyperkalemia |
| Pat. No. 8282913 DP* Ion binding polymers and uses thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 004: Oct 31, 2023 | May 29, 2027 | |
| Pat. No. 8147873 DP* Methods and compositions for treatment of ion imbalances Claim Types: Formulation Pat. Sub. Date(s): 004: Oct 31, 2023 | Jun 20, 2028 | |
| Pat. No. 8337824 DS* Linear polyol stabilized polyfluoroacrylate compositions Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 004: Oct 31, 2023 | May 29, 2030 | U-1766: Treatment of hyperkalemia |
| Pat. No. 9492476 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Pat. No. 9925212 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Pat. No. 11123363 Potassium-binding agents for treating hypertension and hyperkalemia Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 31, 2023 | Oct 8, 2033 | U-1766: Treatment of hyperkalemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Oct 2, 2026 |
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: THE MEDICINES CO NDA No.: 021338 Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: None | Apr 1, 2024 | |
| Pat. No. 8301238 DP* Two-part electrotransport device Claim Types: Device Pat. Sub. Date(s): 001: None | Sep 30, 2031 | |
| Pat. No. 9364656 Method of storing an electrotransport drug delivery device Claim Types: Process Pat. Sub. Date(s): 001: Jun 21, 2016 | Sep 30, 2031 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9731121 DP* Switch validation circuit and method Claim Types: Device Pat. Sub. Date(s): 001: Sep 12, 2017 | Oct 17, 2031 | |
| Pat. No. 8781571 DP* Switch validation circuit and method Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 001: May 28, 2015 | Mar 31, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8428708 Self-test for analgesic product Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: None | May 21, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8428709 DP* Current control for electrotransport drug delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: May 28, 2015 | Jun 11, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9095706 DP* Self-test for analgesic product Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 3, 2033 |
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist == opioid antagonist
NDA Applicant: INDIVIOR NDA No.: 022410 Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 3, 2024 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9687454 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2017 | Aug 7, 2029 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 11135216 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Aug 7, 2029 | U-3111: Treating opioid use disorder |
| Pat. No. 8475832 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None | Mar 26, 2030 | U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence |
DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse == human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MERCK SHARP DOHME NDA No.: 206510 Prod. No.: 001 DISC (150MG;EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 4, 2015 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 4, 2015 | Sep 11, 2029 *PED | U-1663: Treatment of HIV-1 infection |
ISENTRESS (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MSD SUB MERCK NDA No.: 022145 Prod. No.: 001 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: None | Apr 3, 2024 *PED | |
| Pat. No. 8852632 DS* DP* Pharmaceutical formulation containing a release rate controlling composition Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 27, 2023 | Jan 28, 2028 | U-257: Treatment of HIV infection |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MSD SUB MERCK NDA No.: 203045 Prod. No.: 001 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 20, 2012 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 20, 2012 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MSD SUB MERCK NDA No.: 203045 Prod. No.: 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 002: None | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MSD SUB MERCK NDA No.: 205786 Prod. No.: 001 RX (EQ 100MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 16, 2014 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 16, 2014 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
ISENTRESS HD (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MSD SUB MERCK NDA No.: 022145 Prod. No.: 002 RX (EQ 600MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 3, 2024 *PED | |
| Pat. No. 7754731 DS* DP* Potassium salt of an HIV integrase inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 002: Jun 23, 2017 | Sep 11, 2029 *PED | U-257: Treatment of HIV infection |
| Pat. No. 8771733 DS* DP* Pharmaceutical composition containing an anti-nucleating agent Claim Types: Formulation; Process; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 27, 2023 | Jun 2, 2030 | U-257: Treatment of HIV infection |
| Pat. No. 9649311 DP* Solid pharmaceutical compositions containing an integrase inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 23, 2017 | Apr 21, 2031 *PED | |
| Pat. No. 10772888 Solid pharmaceutical compositions containing an integrase inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 27, 2020 | Mar 30, 2032 | U-1663: Treatment of HIV-1 infection |
ORACEA (CAPSULE) (ORAL) DOXYCYCLINE [GENERIC AB]
NDA Applicant: GALDERMA LABS LP NDA No.: 050805 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394405 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8394406 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8470364 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 26, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8709478 Once daily formulations of tetracyclines Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2014 | Apr 7, 2024 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8206740 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 24, 2025 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 7749532 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 19, 2027 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC NDA No.: 207356 Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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. 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. 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. 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. 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. 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. 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 |
| Pat. No. 12016873 Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2024 | 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 |
RELISTOR (SOLUTION) (SUBCUTANEOUS) METHYLNALTREXONE BROMIDE [Has competitive generic]
Drug Classes: opioid antagonist
NDA Applicant: SALIX PHARMS NDA No.: 021964 Prod. No.: 001 RX (12MG/0.6ML (12MG/0.6ML)); 002 RX (8MG/0.4ML (8MG/0.4ML)); 003 RX (12MG/0.6ML (12MG/0.6ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8552025 DP* Stable methylnaltrexone preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 22, 2013 | Apr 8, 2024 | |
| Pat. No. 9669096 DP* Stable pharmaceutical formulations of methylnaltrexone Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2017 | Apr 8, 2024 | |
| Pat. No. 10376584 DP* Stable pharmaceutical formulations of methylnaltrexone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 10, 2019 | Apr 8, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8420663 Peripheral opioid receptor antagonists and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 24, 2013; 002: None; 003: None | Sep 30, 2029 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8822490 DP* Peripheral opioid receptor antagonists and uses thereof Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): All strengths: Sep 22, 2014 | Sep 30, 2029 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 9180125 DP* Peripheral opioid receptor antagonists and uses thereof Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: Nov 20, 2015 | Sep 30, 2029 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 9492445 DP* Peripheral opioid receptor antagonists and uses thereof Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Aug 30, 2017 | Sep 30, 2029 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8247425 Peripheral opioid receptor antagonists and uses thereof Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): 001: Sep 13, 2012; 002: None; 003: None | Dec 31, 2030 | U-1185: Treatment of opioid-induced constipation |
MAVENCLAD (TABLET) (ORAL) CLADRIBINE
Drug Classes: purine antimetabolite
NDA Applicant: EMD SERONO INC NDA No.: 022561 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888328 DP* Oral formulations of cladribine Claim Types: Formulation; Product-by-process; Method of improving a treatment; Method of use; Process Pat. Sub. Date(s): 001: May 28, 2019 | Apr 11, 2024 | U-2521: Treatment of MS with a tablet with an admixture of (a) an amorphous inclusion complex of cladribine and hydroxypropyl-b-cyclodextrin and (b) amorphous free cladribine and cyclodextrin as a non-inclusion complex, cladribine/cyclodextrin 1:10-1:16 w/w |
| Pat. No. 8785415 DP* Oral formulations of cladribine Claim Types: Formulation; Process; Product-by-process; Method of use Pat. Sub. Date(s): 001: May 28, 2019 | Apr 11, 2024 | U-2523: Treatment of MS with an admixture of (a) an amorphous inclusion complex of cladribine (2CDA) and cyclodextrin and (b) amorphous free 2CDA and cyclodextrin as a non-inclusion complex, formulated as a solid oral form, w/o sign. amounts of cryst. 2CDA |
| Pat. No. 8377903 Cladribine regimen for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2019 | May 31, 2026 | U-2522: Treating RRMS or SPMS with oral cladribine: (i) 2-4 months induction with 1.7 mg/kg - 3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) 2-4 months maintenance with about 1.7 mg/kg cladribine; (iv) cladribine-free period |
| Pat. No. 7713947 Cladribine regimen for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2019 | Oct 16, 2026 | U-2520: Treating MS with oral cladribine acc. to the steps (i) induction period with about 1.7 mg/kg-3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) maintenance period with about 1.7 mg/kg cladribine; (iv) cladribine-free period |
| Pat. No. 10849919 Cladribine regimen for treating progressive forms of multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 9, 2022 | Nov 23, 2038 | U-3411: Treating non-early SPMS by administering oral cladribine at a fixed dose per patient, per body weight and per treatment year, which fixed dose is 1.75 +/- 0.2 mg/kg, to be administered within months 1 and 2 in each of 2 adjacent treatment years |
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 001 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238076 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Apr 15, 2024 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8431685 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7456254 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Dec 30, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Apr 4, 2026 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4 U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4 |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Sep 21, 2028 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2014 | Feb 19, 2029 *PED | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Feb 5, 2014 | Jun 16, 2030 *PED | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 001: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2014 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 30, 2024 | I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2026 PED | M-298: Labeling revisions related to study D1699CC00001 |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238076 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 15, 2024 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8431685 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 13, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7456254 Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 30, 2025 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Apr 4, 2026 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4 U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4 |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Feb 18, 2027 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 5, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Sep 21, 2028 *PED | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 2, 2014 | Sep 21, 2028 *PED | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 5, 2014 | Feb 19, 2029 *PED | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Feb 5, 2014 | Jun 16, 2030 *PED | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 25, 2014 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Pat. No. 11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 19, 2023 | Jan 18, 2040 *PED | U-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes |
| Pat. No. 10973836 Methods of treating heart failure with reduced ejection fraction Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Apr 21, 2021 | Sep 9, 2040 *PED | U-3127: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without Type II diabetes |
| Pat. No. 11903955 Methods of treating heart failure with reduced ejection fraction Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 13, 2024 | Sep 9, 2040 *PED | U-3825: Reduce the risk of cardiovascular death and worsening heart failure in adults with heart failure with reduced ejection fraction, without type ii diabetes, and having an HBA1C of < 5.7% |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 30, 2024 | I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2026 PED | M-298: Labeling revisions related to study D1699CC00001 |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022287 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8722084 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Apr 15, 2024 *PED | |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Apr 15, 2024 *PED | U-1552: For healing of all grades of erosive esophagitis (EE) U-1553: To maintain healing of EE and relief of heartburn U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD) |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 1, 2015 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 17, 2026 *PED | |
| Pat. No. 7790755 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None | Feb 2, 2027 *PED | |
| Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None | Mar 27, 2027 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jan 11, 2028 | |
| Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None | Sep 17, 2030 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Mar 5, 2032 | U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions |
DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208056 Prod. No.: 001 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Apr 15, 2024 *PED | |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 17, 2026 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 11, 2028 *PED | |
| Pat. No. 9241910 DP* Orally-disintegrating solid preparation Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 10, 2029 |
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 DISC (5MG); 002 DISC (10MG); 003 DISC (15MG); 004 DISC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 31, 2019 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 9, 2021 | Mar 10, 2037 | |
| Pat. No. 11896562 Oral amphetamine composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2024 | Mar 10, 2037 | U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients |
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 005 DISC (2.5MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Jul 7, 2021 | Mar 10, 2037 | |
| Pat. No. 11160772 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 005: Dec 9, 2021 | Mar 10, 2037 |
XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC NDA No.: 209022 Prod. No.: 001 RX (0.093MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8522778 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: None | Apr 20, 2024 | |
| Pat. No. 7975690 Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2017 | Dec 29, 2025 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 6, 2018 | Mar 6, 2027 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 11602603 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 5, 2023 | Oct 27, 2028 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Oct 22, 2029 | |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Dec 6, 2030 | |
| Pat. No. 10252010 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: May 8, 2019 | Feb 7, 2031 | |
| Pat. No. 12083270 Delivery device and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 2, 2024 | Apr 4, 2031 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 11033696 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Jul 6, 2021 | May 20, 2033 | |
| Pat. No. 10179216 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Feb 8, 2019 | Jul 8, 2033 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10478574 Nasal administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 10, 2019 | Nov 4, 2033 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 | |
| Pat. No. 10300229 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 18, 2019 | Jul 7, 2035 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 11554229 Nasal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2023 | Feb 23, 2036 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 15, 2027 | I-940: Treatment of chronic rhinosinusitis without nasal polyps (CRSSNP) in adults |
CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone == opioid antagonist
NDA Applicant: NALPROPION NDA No.: 200063 Prod. No.: 001 RX (90MG;8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11278544 Compositions for affecting weight loss Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2022 | Apr 21, 2024 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 7462626 Compositions for affecting weight loss Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Jul 20, 2024 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Jul 20, 2024 | U-1586: For effect on blood glucose parameters in patients with insulin resistance |
| Pat. No. 7375111 DP* Compositions for affecting weight loss Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 6, 2014 | Mar 26, 2025 | |
| Pat. No. 9107837 Sustained release formulation of naltrexone Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2015 | Jun 4, 2027 | U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity |
| Pat. No. 8318788 Layered pharmaceutical formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Nov 8, 2027 | U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss |
| Pat. No. 8722085 Methods for administering weight loss medications Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Oct 6, 2014 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 9125868 Methods for administering weight loss medications Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 15, 2015 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 10307376 Methods for administering weight loss medications Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 17, 2019 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 12048769 Methods for administering weight loss medications Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 19, 2024 | Nov 8, 2027 | U-1585: Use of naltrexone and bupropion based on an escalating dose schedule |
| Pat. No. 8088786 DP* Layered pharmaceutical formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 6, 2014 | Feb 3, 2029 | |
| Pat. No. 11324741 Methods for treating visceral fat conditions Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2022 | May 29, 2029 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 8916195 Sustained release formulation of naltrexone Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 20, 2015 | Feb 2, 2030 | U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity |
| Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 22, 2021 | Jan 10, 2031 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 17, 2016 | Jan 13, 2032 | U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder |
| Pat. No. 10403170 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 5, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11139056 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 5, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 9633575 Methods of treating overweight and obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 29, 2021 | Jun 25, 2033 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2019 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 14, 2020 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 14, 2020 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
| Pat. No. 11998542 Compositions and methods for reducing major adverse cardiovascular events Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 5, 2024 | Jul 2, 2034 | U-1583: For chronic weight management for treating overweight or obesity |
MEGACE ES (SUSPENSION) (ORAL) MEGESTROL ACETATE [GENERIC AB]
Drug Classes: progestin
NDA Applicant: ENDO OPERATIONS NDA No.: 021778 Prod. No.: 001 RX (125MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7101576 Nanoparticulate megestrol formulations Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 22, 2024 | U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids) |
| Pat. No. 9040088 Nanoparticulate megestrol formulations Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 11, 2015 | Apr 22, 2024 | U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids) |
| Pat. No. 9101540 DP* Nanoparticulate megestrol formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 13, 2015 | Apr 22, 2024 | U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids) |
| Pat. No. 9101549 Nanoparticulate megestrol formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 13, 2015 | Apr 22, 2024 | U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids) |
| Pat. No. 9107827 Nanoparticulate megestrol formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2015 | Apr 22, 2024 | U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids) |
SOOLANTRA (CREAM) (TOPICAL) IVERMECTIN [GENERIC AB]
Drug Classes: antiparasitic == pediculicide
NDA Applicant: GALDERMA LABS LP NDA No.: 206255 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7550440 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 8080530 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 8093219 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 8415311 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 8470788 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 8815816 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Jan 20, 2015 | Apr 22, 2024 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 11033565 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 22, 2021 | Apr 22, 2024 | |
| Pat. No. 9089587 Treatment of papulopustular rosacea with ivermectin Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2015 | Mar 13, 2034 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 9233117 Treatment of inflammatory lesions of rosacea with ivermectin Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2016 | Mar 13, 2034 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 9233118 Treatment of papulopustular rosacea with ivermectin Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2016 | Mar 13, 2034 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 9782425 Treatment of papulopustular rosacea with ivermectin Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 5, 2018 | Mar 13, 2034 | U-1631: Treatment of inflammatory lesions of rosacea. |
| Pat. No. 10206939 Treatment of papulopustular rosacea with ivermectin Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 19, 2019 | Mar 13, 2034 | U-1631: Treatment of inflammatory lesions of rosacea. |
ONZETRA XSAIL (POWDER) (NASAL) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 206099 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9119932 DP* Nasal delivery device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 23, 2024 | |
| Pat. No. 7975690 DP* Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 8590530 DP* Nasal delivery devices Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9108015 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | |
| Pat. No. 11571531 Powder delivery devices Claim Types: Method of administration Pat. Sub. Date(s): 001: May 19, 2023 | Feb 23, 2026 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 10, 2018 | Mar 6, 2027 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 10398859 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Sep 30, 2019 | Dec 19, 2027 | |
| Pat. No. 8875704 DP* Nasal administration Claim Types: Device; Method of use; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 7, 2028 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10722667 DP* Nasal administration Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 | Dec 30, 2028 | |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 22, 2029 | |
| Pat. No. 8899229 DP* Powder delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2030 | |
| Pat. No. 9649456 DP* Nasal administration Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: May 26, 2017 | Oct 21, 2030 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Dec 6, 2030 | |
| Pat. No. 10478574 Nasal administration Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 9, 2019 | Nov 4, 2033 | U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE
Drug Classes: corticosteroid
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 001 DISC (1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309124 Delayed release tablet with defined core geometry Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 13, 2012 | Apr 23, 2024 | U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet |
| Pat. No. 8394407 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 12, 2013 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9040085 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9186332 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2016 | Aug 3, 2027 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE
Drug Classes: corticosteroid
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 002 DISC (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309124 Delayed release tablet with defined core geometry Claim Types: Method of administration Pat. Sub. Date(s): 002: None | Apr 23, 2024 | |
| Pat. No. 8394407 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 002: None | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9040085 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 25, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9186332 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 4, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 7, 2016 | Aug 3, 2027 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE
Drug Classes: corticosteroid
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 003 DISC (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309124 Delayed release tablet with defined core geometry Claim Types: Method of administration Pat. Sub. Date(s): 003: None | Apr 23, 2024 | U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet |
| Pat. No. 8394407 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 003: None | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9040085 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 003: Jun 25, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9186332 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 4, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 7, 2016 | Aug 3, 2027 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 8168218 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Aug 22, 2012 | Jan 7, 2028 | U-1269: Treatment of rheumatologic, allergic, pulmonary, gastrointestinal, dermatologic diseases or conditions by the use of a delayed release 5mg prednisone tablet |
PROBUPHINE (IMPLANT) (IMPLANTATION) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: partial opioid agonist
NDA Applicant: REACX PHARMS NDA No.: 204442 Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7736665 Implantable polymeric device for sustained release of buprenorphine Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2016 | Apr 25, 2024 | U-1878: For opioid dependence |
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 211911 Prod. No.: 001 RX (10MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 30, 2024 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Feb 19, 2025 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 | |
| Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 | |
| Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 7, 2027 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Device; Product-by-process Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 24, 2029 | |
| Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 24, 2020 | Jul 15, 2031 | |
| Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof Claim Types: Device; Method of use; Process Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | |
| Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 202611 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 16, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 17, 2018 | Apr 30, 2029 *PED | U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 12059409 DP* Claim Types: Pat. Sub. Date(s): All strengths: Aug 28, 2024 | Sep 28, 2029 | |
| Pat. No. 12097189 Pharmaceutical composition for modified release Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 2, 2024 | Sep 28, 2029 | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Pat. No. 10842780 DP* Pharmaceutical composition for modified release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2020 | Mar 28, 2030 *PED | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Pat. No. 11707451 Pharmaceutical composition for modified release Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 21, 2023 | Mar 28, 2030 *PED | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 25, 2024 PED | I-855: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kilograms or more |
MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 213801 Prod. No.: 001 RX (8MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 22, 2021 | Sep 30, 2036 *PED | U-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 25, 2024 PED |
DUAVEE (TABLET) (ORAL) BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Drug Classes: estrogen agonist/antagonist
NDA Applicant: WYETH PHARMS NDA No.: 022247 Prod. No.: 001 RX (EQ 20MG BASE;0.45MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6479535 DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 31, 2013 | May 6, 2024 | U-594: Prevention of postmenopausal osteoporosis U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause |
| Pat. No. 7683051 DS* DP* Crystalline polymorph of bazedoxifene acetate Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process; Product-by-process Pat. Sub. Date(s): 001: Oct 31, 2013 | Mar 10, 2027 | U-594: Prevention of postmenopausal osteoporosis U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause |
OMONTYS PRESERVATIVE FREE (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) PEGINESATIDE ACETATE
Drug Classes: erythropoiesis-stimulating agent (ESA)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 202799 Prod. No.: 001 DISC (EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)); 002 DISC (EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)); 003 DISC (EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)); 004 DISC (EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)); 005 DISC (EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)); 006 DISC (EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)); 007 DISC (EQ 10MG BASE/ML (EQ 10MG BASE/ML)); 008 DISC (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7084245 DS* DP* Peptides that bind to the erythropoietin receptor Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | May 12, 2024 | U-1238: Treatment of anemia due to chronic kidney disease |
| Pat. No. 7414105 DS* DP* Peptides that bind to the erythropoietin receptor Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | May 12, 2024 | U-1238: Treatment of anemia due to chronic kidney disease |
| Pat. No. 7528104 DS* DP* Peptides that bind to the erythropoietin receptor Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | May 12, 2024 | |
| Pat. No. 7919118 DS* DP* Spacer moiety for poly (ethylene glycol) modified peptide based compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | May 12, 2024 | |
| Pat. No. 7550433 Erythropoietin receptor peptide formulations and uses Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | Jun 2, 2026 | U-1238: Treatment of anemia due to chronic kidney disease |
| Pat. No. 7919461 Erythropoietin receptor peptide formulations and uses Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | Jun 2, 2026 | U-1238: Treatment of anemia due to chronic kidney disease |
ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE NDA No.: 209936 Prod. No.: 001 DISC (60MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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: 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 |
NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: AZURITY NDA No.: 203340 Prod. No.: 002 RX (6MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8517997 DP* Dispenser for medicaments and method and apparatus for making same Claim Types: Device Pat. Sub. Date(s): 002: Jul 8, 2020 | May 14, 2024 | |
| Pat. No. 10342787 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 10576070 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 8, 2020 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11207306 Non-aqueous liquid nimodipine compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11413277 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment Pat. Sub. Date(s): 002: Aug 25, 2022 | Apr 16, 2038 | U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms |
| Pat. No. 11806338 DP* Non-aqueous liquid nimodipine compositions Claim Types: Formulation claimed by its inherent performace characteristics; Device Pat. Sub. Date(s): 002: Nov 17, 2023 | Apr 16, 2038 |
EQUETRO (CAPSULE, EXTENDED RELEASE) (ORAL) CARBAMAZEPINE [Has competitive generic]
Drug Classes: mood stabilizer
NDA Applicant: VALIDUS PHARMS NDA No.: 021710 Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6977253 Methods for the treatment of bipolar disorder using carbamazepine Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 19, 2024 | U-693: The recommended initial dose of EQUETRO is 400mg/day given in divided doses, twice daily. The dose should be adjusted in 200mg daily increments to achieve optimal clinical response. |
ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
NDA Applicant: SHIONOGI INC NDA No.: 022129 Prod. No.: 001 DISC (5%**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7294342 Ectoparasite asphyxiator compositions and methods for their application Claim Types: Method of use Pat. Sub. Date(s): 001: None | May 19, 2024 | U-970: Topical treatment of lice infestations |
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 | |
| Pat. No. 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. 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 |
VIZAMYL (INJECTABLE) (INTRAVENOUS) FLUTEMETAMOL F-18
NDA Applicant: GE HEALTHCARE NDA No.: 203137 Prod. No.: 002 RX (121.5mCi/30ML (4.05mCi/ML)) NDA No.: 203137 Prod. No.: 001 DISC (40.5mCi/10ML (4.05mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8236282 DS* DP* Benzothiazole derivative compounds, compositions and uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 25, 2013; 002: None | May 21, 2024 | |
| Pat. No. 7270800 DS* DP* Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Mar 28, 2014 | Sep 3, 2025 | U-336: Diagnostic radioimaging |
| Pat. No. 8916131 DP* Radiopharmaceutical composition Claim Types: Composition Pat. Sub. Date(s): All strengths: Feb 18, 2015 | Sep 16, 2028 |
PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209939 Prod. No.: 001 RX (240MG); 002 RX (480MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 7, 2017 | May 22, 2024 | |
| Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 21, 2020 | Jan 18, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Aug 2, 2026 | D-189: Extension of letermovir dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease |
| Exclusivity Code: I - New Indication | Jun 5, 2026 | I-916: Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) |
| Exclusivity Code: NPP - New patient population | Aug 30, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 8, 2024 | ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 5, 2030 | ODE-423: For prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 30, 2031 | ODE-495: Prophylaxis of cytomegalovirus (CMV) disease in pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [d+/r-]) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 30, 2031 | ODE-497: Prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209940 Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 7, 2017 | May 22, 2024 | |
| Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 29, 2020 | Jan 18, 2029 | |
| Pat. No. 10603384 DP* Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative Claim Types: Formulation; Product-by-process; Process; Method of use Pat. Sub. Date(s): All strengths: Apr 29, 2020 | Feb 28, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Aug 2, 2026 | D-189: Extension of letermovir dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease |
| Exclusivity Code: I - New Indication | Jun 5, 2026 | I-916: Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) |
| Exclusivity Code: NPP - New patient population | Aug 30, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 8, 2024 | ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 5, 2030 | ODE-423: For prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 30, 2031 | ODE-495: Prophylaxis of cytomegalovirus (CMV) disease in pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [d+/r-]) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 30, 2031 | ODE-497: Prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
NAROPIN (SOLUTION) (INJECTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA NDA No.: 020533 Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | May 23, 2024 | |
| Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Oct 18, 2025 | |
| Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 6, 2014 | Nov 28, 2026 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2019 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 27, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 002 RX (4MG/3ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Sep 24, 2020 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Dec 21, 2020 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 003 RX (8MG/3ML (2.68MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Apr 29, 2022 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Oct 7, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 003: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Mar 20, 2026 | U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 29, 2022 | Dec 5, 2031 | U-3355: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 003: Apr 29, 2022 | Feb 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Mar 28, 2025 | D-185: Addition of a 3rd maintenance dose of semaglutide |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 004 RX (2MG/3ML (0.68MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 004: Nov 14, 2022 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Oct 20, 2025 | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Mar 20, 2026 | U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Dec 5, 2031 | U-3469: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 004: Nov 14, 2022 | Feb 1, 2032 | |
| Pat. No. 10335462 DP* Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 004: Nov 14, 2022 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 203496 Prod. No.: 001 RX (EQ 0.125MG BASE); 005 RX (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jan 13, 2014; 005: Feb 9, 2017 | May 24, 2024 | |
| Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Jun 17, 2015; 005: Feb 9, 2017 | May 24, 2024 | |
| Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 8, 2016; 005: Feb 9, 2017 | May 24, 2024 | U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1). |
| Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Composition Pat. Sub. Date(s): 001: Aug 23, 2016; 005: Feb 9, 2017 | May 24, 2024 | |
| Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Jul 14, 2024 | U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1). |
| Pat. No. 9393203 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2016; 005: Feb 9, 2017 | Apr 27, 2026 | U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil |
| Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Jul 30, 2026 | |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Mar 14, 2017 | Dec 15, 2028 | |
| Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Mar 28, 2017 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 15, 2023 | Dec 15, 2028 | |
| Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Formulation; Method of use; Composition Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Feb 13, 2030 | |
| Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs Claim Types: Drug in a container; Process Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Jan 22, 2031 | |
| Pat. No. 8747897 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 13, 2014; 005: Feb 9, 2017 | Aug 11, 2031 | U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2026 | ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 203496 Prod. No.: 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 13, 2014 | May 24, 2024 | |
| Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jun 17, 2015 | May 24, 2024 | |
| Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2016 | May 24, 2024 | U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1). |
| Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Composition Pat. Sub. Date(s): All strengths: Aug 23, 2016 | May 24, 2024 | |
| Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jul 14, 2024 | U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1). |
| Pat. No. 9393203 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2016 | Apr 27, 2026 | U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil |
| Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jul 30, 2026 | |
| Pat. No. 8497393 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Dec 15, 2028 | |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Mar 14, 2017 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 15, 2023 | Dec 15, 2028 | |
| Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Formulation; Method of use; Composition Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Feb 13, 2030 | |
| Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs Claim Types: Drug in a container; Process Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jan 22, 2031 | |
| Pat. No. 8747897 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2014 | Aug 11, 2031 | U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2026 | ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
REMODULIN (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS; IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 021272 Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 2, 2015; 002: Dec 2, 2015; 003: Dec 2, 2015; 004: Dec 2, 2015; 005: Aug 24, 2021 | May 24, 2024 | U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration |
| Pat. No. 9713599 Parenteral formulations of treprostinil Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 25, 2017; 002: Jul 25, 2017; 003: Jul 25, 2017; 004: Jul 25, 2017; 005: Aug 24, 2021 | Dec 16, 2024 | U-2036: A method of treating pulmonary hypertension comprising parenterally administering a formulation comprising a) 0.1 to 5% w/v of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer |
| Pat. No. 10076505 DP* Inhalation formulations of Treprostinil Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 1, 2018; 002: Oct 1, 2018; 003: Oct 1, 2018; 004: Oct 1, 2018; 005: Aug 24, 2021 | Dec 16, 2024 | |
| Pat. No. 10695308 Inhalation formulations of treprostinil Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2020; 002: Jul 8, 2020; 003: Jul 8, 2020; 004: Jul 8, 2020; 005: Aug 24, 2021 | Dec 16, 2024 | U-2845: A method of treating a human patient suffering from pulmonary hypertension |
| Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 18, 2014; 002: Feb 18, 2014; 003: Feb 18, 2014; 004: Feb 18, 2014; 005: Aug 24, 2021 | Sep 5, 2028 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
| Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 25, 2014; 002: Feb 25, 2014; 003: Feb 25, 2014; 004: Feb 25, 2014; 005: Aug 24, 2021 | Sep 5, 2028 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 14, 2017; 002: Mar 14, 2017; 003: Mar 14, 2017; 004: Mar 14, 2017; 005: Aug 24, 2021 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 15, 2023 | Dec 15, 2028 | |
| Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 23, 2011; 002: None; 003: None; 004: None; 005: Aug 24, 2021 | Mar 29, 2029 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS; INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 021272 Prod. No.: 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 20, 2023 | May 24, 2024 | U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration |
| Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 20, 2023 | Sep 5, 2028 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
| Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 20, 2023 | Sep 5, 2028 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Oct 20, 2023 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Oct 20, 2023 | Dec 15, 2028 | |
| Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Oct 20, 2023 | Mar 29, 2029 | U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration |
ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HALEON US HOLDINGS 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 |
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS 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 |
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE NDA No.: 022369 Prod. No.: 001 RX (0.03%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012 | May 25, 2024 | U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth |
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: GALDERMA LABS LP NDA No.: 204708 Prod. No.: 001 RX (EQ 0.33% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 27, 2014 | May 25, 2024 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Sep 13, 2013 | May 24, 2025 | |
| Pat. No. 8410102 Methods and compositions for treating or preventing erythema Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | May 24, 2025 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | May 24, 2025 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 7439241 Compounds, formulations, and methods for treating or preventing rosacea Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Aug 25, 2025 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8513247 DP* Methods and compositions for safe and effective treatment of erythema Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 25, 2031 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8513249 DP* Methods and compositions for safe and effective treatment of erythema Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 25, 2031 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 9861631 Methods and compositions for safe and effective treatment of erythema Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 25, 2018 | Mar 25, 2031 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 9861632 Methods and compositions for safe and effective treatment of erythema Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 25, 2018 | Mar 25, 2031 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8053427 DP* Brimonidine gel composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Jun 13, 2031 | U-1428: Topical treatment of facial erythema of rosacea |
| Pat. No. 8163725 DP* Gel compositions and methods of use Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Jun 13, 2031 | |
| Pat. No. 10201517 DP* Brimonidine gel compositions and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 13, 2019 | Jun 13, 2031 |
OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ZYLA NDA No.: 202080 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 18, 2016 | May 26, 2024 | |
| Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 14, 2011 | Mar 16, 2025 |
ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP NDA No.: 207620 Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation; Kit Pat. Sub. Date(s): All strengths: Aug 6, 2015 | May 27, 2024 *PED | |
| Pat. No. 8101659 DP* Methods of treatment and pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Jul 15, 2025 *PED | |
| Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 7, 2016 | May 8, 2027 *PED | U-1723: Treatment of heart failure |
| Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): All strengths: Aug 6, 2015 | Nov 27, 2027 *PED | |
| Pat. No. 9517226 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 9937143 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 16, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11135192 Inhibitors for treating diseases characterized by atrial enlargement or remodeling Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 18, 2021 | Aug 22, 2033 | U-3084: Treatment of heart failure with preserved ejection fraction |
| Pat. No. 11058667 Sacubitril-valsartan dosage regimen for treating heart failure Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Jul 13, 2021 | May 9, 2036 | U-3170: Treating chronic heart failure with reduced ejection fraction in patients not taking an ACE inhibitor or an ARB or previously taking low doses of these agents, by titrating up from half the usually recommended starting dose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 16, 2024 | M-82: Labeling revisions related to clinical studies |
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
| 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. 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 |
NUVIGIL (TABLET) (ORAL) ARMODAFINIL [GENERIC AB]
NDA Applicant: CEPHALON NDA No.: 021875 Prod. No.: 001 RX (50MG); 003 RX (150MG); 004 RX (250MG); 005 RX (200MG) NDA No.: 021875 Prod. No.: 002 DISC (100MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 29, 2024 *PED | |
| Pat. No. 7132570 DS* DP* Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: None | Jun 18, 2024 *PED |
PROVIGIL (TABLET) (ORAL) MODAFINIL [GENERIC AB]
Drug Classes: sympathomimetic-like agent
NDA Applicant: CEPHALON NDA No.: 020717 Prod. No.: 001 RX (100MG); 002 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | May 29, 2024 *PED |
ZONTIVITY (TABLET) (ORAL) VORAPAXAR SULFATE
Drug Classes: protease-activated receptor-1 (PAR-1) antagonist
NDA Applicant: KEY THERAP NDA No.: 204886 Prod. No.: 001 DISC (EQ 2.08MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7713999 DS* DP* Thrombin receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 14, 2018 | May 30, 2024 | U-2291: Reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD) |
| Pat. No. 7304078 DS* DP* Thrombin receptor antagonists Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jun 5, 2014 | Dec 23, 2027 | U-1512: Reduction of thrombotic cardiovascular events |
ILEVRO (SUSPENSION/DROPS) (OPHTHALMIC) NEPAFENAC
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HARROW EYE NDA No.: 203491 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947295 DP* Ophthalmic compositions containing a synergistic combination of two polymers Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 15, 2013 | Jun 8, 2024 | |
| Pat. No. 9662398 DP* Carboxylvinyl polymer-containing nanoparticle suspensions Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2017 | Dec 1, 2030 | |
| Pat. No. 8921337 DP* Carboxyvinyl polymer-containing nanoparticle suspensions Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 8, 2015 | Mar 31, 2032 |
ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL [GENERIC AB]
Drug Classes: microtubule inhibitor
NDA Applicant: BRISTOL-MYERS NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 |
| 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 |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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. 11476952 DP* Pharma-informatics system Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Apr 28, 2026 | |
| 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. 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. 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. 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. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| 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. 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. 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. 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. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| 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. 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. 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. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| 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. 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. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| 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. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| 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. 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. 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. 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. 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. 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. 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 |
TPOXX (CAPSULE) (ORAL) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES NDA No.: 208627 Prod. No.: 001 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Composition; Compound Pat. Sub. Date(s): 001: Aug 9, 2018 | Jun 18, 2024 | |
| Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2018 | Jul 23, 2027 | |
| Pat. No. 9339466 DS* DP* Polymorphic forms of ST-246 and methods of preparation Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 001: Aug 9, 2018 | Mar 23, 2031 | |
| Pat. No. 7737168 Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 9, 2018 | Sep 4, 2031 | U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg |
| Pat. No. 11890270 Polymorphic forms of ST-246 and methods of preparation Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 27, 2024 | Aug 8, 2032 | U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 13, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 13, 2025 | ODE-200: Indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg |
TPOXX (SOLUTION) (INTRAVENOUS) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES NDA No.: 214518 Prod. No.: 001 RX (200MG/20ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Composition; Compound Pat. Sub. Date(s): 001: Jun 10, 2022 | Jun 18, 2024 | |
| Pat. No. 8530509 DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Composition Pat. Sub. Date(s): 001: Jun 10, 2022 | Jun 18, 2024 | |
| Pat. No. 8802714 Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2022 | Jun 18, 2024 | U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg |
| Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2022 | Jul 23, 2027 | |
| Pat. No. 9233097 DP* ST-246 liquid formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2022 | Aug 2, 2031 | |
| Pat. No. 9907859 ST-246 liquid formulations and methods Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2022 | Aug 2, 2031 | U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg |
| Pat. No. 10576165 DP* ST-246 liquid formulations and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2022 | Aug 2, 2031 | |
| Pat. No. 7737168 Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2022 | Sep 4, 2031 | U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 13, 2023 |
XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: rifamycin antibacterial
NDA Applicant: SALIX PHARMS NDA No.: 021361 Prod. No.: 001 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7045620 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Jun 19, 2024 | |
| Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: None | Jun 19, 2024 | |
| Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Apr 7, 2011 | Jun 19, 2024 | |
| Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 8, 2012 | Jun 19, 2024 | |
| Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 8, 2012 | Jun 19, 2024 | |
| Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Oct 1, 2014 | Jun 19, 2024 | |
| Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition Pat. Sub. Date(s): 001: Nov 5, 2014 | Jun 19, 2024 | |
| Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 7, 2011 | Jun 1, 2025 | |
| Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Sep 16, 2013 | Feb 27, 2026 | |
| Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jul 11, 2014 | Feb 27, 2026 | U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence |
| Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Jun 8, 2016 | Feb 27, 2026 | |
| Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 14, 2020 | Feb 27, 2026 | U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older |
| Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jun 18, 2012 | Sep 2, 2027 | |
| Pat. No. 7928115 Methods of treating travelers diarrhea and hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2011 | Jul 24, 2029 | U-1121: Method of treating travelers' diarrhea |
XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: rifamycin antibacterial
NDA Applicant: SALIX PHARMS NDA No.: 021361 Prod. No.: 002 RX (550MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7045620 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: None | Jun 19, 2024 | |
| Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Apr 7, 2011 | Jun 19, 2024 | |
| Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation Pat. Sub. Date(s): 002: Apr 7, 2011 | Jun 19, 2024 | |
| Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 002: May 9, 2012 | Jun 19, 2024 | |
| Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: May 8, 2012 | Jun 19, 2024 | |
| Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 002: Oct 1, 2014 | Jun 19, 2024 | |
| Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition Pat. Sub. Date(s): 002: Nov 5, 2014 | Jun 19, 2024 | |
| Pat. No. 7915275 Use of polymorphic forms of rifaximin for medical preparations Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 18, 2015 | Feb 23, 2025 | U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof. U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. |
| Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Apr 7, 2011 | Jun 1, 2025 | |
| Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 002: Sep 16, 2013 | Feb 27, 2026 | |
| Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 002: Jul 11, 2014 | Feb 27, 2026 | U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof. U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. |
| Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 002: Jun 8, 2016 | Feb 27, 2026 | |
| Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 14, 2020 | Feb 27, 2026 | U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older |
| Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Jun 18, 2012 | Sep 2, 2027 | U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof. U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. |
| Pat. No. 10456384 Methods for treating irritable bowel syndrome (IBS) Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2019 | Feb 26, 2029 | U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older |
| Pat. No. 10765667 Methods for treating irritable bowel syndrome (IBS) Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 19, 2020 | Feb 26, 2029 | U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older |
| Pat. No. 11564912 Methods for treating irritable bowel syndrome (IBS) Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 2, 2023 | Feb 26, 2029 | U-3511: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult female subjects and symptoms thereof U-3512: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult female subjects |
| Pat. No. 11779571 Methods for treating irritable bowel syndrome (IBS) Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 23, 2023 | Feb 26, 2029 | U-3706: Treatment of bloating associated with diarrhea-predominant irritable bowel syndrome (IBS-D) in adult female subjects |
| Pat. No. 8309569 Methods for treating diarrhea-associated irritable bowel syndrome Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 18, 2015 | Jul 18, 2029 | U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof. U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults. |
| Pat. No. 8829017 Methods of treating traveler's diarrhea and hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2014 | Jul 24, 2029 | U-1562: Treatment of patients with hepatic encephalopathy (he) |
| Pat. No. 8946252 Methods of treating traveler's diarrhea and hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 3, 2015 | Jul 24, 2029 | U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence |
| Pat. No. 9421195 Methods of treating hepatic encephalopathy Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Oct 11, 2016 | Jul 24, 2029 | U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence |
| Pat. No. 9629828 Methods of treating traveler's diarrhea and hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 27, 2017 | Jul 24, 2029 | U-1994: Reduction in risk of overt hepatic encephalopathy (HE) in adults |
| Pat. No. 10314828 Methods of treating hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 1, 2019 | Jul 24, 2029 | U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence |
| Pat. No. 10335397 Methods of treating hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 24, 2019 | Jul 24, 2029 | U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode |
| Pat. No. 10709694 Methods of treating hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 23, 2020 | Jul 24, 2029 | U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode |
| Pat. No. 8642573 Methods of treating hepatic encephalopathy Claim Types: Method of administration Pat. Sub. Date(s): 002: None | Oct 2, 2029 | U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence |
| Pat. No. 8969398 Methods of treating hepatic encephalopathy Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 4, 2015 | Oct 2, 2029 | U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence |
MOVANTIK (TABLET) (ORAL) NALOXEGOL OXALATE
Drug Classes: opioid antagonist
NDA Applicant: VALINOR NDA No.: 204760 Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056500 DP* Polymer conjugates of opioid antagonists Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2015 | Jun 29, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8067431 Chemically modified small molecules Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Dec 16, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 7786133 DS* DP* Chemically modified small molecules Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Sep 16, 2028 | |
| Pat. No. 9012469 DS* DP* Crystalline naloxol-peg conjugate Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: May 15, 2015 | Apr 2, 2032 |
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 210450 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2029 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 11707464 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 23, 2023 | Mar 14, 2034 | U-3672: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix for up to 24 months |
| Pat. No. 10537572 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 19, 2020 | Sep 1, 2036 | U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin |
| Pat. No. 10682351 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 15, 2020 | Sep 1, 2036 | U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole |
| Pat. No. 11690854 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Apr 19, 2038 | U-3653: Management of moderate to severe pain associated with endometriosis in a patient with moderate hepatic impairment |
| Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2024 | Aug 20, 2038 | |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Aug 27, 2040 | U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 210450 Prod. No.: 002 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2029 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 11344551 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 27, 2022 | Mar 14, 2034 | U-3388: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women to reduce dysmenorrhea and non-menstrual pelvic pain U-3389: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women having dyspareunia associated with endometriosis |
| Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 29, 2024 | Aug 20, 2038 | |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 002: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 2, 2023 | Aug 27, 2040 | U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
XEGLYZE (LOTION) (TOPICAL) ABAMETAPIR
NDA Applicant: HATCHTECH NDA No.: 206966 Prod. No.: 001 DISC (0.74%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8212038 DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Jul 16, 2024 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Pat. No. 9357783 DP* Methods and compositions for controlling ectoparasites Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 31, 2020 | Jul 16, 2024 | |
| Pat. No. 9839631 DS* DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Jul 16, 2024 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Pat. No. 7812163 DP* Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Oct 28, 2026 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Pat. No. 10292389 DP* Pediculicidal composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Dec 17, 2034 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 24, 2025 |
RUBRACA (TABLET) (ORAL) RUCAPARIB CAMSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: PHARMAAND NDA No.: 209115 Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7351701 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 7531530 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 8754072 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9045487 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9861638 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 6, 2018 | Feb 10, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 10278974 DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jun 4, 2019 | Feb 10, 2031 | |
| 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): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 4, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Pat. No. 9987285 DP* High dosage strength tablets of rucaparib Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 28, 2018 | Aug 17, 2035 | |
| Pat. No. 10130636 High dosage strength tablets of rucaparib Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2018 | Aug 17, 2035 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 6, 2025 | ODE-168: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy |
INVOKAMET (TABLET) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS NDA No.: 204353 Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8785403 DP* Glucopyranoside compound Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 4, 2014 | Jul 30, 2024 | |
| Pat. No. 8222219 Glucopyranoside compound Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 4, 2014 | Apr 11, 2025 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7943788 DS* DP* Glucopyranoside compound Claim Types: Compound; Process; Composition Pat. Sub. Date(s): All strengths: Sep 4, 2014 | Jul 14, 2027 | |
| Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Sep 4, 2014 | Dec 3, 2027 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate Claim Types: New polymorph, salt or hydrate; Process; Method of use Pat. Sub. Date(s): All strengths: Sep 4, 2014 | Feb 26, 2029 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 11576894 DP* Combination therapy for the treatment of diabetes Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 13, 2023 | Jul 6, 2030 |
INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS NDA No.: 205879 Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8785403 DP* Glucopyranoside compound Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Jul 30, 2024 | |
| Pat. No. 8222219 Glucopyranoside compound Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Apr 11, 2025 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7943788 DS* DP* Glucopyranoside compound Claim Types: Compound; Process; Composition Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Jul 14, 2027 | |
| Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Dec 3, 2027 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate Claim Types: New polymorph, salt or hydrate; Process; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 26, 2029 | U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients U-493: Treatment of Type 2 Diabetes Mellitus |
ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)**)
| 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: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)**)
| 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 |
LIVALO (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: KOWA CO NDA No.: 022363 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8557993 DP* Crystalline forms of pitavastatin calcium Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 12, 2013 | Aug 2, 2024 *PED | |
| Pat. No. 7022713 Hyperlipemia therapeutic agent Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 19, 2024 *PED | U-998: Adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia |
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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 | |
| 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 |
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: ENDO PHARMS NDA No.: 201655 Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8114383 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Aug 8, 2024 | |
| Pat. No. 8192722 DP* Abuse-proof dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Sep 15, 2025 | |
| Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Jun 21, 2027 | U-1598: Method of administration of controlled release oxymorphone |
| Pat. No. 7851482 DS* Method for making analgesics Claim Types: Composition; Method of use; Process Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None | Jul 10, 2029 | |
| Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 7, 2014 | Nov 22, 2029 |
NINLARO (CAPSULE) (ORAL) IXAZOMIB CITRATE
Drug Classes: proteasome inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208462 Prod. No.: 001 RX (EQ 2.3MG BASE); 002 RX (EQ 3MG BASE); 003 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546608 DS* Proteasome inhibitors and methods of using the same Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Aug 12, 2024 | |
| Pat. No. 9233115 Proteasome inhibitors and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 8, 2016 | Aug 12, 2024 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Pat. No. 7687662 DS* DP* Proteasome inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Aug 6, 2027 | |
| Pat. No. 8003819 DS* DP* Proteasome inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Aug 6, 2027 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Pat. No. 8530694 DS* DP* Proteasome inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Aug 6, 2027 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Pat. No. 8871745 Proteasome inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Aug 6, 2027 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Pat. No. 8859504 DS* DP* Boronate ester compounds and pharmaceutical compositions thereof Claim Types: Compound; New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Jun 16, 2029 | |
| Pat. No. 9175017 Boronate ester compounds and pharmaceutical compositions thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Jun 16, 2029 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Pat. No. 7442830 DS* DP* Proteasome inhibitors Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Dec 14, 2015 | Nov 20, 2029 | U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy |
PREZCOBIX (TABLET) (ORAL) COBICISTAT; DARUNAVIR
Drug Classes: CYP3A inhibitor == human immunodeficiency virus (HIV-1) protease inhibitor
NDA Applicant: JANSSEN PRODS NDA No.: 205395 Prod. No.: 001 RX (150MG;800MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Feb 26, 2015 | Aug 16, 2024 *PED | |
| Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Feb 26, 2015 | Jun 26, 2027 *PED | |
| Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Feb 26, 2015 | Sep 3, 2029 | U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase U-2939: Treatment of HIV infection in adults and pediatric patients weighing at least 40kg using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase |
| Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 5, 2018 | Oct 6, 2032 |
PREZISTA (TABLET) (ORAL) DARUNAVIR [GENERIC AB]
Drug Classes: human immunodeficiency virus (HIV-1) protease inhibitor
NDA Applicant: JANSSEN PRODS NDA No.: 021976 Prod. No.: 002 RX (600MG); 004 RX (75MG); 005 RX (150MG); 006 RX (800MG) NDA No.: 021976 Prod. No.: 001 DISC (300MG**); 003 DISC (400MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2013 | Aug 16, 2024 *PED | |
| Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: None | Jun 26, 2027 *PED |
PREZISTA (SUSPENSION) (ORAL) DARUNAVIR
Drug Classes: human immunodeficiency virus (HIV-1) protease inhibitor
NDA Applicant: JANSSEN PRODS NDA No.: 202895 Prod. No.: 001 RX (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Sep 18, 2013 | Aug 16, 2024 *PED | |
| Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jan 13, 2012 | Jun 26, 2027 *PED |
VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor
NDA Applicant: ABBVIE NDA No.: 206619 Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2015 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Dec 19, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: May 6, 2015 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 10, 2031 | |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 1, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 13, 2032 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 16, 2017 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Formulation; Method of use; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 14, 2019 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == CYP3A inhibitor == HIV-1 protease inhibitor
NDA Applicant: ABBVIE NDA No.: 208624 Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 13, 2032 | |
| Pat. No. 10201541 DP* Compositions and methods for treating HCV Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | |
| Pat. No. 10201584 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 9333204 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 9744170 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10105365 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
COMBIVENT RESPIMAT (SPRAY, METERED) (INHALATION) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021747 Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011 | Aug 26, 2024 | |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Nov 2, 2011 | May 26, 2025 | |
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Nov 2, 2011 | Oct 10, 2026 | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 4, 2015 | Mar 31, 2027 | |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Nov 2, 2011 | Mar 13, 2028 | |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 4, 2015 | Oct 16, 2030 |
FOSRENOL (TABLET, CHEWABLE) (ORAL) LANTHANUM CARBONATE [GENERIC AB]
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021468 Prod. No.: 002 RX (EQ 500MG BASE); 003 RX (EQ 750MG BASE); 004 RX (EQ 1GM BASE) NDA No.: 021468 Prod. No.: 001 DISC (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381428 Stabilized lanthanum carbonate compositions Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: None | Aug 26, 2024 | U-890: Reduction of serum phosphate in patients with end stage renal disease |
| Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Aug 26, 2024 |
FOSRENOL (POWDER) (ORAL) LANTHANUM CARBONATE
NDA Applicant: TAKEDA PHARMS USA NDA No.: 204734 Prod. No.: 001 RX (EQ 750MG BASE); 002 RX (EQ 1GM BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 20, 2014 | Aug 26, 2024 | |
| Pat. No. 8980327 DP* Capsule and powder formulations containing lanthanum compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 2, 2015 | Dec 1, 2030 | |
| Pat. No. 9023397 DP* Capsule and powder formulations containing lanthanum compounds Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Dec 16, 2015 | Dec 1, 2030 |
STRIVERDI RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 203108 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Aug 15, 2014 | Aug 26, 2024 | |
| Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 15, 2014 | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2014 | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Aug 15, 2014 | May 26, 2025 | |
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 15, 2014 | Oct 10, 2026 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
| Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 15, 2014 | Jan 19, 2027 | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 3, 2015 | Mar 31, 2027 | |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Aug 15, 2014 | Mar 13, 2028 | |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 3, 2015 | Oct 16, 2030 |
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ABBVIE NDA No.: 050790 Prod. No.: 002 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8629111 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8633162 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8648048 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 9248191 DLR* Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8292129 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 25, 2031 | |
| Pat. No. 8561859 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 16, 2032 | |
| Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 7, 2034 | |
| Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | May 11, 2034 |
DIFFERIN (GEL) (TOPICAL) ADAPALENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021753 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7737181 DP* Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 29, 2024 | |
| Pat. No. 7579377 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 23, 2025 | U-818: Topical treatment of acne vulgaris |
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 DISC (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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 |
| 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 |
ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VELOXIS PHARMS INC NDA No.: 206406 Prod. No.: 001 RX (EQ 0.75MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7994214 DP* Solid dispersions comprising tacrolimus Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | |
| Pat. No. 8486993 DP* Solid dispersions comprising tacrolimus Claim Types: Formulation; Product-by-process; Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 8586084 Modified release compositions comprising tacrolimus Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 8591946 DP* Modified release compositions comprising tacrolimus Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | |
| Pat. No. 8617599 DP* Modified release compositions comprising tacrolimus Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | |
| Pat. No. 8623410 DP* Modified release compositions comprising tacrolimus Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | |
| Pat. No. 8623411 Modified release compositions comprising tacrolimus Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 8889185 Modified release compositions comprising tacrolimus Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 8889186 Modified release compositions comprising tacrolimus Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 9161907 DP* Modified release compositions comprising tacrolimus Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 13, 2015 | Aug 30, 2024 | U-1752: Prophylaxis of organ rejection |
| Pat. No. 9757362 DP* Modified release compositions comprising tacrolimus Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2017 | Aug 30, 2024 | |
| Pat. No. 9763920 DP* Solid dispersions comprising tacrolimus Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Dec 20, 2017 | Aug 30, 2024 | |
| Pat. No. 10548880 Solid dispersions comprising tacrolimus Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2020 | Aug 30, 2024 | U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations U-2678: Prophylaxis of organ rejection in de novo transplant patient |
| Pat. No. 11077096 DP* Modified release compositions comprising tacrolimus Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jul 8, 2022 | Aug 30, 2024 | |
| Pat. No. 9549918 DP* Stabilized tacrolimus composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 2, 2017 | May 30, 2028 | |
| Pat. No. 10166190 DP* Stabilized tacrolimus composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 14, 2019 | May 30, 2028 | |
| Pat. No. 10864199 Tacrolimus for improved treatment of transplant patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 6, 2021 | May 30, 2028 | U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations U-2678: Prophylaxis of organ rejection in de novo transplant patient |
| Pat. No. 11110081 Tacrolimus for improved treatment of transplant patients Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Sep 16, 2021 | May 30, 2028 | U-2678: Prophylaxis of organ rejection in de novo transplant patient |
| Pat. No. 11123331 Tacrolimus for improved treatment of transplant patients Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Sep 28, 2021 | May 30, 2028 | U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations |
| Pat. No. 11419823 DP* Stabilized tacrolimus composition Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 24, 2022 | May 30, 2028 | |
| Pat. No. 12083103 Tacrolimus for improved treatment of transplant patients Claim Types: Method of use; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Sep 12, 2024 | May 30, 2028 | U-2678: Prophylaxis of organ rejection in de novo transplant patient |
| Pat. No. 8664239 Tacrolimus for improved treatment of transplant patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2028 | U-1752: Prophylaxis of organ rejection U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations U-2678: Prophylaxis of organ rejection in de novo transplant patient |
| Pat. No. 8685998 DP* Tacrolimus for improved treatment of transplant patients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 24, 2015 | Aug 30, 2028 | U-1752: Prophylaxis of organ rejection U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations U-2678: Prophylaxis of organ rejection in de novo transplant patient |
EPIDUO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022320 Prod. No.: 001 RX (0.1%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7964202 DP* Method for treatment of common acne Claim Types: Method of use; Drug in a container Pat. Sub. Date(s): 001: Jun 23, 2011 | Sep 1, 2024 | U-1078: Treatment of acne |
| Pat. No. 7820186 DP* Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 2, 2010 | Nov 23, 2025 | |
| Pat. No. 8071644 DP* Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2011 | Jul 18, 2027 | U-1078: Treatment of acne |
| Pat. No. 8080537 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Dec 21, 2011 | Jul 18, 2027 | U-1078: Treatment of acne |
| Pat. No. 8129362 Combination/association of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 4, 2012 | Jul 18, 2027 | U-1078: Treatment of acne |
MOVIPREP (FOR SOLUTION) (ORAL) ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE [GENERIC AA]
NDA Applicant: SALIX PHARMS NDA No.: 021881 Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169381 DS* DP* Colon cleansing compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: None | Sep 1, 2024 | |
| Pat. No. 7658914 DS* DP* Colon cleansing compositions Claim Types: Kit; Formulation Pat. Sub. Date(s): 001: None | Sep 1, 2024 |
MULPLETA (TABLET) (ORAL) LUSUTROMBOPAG
NDA Applicant: VANCOCIN ITALIA NDA No.: 210923 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7601746 DS* DP* Compounds exhibiting thrombopoietin receptor agonism Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 7, 2018 | Sep 5, 2024 | U-2344: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure |
| Pat. No. 8889722 DS* DP* Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 7, 2018 | Jul 29, 2028 | |
| Pat. No. 8530668 DS* DP* Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 7, 2018 | Jan 21, 2030 | |
| Pat. No. 9427402 DP* Preparation for improving solubility of poorly soluble drug Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Aug 7, 2018 | Sep 29, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 31, 2023 |
IQIRVO (TABLET) (ORAL) ELAFIBRANOR
NDA Applicant: IPSEN NDA No.: 218860 Prod. No.: 001 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7632870 DP* Composition based on substituted 1,3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 25, 2024 | Sep 9, 2024 | |
| Pat. No. 7943661 DS* DP* Substituted 1,3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof Claim Types: Compound; Process; Composition Pat. Sub. Date(s): 001: Jun 25, 2024 | Sep 9, 2024 | |
| Pat. No. 11185519 Methods of treatment of cholestatic diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2024 | Mar 30, 2037 | U-3955: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA |
| Pat. No. 11331292 Methods of treatment of cholestatic diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2024 | Mar 30, 2037 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 11850223 Methods of treatment of cholestatic diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2024 | Mar 30, 2037 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 11857523 Methods of treatment of cholestatic diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2024 | Mar 30, 2037 | U-3955: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 10, 2029 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 10, 2031 | ODE-486: Treatment of primary biliary cholangitis (PBC) in adults who have had an inadequate response to ursodeoxycholic acid (UDCA), or in patients unable to tolerate UDCA |
RYTELO (POWDER) (INTRAVENOUS) IMETELSTAT SODIUM
NDA Applicant: GERON NDA No.: 217779 Prod. No.: 001 RX (EQ 47MG BASE/VIAL); 002 RX (EQ 188MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9388415 Modified oligonucleotides for telomerase inhibition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 3, 2024 | Sep 9, 2024 | U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia |
| Pat. No. 9388416 Modified oligonucleotides for telomerase inhibition Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 3, 2024 | Sep 9, 2024 | U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia |
| Pat. No. 7494982 DS* DP* Modified oligonucleotides for telomerase inhibition Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jul 3, 2024 | Dec 27, 2025 | |
| Pat. No. 9375485 Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 3, 2024 | Mar 15, 2033 | U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 6, 2031 | ODE-482: Treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA) |
VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
Drug Classes: sclerosing agent
NDA Applicant: PROVENSIS NDA No.: 205098 Prod. No.: 001 RX (180MG/18ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8122917 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit Pat. Sub. Date(s): 001: None | Sep 9, 2024 | |
| Pat. No. 7731986 DS* DP* Therapeutic foam Claim Types: Formulation; Drug in a container; Device; Process; Method of use Pat. Sub. Date(s): 001: None | Nov 17, 2024 | U-1463: A method of intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities |
| Pat. No. 7814943 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit; Method of use Pat. Sub. Date(s): 001: None | Nov 19, 2027 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 9480652 DP* Aerosol valve Claim Types: Device; Process Pat. Sub. Date(s): 001: Nov 30, 2016 | May 12, 2032 |
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 213388 Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 29, 2020 | Sep 10, 2024 | |
| Pat. No. 11459305 DP* Processes for the preparation of uracil derivatives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 2, 2022 | Nov 7, 2028 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 29, 2020 | Jul 6, 2029 | |
| Pat. No. 10881659 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11045470 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 27, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 12083227 DP* Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 8, 2024 | Aug 20, 2038 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Feb 6, 2023 | Jul 23, 2039 | |
| Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023 | Aug 27, 2040 | U-3655: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) using 300 mg elagolix while co-administering omeprazole |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: OCULAR THERAPEUTIX NDA No.: 208742 Prod. No.: 001 RX (0.4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9254267 DP* Composite hydrogel drug delivery systems Claim Types: Process Pat. Sub. Date(s): 001: Jan 30, 2019 | Sep 11, 2024 | |
| Pat. No. 8563027 Drug delivery through hydrogel plugs Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Jan 30, 2019 | Feb 12, 2030 | U-2487: DEXTENZA is approved for the treatment of ocular pain following ophthalmic surgery |
| Pat. No. 8409606 DP* Drug delivery through hydrogel plugs Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2019 | May 14, 2030 | |
| Pat. No. 11458041 Punctal plug and bioadhesives Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 20, 2022 | Nov 16, 2037 | U-1680: Treatment of ocular itching associated with allergic conjunctivitis U-3455: Treatment of ocular inflammation and pain following ophthalmic surgery |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 7, 2024 | I-876: Treatment of ocular itching associated with allergic conjunctivitis |
AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: chloride channel activator
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. 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. 8338639 DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jan 23, 2027 | |
| Pat. No. 8779187 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Aug 7, 2014 | Jan 23, 2027 | |
| Pat. No. 8026393 DP* Soft-gelatin capsule formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Oct 25, 2027 |
VANDAZOLE (GEL) (VAGINAL) METRONIDAZOLE [Has competitive generic]
Drug Classes: nitroimidazole antimicrobial
NDA Applicant: TEVA PHARMS NDA No.: 021806 Prod. No.: 001 RX (0.75%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7456207 DP* Vaginal pharmaceutical compositions and methods for preparing them Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Jan 20, 2011 | Sep 22, 2024 |
CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS INC NDA No.: 208692 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8497284 C-met modulators and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | Sep 24, 2024 | U-1220: Treatment of renal cell carcinoma U-1480: Treatment of advanced renal cell carcinoma U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Pat. No. 7579473 DS* DP* c-Met modulators and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 24, 2016 | Aug 14, 2026 | |
| Pat. No. 11091439 DS* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms therof for the treatment of cancer Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11091440 DP* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)- N'-(4-fluorophenyl)cyclopropane-1,1 -dicarboxamide, and crystalline forms thereof for the treatment of cancer Claim Types: Composition Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11098015 Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms thereof for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | U-1220: Treatment of renal cell carcinoma U-1480: Treatment of advanced renal cell carcinoma U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy |
| Pat. No. 8877776 DS* DP* (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | Oct 8, 2030 | U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy |
| Pat. No. 10034873 C-met modulator pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 12, 2019 | Jul 18, 2031 | U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Pat. No. 10039757 C-Met modulator pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Jul 18, 2031 | U-1480: Treatment of advanced renal cell carcinoma |
| Pat. No. 11298349 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2022 | Feb 10, 2032 | |
| Pat. No. 9724342 DP* C-met modulator pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 25, 2017 | Jul 9, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 22, 2024 | I-854: For the treatment of patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab |
| Exclusivity Code: I - New Indication | Sep 17, 2024 | I-873: Treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 14, 2026 | ODE-227: Indicated for treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 17, 2028 | ODE-375: The treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible |
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: ACERUS PHARMS NDA No.: 201656 Prod. No.: 001 DISC (0.00083MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7799761 DP* Pharmaceutical compositions including low dosages of desmopressin Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2017 | Sep 26, 2024 | |
| Pat. No. 9539302 DP* Safe desmopressin administration Claim Types: Device Pat. Sub. Date(s): 001: Mar 31, 2017 | Jun 15, 2030 | |
| Pat. No. 11419914 Safe desmopressin administration Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2022 | Jun 15, 2030 | U-3431: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by inducing an antidiuretic effect by intranasally administering a plume of droplets comprising a dose of about 0.05-5 mcg desmopressin |
| Pat. No. 12090190 DP* Safe desmopressin administration Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 11, 2024 | Jun 15, 2030 | U-4003: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by intranasally administering a plume of droplets comprising a dose of 0.75 mcg or 1.5 mcg desmopressin |
SUSTOL (INJECTABLE) (SUBCUTANEOUS) GRANISETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HERON THERAPS INC NDA No.: 022445 Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252304 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 31, 2016 | Sep 28, 2024 | |
| Pat. No. 8252305 Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2016 | Sep 28, 2024 | U-1891: Treatment or prevention of nausea and vomiting |
| Pat. No. 8715710 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron Claim Types: Composition Pat. Sub. Date(s): 001: Aug 30, 2016 | Sep 28, 2024 | |
| Pat. No. 9913910 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2018 | Sep 28, 2024 | U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy |
| Pat. No. 10357570 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Sep 28, 2024 | U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy |
FENOGLIDE (TABLET) (ORAL) FENOFIBRATE [Has competitive generic]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: SALIX NDA No.: 022118 Prod. No.: 001 DISC (40MG); 002 DISC (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8124125 DP* Solid dosage form comprising a fibrate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 19, 2012; 002: None | Oct 1, 2024 | U-1234: For reducing total cholesterol (total-c), ldl-c, apo-lipoprotein b, or total triglycerides, and treating hypertriglyceridemia |
| Pat. No. 8481078 DP* Solid dosage form comprising a fibrate Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Oct 1, 2024 | U-1416: Use of fenofibrate for reducing elevated total cholesterol (total-C), LDL-C, Apo-lipoprotein B, or total triglycerides |
| Pat. No. 9173847 DP* Tablet comprising a fibrate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 13, 2015 | Oct 1, 2024 | |
| Pat. No. 7658944 DP* Solid dosage form comprising a fibrate Claim Types: Formulation;Process Pat. Sub. Date(s): All strengths: None | Dec 9, 2024 |
PRIALT (INJECTABLE) (INTRATHECAL) ZICONOTIDE ACETATE
Drug Classes: N-type calcium channel antagonist
NDA Applicant: TERSERA NDA No.: 021060 Prod. No.: 001 RX (500MCG/20ML (25MCG/ML)); 002 RX (100MCG/1ML (100MCG/ML)); 004 RX (500MCG/5ML (100MCG/ML)) NDA No.: 021060 Prod. No.: 003 DISC (200MCG/2ML (100MCG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8653033 Method for administering omega-conopeptide Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 19, 2014 | Oct 1, 2024 | U-48: Analgesia U-55: Treatment of pain |
| Pat. No. 8765680 Method for administering omega-conopeptide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 2, 2014 | Oct 1, 2024 | U-48: Analgesia U-55: Treatment of pain |
| Pat. No. 9707270 Method for administering .omega.-conopeptide Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Aug 16, 2017 | Oct 1, 2024 | U-2084: Treatment of severe chronic pain via intrathecal infusion of ziconotide in patients also receiving morphine |
ALDARA (CREAM) (TOPICAL) IMIQUIMOD
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 |
METHYLIN (SOLUTION) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AA]
Drug Classes: central nervous system stimulant
NDA Applicant: SPECGX LLC NDA No.: 021419 Prod. No.: 001 RX (5MG/5ML); 002 RX (10MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7691880 DP* Methylphenidate solution and associated methods of administration and production Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Oct 7, 2024 |
XOPENEX HFA (AEROSOL, METERED) (INHALATION) LEVALBUTEROL TARTRATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: LUPIN NDA No.: 021730 Prod. No.: 001 RX (EQ 0.045MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7256310 DS* DP* Levalbuterol salt Claim Types: Compound; Composition; Formulation; Device; Process; Method of use Pat. Sub. Date(s): 001: None | Oct 8, 2024 | U-636: Treatment or prevention of bronchospasm or asthmatic symptoms |
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 200533 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None | Oct 10, 2024 | |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None | Dec 27, 2025 *PED | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 11344512 Titration of tapentadol Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Oct 21, 2028 *PED | U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Mar 22, 2029 *PED | U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203341 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 500MG BASE); 003 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE42376 DS* Substituted 3-cyanoquinolines Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Oct 13, 2024 *PED | |
| Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Jun 11, 2026 *PED | U-1283: A method of treating chronic myelogenous leukemia U-3707: A method of treating patients 1 year of age and older with chronic phase PH+ CML, newly-diagnosed or resistant or intolerant to prior therapy U-3708: A method of treating patients with accelerated, or blast phase PH+ CML with resistance or intolerance to prior therapy |
| Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Jun 11, 2026 *PED | |
| Pat. No. 7767678 DS* DP* Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | May 23, 2027 *PED | |
| Pat. No. 11103497 Treatment of imatinib resistant leukemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 29, 2021 | Aug 28, 2034 *PED | U-3216: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the BCRABL protein at 949T>C U-3217: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at F317L |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 26, 2027 PED | I-923: For the treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 19, 2025 PED | ODE-163: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 26, 2031 PED | ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
BOSULIF (CAPSULE) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 217729 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE42376 DS* DP* Substituted 3-cyanoquinolines Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Oct 13, 2024 *PED | |
| Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Jun 11, 2026 *PED | U-3707: A method of treating patients 1 year of age and older with chronic phase PH+ CML, newly-diagnosed or resistant or intolerant to prior therapy U-3708: A method of treating patients with accelerated, or blast phase PH+ CML with resistance or intolerance to prior therapy |
| Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Jun 11, 2026 *PED | |
| Pat. No. 7767678 DS* DP* Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Oct 26, 2023 | May 23, 2027 *PED | |
| Pat. No. 11103497 Treatment of imatinib resistant leukemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Aug 28, 2034 *PED | U-3216: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the BCRABL protein at 949T>C U-3217: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at F317L |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 26, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 26, 2031 PED | ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 DISC (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 29, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 209210 Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 4, 2031 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 DISC (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | May 12, 2028 *PED | |
| Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Jul 12, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Sep 25, 2028 *PED | |
| Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 25, 2028 *PED | |
| Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Aug 4, 2029 *PED | |
| Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Nov 19, 2029 *PED | |
| Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 7, 2030 *PED | |
| Pat. No. 8721615 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 202971 Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 19, 2024 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 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. 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. 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. 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. 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. 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 |
DEFENCATH (SOLUTION) (N/A) HEPARIN SODIUM; TAUROLIDINE
Drug Classes: anticoagulant == unfractionated heparin
NDA Applicant: CORMEDIX NDA No.: 214520 Prod. No.: 001 RX (3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)); 002 RX (5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8541393 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Dec 14, 2023 | Nov 2, 2024 | U-3774: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter |
| Pat. No. 9339036 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 14, 2023 | Nov 2, 2024 | |
| Pat. No. 7696182 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Dec 14, 2023 | May 16, 2025 | U-3774: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter |
| Pat. No. 11738120 DS* DP* Synthesis of taurolidine, purity profiles and polymorphs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 14, 2023 | Apr 15, 2042 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 15, 2033 GAIN |
OMEGAVEN (EMULSION) (INTRAVENOUS) FISH OIL TRIGLYCERIDES
NDA Applicant: FRESENIUS KABI USA NDA No.: 210589 Prod. No.: 001 RX (5GM/50ML (0.1GM/ML)); 002 RX (10GM/100ML (0.1GM/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10350186 Treatment and prevention of liver disease associated with parenteral nutrition (PN) Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019 | Nov 5, 2024 | U-2585: Treatment of parenteral nutrition-associated cholestasis in patients under the age of 12 |
| Pat. No. 9566260 DP* Treatment and prevention of liver disease associated with parenteral nutrition (PN) Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 27, 2018 | Jul 11, 2025 | U-2366: Treatment of liver disease through nutrition for patients under the age of 12 |
| Pat. No. 9629821 DP* Treatment and prevention of liver disease associated with parenteral nutrition (PN) Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 27, 2018 | Jul 11, 2025 | U-2367: Use for patients with parenteral nutrition associated cholestasis or parenteral nutrition associated liver disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 27, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 27, 2025 | ODE-202: Indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC) |
XIIDRA (SOLUTION/DROPS) (OPHTHALMIC) LIFITEGRAST [GENERIC AB]
Drug Classes: lymphocyte function-associated antigen-1 (LFA-1) antagonist
NDA Applicant: BAUSCH AND LOMB INC NDA No.: 208073 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7745460 DS* DP* Modulators of cellular adhesion Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 3, 2016 | Nov 5, 2024 | U-1880: Treatment of signs and symptoms of dry eye disease (DED) |
| Pat. No. 7790743 Modulators of cellular adhesion Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 3, 2016 | Nov 5, 2024 | U-1880: Treatment of signs and symptoms of dry eye disease (DED) |
| Pat. No. 7928122 DS* DP* Modulators of cellular adhesion Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Aug 3, 2016 | Nov 5, 2024 | |
| Pat. No. 9216174 DP* Modulators of cellular adhesion Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Aug 3, 2016 | Nov 5, 2024 | |
| Pat. No. 10124000 Modulators of cellular adhesion Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2018 | Nov 5, 2024 | U-1900: Treatment of the signs and symptoms of dry eye disease (DED) |
| Pat. No. 7314938 DS* DP* Modulators of cellular adhesion Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 3, 2016 | Mar 10, 2025 | |
| Pat. No. 8084047 DS* DP* Compositions and methods for treatment of eye disorders Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 3, 2016 | May 17, 2026 | |
| Pat. No. 8592450 Compositions and methods for treatment of eye disorders Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 3, 2016 | May 17, 2026 | U-1880: Treatment of signs and symptoms of dry eye disease (DED) |
| Pat. No. 8367701 DP* Crystalline pharmaceutical and methods of preparation and use thereof Claim Types: Composition; New polymorph, salt or hydrate; Process; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 3, 2016 | Apr 15, 2029 | U-1880: Treatment of signs and symptoms of dry eye disease (DED) |
| Pat. No. 9447077 Crystalline pharmaceutical and methods of preparation and use thereof Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Oct 6, 2016 | Apr 15, 2029 | U-1900: Treatment of the signs and symptoms of dry eye disease (DED) |
| Pat. No. 8168655 Compositions and methods for treatment of eye disorders Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 3, 2016 | May 9, 2029 | U-1880: Treatment of signs and symptoms of dry eye disease (DED) |
| Pat. No. 9353088 DP* Crystalline pharmaceutical and methods of preparation and use thereof Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Aug 3, 2016 | Oct 21, 2030 | |
| Pat. No. 9890141 DS* Crystalline pharmaceutical and methods of preparation and use thereof Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 5, 2018 | Oct 21, 2030 | |
| Pat. No. 8927574 DP* Crystalline pharmaceutical and methods of preparation and use thereof Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Aug 3, 2016 | Nov 12, 2030 | |
| Pat. No. 9085553 DP* LFA-1 inhibitor and methods of preparation and polymorph thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Aug 3, 2016 | Jul 25, 2033 | |
| Pat. No. 11058677 DP* LFA-1 inhibitor formulations Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jul 23, 2021 | Dec 18, 2033 |
FLONASE SENSIMIST ALLERGY RELIEF (SPRAY, METERED) (NASAL) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: HALEON US HOLDINGS NDA No.: 022051 Prod. No.: 002 OTC (0.0275MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9320862 DP* Fluid dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Aug 31, 2016 | Nov 6, 2024 | |
| Pat. No. 8062264 DP* Fluid dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Aug 31, 2016 | Apr 5, 2026 | |
| Pat. No. 8347879 DP* Fluid dispensing device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: Aug 31, 2016 | Jul 15, 2028 | |
| Pat. No. 8147461 DP* Fluid dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Aug 31, 2016 | Oct 15, 2028 |
NOURIANZ (TABLET) (ORAL) ISTRADEFYLLINE
NDA Applicant: KYOWA KIRIN NDA No.: 022075 Prod. No.: 001 RX (20MG); 002 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7541363 DS* DP* Microcrystal Claim Types: Physical characteristic of a bulk compound; Composition; Product-by-process Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Nov 13, 2024 | |
| Pat. No. 8318201 DP* Method of stabilizing diarylvinylene compound Claim Types: Process Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Sep 5, 2027 | |
| Pat. No. 7727993 DP* Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Sep 25, 2019 | Jan 28, 2028 | U-2623: A method of reducing off time from L-dopa therapy, comprising administering, to a human patient with parkinson's disease, an effective amount of istradefylline, wherein the patient currently receives said L-dopa therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 27, 2024 |
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7166722 DS* DP* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Nov 16, 2024 | |
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Apr 26, 2025 | U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor |
| Pat. No. 11504365 Use of tivozanib to treat subjects with refractory cancer Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Dec 1, 2022 | Nov 5, 2039 | U-3476: Treatment of adults with moderate hepatic impairment and relapsed or refractory advanced renal cell carcinoma following two or more prior systemic anti-cancer therapies with 1mg tivozanib HCl orally for 21 days followed by no drug for 7 days |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2026 |
PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: VANDA PHARMS INC NDA No.: 213498 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9000018 Thiazolidin-4-one-derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Nov 16, 2024 | U-3102: Reduction of circulating lymphocytes in treating relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. RE43728 DS* DP* Thiazolidin-4-one derivatives Claim Types: Composition; Compound; Process Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Nov 16, 2025 | |
| Pat. No. 8273779 Thiazolidin 4-one derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Dec 17, 2025 | U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. 9062014 DS* DP* Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-0-tolyl-thiazolidin-4-one Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | May 6, 2032 | U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. 10220023 Dosing regimen for a selective S1P.sub.1 receptor agonist Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Dec 10, 2035 | U-3103: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults using a dose titration schedule followed by a maintenance dose |
| Pat. No. 11951097 Methods of treating multiple sclerosis Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: May 2, 2024 | Oct 10, 2042 | U-3891: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults being treated with a beta-blocker or in adults reinitiating treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 18, 2026 |
PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: VANDA PHARMS INC NDA No.: 213498 Prod. No.: 006 RX (7MG); 007 RX (8MG); 008 RX (9MG); 009 RX (10MG); 010 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43728 DS* DP* Thiazolidin-4-one derivatives Claim Types: Composition; Compound; Process Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Nov 16, 2024 | |
| Pat. No. 9000018 Thiazolidin-4-one-derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Nov 16, 2024 | U-3102: Reduction of circulating lymphocytes in treating relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. 8273779 Thiazolidin 4-one derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Dec 17, 2025 | U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. 9062014 DS* DP* Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-0-tolyl-thiazolidin-4-one Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Apr 14, 2021 | May 6, 2032 | U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults |
| Pat. No. 10220023 Dosing regimen for a selective S1P.sub.1 receptor agonist Claim Types: Dosaage regimen Pat. Sub. Date(s): All strengths: Apr 14, 2021 | Dec 10, 2035 | U-3103: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults using a dose titration schedule followed by a maintenance dose |
| Pat. No. 11951097 Methods of treating multiple sclerosis Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: May 2, 2024 | Oct 10, 2042 | U-3891: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults being treated with a beta-blocker or in adults reinitiating treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 18, 2026 |
TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: SEAGEN NDA No.: 213411 Prod. No.: 001 RX (50MG); 002 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7452895 DS* DP* Quinazoline analogs as receptor tyrosine kinase inhibitors Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 29, 2020 | Nov 16, 2024 | U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer |
| Pat. No. 9693989 DP* N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 29, 2020 | May 9, 2027 | U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer |
| Pat. No. 8648087 DS* DP* N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases Claim Types: Compound; Process Pat. Sub. Date(s): All strengths: Apr 29, 2020 | Apr 12, 2031 | |
| Pat. No. 9457093 DP* Solid dispersions of a ERB2 (HER2) inhibitor Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Apr 29, 2020 | Oct 12, 2032 | U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer |
| Pat. No. 11504370 Treatment of brain cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 5, 2022 | Mar 25, 2033 | U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer |
| Pat. No. 11207324 Treatment of HER2 positive cancers Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 2, 2023 | Apr 27, 2038 | U-3783: Combination treatment with tucatinib and trastuzumab of adults with ras wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following previous treatment as claimed |
| Pat. No. 11666572 Treatment of HER2 positive cancers Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 29, 2024 | Apr 27, 2038 | U-3783: Combination treatment with tucatinib and trastuzumab of adults with ras wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following previous treatment as claimed |
| Pat. No. 12048698 Treatment of HER2 positive cancers Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 28, 2024 | Apr 27, 2038 | U-3783: Combination treatment with tucatinib and trastuzumab of adults with ras wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following previous treatment as claimed |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 19, 2026 | I-906: Tucatinib in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy |
| Exclusivity Code: NCE - New chemical entity | Apr 17, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 17, 2027 | ODE-309: Indicated for use in combination with trastuzumab and capecitabine for treatment of adult patients with metastatic HER2-positive breast cancer and brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 19, 2030 | ODE-422: Treatment of adult patients with ras wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy |
LONHALA MAGNAIR KIT (SOLUTION) (INHALATION) GLYCOPYRROLATE
Drug Classes: anticholinergic == antimuscarinic agent
NDA Applicant: SUMITOMO PHARMA AM NDA No.: 208437 Prod. No.: 001 DISC (25MCG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7458372 DP* Inhalation therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 18, 2024 | |
| Pat. No. 7931212 DP* Fluid droplet production apparatus and method Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 25, 2025 | |
| Pat. No. 11278683 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Aug 16, 2026 | |
| Pat. No. 9265900 DP* Disposable ampoule for an aerosol generating device Claim Types: Drug in a container; Product-by-process; Method of use Pat. Sub. Date(s): 001: Jan 2, 2018 | Dec 7, 2028 | |
| Pat. No. 10940110 DP* Method and system for the treatment of chronic COPD with nebulized anticholinergic administrations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2021 | Feb 26, 2029 | U-1773: Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9789270 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Oct 30, 2030 | |
| Pat. No. 9168556 DP* Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 2, 2018 | Sep 1, 2032 | |
| Pat. No. 9604018 DP* Aerosol therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | May 16, 2033 | |
| Pat. No. 10376661 DP* Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Sep 5, 2019 | Sep 14, 2035 | |
| Pat. No. 10688518 DP* Method of manufacturing a vibratable head for an aerosol generator and vibratable head for an aerosol generator Claim Types: Part of a dosage form; Device; Process Pat. Sub. Date(s): 001: Jun 30, 2020 | Nov 12, 2036 | |
| Pat. No. 10744277 DP* Aerosol delivery device and method of operating the aerosol delivery device Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 1, 2020 | Dec 7, 2036 | U-2941: A method of using an aerosol delivery device to aerosolize glycopyrrolate for the treatment of chronic obstructive pulmonary disease (COPD) |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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. 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. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2023 | Dec 12, 2026 | |
| 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. 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. 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. 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. 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 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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. 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. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Mar 29, 2023 | Dec 12, 2026 | |
| 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. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 12, 2028 | |
| 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. 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. 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. 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. 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. 11771830 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 20, 2023 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. 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. 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. 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. 11590286 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Mar 29, 2023 | Dec 12, 2026 | |
| 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. 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. 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. 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. 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. 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. 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. 11771830 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 20, 2023 | Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
EVZIO (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: KALEO INC NDA No.: 205787 Prod. No.: 001 DISC (0.4MG/0.4ML (0.4MG/0.4ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Nov 23, 2024 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | 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, 2014 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Nov 23, 2024 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 2, 2015 | Nov 23, 2024 | |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 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. 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. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Jan 15, 2025 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Mar 21, 2025 | |
| 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. 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. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 16, 2015 | Mar 31, 2026 | |
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Jun 10, 2026 | |
| 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 | |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2016 | Feb 20, 2027 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Feb 27, 2027 | |
| 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. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Mar 12, 2028 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Oct 30, 2028 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Nov 25, 2028 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Apr 10, 2029 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Nov 2, 2029 | |
| Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Mar 27, 2015 | Feb 28, 2031 | |
| Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: May 15, 2015 | Feb 28, 2031 | |
| Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Nov 2, 2016 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: Jun 19, 2019 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 10143972 Ultrafiltration membrane and a preparation method thereof Claim Types: Process Pat. Sub. Date(s): 001: Jan 2, 2019 Comments: Typo in the patent number. Likely should be 10,143,792. | May 24, 2031 | U-2476: Use of a delivery device to deliver a dose of naloxone |
| Pat. No. 8627816 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: May 23, 2014 | Feb 4, 2032 | |
| Pat. No. 9517307 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 19, 2016 | Jul 18, 2034 | U-1925: Use of an auto injector to administer naloxone HCl |
| Pat. No. 10220158 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2019 | Mar 20, 2035 | U-2500: Use of a delivery device to deliver a bioequivalent dose of a naloxone composition via a needle |
EVZIO (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: KALEO INC NDA No.: 209862 Prod. No.: 001 DISC (2MG/0.4ML (2MG/0.4ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 23, 2024 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | 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: Nov 7, 2016 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 23, 2024 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 23, 2024 | |
| 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. 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. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Jan 15, 2025 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Mar 21, 2025 | |
| 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. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 1, 2026 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Mar 31, 2026 | |
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Jun 1, 2026 | |
| 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 | |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 20, 2027 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 27, 2027 | |
| 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. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Mar 12, 2028 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Oct 30, 2028 | |
| Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 25, 2028 | |
| Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Nov 7, 2016 | Apr 10, 2029 | |
| Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Nov 2, 2029 | |
| Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 28, 2031 | |
| Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 28, 2031 | |
| Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: Jun 19, 2019 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 2, 2019 | May 24, 2031 | U-2476: Use of a delivery device to deliver a dose of naloxone |
| Pat. No. 8627816 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Nov 7, 2016 | Feb 4, 2032 | |
| Pat. No. 9517307 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 19, 2016 | Jul 18, 2034 | U-1925: Use of an auto injector to administer naloxone HCl |
| Pat. No. 10220158 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2019 | Mar 20, 2035 | U-2500: Use of a delivery device to deliver a bioequivalent dose of a naloxone composition via a needle |
NALOXONE HYDROCHLORIDE (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: KALEO INC NDA No.: 215457 Prod. No.: 001 DISC (10MG/0.4ML (10MG/0.4ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | 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: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Nov 23, 2024 | |
| Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Jan 15, 2025 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Mar 21, 2025 | |
| Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Apr 30, 2025 | |
| 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 | |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Mar 12, 2028 | |
| Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Feb 28, 2031 | |
| Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Feb 28, 2031 | |
| Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Mar 25, 2022 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 9814838 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Feb 28, 2031 | |
| Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: Mar 25, 2022 | Feb 28, 2031 | U-1907: Use of a delivery device to administer a dose of naloxone |
| Pat. No. 10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 25, 2022 | May 24, 2031 | U-2476: Use of a delivery device to deliver a dose of naloxone |
SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 206321 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Oct 11, 2022 | Oct 20, 2025 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: May 20, 2022 | Jan 20, 2026 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 13, 2026 *PED | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Apr 20, 2026 *PED | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 22, 2021 | Jul 17, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Jul 26, 2026 *PED | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Jan 17, 2027 *PED | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 13, 2017 | Jan 17, 2027 *PED | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 1, 2019 | Jan 17, 2027 *PED | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Feb 3, 2027 *PED | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2017 | Aug 27, 2027 *PED | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Oct 26, 2016 Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Mar 27, 2028 *PED | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Aug 1, 2032 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2018 | Jul 9, 2037 *PED | U-2438: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with Type 2 diabetes and cardiovascular disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 4, 2023 |
VICTOZA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NORDISK INC NDA No.: 022341 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 8114833 DS* DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 13, 2012 | Feb 13, 2026 *PED | |
| Pat. No. 9265893 DP* Injection button Claim Types: Device Pat. Sub. Date(s): 001: Mar 14, 2016 | Mar 23, 2033 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Jul 9, 2037 *PED | U-2313: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with Type 2 diabetes mellitus and established cardiovascular disease by administering liraglutide |
REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE [GENERIC AB]
Drug Classes: thalidomide analog
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 021880 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (25MG); 005 RX (2.5MG); 006 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7855217 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Jan 13, 2011; 002: None; 003: Jan 17, 2012; 004: None; 005: Jan 17, 2012; 006: None | Nov 24, 2024 | |
| Pat. No. 7465800 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: None; 005: Jan 17, 2012; 006: None | Apr 27, 2027 | |
| Pat. No. 8741929 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 17, 2014 | Mar 8, 2028 | U-1983: Use of REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 22, 2024 | ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct) |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 28, 2026 | ODE-241: Indicated in combination with a rituximab product for the treatment of adult patients with previously treated follicular lymphoma (FL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 28, 2026 | ODE-245: Indicated in combination with a rituximab product for the treatment of adult patients with previously treated marginal zone lymphoma (MZL) |
SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO OPERATIONS NDA No.: 022239 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8287489 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 16, 2012 | Dec 6, 2024 | |
| Pat. No. 7901385 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Mar 23, 2011 | Jul 31, 2026 | |
| Pat. No. 7776007 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 4, 2011 | Nov 22, 2026 |
HYCAMTIN (CAPSULE) (ORAL) TOPOTECAN HYDROCHLORIDE
Drug Classes: topoisomerase inhibitor
NDA Applicant: SANDOZ NDA No.: 020981 Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8158645 DP* Compound, corresponding compositions, preparation and/or treatment methods Claim Types: Product-by-process Pat. Sub. Date(s): 001: May 11, 2012; 002: None | Dec 10, 2024 |
REMODULIN (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 208276 Prod. No.: 001 DISC (20MG/20ML (1MG/ML)); 002 DISC (50MG/20ML (2.5MG/ML)); 003 DISC (100MG/20ML (5MG/ML)); 004 DISC (200MG/20ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9713599 Parenteral formulations of treprostinil Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018 | Dec 16, 2024 | U-2036: A method of treating pulmonary hypertension comprising parenterally administering a formulation comprising a) 0.1 to 5% w/v of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer |
| Pat. No. 10076505 DP* Inhalation formulations of Treprostinil Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018 | Dec 16, 2024 | |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018 | Dec 15, 2028 |
ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| 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. 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. 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) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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. 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. 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) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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 |
VICTRELIS (CAPSULE) (ORAL) BOCEPREVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 202258 Prod. No.: 001 DISC (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43298 DS* DP* Peptides as NS3-serine protease inhibitors of hepatitis C virus Claim Types: Compound; Intermediate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None | Dec 22, 2024 | U-1128: Treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients (>=18 years of age) with compensated liver disease |
| Pat. No. 8119602 Administration of HCV protease inhibitors in combination with food to improve bioavailability Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 21, 2012 | Mar 17, 2027 | U-1233: Treatment of chronic hepatitis C (CHC) genotype 1 infection, administered with food |
| Pat. No. 7772178 DP* Pharmaceutical formulations and methods of treatment using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 10, 2011 | Nov 11, 2027 | U-1128: Treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients (>=18 years of age) with compensated liver disease |
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: CEPHALON NDA No.: 021947 Prod. No.: 001 DISC (EQ 0.1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 13, 2012 | Dec 30, 2024 | |
| Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011 | Jun 15, 2028 |
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: CEPHALON NDA No.: 021947 Prod. No.: 002 DISC (EQ 0.2MG BASE); 003 DISC (EQ 0.4MG BASE); 004 DISC (EQ 0.6MG BASE); 005 DISC (EQ 0.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Dec 30, 2024 | |
| Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 002: Feb 23, 2012; 003: None; 004: None; 005: None | Dec 30, 2024 | |
| Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011 | Jun 15, 2028 | |
| Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011 | Jun 15, 2028 |