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. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 1, 2024 | U-2672: Treatment of acute hepatic porphyria |
| 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 | May 14, 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) |
TASIGNA (CAPSULE) (ORAL) NILOTINIB HYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS NDA No.: 022068 Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 50MG BASE)
| 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 orintolerance to prior tyrosine-kinase inhibitor (TKI) therapy |
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
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. 8069851 DP* Aeorosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Sep 24, 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 [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 RX (600MG;200MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 13, 2024 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 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 |
STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Other == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents
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* [Extended 1011 days (2.8 years)] 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: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-hepatitis B (HBV) Agents
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: Antipsychotics:2nd Generation/Atypical
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 diseases Claim 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* [Extended 1315 days (3.6 years)] Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2016 | Apr 29, 2030 |
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical
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 diseases Claim 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* [Extended 1315 days (3.6 years)] Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim 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: Antipsychotics:2nd Generation/Atypical
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 diseases Claim 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* [Extended 1315 days (3.6 years)] Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim 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: Antibacterials:Macrolides
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: NPP - New patient population | Jul 24, 2023 PED | |
| 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
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-inflammatories
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
NDA Applicant: EISAI INC NDA No.: 201532 Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)] 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 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 28, 2023 | ODE-107: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen |
RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: EPI HLTH 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 [GENERIC AT]
Drug Classes: Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives
NDA Applicant: MYLAN NDA No.: 050801 Prod. No.: 001 RX (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 |
DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: Antibacterials:Macrolides
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 23, 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: NP - New product | Jul 24, 2023 PED | |
| 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) |
TORISEL (SOLUTION) (INTRAVENOUS) TEMSIROLIMUS [GENERIC AP]
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 [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
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* [Extended 945 days (2.6 years)] 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. |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
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* [Extended 945 days (2.6 years)] 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: Gastrointestinal Agents:Anti-Constipation Agents
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. |
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] 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. |
| 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. |
| 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. |
| 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. |
MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES NDA No.: 214846 Prod. No.: 001 RX (1MG;0.5MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jun 21, 2021 | Jan 28, 2024 | |
| 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, 2024 | |
| 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. 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 |
| 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: NCE - New chemical entity | Dec 18, 2025 | |
| Exclusivity Code: NP - New product | May 26, 2024 |
ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES NDA No.: 214621 Prod. No.: 001 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 14, 2021 | Jan 28, 2024 | |
| 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, 2024 | |
| 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. 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2025 |
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == Ophthalmic Agents:Ophthalmic Combinations
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 |
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
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 |
OSPHENA (TABLET) (ORAL) OSPEMIFENE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Selective Estrogen Receptor Modifying Agents == Sexual Disorder Agents:Sexual Disorder Agents (Female)
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 [Extended 5 years] 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: Antibacterials:Macrolides == Ophthalmic Agents:Ophthalmic Anti-Infectives
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: Antivirals:Anti-HIV Agents, Other == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents
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* [Extended 1076 days (2.9 years)] 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 inibits 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 |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders
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: Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: AQUESTIVE NDA No.: 212640 Prod. No.: 001 RX (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 |
LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
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. 9907794 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 19, 2018 | May 26, 2026 | |
| 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. 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: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents
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: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents
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* [Extended 1824 days (5 years)] Substituted indolines which inhibit receptor tyrosine kinases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 22, 2014 | Oct 1, 2025 | |
| 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 | Dec 20, 2025 | 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 | Jun 4, 2029 | |
| 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 | Jun 7, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 6, 2022 | I-805: Slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease |
| Exclusivity Code: I - New Indication | Mar 9, 2023 | I-825: Treatment for chronic fibrosing interstitial lung diseases with a progressive phenotype |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2026 | ODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD) |
ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX NDA No.: 210583 Prod. No.: 001 DISC (30MG/ML (30MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 20, 2023 |
GRALISE (TABLET) (ORAL) GABAPENTIN [Has competitive generic]
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == Central Nervous System Agents:Central Nervous System, Other
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
NDA Applicant: ENDO PHARMS INC NDA No.: 021642 Prod. No.: 001 RX (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 |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
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 |
ULORIC (TABLET) (ORAL) FEBUXOSTAT [GENERIC AB]
Drug Classes: Antigout Agents
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: Antineoplastics:Molecular Target Inhibitors
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: Antineoplastics:Molecular Target Inhibitors
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-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-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 |
| 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 |
| 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. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| 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-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 |
| 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-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 |
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 27, 2022 | I-818: Maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Exclusivity Code: I - New Indication | May 8, 2023 | I-831: W/bevacizumab for maintenance tx of adults w/adv. epithelial ovarian, fallopian tube or primary peritoneal ca in complete or partial response to first-line platinum-based chemo & ca associated w/ homologous recombination deficiency positive status |
| Exclusivity Code: I - New Indication | May 19, 2023 | I-832: Tx of adult pts with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone |
| 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: 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: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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 [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Thyroid)
NDA Applicant: INSTITUT BIOCHIMIQUE 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: Electrolytes/ Minerals/ Metals/ Vitamins:Potassium Binders
NDA Applicant: VIFOR PHARMA NDA No.: 205739 Prod. No.: 001 RX (EQ 8.4GM BASE/PACKET); 002 RX (EQ 16.8GM BASE/PACKET); 003 RX (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* [Extended 832 days (2.3 years)] 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 |
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
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 |
ORACEA (CAPSULE) (ORAL) DOXYCYCLINE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents
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: Antibacterials:Aminoglycosides
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 |
| 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
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
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: Central Nervous System Agents:Multiple Sclerosis Agents
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 |
BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
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* [Extended 1663 days (4.6 years)] Substituted 3-cyanoquinolines Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Apr 13, 2024 | |
| 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 | Dec 11, 2025 | U-1283: A method of treating chronic myelogenous leukemia |
| 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 | Dec 11, 2025 | |
| 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 | Nov 23, 2026 | |
| Pat. No. 11103497 Treatment of imatinib resistant leukemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 29, 2021 | Feb 28, 2034 | 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: ODE - Orphan drug exclusivity | Dec 19, 2024 | ODE-163: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) |
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 001 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238076 DP* 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 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Apr 13, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Apr 13, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | Jun 30, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Oct 4, 2025 | 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 | Aug 18, 2026 | 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 | Aug 18, 2026 | 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 | Jun 20, 2027 | 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 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 5, 2014 | Mar 21, 2028 | 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 | Mar 21, 2028 | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2014 | Aug 19, 2028 | |
| 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 | Dec 16, 2029 | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 001: Nov 15, 2017 | Jan 18, 2030 | |
| 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 | May 26, 2030 | 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 | May 5, 2023 | I-834: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction |
| Exclusivity Code: I - New Indication | Oct 18, 2022 | I-841: To reduce the risk of hospitalization for heart failure in adults with Type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors |
| 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 |
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238076 DP* 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 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 13, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 13, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Jun 30, 2025 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide |
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Oct 4, 2025 | 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 | Aug 18, 2026 | 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 | Aug 18, 2026 | 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 | Jun 20, 2027 | 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 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 5, 2014 | Mar 21, 2028 | 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 | Mar 21, 2028 | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 5, 2014 | Aug 19, 2028 | |
| 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 | Dec 16, 2029 | |
| Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jan 18, 2030 | |
| 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 | May 26, 2030 | 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. 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 | Mar 9, 2040 | 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 5, 2023 | I-834: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction |
| Exclusivity Code: I - New Indication | Oct 18, 2022 | I-841: To reduce the risk of hospitalization for heart failure in adults with Type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors |
| 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 |
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG) 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): 001: Jan 31, 2019; 002: Jan 31, 2019; 003: Jan 31, 2019; 004: Jan 31, 2019; 005: Jul 7, 2021 | Apr 19, 2024 | |
| Pat. No. 10441554 DP* Oral amphetamine composition Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 15, 2019; 002: Oct 15, 2019; 003: Oct 15, 2019; 004: Oct 15, 2019; 005: Jul 7, 2021 | 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 |
CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents
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. 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 |
MEGACE ES (SUSPENSION) (ORAL) MEGESTROL ACETATE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: ENDO PHARMS INC 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: Antiparasitics:Anthelmintics == Dermatological Agents:Pediculicides/Scabicides
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. |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 001 RX (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 [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 002 RX (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 [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids
NDA Applicant: HORIZON NDA No.: 202020 Prod. No.: 003 RX (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: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence
NDA Applicant: TITAN 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: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 4, 2023 |
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary
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. 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 |
| 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: Genitourinary Agents:Antispasmodics, Urinary
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 | Oct 1, 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
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
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* [Extended 684 days (1.9 years)] 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: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: BAYER HEALTHCARE NDA No.: 209936 Prod. No.: 001 RX (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: NCE - New chemical entity | Sep 14, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 14, 2024 | ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
EQUETRO (CAPSULE, EXTENDED RELEASE) (ORAL) CARBAMAZEPINE [Has competitive generic]
Drug Classes: Anticonvulsants:Sodium Channel Agents == Bipolar Agents:Mood Stabilizers == Central Nervous System Agents:Central Nervous System, Other
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
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
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
Drug Classes: Antipsychotics:1st Generation/Typical
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 |
PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: Antivirals:Anti-cytomegalovirus (CMV) Agents
NDA Applicant: MERCK SHARP DOHME NDA No.: 209939 Prod. No.: 001 RX (240MG); 002 RX (480MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 21, 2020 | May 22, 2024 | |
| 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 8, 2022 | |
| 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) |
PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: Antivirals:Anti-cytomegalovirus (CMV) Agents
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. RE46791 DS* DP* Substituted dihydroquinazolines Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 29, 2020 | May 22, 2024 | |
| 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. 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: NCE - New chemical entity | Nov 8, 2022 | |
| 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) |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
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* 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. 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: I - New Indication | Oct 18, 2022 | I-820: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
| 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: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
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. 9604901 DS* 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. 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: I - New Indication | Oct 18, 2022 | I-820: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
| 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) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
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. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 28, 2017; 002: Mar 28, 2017; 003: Mar 28, 2017; 004: Mar 28, 2017; 005: Aug 24, 2021 | 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 |
ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020589 Prod. No.: 002 OTC (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 24, 2019 | May 25, 2024 |
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021587 Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 24, 2019 | May 25, 2024 |
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
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 |
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
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]
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
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]
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: Blood Products and Modifiers:Anticoagulants
NDA Applicant: XSPIRE PHARMA NDA No.: 204886 Prod. No.: 001 RX (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* [Extended 1356 days (3.7 years)] 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: Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: NOVARTIS 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
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 6, 2023 PED | M-14: Additional clinical trial information added to pediatric use subsection |
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. 8530509 DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases Claim Types: Composition Pat. Sub. Date(s): 001: Aug 9, 2018 | 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: Aug 9, 2018 | Jun 18, 2024 | U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 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: 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 [Extended 1585 days (4.3 years)] 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 |
| 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 [Extended 1585 days (4.3 years)] 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: Antibacterials:Antibacterials, Other == Gastrointestinal Agents:Anti-Diarrheal Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other
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: Antibacterials:Antibacterials, Other == Gastrointestinal Agents:Anti-Diarrheal Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other
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. 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: Gastrointestinal Agents:Anti-Constipation Agents
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* [Extended 272 days (0.7 years)] 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 |
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
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. 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, 2024 | |
| 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. 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. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 | |
| Exclusivity Code: NP - New product | May 29, 2023 |
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
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. 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, 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. 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. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
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. 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, 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. 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. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
XEGLYZE (LOTION) (TOPICAL) ABAMETAPIR
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
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 |
INVOKAMET (TABLET) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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 [Extended 255 days (0.7 years)] 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 |
INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
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 [Extended 255 days (0.7 years)] 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: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: May 27, 2011 | Jul 30, 2024 *PED | |
| Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 3, 2013 | Jul 30, 2024 *PED | |
| Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8598219 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 30, 2024 *PED | |
| Pat. No. 8729094 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 21, 2014 | Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
| Pat. No. 9066980 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
| Pat. No. 9125905 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Process; Drug in a container Pat. Sub. Date(s): 001: Sep 9, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 5, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Sep 27, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Oct 25, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457021 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 25, 2016 | Jul 30, 2024 *PED |
ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Sep 3, 2013 | Jul 30, 2024 *PED | |
| Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jul 30, 2024 *PED | |
| Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 5, 2015 | Jul 30, 2024 *PED | |
| Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Sep 27, 2016 | Jul 30, 2024 *PED | |
| Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Oct 25, 2016 | Jul 30, 2024 *PED |
LIVALO (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors
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: Adjuncitve [sic, "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: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
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 |
NINLARO (CAPSULE) (ORAL) IXAZOMIB CITRATE
Drug Classes: Antineoplastics:Antineoplastics, Other
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2022 | ODE-103: 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: Antivirals:Anti-HIV Agents, Other == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations
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: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations
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: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations
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: Antivirals:Anti-hepatitis C (HCV) Agents
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* [Extended 93 days (0.3 years)] 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: Antivirals:Anti-hepatitis C (HCV) Agents == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI)
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* [Extended 93 days (0.3 years)] 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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
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]
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders
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
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders
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 |
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: ABBVIE NDA No.: 050790 Prod. No.: 002 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8629111 DP* 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 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* 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 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* 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 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 |
XARELTO (FOR SUSPENSION) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants
NDA Applicant: JANSSEN PHARMS NDA No.: 215859 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022 | Aug 28, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jun 20, 2025 PED |
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: Dermatological Agents:Topical Anti-infectives
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (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: Dermatological Agents:Dermatitis and Pruritus Agents == Immunological Agents:Immunosuppressants
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. 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 10, 2022 | ODE-94: Prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants |
EPIDUO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives
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. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 19, 2013 | Jul 12, 2027 | U-1078: Treatment of acne |
| 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]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other
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
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
NDA Applicant: SHIONOGI INC 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 |
VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
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 |
DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories
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: Gastrointestinal Agents:Anti-Constipation Agents
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: Antibacterials:Antibacterials, Other
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: Antineoplastics:Molecular Target Inhibitors
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* [Extended 689 days (1.9 years)] 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: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
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 |
SUSTOL (INJECTION, EXTENDED RELEASE) (SUBCUTANEOUS) GRANISETRON
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts
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 [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives
NDA Applicant: SALIX NDA No.: 022118 Prod. No.: 001 RX (40MG); 002 RX (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
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 [Has competitive generic]
Drug Classes: Dermatological Agents:Dermatological Agents, Other
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 Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines
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 |
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
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: NOVARTIS 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: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: GLAXOSMITHKLINE CONS 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. 8752543 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 |
PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: JANSSEN PHARMS NDA No.: 213498 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG); 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 18, 2026 |
TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
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-3510: Combination treatment of colorectal cancer including ras wild-type HER2 (ERBB2)-positive or -overexpressing unresectable or metastatic colorectal cancer |
| 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 metastic setting |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Nov 23, 2024 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2012 | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 23, 2013 | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 16, 2015 | Nov 23, 2024 | |
| Pat. No. 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: Feb 22, 2013 | Jan 15, 2025 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Mar 21, 2025 | |
| Pat. No. 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. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2015 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Apr 11, 2016 | Feb 1, 2026 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Jun 1, 2026 | |
| Pat. No. 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. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 001: Feb 18, 2016 | Feb 20, 2027 | |
| Pat. No. 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. 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: Feb 22, 2013 | Mar 12, 2028 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 | Oct 30, 2028 | |
| Pat. No. 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: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 002: None | Nov 23, 2024 | |
| Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 15, 2014 | Nov 23, 2024 | |
| Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 29, 2015 | Nov 23, 2024 | |
| Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jul 16, 2015 | Nov 23, 2024 | |
| Pat. No. 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. 7731690 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Jan 15, 2025 | |
| Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 21, 2025 | |
| Pat. No. 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. 9149579 Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 002: Nov 6, 2015 | Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
| Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 23, 2016 | Feb 1, 2026 | |
| Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 11, 2016 | Feb 1, 2026 | |
| Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Feb 5, 2015 | Mar 31, 2026 | |
| Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Jun 1, 2026 | |
| Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 22, 2021 | Jun 25, 2026 | |
| Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system Claim Types: Device Pat. Sub. Date(s): 002: Feb 18, 2016 | Feb 20, 2027 | |
| Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Feb 27, 2027 | |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Aug 23, 2017 | May 23, 2027 | U-2092: Method for confirming dose delivery |
| Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Mar 12, 2028 | |
| Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None | Oct 30, 2028 | |
| Pat. No. 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 |