The Condensed List contains products that have at least one patent with compound, composition or "new polymorph, salt or hydrate" claims.
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. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED |
TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD NDA No.: 021752 Prod. No.: 001 RX (200MG;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | 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. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use | 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 | 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 | 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 | Jan 13, 2024 | U-257: Treatment of HIV infection |
TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD NDA No.: 021752 Prod. No.: 003 RX (133MG;200MG); 004 RX (167MG;250MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-1259: Prophylaxis of HIV-1 infection U-248: Treatment of HIV U-541: Method of treatment of adults infected with HIV-1 |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | 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. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED |
EMTRIVA (SOLUTION) (ORAL) EMTRICITABINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: GILEAD NDA No.: 021896 Prod. No.: 001 RX (10MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED |
ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 RX (600MG;200MG;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of hiv-1 infection in adults |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of hiv-1 infection in adults |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of hiv-1 infection in adults |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of hiv-1 infection in adults |
Pat. No. 6939964 DS* Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Jul 20, 2018 *PED | |
Pat. No. 6639071 DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4- trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Aug 14, 2018 *PED | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of hiv-1 infection in adults |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use | 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 | 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 | 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 | Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat. No. 9018192 Unitary pharmaceutical dosage form Claim Types: Method of use | 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 | 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 | Apr 28, 2029 |
COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 202123 Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 7067522 DS* DP* 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents Claim Types: Compound; Composition; Process; Method of use | Dec 20, 2019 | |
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents Claim Types: Compound; Process; Composition; Method of use | Feb 26, 2021 | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile Claim Types: Formulation | Aug 9, 2022 | |
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process | Apr 11, 2023 | |
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use | 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 | 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 | 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 | Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat. No. 7125879 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation | Apr 21, 2025 | U-257: Treatment of HIV infection |
Pat. No. 8841310 DP* Combinations of a pyrimidine containing NNRTI with RT inhibitors Claim Types: Formulation; Method of use; Kit | Dec 9, 2025 | U-257: Treatment of HIV infection |
STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: CYP3A inhibitor; HIV integrase strand transfer inhibitor (HIV-1 INSTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 203100 Prod. No.: 001 RX (150MG;150MG;200MG;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Claim Types: Formulation; Method of use | 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 | 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 | 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 | Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat. No. 7176220 DS* DP* 4-oxoquinoline compound and use thereof as pharmaceutical agent Claim Types: Method of use; Compound; Composition | Aug 27, 2026 | 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 | Oct 26, 2026 | 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 | Oct 26, 2026 | |
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use | Sep 3, 2029 | 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 | Sep 3, 2029 | U-257: Treatment of HIV infection |
Pat. No. 8633219 DP* Combination therapy Claim Types: Method of use; Formulation | Apr 24, 2030 | U-257: Treatment of HIV infection |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Jan 27, 2020 |
GENVOYA (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: CYP3A inhibitor; HIV integrase strand transfer inhibitor (HIV-1 INSTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 207561 Prod. No.: 001 RX (150MG;150MG;200MG;EQ 10MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use | Feb 2, 2022 | U-257: Treatment of HIV infection |
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation | May 7, 2022 | |
Pat. No. 7176220 DS* DP* 4-oxoquinoline compound and use thereof as pharmaceutical agent Claim Types: Method of use; Compound; Composition | Aug 27, 2026 | 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 | Oct 26, 2026 | 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 | Oct 26, 2026 | |
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use | Sep 3, 2029 | 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 | Sep 3, 2029 | U-257: Treatment of HIV infection |
Pat. No. 8633219 DP* Combination therapy Claim Types: Method of use; Formulation | Apr 24, 2030 | U-257: Treatment of HIV infection |
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process | Aug 15, 2032 | U-257: Treatment of HIV infection |
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use | Aug 15, 2032 | U-257: Treatment of HIV infection |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Nov 5, 2020 | |
Exclusivity Code: NPP - New patient population | Sep 25, 2020 |
DESCOVY (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208215 Prod. No.: 001 RX (200MG;EQ 25MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use | Feb 2, 2022 | U-257: Treatment of HIV infection |
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation | May 7, 2022 | |
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process | Aug 15, 2032 | U-257: Treatment of HIV infection |
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use | Aug 15, 2032 | U-257: Treatment of HIV infection |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Nov 5, 2020 | |
Exclusivity Code: NPP - New patient population | Sep 25, 2020 |
ODEFSEY (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208351 Prod. No.: 001 RX (200MG;EQ 25MG BASE;EQ 25MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5914331 DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | Jan 2, 2018 *PED | |
Pat. No. 7067522 DS* DP* 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents Claim Types: Compound; Composition; Process; Method of use | Dec 20, 2019 | |
Pat. No. 6838464 DS* DP* 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents Claim Types: Compound; Process; Composition; Method of use | Feb 26, 2021 | |
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | May 4, 2021 *PED | U-257: Treatment of HIV infection |
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | Sep 9, 2021 *PED | |
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use | Feb 2, 2022 | U-257: Treatment of HIV infection |
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation | May 7, 2022 | |
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile Claim Types: Formulation | Aug 9, 2022 | |
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Process | Apr 11, 2023 | |
Pat. No. 7125879 DS* DP* HIV inhibiting pyrimidines derivatives Claim Types: Compound; Composition; Method of use; Formulation | Apr 21, 2025 | U-257: Treatment of HIV infection |
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process | Aug 15, 2032 | U-257: Treatment of HIV infection |
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use | Aug 15, 2032 | U-257: Treatment of HIV infection |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Aug 21, 2020 | M-206: Information added to labeling regarding 48 week efficacy, resistance and safety data on virologically suppressed HIV-1 infected adults switching from COMPLERA to ODEFSEY |
Exclusivity Code: M - Miscellaneous | Aug 21, 2020 | M-207: Information added to labeling regarding 48 week efficacy, resistance and safety data on virologically suppressed HIV-1 infected adults switching from ATRIPLA to ODEFSEY |
Exclusivity Code: NCE - New chemical entity | Nov 5, 2020 |
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 RX (2MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6956026 Use of exendins for the reduction of food intake Claim Types: Method of use | Jan 7, 2018 | U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4 |
Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity Claim Types: Method of use | Jan 7, 2018 | U-1224: Reductions in body weight are observed with exenatide |
Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use | Jan 14, 2020 | U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation; Process; Method of use; Product-by-process | May 25, 2020 | |
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation | May 25, 2020 | |
Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions Claim Types: Formulation; Method of administration | Aug 10, 2020 | |
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Method of use | Oct 4, 2020 | U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process | Aug 31, 2021 | |
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process | Oct 9, 2022 | |
Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation | Apr 15, 2024 | |
Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 15, 2024 | U-412: Treatment of Type 2 diabetes |
Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Jun 30, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus U-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4 U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4 U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4 |
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 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation | Mar 21, 2028 | |
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use | 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 | Mar 21, 2028 | |
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation | 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 | Dec 16, 2029 | |
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 | 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: M - Miscellaneous | Sep 24, 2018 | M-162: Inclusion of efficacy and safety data to the prescribing information of BYDUREON based on study GWDE |
Exclusivity Code: M - Miscellaneous | Oct 20, 2020 | M-212: Information added to the labeling regarding the safety and efficacy of dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and exenatide extended release |
Exclusivity Code: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 RX (2MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6956026 Use of exendins for the reduction of food intake Claim Types: Method of use | Jan 7, 2018 | U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4 |
Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity Claim Types: Method of use | Jan 7, 2018 | U-1224: Reductions in body weight are observed with exenatide |
Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use | Jan 14, 2020 | U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation; Process; Method of use; Product-by-process | May 25, 2020 | |
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation | May 25, 2020 | |
Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions Claim Types: Formulation; Method of administration | Aug 10, 2020 | |
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Method of use | Oct 4, 2020 | U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process | Aug 31, 2021 | |
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process | Oct 9, 2022 | |
Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation | Apr 15, 2024 | |
Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 15, 2024 | U-412: Treatment of Type 2 diabetes |
Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use | Jun 30, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus U-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4 U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4 U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4 |
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 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device | Nov 12, 2027 | |
Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device | Jan 12, 2028 | |
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation | Mar 21, 2028 | |
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use | 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 | Mar 21, 2028 | |
Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device | Mar 25, 2028 | |
Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process | Mar 25, 2028 | |
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation | Aug 19, 2028 | |
Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device | Feb 4, 2029 | |
Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device | May 19, 2029 | |
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process | Dec 16, 2029 | |
Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device | Jan 7, 2030 | |
Pat. No. 8721615 DP* Typo in the monthly Orange Book patent data file. The actual number is 8721615 Claim Types: | 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 | 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: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
VIREAD (TABLET) (ORAL) TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 021356 Prod. No.: 001 RX (300MG); 002 RX (150MG); 003 RX (200MG); 004 RX (250MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
VIREAD (POWDER) (ORAL) TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 022577 Prod. No.: 001 RX (40MG/SCOOPFUL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | Jan 25, 2018 *PED | U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older U-248: Treatment of HIV U-250: Treatment of hepatitis B infection U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents U-999: Treatment of chronic hepatitis B in adult patients |
ZORTRESS (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS NDA No.: 021560 Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (0.75MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6239124 Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin Claim Types: Formulation; Method of use; Kit; Process | Jan 29, 2018 *PED | U-1049: Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a renal transplant |
Pat. No. 6455518 Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory compositions comprising cyclosporine A and 40-0-(2-hydroxyethyl)-rapamycin Claim Types: Formulation; Method of use | Jan 29, 2018 *PED | U-1049: Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a renal transplant U-1365: Prophylaxis of allograft rejection in adult patients receiving a liver transplant |
Pat. No. 5665772 DS* DP* O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants Claim Types: Compound; Composition; Method of use | Mar 9, 2020 *PED | U-1049: Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a renal transplant U-1365: Prophylaxis of allograft rejection in adult patients receiving a liver transplant |
STIOLTO RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist; anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206756 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE39820 DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition | Jan 30, 2018 | U-1702: Treatment of copd |
Pat. No. 6846413 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 6977042 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 7802568 DP* Cartridge for a liquid Claim Types: Device | Aug 26, 2019 *PED | |
Pat. No. 6988496 DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container | Aug 23, 2020 *PED | |
Pat. No. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device | Aug 4, 2021 | |
Pat. No. 7491719 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments Claim Types: Compound; New polymorph, salt or hydrate; Composition | Nov 10, 2023 | |
Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate | Nov 10, 2023 | |
Pat. No. 7786111 DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Composition; Formulation | Nov 10, 2023 | |
Pat. No. 8044046 Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Method of use | Nov 10, 2023 | U-1702: Treatment of copd |
Pat. No. 7056916 DS* DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; Composition; Formulation | Dec 7, 2023 | |
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device | Feb 26, 2025 *PED | |
Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use | May 12, 2025 | U-1703: Treatment of respiratory complaints |
Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use | May 12, 2025 | U-1702: Treatment of copd |
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process | May 26, 2025 | |
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process | Mar 31, 2027 | |
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 | Apr 10, 2027 *PED | |
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device | Sep 13, 2028 *PED | |
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration | Oct 16, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Mar 18, 2019 | M-173: Information added to the clinical studies section of the labeling describing the effects of STIOLTO RESPIMAT on COPD patients |
Exclusivity Code: NC - New combination | May 21, 2018 | |
Exclusivity Code: NCE - New chemical entity | Jul 31, 2019 |
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug; serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: PERNIX IRELAND LTD NDA No.: 021926 Prod. No.: 001 RX (500MG;EQ 85MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6060499 DP* Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs Claim Types: Method of use; Formulation; Drug in a container | Feb 14, 2018 *PED | U-867: Treatment of migraine |
Pat. No. 6586458 DP* Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs Claim Types: Method of use; Composition; Drug in a container | Feb 14, 2018 *PED | U-867: Treatment of migraine |
Pat. No. 8022095 DP* Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs Claim Types: Formulation; Method of use | Feb 14, 2018 *PED | U-867: Treatment of migraine |
Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration | Apr 2, 2026 *PED | U-867: Treatment of migraine |
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Drug Classes: nonsteroidal anti-inflammatory drug; serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: PERNIX IRELAND LTD NDA No.: 021926 Prod. No.: 002 DISC (60MG;EQ 10MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5872145 DP* Formulation of 5-HT agonist and NSAID for treatment of migraine Claim Types: Method of use; Formulation; Product-by-process | Feb 14, 2018 *PED | U-1719: Acute treatment of migraine |
Pat. No. 6060499 DP* Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs Claim Types: Method of use; Formulation; Drug in a container | Feb 14, 2018 *PED | U-1719: Acute treatment of migraine |
Pat. No. 6586458 DP* Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs Claim Types: Method of use; Composition; Drug in a container | Feb 14, 2018 *PED | U-1719: Acute treatment of migraine |
Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration | Apr 2, 2026 *PED | U-1719: Acute treatment of migraine |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Nov 14, 2018 PED |
CRIXIVAN (CAPSULE) (ORAL) INDINAVIR SULFATE
Drug Classes: HIV protease inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 020685 Prod. No.: 001 RX (EQ 400MG BASE); 003 RX (EQ 200MG BASE) NDA No.: 020685 Prod. No.: 005 DISC (EQ 333MG BASE); 006 DISC (EQ 100MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6645961 DP* Dry granulation formulation for an HIV protease inhibitor Claim Types: Formulation; Process | Mar 4, 2018 | |
Pat. No. 6689761 Combination therapy for HIV infection Claim Types: Composition; Method of use | Feb 10, 2021 | U-554: Treating HIV infection with indinavir sulfate in combination with antiretroviral agents |
SENSIPAR (TABLET) (ORAL) CINACALCET HYDROCHLORIDE [GENERIC AB]
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: AMGEN NDA No.: 021688 Prod. No.: 001 RX (EQ 30MG BASE); 002 RX (EQ 60MG BASE); 003 RX (EQ 90MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6011068 DS* DP* [Extended 449 days (1.2 years)] Calcium receptor-active molecules Claim Types: Compound; Composition | Mar 8, 2018 | |
Pat. No. 7829595 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation; Method of use | Sep 22, 2026 | U-1098: Method of treating hyperparathyroidism; method of treating hypercalcemia |
Pat. No. 9375405 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation | Sep 22, 2026 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | May 23, 2020 | M-200: Clinical information added to the use in specific populations section of the labeling. |
Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2021 | ODE-78: Treatment of hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 25, 2018 | ODE-8: Treatment of severe hypercalcemia in patients with primaryhyperparathyroidism who are unable to undergo parathyroidectomy |
GIAZO (TABLET) (ORAL) BALSALAZIDE DISODIUM [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL NDA No.: 022205 Prod. No.: 001 RX (1.1GM)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6197341 DP* Formulations of balsalazide and its derivatives Claim Types: Composition; Process; Method of use | Mar 13, 2018 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
Pat. No. 9192616 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of use | Aug 2, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
Pat. No. 7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of administration | Aug 24, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
Pat. No. 7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of administration | Aug 24, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
Pat. No. 8497256 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males Claim Types: Method of use; Method of administration | Jun 23, 2031 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
FACTIVE (TABLET) (ORAL) GEMIFLOXACIN MESYLATE [GENERIC AB]
Drug Classes: quinolone antimicrobial
NDA Applicant: LG CHEM LTD NDA No.: 021158 Prod. No.: 001 RX (EQ 320MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6723734 DS* DP* Salt of naphthyridine carboxylic acid derivative Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process | Mar 20, 2018 | |
Pat. No. 6340689 Methods of use of quinolone compounds against atypical upper respiratory pathogenic bacteria Claim Types: Method of use | Sep 14, 2019 | U-512: Use of quinolone compounds against atypical upper respiratory pathogenic bacteria |
Pat. No. 6262071 Methods of use of antimicrobial compounds against pathogenic amycoplasma bacteria Claim Types: Method of use | Sep 21, 2019 | U-513: Methods of use of antimicrobial compounds against pathogenic amycoplasma bacteria |
Pat. No. 6331550 Methods of use of quinolone compounds against anaerobic pathogenic bacteria Claim Types: Method of use | Sep 21, 2019 | U-511: Use of quinolone compounds against anaerobic pathogenic bacteria |
Pat. No. 6455540 Methods of use of quinolone compounds against anaerobic pathogenic bacteria Claim Types: Method of use | Sep 21, 2019 | U-511: Use of quinolone compounds against anaerobic pathogenic bacteria |
Pat. No. 6803376 DS* DP* Method of use of quinolone compounds against pneumococcal and haemophilus bacteria Claim Types: Method of use | Sep 21, 2019 | U-608: Use of quinolone compounds against pneumococcal pathogenic bacteria U-609: Use of quinolone compounds against quinolone-resistant pneumococcal pathogenic bacteria |
FORTAMET (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB2]
Drug Classes: biguanide
NDA Applicant: ANDRX LABS LLC NDA No.: 021574 Prod. No.: 001 RX (500MG); 002 RX (1GM)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6099859 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | Mar 20, 2018 | |
Pat. No. 6495162 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | Mar 20, 2018 | |
Pat. No. 7919116 DP* Controlled release metformin formulations Claim Types: Method of administration | Mar 20, 2018 | |
Pat. No. 8475841 Controlled release metformin formulations Claim Types: Method of administration | Mar 20, 2018 | U-604: Method of lowering blood glucose by once daily administration |
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin Claim Types: Method of use | Mar 17, 2021 | U-604: Method of lowering blood glucose by once daily administration |
Pat. No. 6866866 DP* Controlled release metformin compositions Claim Types: Composition; Formulation | Mar 17, 2021 |
ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022024 Prod. No.: 001 RX (1GM;EQ 15MG BASE); 002 RX (1GM;EQ 30MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6099859 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | Mar 20, 2018 | |
Pat. No. 6495162 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | Mar 20, 2018 | |
Pat. No. 7919116 Controlled release metformin formulations Claim Types: Method of administration | Mar 20, 2018 | U-1120: To reduce gastrointestinal side effects administer with a meal; as starting dose administer once daily with evening meal U-973: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone or metformin alone |
Pat. No. 8475841 Controlled release metformin formulations Claim Types: Method of administration | Mar 20, 2018 | U-973: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone or metformin alone |
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin Claim Types: Method of use | Mar 17, 2021 | U-974: Adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes who are already treated with a pioglitazone and metformin |
Pat. No. 6866866 DP* Controlled release metformin compositions Claim Types: Composition; Formulation | Mar 17, 2021 | |
Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation | Sep 19, 2023 | |
Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation | Sep 19, 2023 | |
Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation | Sep 19, 2023 | |
Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation | Jul 31, 2026 | |
Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation | Jul 31, 2026 |
BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203341 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 500MG BASE); 003 RX (EQ 400MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6002008 DS* DP* Substituted 3-cyano quinolines Claim Types: Compound; Method of use; Composition | Mar 27, 2018 | U-1284: A method of treating a neoplasm |
Pat. No. RE42376 DS* Substituted 3-cyanoquinolines Claim Types: Compound; Composition | Apr 13, 2024 | |
Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Formulation | Dec 11, 2025 | |
Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Method of use | Jan 23, 2026 | U-1283: A method of treating chronic myelogenous leukemia |
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 | Nov 23, 2026 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Dec 19, 2020 | I-759: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+CML) |
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) |
Exclusivity Code: ODE - Orphan drug exclusivity | Sep 4, 2019 | ODE-30: Treatment of adult patients with chronic, accelerated or blast phase philadelphia chromosome-positive (ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy |
KETEK (TABLET) (ORAL) TELITHROMYCIN
Drug Classes: ketolide antibacterial
NDA Applicant: SANOFI AVENTIS US NDA No.: 021144 Prod. No.: 001 DISC (400MG); 002 DISC (300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5635485 DS* DP* [Extended 1076 days* (2.9 years)] Erythromycin compounds Claim Types: Compound; Method of use | Apr 1, 2018 | U-578: Treatment of community acquired pneumonia, acute exacerbation of chronic bronchitis, and acute bacterial sinusitis caused by susceptible strains of designated microorganisms in patients 18 years and older. |
NASONEX (SPRAY, METERED) (NASAL) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: MERCK SHARP DOHME NDA No.: 020762 Prod. No.: 001 RX (EQ 0.05MG BASE/SPRAY)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6127353 DS* DP* Mometasone furoate monohydrate, process for making same and pharmaceutical compositions Claim Types: New polymorph, salt or hydrate; Composition; Formulation | Apr 3, 2018 *PED |
ALVESCO (AEROSOL, METERED) (INHALATION) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021658 Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6120752 DP* Medicinal aerosol products containing formulations of ciclesonide and related steroids Claim Types: Device; Drug in a container | May 13, 2018 | |
Pat. No. 6264923 DP* Medicinal aerosol formulation of ciclesonide and related compounds Claim Types: Composition; Formulation; Drug in a container | May 13, 2018 | |
Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases Claim Types: Method of use | Feb 1, 2028 | U-1355: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. patent claims method for treating a respiratory disease in a child |
ZETONNA (AEROSOL, METERED) (NASAL) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 202129 Prod. No.: 001 RX (0.037MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6120752 DP* Medicinal aerosol products containing formulations of ciclesonide and related steroids Claim Types: Device; Drug in a container | May 13, 2018 | |
Pat. No. 6264923 DP* Medicinal aerosol formulation of ciclesonide and related compounds Claim Types: Composition; Formulation; Drug in a container | May 13, 2018 | |
Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases Claim Types: Method of use | Feb 1, 2028 | U-1357: Treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. patent claims methods for treating a respiratory disease in a child |
NEUTREXIN (INJECTABLE) (INJECTION) TRIMETREXATE GLUCURONATE
NDA Applicant: MEDIMMUNE ONCOLOGY NDA No.: 020326 Prod. No.: 001 DISC (EQ 25MG BASE/VIAL); 002 DISC (EQ 200MG BASE/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6017922 Thermally stable trimetrexates and processes for producing the same Claim Types: New polymorph, salt or hydrate; Composition | May 18, 2018 |
CIALIS (TABLET) (ORAL) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY NDA No.: 021368 Prod. No.: 001 RX (5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5859006 DS* DP* [Extended 679 days* (1.9 years)] Tetracyclic derivatives; process of preparation and use Claim Types: Compound; Method of use; Composition; Process | May 21, 2018 *PED | |
Pat. No. 6943166 Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Claim Types: Method of use | Oct 26, 2020 *PED | U-1184: Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia U-155: Treatment of erectile dysfunction U-614: Treatment of sexual dysfunction |
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions Claim Types: Formulation; Method of use | Oct 26, 2020 *PED | U-1184: Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia U-155: Treatment of erectile dysfunction |
Pat. No. 6821975 DS* DP* Beta-carboline drug products Claim Types: Formulation; Method of use; Process | May 19, 2021 *PED | U-1184: Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia U-533: Erectile dysfunction U-614: Treatment of sexual dysfunction |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Aug 15, 2021 PED | M-219: Information added to the pediatric use section of the labeling regarding a new clinical trial in patients 7 to 14 years of age with duchenne muscular dystrophy |
CIALIS (TABLET) (ORAL) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY NDA No.: 021368 Prod. No.: 002 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5859006 DS* DP* [Extended 679 days* (1.9 years)] Tetracyclic derivatives; process of preparation and use Claim Types: Compound; Method of use; Composition; Process | May 21, 2018 *PED | |
Pat. No. 6943166 Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Claim Types: Method of use | Oct 26, 2020 *PED | U-155: Treatment of erectile dysfunction U-614: Treatment of sexual dysfunction |
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions Claim Types: Formulation; Method of use | Oct 26, 2020 *PED | U-155: Treatment of erectile dysfunction |
Pat. No. 6821975 DS* DP* Beta-carboline drug products Claim Types: Formulation; Method of use; Process | May 19, 2021 *PED | U-533: Erectile dysfunction U-614: Treatment of sexual dysfunction |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Aug 15, 2021 PED | M-219: Information added to the pediatric use section of the labeling regarding a new clinical trial in patients 7 to 14 years of age with duchenne muscular dystrophy |
CIALIS (TABLET) (ORAL) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY NDA No.: 021368 Prod. No.: 003 RX (20MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5859006 DS* DP* [Extended 679 days* (1.9 years)] Tetracyclic derivatives; process of preparation and use Claim Types: Compound; Method of use; Composition; Process | May 21, 2018 *PED | |
Pat. No. 6943166 Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Claim Types: Method of use | Oct 26, 2020 *PED | U-614: Treatment of sexual dysfunction |
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions Claim Types: Formulation; Method of use | Oct 26, 2020 *PED | U-155: Treatment of erectile dysfunction |
Pat. No. 6821975 DS* DP* Beta-carboline drug products Claim Types: Formulation; Method of use; Process | May 19, 2021 *PED | U-533: Erectile dysfunction U-614: Treatment of sexual dysfunction |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Aug 15, 2021 PED | M-219: Information added to the pediatric use section of the labeling regarding a new clinical trial in patients 7 to 14 years of age with duchenne muscular dystrophy |
CIALIS (TABLET) (ORAL) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY NDA No.: 021368 Prod. No.: 004 RX (2.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5859006 DS* DP* [Extended 679 days* (1.9 years)] Tetracyclic derivatives; process of preparation and use Claim Types: Compound; Method of use; Composition; Process | May 21, 2018 *PED | |
Pat. No. 6943166 Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Claim Types: Method of use | Oct 26, 2020 *PED | U-155: Treatment of erectile dysfunction |
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions Claim Types: Formulation; Method of use | Oct 26, 2020 *PED | U-155: Treatment of erectile dysfunction |
Pat. No. 6821975 DS* DP* Beta-carboline drug products Claim Types: Formulation; Method of use; Process | May 19, 2021 *PED | U-533: Erectile dysfunction U-614: Treatment of sexual dysfunction |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Aug 15, 2021 PED | M-219: Information added to the pediatric use section of the labeling regarding a new clinical trial in patients 7 to 14 years of age with duchenne muscular dystrophy |
ADCIRCA (TABLET) (ORAL) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: ELI LILLY CO NDA No.: 022332 Prod. No.: 001 RX (20MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5859006 DS* DP* [Extended 679 days* (1.9 years)] Tetracyclic derivatives; process of preparation and use Claim Types: Compound; Method of use; Composition; Process | May 21, 2018 *PED | U-975: Treatment of pulmonary hypertension |
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions Claim Types: Formulation; Method of use | Oct 26, 2020 *PED | |
Pat. No. 6821975 DS* DP* Beta-carboline drug products Claim Types: Formulation; Method of use; Process | May 19, 2021 *PED |
VYZULTA (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROSTENE BUNOD
NDA Applicant: BAUSCH AND LOMB NDA No.: 207795 Prod. No.: 001 RX (0.024%)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6211233 DS* DP* Prostaglandin pharmaceutical compositions Claim Types: Compound; Method of use | Jun 17, 2018 | |
Pat. No. 7629345 DP* Prostaglandin derivatives Claim Types: Composition; Method of use | Jan 5, 2025 | U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
Pat. No. 7910767 DS* DP* Prostaglandin derivatives Claim Types: Compound; Process; Composition; Method of use | Jan 5, 2025 | U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
Pat. No. 8058467 DS* Prostaglandin derivatives Claim Types: Compound; Method of use | Jan 5, 2025 | U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
Pat. No. 7273946 DS* DP* Prostaglandin derivatives Claim Types: Compound; Process; Composition; Method of use | Oct 3, 2025 | U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
APIDRA (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML)); 002 RX (300 UNITS/3ML (100 UNITS/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | Jun 18, 2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation | Mar 22, 2022 | |
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use | Mar 22, 2022 | U-471: Method of treating a patient suffering from diabetes mellitus |
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Process | Jan 25, 2023 | U-471: Method of treating a patient suffering from diabetes mellitus |
APIDRA SOLOSTAR (INJECTABLE) (SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 003 RX (300 UNITS/3ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | Jun 18, 2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation | Mar 22, 2022 | |
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use | Mar 22, 2022 | U-471: Method of treating a patient suffering from diabetes mellitus |
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Process | Jan 25, 2023 | U-471: Method of treating a patient suffering from diabetes mellitus |
Pat. No. 8603044 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9233211 DP* Relating to a pen-type injector Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9408979 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9526844 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9775954 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device; Method of administration | Mar 2, 2024 | U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve |
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Mar 3, 2024 | |
Pat. No. 9011391 Pen-type injector Claim Types: Method of use | Mar 26, 2024 | U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve |
Pat. No. 8992486 DP* Pen-type injector Claim Types: Device | Jun 5, 2024 | |
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 16, 2024 | |
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 17, 2024 | |
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 19, 2024 | |
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 28, 2024 | |
Pat. No. 8512297 DP* Pen-type injector Claim Types: Device | Sep 15, 2024 | |
Pat. No. 8679069 DP* Pen-type injector Claim Types: Device | Apr 12, 2025 | |
Pat. No. 7918833 DP* Pen-type injector Claim Types: Device | Sep 23, 2027 | |
Pat. No. 9717852 DP* Cartridge holder and pen-type injector Claim Types: Device | Apr 8, 2033 |
FLOVENT HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD NDA No.: 021433 Prod. No.: 002 RX (0.11MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6170717 DP* Valve for aerosol container Claim Types: Device | Jun 23, 2018 *PED | |
Pat. No. 6315173 DP* Valve for aerosol container Claim Types: Device | Jun 23, 2018 *PED | |
Pat. No. 6510969 DP* Valve for aerosol container Claim Types: Device | Jun 23, 2018 *PED | |
Pat. No. 6966467 DP* Valve for aerosol container Claim Types: Device | Jun 23, 2018 *PED | |
Pat. No. 6161724 DP* Indicating device Claim Types: Device | Jul 16, 2018 *PED | |
Pat. No. 6435372 DP* Delivery system for a medicament and method for the assembly thereof Claim Types: Device; Process | Jul 16, 2018 *PED | |
Pat. No. 6938796 DP* Indicating device Claim Types: Device; Process; Method of administration | Jul 16, 2018 *PED | |
Pat. No. 6997349 DP* Indicating device Claim Types: Device; Kit; Process | Jul 16, 2018 *PED | |
Pat. No. 7143908 DP* Indicating device Claim Types: Device; Process | Jul 16, 2018 *PED | |
Pat. No. 6431168 DP* Dispenser with doses' counter Claim Types: Device; Method of administration; Drug in a container | Dec 8, 2018 *PED | |
Pat. No. 7107986 DP* Dispenser with doses' counter Claim Types: Device | Dec 8, 2018 *PED | |
Pat. No. 7350676 DP* Valve for aerosol container Claim Types: Device | Feb 24, 2019 *PED | |
Pat. No. 9861771 DP* Device housing for an aerosol container Claim Types: Device | Oct 11, 2020 | |
Pat. No. 6743413 Suspension aerosol formulations Claim Types: Composition; Device; Method of use | Dec 1, 2021 *PED | U-581: Method of treating a condition capable of treatment by inhalation, e.g. asthma, comprising administration of a formulation claimed in US Patent No. 6743413 |
Pat. No. 7832351 DP* Actuation indicator for a dispensing device Claim Types: Device | Dec 19, 2023 *PED | |
Pat. No. 7500444 DP* Actuation indicator for a dispensing device Claim Types: Device | Aug 26, 2026 *PED |
LEXIVA (TABLET) (ORAL) FOSAMPRENAVIR CALCIUM [GENERIC AB]
NDA Applicant: VIIV HLTHCARE NDA No.: 021548 Prod. No.: 001 RX (EQ 700MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6436989 DS* DP* Prodrugs of aspartyl protease inhibitors Claim Types: Compound; Composition; Method of use | Jun 24, 2018 *PED | U-257: Treatment of HIV infection |
Pat. No. 6514953 DS* DP* Calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl- 2-(phosphonooxy)propylcarbamate Claim Types: New polymorph, salt or hydrate; Process; Method of use; | Jan 15, 2020 *PED | U-257: Treatment of HIV infection |
LEXIVA (SUSPENSION) (ORAL) FOSAMPRENAVIR CALCIUM
NDA Applicant: VIIV HLTHCARE NDA No.: 022116 Prod. No.: 001 RX (EQ 50MG BASE/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6436989 DS* DP* Prodrugs of aspartyl protease inhibitors Claim Types: Compound; Composition; Method of use | Jun 24, 2018 *PED | U-257: Treatment of HIV infection |
SOLTAMOX (SOLUTION) (ORAL) TAMOXIFEN CITRATE
Drug Classes: estrogen agonist/antagonist
NDA Applicant: MIDATECH PHARMA US NDA No.: 021807 Prod. No.: 001 RX (EQ 20MG BASE/10ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6127425 DP* Oral liquid medicine solution Claim Types: Composition; Formulation; Process | Jun 26, 2018 |
EMEND (CAPSULE) (ORAL) APREPITANT [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK NDA No.: 021549 Prod. No.: 001 RX (80MG); 002 RX (125MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Jul 1, 2018 | U-1743: For the prevention of nausea and vomiting associated with chemotherapy U-1744: Prevention of post-operative nausea and vomiting U-745: Treatment or prevention of emesis U-745: Treatment or prevention of emesis |
Pat. No. 6096742 Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Jul 1, 2018 | |
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist Claim Types: Formulation; Method of use | Sep 26, 2027 | U-1743: For the prevention of nausea and vomiting associated with chemotherapy U-901: Prevention of postoperative nausea and vomiting |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
EMEND (CAPSULE) (ORAL) APREPITANT [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK NDA No.: 021549 Prod. No.: 003 RX (40MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Jul 1, 2018 | U-1743: For the prevention of nausea and vomiting associated with chemotherapy U-1744: Prevention of post-operative nausea and vomiting U-745: Treatment or prevention of emesis |
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist Claim Types: Formulation; Method of use | Sep 26, 2027 | U-1743: For the prevention of nausea and vomiting associated with chemotherapy U-901: Prevention of postoperative nausea and vomiting |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
EMEND (FOR SUSPENSION) (ORAL) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MSD MERCK CO NDA No.: 207865 Prod. No.: 001 RX (125MG/KIT)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Jul 1, 2018 | U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV) |
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist Claim Types: Formulation; Method of use | Sep 26, 2027 | U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
BRILINTA (TABLET) (ORAL) TICAGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022433 Prod. No.: 001 RX (90MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6251910 DS* 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists Claim Types: Compound; Composition; Method of use; Process | Jul 15, 2018 | |
Pat. No. 6525060 DS* DP* Triazolo(4,5-d)pyrimidine compounds Claim Types: Compound; Composition; Method of use | Dec 2, 2019 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1862: Treatment of post-myocardial infarction U-1863: Treatment of stroke |
Pat. No. 7250419 DS* DP* Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition Claim Types: Compound; Composition; Method of use | Dec 2, 2019 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1864: Treatment of myocardial infarction U-1865: Treatment of thrombotic stroke U-1866: Treatment of stable and unstable angina U-1867: Method of inhibiting platelet aggregation |
Pat. No. 7265124 DS* DP* Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound Claim Types: New polymorph, salt or hydrate; Process; Method of use | Jul 9, 2021 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarction U-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease |
Pat. No. RE46276 DS* DP* Triazolo(4,5-D)pyrimidine compounds Claim Types: Compound; Composition; Process; Method of use | Oct 30, 2024 | U-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction |
Pat. No. 8425934 DP* Pharmaceutical compositions Claim Types: Formulation | Apr 17, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Sep 3, 2018 | I-714: Extends the 2011 approval of BRILINTA for use beginning with ACS to use beginning more remote from myocardial infarction |
BRILINTA (TABLET) (ORAL) TICAGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022433 Prod. No.: 002 RX (60MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6251910 DS* 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists Claim Types: Compound; Composition; Method of use; Process | Jul 15, 2018 | |
Pat. No. 6525060 DS* DP* Triazolo(4,5-d)pyrimidine compounds Claim Types: Compound; Composition; Method of use | Dec 2, 2019 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1862: Treatment of post-myocardial infarction U-1863: Treatment of stroke |
Pat. No. 7250419 DS* DP* Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition Claim Types: Compound; Composition; Method of use | Dec 2, 2019 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1864: Treatment of myocardial infarction U-1865: Treatment of thrombotic stroke U-1866: Treatment of stable and unstable angina U-1867: Method of inhibiting platelet aggregation |
Pat. No. 7265124 DS* DP* Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound Claim Types: New polymorph, salt or hydrate; Process; Method of use | Jul 9, 2021 | U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarction U-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease |
Pat. No. RE46276 DS* DP* Triazolo(4,5-D)pyrimidine compounds Claim Types: Compound; Composition; Process; Method of use | Oct 30, 2024 | U-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction |
Pat. No. 8425934 DP* Pharmaceutical compositions Claim Types: Formulation | Apr 17, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NS - New strength | Sep 3, 2018 |
PAXIL (CAPSULE) (ORAL) PAROXETINE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: APOTEX TECHNOLOGIES NDA No.: 020885 Prod. No.: 001 DISC (EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 002 DISC (EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 003 DISC (EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 004 DISC (EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6172233 Process for making paroxetine Claim Types: Product-by-process; Process | Jul 15, 2018 *PED | |
Pat. No. 6063927 Paroxetine derivatives Claim Types: Composition; Product-by-process | Oct 23, 2019 *PED |
SUSTIVA (CAPSULE) (ORAL) EFAVIRENZ [GENERIC AB]
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 020972 Prod. No.: 001 RX (50MG); 003 RX (200MG) NDA No.: 020972 Prod. No.: 002 DISC (100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6939964 DS* Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Jul 20, 2018 *PED | |
Pat. No. 6639071 DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4- trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Aug 14, 2018 *PED | |
Pat. No. 6238695 DP* Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Claim Types: Formulation; Process | Oct 6, 2019 *PED | |
Pat. No. 6555133 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Claim Types: Method of use | Oct 6, 2019 *PED | U-248: Treatment of HIV |
SUSTIVA (TABLET) (ORAL) EFAVIRENZ [GENERIC AB]
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 021360 Prod. No.: 002 RX (600MG) NDA No.: 021360 Prod. No.: 001 DISC (300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6939964 DS* Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Jul 20, 2018 *PED | |
Pat. No. 6639071 DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4- trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | Aug 14, 2018 *PED |
VALTURNA (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; VALSARTAN
Drug Classes: renin inhibitor; angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022217 Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use | Jul 21, 2018 | U-3: Treatment of hypertension |
Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension Claim Types: Composition | Jul 3, 2026 |
TEKAMLO (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker
NDA Applicant: NOVARTIS NDA No.: 022545 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE); 002 DISC (EQ 150MG BASE;EQ 10MG BASE); 003 DISC (EQ 300MG BASE;EQ 5MG BASE); 004 DISC (EQ 300MG BASE;EQ 10MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use | Jul 21, 2018 | U-3: Treatment of hypertension |
Pat. No. 8613949 DP* Galenical formulations of organic compounds Claim Types: Formulation; Process | Dec 21, 2029 |
AMTURNIDE (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS NDA No.: 200045 Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use | Jul 21, 2018 | U-3: Treatment of hypertension |
Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases Claim Types: Composition; Formulation | Nov 15, 2021 | |
Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation | May 16, 2023 |
HEPSERA (TABLET) (ORAL) ADEFOVIR DIPIVOXIL [GENERIC AB]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: GILEAD NDA No.: 021449 Prod. No.: 001 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6451340 DS* DP* Nucleotide analog compositions Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation | Jul 23, 2018 | U-470: Therapy in chronic hepatitis B virus infection |
RAVICTI (LIQUID) (ORAL) GLYCEROL PHENYLBUTYRATE
Drug Classes: hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: HORIZON THERAPS INC NDA No.: 203284 Prod. No.: 001 RX (1.1GM/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5968979 DS* DP* Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders Claim Types: Method of use; Compound; Formulation; Composition | Jul 28, 2018 | U-1378: Treatment of a nitrogen metabolism disorder |
Pat. No. 8642012 Methods of treatment using ammonia-scavenging drugs Claim Types: Method of use; Method of administration | Sep 22, 2030 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat. No. 9561197 Methods of therapeutic monitoring of phenylacetic acid prodrugs Claim Types: Method of use | Sep 22, 2030 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat. No. 9962359 Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use | Sep 22, 2030 | U-1816: Treatment of a urea cycle disorder |
Pat. No. 9999608 Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use | Sep 22, 2030 | U-1816: Treatment of a urea cycle disorder |
Pat. No. 8404215 Methods of therapeutic monitoring of nitrogen scavenging Claim Types: Method of administration | Mar 9, 2032 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat. No. 9095559 Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of improving a treatment; Method of use | Mar 9, 2032 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat. No. 9254278 Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use; Method of administration | Mar 9, 2032 | U-1816: Treatment of a urea cycle disorder |
Pat. No. 9326966 Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of administration | Mar 9, 2032 | U-1816: Treatment of a urea cycle disorder |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Apr 28, 2020 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-157: For use as a nitrogen-binding agent for chronic management of pediatric patients >=2 months and < 2 years of age with urea cycle disorders (UCDS) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 1, 2020 | ODE-42: Use as a nitrogen-binding adjunctive therapy for chronic mgmt of adult and pediatric patients at least 2 yrs with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone |
LETAIRIS (TABLET) (ORAL) AMBRISENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: GILEAD NDA No.: 022081 Prod. No.: 001 RX (5MG); 002 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE42462 DS* Carboxylic acid derivatives, their preparation and use Claim Types: Compound | Jul 29, 2018 | |
Pat. No. 8377933 Method for treating a pulmonary hypertension condition Claim Types: Method of administration; Method of use | Dec 11, 2027 | U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil |
Pat. No. 9474752 Method for treating a pulmonary hypertension condition Claim Types: Method of use | Dec 11, 2027 | U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil |
Pat. No. 9549926 Compositions and methods of treating pulmonary hypertension Claim Types: Method of use | Oct 14, 2031 | U-1965: For the treatment of pulmonary arterial hypertension (PAH) in combination with tadalafil, wherein the weight ratio of ambrisentan to tadalafil is about 1:2 to about 1:3 |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Oct 2, 2018 | I-716: Revised indication to include language about the benefits of using LETAIRIS in combination with tadalafil to reduce the risk of disease progression and hospitalization for worsening PAH and to improve exercise ability, based on the ambition study |
GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives Claim Types: Compound; Method of use; Composition | Jul 29, 2018 | U-1067: Treatment of cancer |
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound | Jan 22, 2022 | |
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use | Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process | Oct 10, 2029 | |
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process | Dec 19, 2029 | |
Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation | Jul 5, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
Exclusivity Code: NCE - New chemical entity | Jul 12, 2018 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 003 RX (EQ 40MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives Claim Types: Compound; Method of use; Composition | Jul 29, 2018 | U-1067: Treatment of cancer |
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound | Jan 22, 2022 | |
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use | Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process | Oct 10, 2029 | |
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process | Dec 19, 2029 | |
Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation | Jul 5, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Apr 15, 2019 | I-730: New indication for the treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
Exclusivity Code: NCE - New chemical entity | Jul 12, 2018 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021395 Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE39820 DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition | Jul 30, 2018 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
Pat. No. 6777423 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions Claim Types: New polymorph, salt or hydrate; Process | Mar 24, 2022 *PED | |
Pat. No. 6908928 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof,and pharmaceutical compositions Claim Types: Composition; Product-by-process; Method of use | Mar 24, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema U-762: Treatment of chronic obstructive pulmonary disease |
Pat. No. 7309707 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: New polymorph, salt or hydrate; Process | Mar 24, 2022 *PED | |
Pat. No. 7642268 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: Composition; Formulation | Mar 24, 2022 *PED | |
Pat. No. RE38912 DP* Process for preparing powder formulations Claim Types: Product-by-process; Process | Apr 11, 2022 *PED | |
Pat. No. 7070800 DP* Inhalable powder containing tiotropium Claim Types: Formulation; Process; Method of use | Jul 22, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
Pat. No. 8022082 DP* Method for the administration of an anticholinergic by inhalation Claim Types: Method of administration; Kit | Jul 19, 2026 *PED | U-1186: Administration of an inhalable powder comprising tiotropium via device |
Pat. No. 7694676 DP* Dry powder inhaler Claim Types: Device | Sep 12, 2027 *PED | |
Pat. No. 9010323 DP* Inhaler and sieve for an inhaler Claim Types: Device | Apr 19, 2030 |
SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021936 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE39820 DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition | Jul 30, 2018 *PED | U-1593: Maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, and reduction of exacerbations in COPD patients. |
Pat. No. 6846413 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 6977042 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 7802568 DP* Cartridge for a liquid Claim Types: Device | Aug 26, 2019 *PED | |
Pat. No. 6988496 DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container | Aug 23, 2020 *PED | |
Pat. No. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device | Feb 4, 2022 *PED | |
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device | Feb 26, 2025 *PED | |
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process | Nov 26, 2025 *PED | |
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 | Apr 10, 2027 *PED | |
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process | Oct 1, 2027 *PED | |
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device | Sep 13, 2028 *PED | |
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration | Apr 16, 2031 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Mar 24, 2018 PED | |
Exclusivity Code: NPP - New patient population | Aug 15, 2020 PED |
SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021936 Prod. No.: 002 RX (EQ 0.00125MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE39820 DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition | Jul 30, 2018 *PED | |
Pat. No. 6846413 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 6977042 DP* Microstructured filter Claim Types: Device | Feb 28, 2019 *PED | |
Pat. No. 7802568 DP* Cartridge for a liquid Claim Types: Device | Aug 26, 2019 *PED | |
Pat. No. 6988496 DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container | Aug 23, 2020 *PED | |
Pat. No. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device | Feb 4, 2022 *PED | |
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device | Feb 26, 2025 *PED | |
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process | Nov 26, 2025 *PED | |
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 | Apr 10, 2027 *PED | |
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process | Oct 1, 2027 *PED | |
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device | Sep 13, 2028 *PED | |
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration | Apr 16, 2031 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Mar 15, 2019 PED | |
Exclusivity Code: NPP - New patient population | Aug 15, 2020 PED |
ZITHROMAX (FOR SUSPENSION) (ORAL) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050693 Prod. No.: 001 RX (EQ 1GM BASE/PACKET)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZITHROMAX (FOR SUSPENSION) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050710 Prod. No.: 001 RX (EQ 100MG BASE/5ML); 002 RX (EQ 200MG BASE/5ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZITHROMAX (TABLET) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050711 Prod. No.: 001 RX (EQ 250MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZITHROMAX (TABLET) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050730 Prod. No.: 001 RX (EQ 600MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZITHROMAX (INJECTABLE) (INJECTION) AZITHROMYCIN [GENERIC AP]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050733 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZITHROMAX (TABLET) (ORAL) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050784 Prod. No.: 001 RX (EQ 500MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
ZMAX (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV NDA No.: 050797 Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 | |
Pat. No. 6984403 DP* Azithromycin dosage forms with reduced side effects Claim Types: Formulation; Method of use | 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 | Feb 14, 2024 |
LUSEDRA (SOLUTION) (INTRAVENOUS) FOSPROPOFOL DISODIUM
NDA Applicant: EISAI INC NDA No.: 022244 Prod. No.: 001 DISC (1050MG/30ML (35MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6872838 DS* Water soluble prodrugs of hindered alcohols Claim Types: Compound | Aug 7, 2018 | |
Pat. No. 6204257 DS* DP* Water soluble prodrugs of hindered alcohols Claim Types: Compound; Composition; Process; Method of use | Jul 1, 2022 | U-945: Sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation |
REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE NDA No.: 021880 Prod. No.: 001 RX (5MG); 006 RX (20MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6045501 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6561976 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of improving a treatment | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6908432 Methods for delivering a drug to a patient while preventing the exposure of afoetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 8204763 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1249: Treatment of male patient having a disease or condition responsive to a teratogenic drug |
Pat. No. 8589188 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of use | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 5635517 DS* [Extended 1167 days (3.2 years)] Method of reducing TNF.alpha. levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines Claim Types: Method of use; Compound | Oct 4, 2019 | |
Pat. No. 6315720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug Claim Types: Method of administration | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6561977 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6755784 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 8315886 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of administration | Oct 23, 2020 | U-1249: Treatment of male patient having a disease or condition responsive to a teratogenic drug |
Pat. No. 8626531 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of administration; Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 7189740 Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes Claim Types: Method of use | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 8404717 Methods of treating myelodysplastic syndromes using lenalidomide Claim Types: Method of administration | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 9056120 Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine Claim Types: Method of use | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 8530498 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 8648095 Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 9101621 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 9101622 Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 7468363 Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use | Oct 7, 2023 | U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL) U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL) |
Pat. No. 7968569 Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use | Oct 7, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 7855217 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate; Composition; Formulation | Nov 24, 2024 | |
Pat. No. 7465800 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate | Apr 27, 2027 | |
Pat. No. 8741929 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas Claim Types: Method of use | Mar 8, 2028 | U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Feb 17, 2018 | I-706: Expanded indication for the treatment of patients with multiple myeloma |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 22, 2024 | ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct) |
Exclusivity Code: ODE - Orphan drug exclusivity | Jun 5, 2020 | ODE-49: Treatment of mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 17, 2022 | ODE-88: For use in combination with dexamethasone for the treatment of patients with multiple myeloma who have not received at least one prior therapy (first line treatment) |
REVLIMID (CAPSULE) (ORAL) LENALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE NDA No.: 021880 Prod. No.: 002 RX (10MG); 003 RX (15MG); 004 RX (25MG); 005 RX (2.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6045501 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6561976 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of improving a treatment | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6908432 Methods for delivering a drug to a patient while preventing the exposure of afoetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 8204763 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of administration | Aug 28, 2018 | U-1249: Treatment of male patient having a disease or condition responsive to a teratogenic drug |
Pat. No. 8589188 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug Claim Types: Method of use | Aug 28, 2018 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 5635517 DS* [Extended 1167 days (3.2 years)] Method of reducing TNF.alpha. levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines Claim Types: Method of use; Compound | Oct 4, 2019 | |
Pat. No. 6315720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug Claim Types: Method of administration | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6561977 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 6755784 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 8315886 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of administration | Oct 23, 2020 | U-1249: Treatment of male patient having a disease or condition responsive to a teratogenic drug |
Pat. No. 8626531 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated Claim Types: Method of administration; Method of improving a treatment | Oct 23, 2020 | U-1210: Use of REVLIMID (lenalidomide) while preventing the exposure of a fetus or other contraindicated individual to REVLIMID (lenalidomide) |
Pat. No. 7189740 Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes Claim Types: Method of use | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 8404717 Methods of treating myelodysplastic syndromes using lenalidomide Claim Types: Method of administration | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 9056120 Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine Claim Types: Method of use | Apr 11, 2023 | U-1215: Use of REVLIMID (lenalidomide) for the treatment of transfusion-dependent anemia in myelodysplastic syndromes (MDS) |
Pat. No. 8530498 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 8648095 Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 9101621 Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 9101622 Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone Claim Types: Method of use | May 15, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 7468363 Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use | Oct 7, 2023 | U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL) |
Pat. No. 7968569 Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: Method of use | Oct 7, 2023 | U-1216: Use of REVLIMID (lenalidomide) for the treatment of multiple myeloma |
Pat. No. 7855217 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate; Composition; Formulation | Nov 24, 2024 | |
Pat. No. 7465800 DS* DP* Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione Claim Types: New polymorph, salt or hydrate | Apr 27, 2027 | |
Pat. No. 8741929 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas Claim Types: Method of use | Mar 8, 2028 | U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Feb 17, 2018 | I-706: Expanded indication for the treatment of patients with multiple myeloma |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 22, 2024 | ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct) |
Exclusivity Code: ODE - Orphan drug exclusivity | Jun 5, 2020 | ODE-49: Treatment of mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 17, 2022 | ODE-88: For use in combination with dexamethasone for the treatment of patients with multiple myeloma who have not received at least one prior therapy (first line treatment) |
STRIVERDI RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 203108 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6846413 DP* Microstructured filter Claim Types: Device | Aug 28, 2018 | |
Pat. No. 6977042 DP* Microstructured filter Claim Types: Device | Aug 28, 2018 | |
Pat. No. 7802568 DP* Cartridge for a liquid Claim Types: Device | Feb 26, 2019 | |
Pat. No. 6988496 DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container | Feb 23, 2020 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
Pat. No. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device | Aug 4, 2021 | |
Pat. No. 7491719 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments Claim Types: Compound; New polymorph, salt or hydrate; Composition | Nov 10, 2023 | |
Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate | Nov 10, 2023 | |
Pat. No. 7786111 DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Composition; Formulation | Nov 10, 2023 | |
Pat. No. 8044046 Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Method of use | Nov 10, 2023 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
Pat. No. 7056916 DS* DP* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; Composition; Formulation | Dec 7, 2023 | |
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device | Aug 26, 2024 | |
Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use | May 12, 2025 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process | 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 | Oct 10, 2026 | U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema |
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process | Mar 31, 2027 | |
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device | Mar 13, 2028 | |
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration | Oct 16, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jul 31, 2019 |
EXUBERA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: PFIZER NDA No.: 021868 Prod. No.: 001 DISC (1MG/INH); 002 DISC (3MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6685967 DP* Methods and compositions for pulmonary delivery of insulin Claim Types: Formulation; Composition; Process | Sep 11, 2018 | |
Pat. No. 6257233 Dry powder dispersing apparatus and methods for their use Claim Types: Device; Method of use | May 14, 2019 | U-704: Method of administering insulin via inhalation |
Pat. No. 6546929 Dry powder dispersing apparatus and methods for their use Claim Types: Device; Method of use | May 14, 2019 | U-704: Method of administering insulin via inhalation |
Pat. No. 6582728 DP* Spray drying of macromolecules to produce inhaleable dry powders Claim Types: Product-by-process; Process | Jun 24, 2020 |
ASMANEX TWISTHALER (POWDER) (INHALATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: MERCK SHARP DOHME NDA No.: 021067 Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6503537 DP* Preparation of powder agglomerates Claim Types: Composition; Product-by-process; Device; Process | Sep 17, 2018 *PED | |
Pat. No. 8173172 DP* Preparation of powder agglomerates Claim Types: Formulation; Process | Sep 17, 2018 *PED |
EPIVIR (SOLUTION) (ORAL) LAMIVUDINE [GENERIC AA]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 020596 Prod. No.: 001 RX (10MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6004968 DP* Pharmaceutical compositions containing lamivudine Claim Types: Formulation; Composition; Method of use | Sep 20, 2018 *PED | U-248: Treatment of HIV |
EPIVIR-HBV (SOLUTION) (ORAL) LAMIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021004 Prod. No.: 001 RX (5MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6004968 Pharmaceutical compositions containing lamivudine Claim Types: Formulation; Composition; Method of use | Sep 20, 2018 *PED |
ZYPREXA RELPREVV (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) OLANZAPINE PAMOATE
Drug Classes: atypical antipsychotic
NDA Applicant: ELI LILLY CO NDA No.: 022173 Prod. No.: 001 RX (EQ 210MG BASE/VIAL); 002 RX (EQ 300MG BASE/VIAL); 003 RX (EQ 405MG BASE/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6169084 DS* DP* 2-methyl-thieno-benzodiazepine formulation Claim Types: New polymorph, salt or hydrate | Sep 30, 2018 | U-1026: A method of treating human suffering from or susceptible to psychosis. |
NOXAFIL (SUSPENSION) (ORAL) POSACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: SCHERING NDA No.: 022003 Prod. No.: 001 RX (40MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6958337 DS* DP* Crystalline antifungal polymorph Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Oct 5, 2018 | U-760: Prophylaxis of invasive aspergillus and candida infections and treatment of oropharyngeal candidiasis |
Pat. No. 5661151 DS* DP* [Extended 1788 days (4.9 years)] Tetrahydrofuran antifungals Claim Types: Compound; Composition | Jul 19, 2019 | U-760: Prophylaxis of invasive aspergillus and candida infections and treatment of oropharyngeal candidiasis |
Pat. No. 8263600 DP* Antifungal composition with enhanced bioavailability Claim Types: Formulation | Apr 1, 2022 |
SPINRAZA (SOLUTION) (INTRATHECAL) NUSINERSEN SODIUM
Drug Classes: antisense oligonucleotide; survival motor neuron-2 (SMN2)-directed
NDA Applicant: BIOGEN IDEC NDA No.: 209531 Prod. No.: 001 RX (12MG/5ML (2.4MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6210892 Alteration of cellular behavior by antisense modulation of mRNA processing Claim Types: Method of use | Oct 7, 2018 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA |
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound | Sep 5, 2023 | |
Pat. No. 8110560 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences Claim Types: Method of use | Dec 5, 2025 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site |
Pat. No. 7838657 DS* Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences Claim Types: Compound | Jul 11, 2027 | |
Pat. No. 8361977 DS* DP* Compositions and methods for modulation of SMN2 splicing Claim Types: Compound; Composition | May 27, 2030 | |
Pat. No. 9717750 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use; Method of administration | Jun 17, 2030 | U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA U-1943: Treatment of spinal muscular atrophy U-2093: Treatment of type ii spinal muscular atrophy U-2094: Treatment of type iii spinal muscular atrophy |
Pat. No. 8980853 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use | Nov 24, 2030 | U-1941: Treatment of infantile-onset spinal muscular atrophy |
Pat. No. 9926559 Compositions and methods for modulation of SMN2 splicing in a subject Claim Types: Method of use | Jan 9, 2034 | U-1943: Treatment of spinal muscular atrophy |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | May 14, 2021 | M-226: Changes to the labeling based on results from a controlled clinical trial in patients with later-onset spinal muscular atrophy |
Exclusivity Code: NCE - New chemical entity | Dec 23, 2021 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 23, 2023 | ODE-127: Treatment of spinal muscular atrophy in pediatric and adult patients |
TIKOSYN (CAPSULE) (ORAL) DOFETILIDE [GENERIC AB]
Drug Classes: antiarrhythmic
NDA Applicant: PFIZER NDA No.: 020931 Prod. No.: 001 RX (0.125MG); 002 RX (0.25MG); 003 RX (0.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6124363 Dofetilide polymorphs Claim Types: New polymorph, salt or hydrate; Composition; Method of use | Oct 9, 2018 |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON PHARMA USA NDA No.: 022511 Prod. No.: 001 RX (EQ 20MG BASE;500MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7745466 DP* Form of S-omeprazole Claim Types: Formulation; Method of use | Oct 13, 2018 | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of use; Method of administration | Mar 10, 2031 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Jul 6, 2020 |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON PHARMA USA NDA No.: 022511 Prod. No.: 002 RX (EQ 20MG BASE;375MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7745466 DP* Form of S-omeprazole Claim Types: Formulation; Method of use | Oct 13, 2018 | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | U-1053: Risk-reduction of nsaid-associated gastric ulcer |
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation | May 31, 2022 | |
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Jul 6, 2020 |
FOSRENOL (TABLET, CHEWABLE) (ORAL) LANTHANUM CARBONATE [GENERIC AB]
Drug Classes: phosphate binder
NDA Applicant: SHIRE LLC 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. 5968976 DP* [Extended 951 days* (2.6 years)] Pharmaceutical composition containing selected lanthanum carbonate hydrates Claim Types: Composition; Process; Method of use | Oct 26, 2018 | U-613: Reduction of serum phosphate |
Pat. No. 7381428 Stabilized lanthanum carbonate compositions Claim Types: Method of improving a treatment | 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 | Aug 26, 2024 |
FOSRENOL (POWDER) (ORAL) LANTHANUM CARBONATE
Drug Classes: phosphate binder
NDA Applicant: SHIRE DEV LLC NDA No.: 204734 Prod. No.: 001 RX (EQ 750MG BASE); 002 RX (EQ 1GM BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5968976 DP* [Extended 951 days* (2.6 years)] Pharmaceutical composition containing selected lanthanum carbonate hydrates Claim Types: Composition; Process; Method of use | Oct 26, 2018 | U-1592: To reduce serum phosphate in patients with end stage renal disease |
Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds Claim Types: Formulation | Aug 26, 2024 | |
Pat. No. 8980327 DP* Capsule and powder formulations containing lanthanum compounds Claim Types: Formulation | Dec 1, 2030 | |
Pat. No. 9023397 DP* Capsule and powder formulations containing lanthanum compounds Claim Types: Drug in a container | Dec 1, 2030 |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021379 Prod. No.: 001 RX (22.5MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021488 Prod. No.: 001 RX (30MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021731 Prod. No.: 001 RX (45MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-621: Method of treating cancer |
Pat. No. 6773714 Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-621: Method of treating cancer |
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
Pat. No. 9914802 DS* DP* Sustained release polymer Claim Types: Method of use; Process; Formulation | Nov 13, 2020 | U-1666: Palliative treatment of prostate cancer |
Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
OTEZLA (TABLET) (ORAL) APREMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: CELGENE CORP NDA No.: 205437 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6020358 DS* DP* Substituted phenethylsulfones and method of reducing TNF.alpha. levels Claim Types: Compound; Method of use; Composition | Oct 30, 2018 | U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4 |
Pat. No. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof Claim Types: Method of use | Mar 19, 2023 | U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4 |
Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione Claim Types: Method of use | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis |
Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione Claim Types: Method of use | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis |
Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione Claim Types: Method of use | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis |
Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: Method of use | Mar 19, 2023 | U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis |
Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione Claim Types: Method of use | Mar 19, 2023 | U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis |
Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof Claim Types: New polymorph, salt or hydrate; Composition | Dec 9, 2023 | |
Pat. No. 7427638 DS* DP* (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Claim Types: Composition; Formulation | Feb 16, 2028 | |
Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast Claim Types: Method of use | May 29, 2034 | U-2232: Treatment of psoriatic arthritis using a dosage titration schedule U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Mar 21, 2019 |
LEVITRA (TABLET) (ORAL) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021400 Prod. No.: 001 RX (5MG); 002 RX (10MG); 004 RX (20MG) NDA No.: 021400 Prod. No.: 003 DISC (2.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6362178 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use | Oct 31, 2018 | U-533: Erectile dysfunction |
Pat. No. 7696206 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use | Oct 31, 2018 | U-533: Erectile dysfunction |
Pat. No. 8841446 DP* Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Formulation | Jul 3, 2023 | |
Pat. No. 8273876 Medicaments containing vardenafil hydrochloride trihydrate Claim Types: Method of use; Process | Jul 23, 2027 | U-1288: Treatment of erectile dysfunction by administering a film-coated tablet |
STAXYN (TABLET, ORALLY DISINTEGRATING) (ORAL) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 200179 Prod. No.: 001 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6362178 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use | Oct 31, 2018 | U-155: Treatment of erectile dysfunction |
Pat. No. 7696206 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use | Oct 31, 2018 | U-155: Treatment of erectile dysfunction |
Pat. No. 8613950 DP* Pharmaceutical forms with improved pharmacokinetic properties Claim Types: Formulation | Dec 23, 2028 |
AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: BLUE EARTH NDA No.: 208054 Prod. No.: 001 RX (9-221mCi/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5808146 DS* Amino acid analogs for tumor imagingClaim Types: Compound | Nov 9, 2018 | |
Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound Claim Types: Diagnostic or surgical method | Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound Claim Types: Formulation | Nov 28, 2026 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | May 27, 2021 |
TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 022387 Prod. No.: 001 RX (0.6MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6521212 Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation Claim Types: Method of use | Nov 13, 2018 | U-1018: Treatment of pulmonary hypertension by inhalation |
Pat. No. 6756033 Method for delivering benzindene prostaglandins by inhalation Claim Types: Method of use | Nov 13, 2018 | U-1018: Treatment of pulmonary hypertension by inhalation |
Pat. No. 9339507 DP* Treprostinil administration by inhalation Claim Types: Kit | Mar 10, 2028 | |
Pat. No. 9358240 Treprostinil administration by inhalation Claim Types: Method of use; Method of administration | May 5, 2028 | U-1849: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device |
Pat. No. 8497393 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM Claim Types: Product-by-process | 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 | Dec 15, 2028 | |
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Claim Types: Product-by-process | Dec 15, 2028 |
ZIAGEN (TABLET) (ORAL) ABACAVIR SULFATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE NDA No.: 020977 Prod. No.: 001 RX (EQ 300MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | Nov 14, 2018 *PED | U-65: Method of treatment of a patient infected with HIV |
ZIAGEN (SOLUTION) (ORAL) ABACAVIR SULFATE [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE NDA No.: 020978 Prod. No.: 001 RX (EQ 20MG BASE/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | Nov 14, 2018 *PED | U-65: Method of treatment of a patient infected with HIV |
Pat. No. 6641843 DP* Pharmaceutical compositions Claim Types: Formulation; Process | Aug 4, 2019 *PED |
TRIZIVIR (TABLET) (ORAL) ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 021205 Prod. No.: 001 RX (EQ 300MG BASE;150MG;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | Nov 14, 2018 *PED | U-65: Method of treatment of a patient infected with HIV |
EPZICOM (TABLET) (ORAL) ABACAVIR SULFATE; LAMIVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 021652 Prod. No.: 001 RX (EQ 600MG BASE;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | Nov 14, 2018 *PED | U-257: Treatment of HIV infection |
TRIUMEQ (TABLET) (ORAL) ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 205551 Prod. No.: 001 RX (EQ 600MG BASE;EQ 50MG BASE;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | Nov 14, 2018 *PED | U-1572: Treatment of human immunodeficiency virus (HIV) infection. |
Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness Claim Types: Compound; Composition | Oct 5, 2027 | |
Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates Claim Types: New polymorph, salt or hydrate | Dec 8, 2029 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Aug 12, 2018 |
NEXIUM (CAPSULE, DELAYED REL PELLETS) (ORAL) ESOMEPRAZOLE MAGNESIUM [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021153 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence U-770: Long-term treatment of pathological hypersecretory conditions |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 8466175 Form of S-omeprazole Claim Types: Method of use | Nov 25, 2018 *PED | U-1417: Use for treatment of Helicobacter infections |
Pat. No. 6147103 Omeprazole process and compositions thereof Claim Types: Formulation | Apr 9, 2019 *PED | |
Pat. No. 6166213 Omeprazole process and compositions thereof Claim Types: Product-by-process; Process Comments: Omeprazole produced by the claimed process that has less than a specified level of residual solvent | Apr 9, 2019 *PED | |
Pat. No. 6191148 Omerazole process and compositions thereof Claim Types: Formulation Comments: Omeprazole having specified purity and residual solvent levels | Apr 9, 2019 *PED | |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-469: Treatment of gastroesophageal reflex disease (GERD) and eradication of H. pylori to reduce risk of duodenal ulcer recurrence U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence U-770: Long-term treatment of pathological hypersecretory conditions |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021957 Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 40MG BASE/PACKET)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence U-773: Pathological hypersecretory conditions |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 8466175 Form of S-omeprazole Claim Types: Method of use | Nov 25, 2018 *PED | U-1417: Use for treatment of Helicobacter infections |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence U-773: Pathological hypersecretory conditions |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021957 Prod. No.: 003 RX (EQ 2.5MG BASE/PACKET); 004 RX (EQ 5MG BASE/PACKET)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022101 Prod. No.: 001 RX (EQ 10MG BASE/PACKET)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis |
NEXIUM 24HR (CAPSULE, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM [GENERIC OTC]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP NDA No.: 204655 Prod. No.: 001 OTC (EQ 20MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1509: Treatment of frequent heartburn by administering a gastric acid reducer U-1875: Treatment of frequent heartburn by administering s-omeprazole trihydrate according to claims 1-3 |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-1509: Treatment of frequent heartburn by administering a gastric acid reducer U-1874: Treatment of frequent heartburn by administering omeprazole according to claims 1-8 |
NEXIUM 24HR (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP NDA No.: 207920 Prod. No.: 001 OTC (EQ 20MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6369085 DS* DP* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | Nov 25, 2018 *PED | U-1784: Method of treating frequent heartburn by administering an esomeprazole magnesium trihydrate as claimed |
Pat. No. 7411070 DS* Form of S-omeprazole Claim Types: New polymorph, salt or hydrate | Nov 25, 2018 *PED | |
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | May 3, 2020 *PED | U-1785: Method of treating frequent heartburn by administering an esomeprazole magnesium formulation as claimed |
IXEMPRA KIT (INJECTABLE) (IV (INFUSION)) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC NDA No.: 022065 Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7125899 DS* DP* Epothilone derivatives Claim Types: Compound; Method of use; Composition; New polymorph, salt or hydrate | Nov 26, 2018 *PED | U-957: A method of treating cancer in a patient comprising administering ixabepilone or pharmaceutical compositions comprising ixabepilone |
Pat. No. RE41911 DS* DP* Epothilone derivatives Claim Types: Compound; Method of use; Composition | Mar 28, 2021 *PED | U-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone |
Pat. No. 6670384 DP* Methods of administering epothilone analogs for the treatment of cancer Claim Types: Formulation; Method of use; Process | Jul 23, 2022 *PED | U-959: Method of treating cancer, IV admin, lyophylized ixabepilone diluted, every week or 3 weeks; lyophilized ixabepilone with solvent(dehydrated ethanol) diluted to concentration of 0.1mg/ml to 0.9mg/ml U-960: Method of treating cancer in a patient comprising intravenously administering to the patient ixabepilone diluted in a parenteral diluent |
Pat. No. 7022330 DP* Parenteral formulation for epothilone analogs Claim Types: Product-by-process; Formulation; Method of use; Process | Jul 23, 2022 *PED | U-958: Method of treating patient comprising mixing first and second vials of product comprising lyophilized ixabepilone to provide an epothilone analog solution, diluting solution with a suitable diluent to prepare intravenous formulation for PT |
Pat. No. RE41393 Treatment of refractory tumors using epothilone derivatives Claim Types: Method of use | Aug 8, 2022 *PED | U-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone |
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases Claim Types: Method of use | Feb 21, 2025 *PED | U-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer |
DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208056 Prod. No.: 001 DISC (30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7399485 DP* Rapidly Disintegrable solid preparation Claim Types: Formulation; Process | Nov 26, 2018 *PED | |
Pat. No. 6328994 DP* Orally disintegrable tablets Claim Types: Formulation | Nov 17, 2019 *PED | |
Pat. No. 7431942 DP* Orally disintegrable tablets Claim Types: Formulation | Nov 17, 2019 *PED | |
Pat. No. 7875292 DP* Orally disintegrable tablets Claim Types: Formulation | Nov 17, 2019 *PED | |
Pat. No. 9145389 DS* DP* Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition | Jun 15, 2020 | |
Pat. No. 6462058 DS* DP* Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use | Dec 15, 2020 *PED | U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
Pat. No. 6939971 Benzimidazole compound crystal Claim Types: Method of use | Dec 15, 2020 *PED | U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
Pat. No. 7285668 DS* Process for the crystallization of (R)- or (S)-lansoprazole Claim Types: New polymorph, salt or hydrate; Process | Dec 15, 2020 *PED | |
Pat. No. 6664276 DS* DP* Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process | Jul 30, 2023 *PED | U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use | Apr 15, 2024 *PED | |
Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation | Jan 17, 2026 | |
Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process | Feb 24, 2026 | |
Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use | Jul 17, 2026 *PED | |
Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation | Jul 11, 2028 *PED | |
Pat. No. 9241910 DP* Orally-disintegrating solid preparation Claim Types: Formulation | Mar 10, 2029 |
RAPAFLO (CAPSULE) (ORAL) SILODOSIN [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: ALLERGAN SALES LLC NDA No.: 022206 Prod. No.: 001 RX (4MG); 002 RX (8MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5387603 DS* DP* [Extended 5 years] 1,5,7-trisubstituted indoline compounds and salts thereof Claim Types: Compound; Composition; Method of use | Dec 1, 2018 |
BANZEL (TABLET) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC NDA No.: 021911 Prod. No.: 002 RX (200MG); 003 RX (400MG) NDA No.: 021911 Prod. No.: 001 DISC (100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 8076362 DP* Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof Claim Types: Formulation | Dec 8, 2018 *PED | |
Pat. No. 7750028 Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide Claim Types: Method of use | Apr 19, 2019 *PED | U-106: Treatment of epilepsy |
Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)] Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic Claim Types: New polymorph, salt or hydrate; Composition | May 14, 2023 *PED |
HETLIOZ (CAPSULE) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC NDA No.: 205677 Prod. No.: 001 RX (20MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 5856529 DS* DP* Benzofuran and dihydrobenzofuran melatonergic agents Claim Types: Compound; Composition; Method of use | Dec 9, 2018 | U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon |
Pat. No. RE46604 Treatment of circadian rhythm disorders Claim Types: Method of use | Jan 25, 2033 | U-2147: Treatment of non-24 hour sleep-wake disorder by orally administering 20mg of tasimelteon once daily before bedtime |
Pat. No. 9060995 Treatment of circadian rhythm disorders Claim Types: Method of improving a treatment | Jan 25, 2033 | U-1710: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with fluvoxamine |
Pat. No. 9539234 Treatment of circadian rhythm disorders Claim Types: Method of use | Jan 25, 2033 | U-1934: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with a strong cyp1a2 inhibitor |
Pat. No. 9549913 Treatment of circadian rhythm disorders Claim Types: Method of use | Jan 25, 2033 | U-1486: Treatment of non-24-hour sleep-wake disorder |
Pat. No. 9855241 Treatment of circadian rhythm disorders Claim Types: Method of use | Jan 25, 2033 | U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon |
Pat. No. 9730910 Treatment of circadian rhythm disorders Claim Types: Method of administration | May 17, 2034 | U-2085: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with rifampin |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jan 31, 2019 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Jan 31, 2021 | ODE-59: Treatment of non-24-hour sleep-wake disorder |
OFORTA (TABLET) (ORAL) FLUDARABINE PHOSPHATE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: SANOFI AVENTIS US NDA No.: 022273 Prod. No.: 001 DISC (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7547776 DS* Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% Claim Types: New polymorph, salt or hydrate | Dec 10, 2018 | |
Pat. No. 7148207 DP* Oral fludara of high-purity formulation with quick release of active ingredient Claim Types: Formulation | Dec 20, 2022 | U-944: Treatment of patients with B-cell chronic lymphocytic leukemia (CLL) |
MOZOBIL (SOLUTION) (SUBCUTANEOUS) PLERIXAFOR
Drug Classes: hematopoietic stem cell mobilizer
NDA Applicant: GENZYME NDA No.: 022311 Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE42152 DP* Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity Claim Types: Composition | Dec 10, 2018 | |
Pat. No. 6987102 Methods to mobilize progenitor/stem cells Claim Types: Method of use | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
Pat. No. 7897590 Methods to mobilize progenitor/stem cells Claim Types: Method of use | Jul 22, 2023 | U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma |
ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL NDA No.: 020835 Prod. No.: 003 RX (35MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety Claim Types: Formulation | Dec 10, 2018 *PED | |
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit | Jan 17, 2019 *PED | U-353: Prevention and treatment of osteoporosis |
Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use | Jan 17, 2019 *PED | U-353: Prevention and treatment of osteoporosis |
Pat. No. 6432932 Method for inhibiting bone resorption Claim Types: Method of use | Jan 17, 2019 *PED | U-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women |
Pat. No. 6465443 DP* Method for inhibiting bone resorption Claim Types: Composition; Kit | Feb 14, 2019 *PED |
ACTONEL WITH CALCIUM (COPACKAGED) (TABLET, TABLET) (ORAL) CALCIUM CARBONATE; RISEDRONATE SODIUM
NDA Applicant: WARNER CHILCOTT NDA No.: 021823 Prod. No.: 001 DISC (EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety Claim Types: Formulation | Dec 10, 2018 *PED | |
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit | Jan 17, 2019 *PED | U-353: Prevention and treatment of osteoporosis |
Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use | Jan 17, 2019 *PED | U-353: Prevention and treatment of osteoporosis |
Pat. No. 6432932 Method for inhibiting bone resorption Claim Types: Method of use | Jan 17, 2019 *PED | U-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women |
Pat. No. 6465443 DP* Method for inhibiting bone resorption Claim Types: Composition; Kit | Feb 14, 2019 *PED |
KENGREAL (POWDER) (INTRAVENOUS) CANGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: CHIESI USA INC NDA No.: 204958 Prod. No.: 001 RX (50MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6114313 DP* Pharmaceutical compositions for freeze dryingClaim Types: Formulation; Process; Method of use | Dec 11, 2018 | U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor |
Pat. No. 6130208 DP* Formulation containing a nucleotide analogue Claim Types: Formulation; Method of use; Process | Jun 29, 2019 | U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor |
Pat. No. 8759316 Maintenance of platelet inhibition during antiplatelet therapy Claim Types: Method of administration | May 13, 2029 | U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor |
Pat. No. 9925265 Methods of treating or preventing stent thrombosis Claim Types: Method of use | May 13, 2029 | U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion |
Pat. No. 9427448 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of use | Nov 10, 2030 | U-1926: Method of treating, reducing the incidence of, or preventing an ischemic event in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and continuous infusion of 4 ug/kg/min for at least 2 hours or the duration of the PCI |
Pat. No. 8680052 Methods of treating, reducing the incidence of, and/or preventing ischemic events Claim Types: Method of administration | Mar 9, 2033 | U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor |
Pat. No. 9295687 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Product-by-process; Drug in a container | Jul 10, 2035 | |
Pat. No. 9439921 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Formulation; Drug in a container | Jul 10, 2035 | |
Pat. No. 9700575 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same Claim Types: Composition; Formulation; Drug in a container | Jul 10, 2035 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jun 22, 2020 |
RAPIVAB (SOLUTION) (INTRAVENOUS) PERAMIVIR
Drug Classes: influenza neuraminidase inhibitor (NAI)
NDA Applicant: BIOCRYST NDA No.: 206426 Prod. No.: 001 RX (200MG/20ML (10MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6562861 DS* Substituted cyclopentane and cyclopentene compounds useful as neuraminidase inhibitors Claim Types: Compound; Composition; Method of use | Dec 17, 2018 | |
Pat. No. 6503745 DS* Cyclopentane and cyclopentene compounds for influenza virus Claim Types: Compound; Diagnostic or surgical method | Nov 5, 2019 | |
Pat. No. 8778997 Antiviral treatments Claim Types: Method of use | May 7, 2027 | U-1627: Treatment of acute uncomplicated influenza in adults |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Dec 19, 2019 | |
Exclusivity Code: NPP - New patient population | Sep 20, 2020 |
ELIDEL (CREAM) (TOPICAL) PIMECROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VALEANT BERMUDA NDA No.: 021302 Prod. No.: 001 RX (1%)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6423722 Crystalline macrolides and process for their preparation Claim Types: New polymorph, salt or hydrate; Method of use; Process | Dec 26, 2018 *PED |
LYRICA (CAPSULE) (ORAL) PREGABALIN
NDA Applicant: PF PRISM CV NDA No.: 021446 Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (75MG); 004 RX (100MG); 005 RX (150MG); 006 RX (200MG); 007 RX (225MG); 008 RX (300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain Claim Types: Method of use | Dec 30, 2018 | U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia |
Pat. No. 6001876 [Extended 533 days* (1.5 years)] Isobutylgaba and its derivatives for the treatment of pain Claim Types: Method of use | Dec 30, 2018 | U-55: Treatment of pain U-819: Management of fibromyalgia |
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)] Gamma amino butyric acid analogs and optical isomers Claim Types: Compound; Composition | Dec 30, 2018 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Dec 22, 2019 | M-193: Information added to the labeling regarding a 15-week, randomized, double-blind, parallel-group, placebo-controlled flexible-dose safety and efficacy study of pregabalin in adolescents (12 through 17 years old) with fibromyalgia |
Exclusivity Code: NPP - New patient population | May 3, 2021 |
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: opioid antagonist
NDA Applicant: ALKERMES NDA No.: 021897 Prod. No.: 001 RX (380MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 6194006 DP* Preparation of microparticles having a selected release profile Claim Types: Product-by-process; Process | Dec 30, 2018 | |
Pat. No. 6379703 DP* Preparation of microparticles having a selected release profile Claim Types: Product-by-process; Process | Dec 30, 2018 | |
Pat. No. 6596316 DP* Preparation of microparticles having a selected release profile Claim Types: Product-by-process; Process | Dec 30, 2018 | |
Pat. No. 6331317 DP* Apparatus and method for preparing microparticles Claim Types: Device; Product-by-process; Process | Nov 12, 2019 | |
Pat. No. 6395304 DP* Apparatus and method for preparing microparticles Claim Types: Formulation; Product-by-process | Nov 12, 2019 | |
Pat. No. 6495166 DP* Apparatus and method for preparing microparticles using in-line solvent extraction Claim Types: Formulation; Product-by-process | Nov 12, 2019 | |
Pat. No. 6537586 DP* Apparatus and method for preparing microparticles Claim Types: Product-by-process; Process | Nov 12, 2019 | |
Pat. No. 6713090 DP* Apparatus and method for preparing microparticles Claim Types: Product-by-process; Process | Nov 12, 2019 | |
Pat. No. 6939033 DP* Method and apparatus for preparing microparticles using in-line solvent extraction Claim Types: Product-by-process; Process | Nov 12, 2019 | |
Pat. No. 6264987 DP* Method for preparing microparticles having a selected polymer molecular weight Claim Types: Product-by-process; Process | May 19, 2020 | |
Pat. No. 6379704 DP* Method for preparing microparticles having a selected polymer molecular weight Claim Types: Product-by-process; Process | May 19, 2020 | |
Pat. No. 6534092 DP* Method for preparing microparticles having a selected polymer molecular weight Claim Types: Product-by-process; Process | May 19, 2020 | |
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation; Process; Method of use; Product-by-process | May 25, 2020 | |
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation | May 25, 2020 | |
Pat. No. 7799345 DP* Preparation of injectable suspensions having improved injectability Claim Types: Composition | May 25, 2020 | |
Pat. No. 7919499 Naltrexone long acting formulations and methods of use Claim Types: Method of use | Oct 15, 2029 | U-1123: Treatment of alcohol dependence U-1124: Prevention of relapse to opioid dependence, following opioid detoxification |
LYRICA (SOLUTION) (ORAL) PREGABALIN
NDA Applicant: PF PRISM CV NDA No.: 022488 Prod. No.: 001 RX (20MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain Claim Types: Method of use | Dec 30, 2018 | U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia |
Pat. No. 6001876 [Extended 533 days* (1.5 years)] Isobutylgaba and its derivatives for the treatment of pain Claim Types: Method of use | Dec 30, 2018 | U-55: Treatment of pain U-819: Management of fibromyalgia |
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)] Gamma amino butyric acid analogs and optical isomers Claim Types: Compound; Composition | Dec 30, 2018 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Dec 22, 2019 | M-193: Information added to the labeling regarding a 15-week, randomized, double-blind, parallel-group, placebo-controlled flexible-dose safety and efficacy study of pregabalin in adolescents (12 through 17 years old) with fibromyalgia |
Exclusivity Code: NPP - New patient population | May 3, 2021 |
LYRICA CR (TABLET, EXTENDED RELEASE) (ORAL) PREGABALIN
NDA Applicant: PFIZER INC NDA No.: 209501 Prod. No.: 001 RX (82.5MG); 002 RX (165MG); 003 RX (330MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain Claim Types: Method of use | Dec 30, 2018 | U-2136: Treatment of neuropathic pain associated with diabetic peripheral neuropathy U-2137: Treatment of postherpetic neuralgia |
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)] Gamma amino butyric acid analogs and optical isomers Claim Types: Compound; Composition | Dec 30, 2018 | |
Pat. No. 8945620 DP* Solid pharmaceutical compositions containing pregabalin Claim Types: Formulation; Method of use | Nov 2, 2026 | U-2136: Treatment of neuropathic pain associated with diabetic peripheral neuropathy U-2137: Treatment of postherpetic neuralgia |
Pat. No. 9144559 DP* Solid pharmaceutical compositions containing pregabalin Claim Types: Formulation | Nov 2, 2026 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Oct 11, 2020 |