Condensed Patent Expiration List
Products whose first patent expiration is in 2018

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.


EMTRIVA (CAPSULE) EMTRICITABINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: GILEAD      NDA No.:
021500  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented 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 *PEDU-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) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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, 2024U-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, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection

TRUVADA (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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) EMTRICITABINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: GILEAD      NDA No.:
021896  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented 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 *PEDU-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) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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, 2024U-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, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9018192 Unitary pharmaceutical dosage form
Claim Types: Method of use
Jun 13, 2026U-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, 2026U-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) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-257: Treatment of HIV infection
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Claim Types: Method of use
Jan 25, 2018 *PEDU-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 *PEDU-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, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 7125879 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Apr 21, 2025U-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, 2025U-257: Treatment of HIV infection

STRIBILD (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-257: Treatment of HIV infection
Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Claim Types: Method of use
Jan 25, 2018 *PEDU-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 *PEDU-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, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Jan 13, 2024U-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, 2026U-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, 2026U-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, 2029U-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, 2029U-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Apr 24, 2030U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 27, 2020 

GENVOYA (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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, 2022U-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, 2026U-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, 2026U-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, 2029U-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, 2029U-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Apr 24, 2030U-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, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Aug 15, 2032U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 5, 2020 
Exclusivity Code: NPP - New patient populationSep 25, 2020 

DESCOVY (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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, 2022U-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, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Aug 15, 2032U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 5, 2020 
Exclusivity Code: NPP - New patient populationSep 25, 2020 

ODEFSEY (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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, 2022U-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, 2025U-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, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Aug 15, 2032U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 21, 2020M-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 - MiscellaneousAug 21, 2020M-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 entityNov 5, 2020 

BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) 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)
PatentsExpirationPatented Use
Pat. No. 6956026 Use of exendins for the reduction of food intake
Claim Types: Method of use
Jan 7, 2018U-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, 2018U-1224: Reductions in body weight are observed with exenatide
Pat. No. 6872700 Methods for glucagon suppression
Claim Types: Method of use
Jan 14, 2020U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil insulin plus metformin therapy
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, 2020U-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, 2020U-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, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Oct 4, 2020U-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: Process; Product-by-process
Aug 31, 2021 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Process; Product-by-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, 2024U-412: Treatment of Type 2 diabetes
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-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, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Jun 30, 2025U-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, 2026U-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, 2026U-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, 2026U-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, 2027U-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, 2028U-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, 2030U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 24, 2018M-162: Inclusion of efficacy and safety data to the prescribing information of BYDUREON based on study GWDE
Exclusivity Code: M - MiscellaneousOct 20, 2020M-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 - MiscellaneousApr 2, 2021M-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) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
022200  Prod. No.: 002 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 6956026 Use of exendins for the reduction of food intake
Claim Types: Method of use
Jan 7, 2018U-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, 2018U-1224: Reductions in body weight are observed with exenatide
Pat. No. 6872700 Methods for glucagon suppression
Claim Types: Method of use
Jan 14, 2020U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil insulin plus metformin therapy
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, 2020U-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, 2020U-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, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Oct 4, 2020U-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: Process; Product-by-process
Aug 31, 2021 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Process; Product-by-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, 2024U-412: Treatment of Type 2 diabetes
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-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, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Jun 30, 2025U-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, 2026U-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, 2026U-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, 2026U-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, 2027U-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, 2028U-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, 2030U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 2, 2021M-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) 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)
PatentsExpirationPatented Use
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Claim Types: Compound; Method of use; Process
Jan 25, 2018 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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) 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)
PatentsExpirationPatented Use
Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Claim Types: Compound; Method of use; Process
Jan 25, 2018 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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) 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)
PatentsExpirationPatented 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, 2018U-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, 2023U-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, 2025U-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, 2025U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 18, 2019M-173: Information added to the clinical studies section of the labeling describing the effects of STIOLTO RESPIMAT on COPD patients
Exclusivity Code: NC - New combinationMay 21, 2018 
Exclusivity Code: NCE - New chemical entityJul 31, 2019 

TREXIMET (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-867: Treatment of migraine

TREXIMET (TABLET) 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-1719: Acute treatment of migraine
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNov 14, 2018 PED 

CRIXIVAN (CAPSULE) 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)
PatentsExpirationPatented 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, 2021U-554: Treating HIV infection with indinavir sulfate in combination with antiretroviral agents

SENSIPAR (TABLET) 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)
PatentsExpirationPatented 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, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 23, 2020M-200: Clinical information added to the use in specific populations section of the labeling.
Exclusivity Code: ODE - Orphan drug exclusivityNov 21, 2021ODE-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 exclusivityFeb 25, 2018ODE-8: Treatment of severe hypercalcemia in patients with primaryhyperparathyroidism who are unable to undergo parathyroidectomy

GIAZO (TABLET) BALSALAZIDE DISODIUM [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
022205  Prod. No.: 001 RX (1.1GM)
PatentsExpirationPatented Use
Pat. No. 6197341 DP* Formulations of balsalazide and its derivatives
Claim Types: Composition; Process; Method of use
Mar 13, 2018U-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, 2026U-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, 2026U-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, 2026U-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, 2031U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients

FACTIVE (TABLET) GEMIFLOXACIN MESYLATE [GENERIC AB]
Drug Classes: quinolone antimicrobial
NDA Applicant: LG CHEM LTD      NDA No.:
021158  Prod. No.: 001 RX (EQ 320MG BASE)
PatentsExpirationPatented 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, 2019U-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, 2019U-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, 2019U-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, 2019U-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, 2019U-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) METFORMIN HYDROCHLORIDE [GENERIC AB2]
Drug Classes: biguanide
NDA Applicant: ANDRX LABS LLC      NDA No.:
021574  Prod. No.: 001 RX (500MG); 002 RX (1GM)
PatentsExpirationPatented 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, 2018U-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, 2021U-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) 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)
PatentsExpirationPatented 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, 2018U-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, 2018U-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, 2021U-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) 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)
PatentsExpirationPatented Use
Pat. No. 6002008 DS* DP* Substituted 3-cyano quinolines
Claim Types: Compound; Method of use; Composition
Mar 27, 2018U-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, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 19, 2020I-759: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+CML)
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2024ODE-163: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
Exclusivity Code: ODE - Orphan drug exclusivitySep 4, 2019ODE-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) TELITHROMYCIN
Drug Classes: ketolide antibacterial
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021144  Prod. No.: 001 DISC (400MG); 002 DISC (300MG)
PatentsExpirationPatented Use
Pat. No. 5635485 DS* DP* [Extended 1076 days* (2.9 years)]
Erythromycin compounds
Claim Types: Compound; Method of use
Apr 1, 2018U-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) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: MERCK SHARP DOHME      NDA No.:
020762  Prod. No.: 001 RX (EQ 0.05MG BASE/SPRAY)
PatentsExpirationPatented 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) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
021658  Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
PatentsExpirationPatented 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, 2028U-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) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
202129  Prod. No.: 001 RX (0.037MG/INH)
PatentsExpirationPatented 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, 2028U-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) TRIMETREXATE GLUCURONATE
NDA Applicant: MEDIMMUNE ONCOLOGY      NDA No.:
020326  Prod. No.: 001 DISC (EQ 25MG BASE/VIAL); 002 DISC (EQ 200MG BASE/VIAL)
PatentsExpirationPatented 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) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY      NDA No.:
021368  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-1184: Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia
U-533: Erectile dysfunction
U-614: Treatment of sexual dysfunction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 15, 2021 PEDM-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) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY      NDA No.:
021368  Prod. No.: 002 RX (10MG)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-155: Treatment of erectile dysfunction
Pat. No. 6821975 DS* DP* Beta-carboline drug products
Claim Types: Formulation; Method of use; Process
May 19, 2021 *PEDU-533: Erectile dysfunction
U-614: Treatment of sexual dysfunction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 15, 2021 PEDM-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) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY      NDA No.:
021368  Prod. No.: 003 RX (20MG)
PatentsExpirationPatented 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 *PEDU-614: Treatment of sexual dysfunction
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions
Claim Types: Formulation; Method of use
Oct 26, 2020 *PEDU-155: Treatment of erectile dysfunction
Pat. No. 6821975 DS* DP* Beta-carboline drug products
Claim Types: Formulation; Method of use; Process
May 19, 2021 *PEDU-533: Erectile dysfunction
U-614: Treatment of sexual dysfunction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 15, 2021 PEDM-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) TADALAFIL [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: LILLY      NDA No.:
021368  Prod. No.: 004 RX (2.5MG)
PatentsExpirationPatented 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 *PEDU-155: Treatment of erectile dysfunction
Pat. No. 7182958 DP* .beta.-carboline pharmaceutical compositions
Claim Types: Formulation; Method of use
Oct 26, 2020 *PEDU-155: Treatment of erectile dysfunction
Pat. No. 6821975 DS* DP* Beta-carboline drug products
Claim Types: Formulation; Method of use; Process
May 19, 2021 *PEDU-533: Erectile dysfunction
U-614: Treatment of sexual dysfunction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 15, 2021 PEDM-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) TADALAFIL [Has competitive generic]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: ELI LILLY CO      NDA No.:
022332  Prod. No.: 001 RX (20MG)
PatentsExpirationPatented 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 *PEDU-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) LATANOPROSTENE BUNOD
NDA Applicant: BAUSCH AND LOMB      NDA No.:
207795  Prod. No.: 001 RX (0.024%)
PatentsExpirationPatented 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, 2025U-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, 2025U-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, 2025U-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, 2025U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

APIDRA (INJECTABLE) 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))
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Jun 18, 2018U-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, 2022U-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, 2023U-471: Method of treating a patient suffering from diabetes mellitus

APIDRA SOLOSTAR (INJECTABLE) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021629  Prod. No.: 003 RX (300 UNITS/3ML)
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Jun 18, 2018U-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, 2022U-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, 2023U-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, 2024U-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, 2024U-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) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD      NDA No.:
021433  Prod. No.: 002 RX (0.11MG/INH)
PatentsExpirationPatented 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 *PEDU-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) FOSAMPRENAVIR CALCIUM [GENERIC AB]
NDA Applicant: VIIV HLTHCARE      NDA No.:
021548  Prod. No.: 001 RX (EQ 700MG BASE)
PatentsExpirationPatented Use
Pat. No. 6436989 DS* DP* Prodrugs of aspartyl protease inhibitors
Claim Types: Compound; Composition; Method of use
Jun 24, 2018 *PEDU-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 *PEDU-257: Treatment of HIV infection

LEXIVA (SUSPENSION) FOSAMPRENAVIR CALCIUM
NDA Applicant: VIIV HLTHCARE      NDA No.:
022116  Prod. No.: 001 RX (EQ 50MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6436989 DS* DP* Prodrugs of aspartyl protease inhibitors
Claim Types: Compound; Composition; Method of use
Jun 24, 2018 *PEDU-257: Treatment of HIV infection

SOLTAMOX (SOLUTION) TAMOXIFEN CITRATE
Drug Classes: estrogen agonist/antagonist
NDA Applicant: MIDATECH PHARMA US      NDA No.:
021807  Prod. No.: 001 RX (EQ 20MG BASE/10ML)
PatentsExpirationPatented Use
Pat. No. 6127425 DP* Oral liquid medicine solution
Claim Types: Composition; Formulation; Process
Jun 26, 2018 

EMEND (CAPSULE) 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)
PatentsExpirationPatented 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, 2018U-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, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

EMEND (CAPSULE) APREPITANT [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK      NDA No.:
021549  Prod. No.: 003 RX (40MG)
PatentsExpirationPatented 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, 2018U-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, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

EMEND (FOR SUSPENSION) 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)
PatentsExpirationPatented 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, 2018U-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, 2027U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

BRILINTA (TABLET) TICAGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
022433  Prod. No.: 001 RX (90MG)
PatentsExpirationPatented 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, 2019U-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, 2019U-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, 2021U-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, 2024U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 3, 2018I-714: Extends the 2011 approval of BRILINTA for use beginning with ACS to use beginning more remote from myocardial infarction

BRILINTA (TABLET) TICAGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
022433  Prod. No.: 002 RX (60MG)
PatentsExpirationPatented 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, 2019U-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, 2019U-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, 2021U-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, 2024U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthSep 3, 2018 

PAXIL (CAPSULE) 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**)
PatentsExpirationPatented 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) 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**)
PatentsExpirationPatented 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 *PEDU-248: Treatment of HIV

SUSTIVA (TABLET) 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**)
PatentsExpirationPatented 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) 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)
PatentsExpirationPatented 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, 2018U-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) 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)
PatentsExpirationPatented 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, 2018U-3: Treatment of hypertension
Pat. No. 8613949 DP* Galenical formulations of organic compounds
Claim Types: Formulation; Process
Dec 21, 2029 

AMTURNIDE (TABLET) 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)
PatentsExpirationPatented 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, 2018U-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) 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)
PatentsExpirationPatented 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, 2018U-470: Therapy in chronic hepatitis B virus infection

RAVICTI (LIQUID) GLYCEROL PHENYLBUTYRATE
Drug Classes: hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: HORIZON THERAPS INC      NDA No.:
203284  Prod. No.: 001 RX (1.1GM/ML)
PatentsExpirationPatented 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, 2018U-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, 2030U-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, 2030U-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, 2030U-1816: Treatment of a urea cycle disorder
Pat. No. 8404215 Methods of therapeutic monitoring of nitrogen scavenging
Claim Types: Method of administration
Mar 9, 2032U-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, 2032U-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, 2032U-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, 2032U-1816: Treatment of a urea cycle disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationApr 28, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityApr 28, 2024ODE-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 exclusivityFeb 1, 2020ODE-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) AMBRISENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: GILEAD      NDA No.:
022081  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented 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, 2027U-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, 2027U-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, 2031U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 2, 2018I-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) 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)
PatentsExpirationPatented Use
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-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, 2026U-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: Process; New polymorph, salt or hydrate
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 12, 2021I-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 entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-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) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
201292  Prod. No.: 003 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-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, 2026U-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: Process; New polymorph, salt or hydrate
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 15, 2019I-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 IndicationJan 12, 2021I-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 entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-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) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021395  Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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: Process; Product-by-process
Apr 11, 2022 *PED 
Pat. No. 7070800 DP* Inhalable powder containing tiotropium
Claim Types: Formulation; Process; Method of use
Jul 22, 2022 *PEDU-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 *PEDU-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) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021936  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
PatentsExpirationPatented 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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 24, 2018 PED 
Exclusivity Code: NPP - New patient populationAug 15, 2020 PED 

SPIRIVA RESPIMAT (SPRAY, METERED) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021936  Prod. No.: 002 RX (EQ 0.00125MG BASE/INH)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 15, 2019 PED 
Exclusivity Code: NPP - New patient populationAug 15, 2020 PED 

ZITHROMAX (FOR SUSPENSION) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050693  Prod. No.: 001 RX (EQ 1GM BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZITHROMAX (FOR SUSPENSION) 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)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZITHROMAX (TABLET) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050711  Prod. No.: 001 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZITHROMAX (TABLET) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050730  Prod. No.: 001 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZITHROMAX (INJECTABLE) AZITHROMYCIN [GENERIC AP]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050733  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZITHROMAX (TABLET) AZITHROMYCIN [GENERIC AB]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050784  Prod. No.: 001 RX (EQ 500MG BASE)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

ZMAX (FOR SUSPENSION, EXTENDED RELEASE) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: PF PRISM CV      NDA No.:
050797  Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
PatentsExpirationPatented 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, 2024U-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) FOSPROPOFOL DISODIUM
NDA Applicant: EISAI INC      NDA No.:
022244  Prod. No.: 001 DISC (1050MG/30ML (35MG/ML))
PatentsExpirationPatented 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, 2022U-945: Sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation

REVLIMID (CAPSULE) LENALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE      NDA No.:
021880  Prod. No.: 001 RX (5MG); 006 RX (20MG)
PatentsExpirationPatented 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, 2018U-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, 2018U-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, 2018U-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, 2018U-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, 2018U-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, 2020U-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, 2020U-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, 2020U-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, 2020U-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, 2020U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2028U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 17, 2018I-706: Expanded indication for the treatment of patients with multiple myeloma
Exclusivity Code: ODE - Orphan drug exclusivityFeb 22, 2024ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct)
Exclusivity Code: ODE - Orphan drug exclusivityJun 5, 2020ODE-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 exclusivityFeb 17, 2022ODE-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) 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)
PatentsExpirationPatented 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, 2018U-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, 2018U-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, 2018U-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, 2018U-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, 2018U-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, 2020U-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, 2020U-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, 2020U-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, 2020U-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, 2020U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2028U-1414: Use of Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 17, 2018I-706: Expanded indication for the treatment of patients with multiple myeloma
Exclusivity Code: ODE - Orphan drug exclusivityFeb 22, 2024ODE-131: Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-hsct)
Exclusivity Code: ODE - Orphan drug exclusivityJun 5, 2020ODE-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 exclusivityFeb 17, 2022ODE-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) OLODATEROL HYDROCHLORIDE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
203108  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
PatentsExpirationPatented 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, 2020U-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, 2023U-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, 2025U-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, 2025U-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, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 31, 2019 

EXUBERA (POWDER) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: PFIZER      NDA No.:
021868  Prod. No.: 001 DISC (1MG/INH); 002 DISC (3MG/INH)
PatentsExpirationPatented Use
Pat. No. 6685967 DP* Methods and compositions for pulmonary delivery of insulin
Claim Types: Process; Formulation; Composition
Sep 11, 2018 
Pat. No. 6257233 Dry powder dispersing apparatus and methods for their use
Claim Types: Device; Method of use
May 14, 2019U-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, 2019U-704: Method of administering insulin via inhalation
Pat. No. 6582728 DP* Spray drying of macromolecules to produce inhaleable dry powders
Claim Types: Process; Product-by-process
Jun 24, 2020 

ASMANEX TWISTHALER (POWDER) 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)
PatentsExpirationPatented Use
Pat. No. 6503537 DP* Preparation of powder agglomerates
Claim Types: Process; Composition; Product-by-process; Device
Sep 17, 2018 *PED 
Pat. No. 8173172 DP* Preparation of powder agglomerates
Claim Types: Formulation; Process
Sep 17, 2018 *PED 

EPIVIR (SOLUTION) 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)
PatentsExpirationPatented Use
Pat. No. 6004968 DP* Pharmaceutical compositions containing lamivudine
Claim Types: Formulation; Composition; Method of use
Sep 20, 2018 *PEDU-248: Treatment of HIV

EPIVIR-HBV (SOLUTION) 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)
PatentsExpirationPatented Use
Pat. No. 6004968 Pharmaceutical compositions containing lamivudine
Claim Types: Formulation; Composition; Method of use
Sep 20, 2018 *PED 

ZYPREXA RELPREVV (SUSPENSION, EXTENDED RELEASE) 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)
PatentsExpirationPatented Use
Pat. No. 6169084 DS* DP* 2-methyl-thieno-benzodiazepine formulation
Claim Types: New polymorph, salt or hydrate
Sep 30, 2018U-1026: A method of treating human suffering from or susceptible to psychosis.

NOXAFIL (SUSPENSION) POSACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: SCHERING      NDA No.:
022003  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 6958337 DS* DP* Crystalline antifungal polymorph
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 5, 2018U-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, 2019U-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) 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))
PatentsExpirationPatented Use
Pat. No. 6210892 Alteration of cellular behavior by antisense modulation of mRNA processing
Claim Types: Method of use
Oct 7, 2018U-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, 2025U-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, 2030U-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, 2030U-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, 2034U-1943: Treatment of spinal muscular atrophy
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 14, 2021M-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 entityDec 23, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityDec 23, 2023ODE-127: Treatment of spinal muscular atrophy in pediatric and adult patients

TIKOSYN (CAPSULE) 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)
PatentsExpirationPatented Use
Pat. No. 6124363 Dofetilide polymorphs
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 9, 2018 

VIMOVO (TABLET, DELAYED RELEASE) 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)
PatentsExpirationPatented Use
Pat. No. 7745466 DP* Form of S-omeprazole
Claim Types: Formulation; Method of use
Oct 13, 2018U-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 *PEDU-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 *PEDU-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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2023U-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, 2029U-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, 2031U-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, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

VIMOVO (TABLET, DELAYED RELEASE) 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)
PatentsExpirationPatented Use
Pat. No. 7745466 DP* Form of S-omeprazole
Claim Types: Formulation; Method of use
Oct 13, 2018U-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 *PEDU-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 *PEDU-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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2023U-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, 2029U-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, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

FOSRENOL (TABLET, CHEWABLE) 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)
PatentsExpirationPatented 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, 2018U-613: Reduction of serum phosphate
Pat. No. 7381428 Stabilized lanthanum carbonate compositions
Claim Types: Method of improving a treatment
Aug 26, 2024U-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) 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)
PatentsExpirationPatented 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, 2018U-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) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.:
021379  Prod. No.: 001 RX (22.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-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, 2018U-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, 2020U-621: Method of treating cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

ELIGARD (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.:
021488  Prod. No.: 001 RX (30MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-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, 2018U-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, 2020U-621: Method of treating cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

ELIGARD (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.:
021731  Prod. No.: 001 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-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, 2018U-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, 2020U-621: Method of treating cancer
Pat. No. 9914802 DS* DP* Sustained release polymer
Claim Types: Method of use; Process; Formulation
Nov 13, 2020U-1666: Palliative treatment of prostate cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

OTEZLA (TABLET) APREMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: CELGENE CORP      NDA No.:
205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 6020358 DS* DP* Substituted phenethylsulfones and method of reducing TNF.alpha. levels
Claim Types: Compound; Method of use; Composition
Oct 30, 2018U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-1505: 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, 2034U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 21, 2019 

LEVITRA (TABLET) 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)
PatentsExpirationPatented Use
Pat. No. 6362178 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-533: Erectile dysfunction
Pat. No. 7696206 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-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: Process; Method of use
Jul 23, 2027U-1288: Treatment of erectile dysfunction by administering a film-coated tablet

STAXYN (TABLET, ORALLY DISINTEGRATING) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.:
200179  Prod. No.: 001 DISC (10MG)
PatentsExpirationPatented Use
Pat. No. 6362178 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-155: Treatment of erectile dysfunction
Pat. No. 7696206 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-155: Treatment of erectile dysfunction
Pat. No. 8613950 DP* Pharmaceutical forms with improved pharmacokinetic properties
Claim Types: Formulation
Dec 23, 2028 

AXUMIN (SOLUTION) FLUCICLOVINE F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: BLUE EARTH      NDA No.:
208054  Prod. No.: 001 RX (9-221mCi/ML)
PatentsExpirationPatented Use
Pat. No. 5808146 DS* Amino acid analogs for tumor imagingClaim Types: CompoundNov 9, 2018 
Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Diagnostic or surgical method
Nov 28, 2026U-1879: Method of diagnosing tumors using positron emission tomography
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 27, 2021 

TYVASO (SOLUTION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
022387  Prod. No.: 001 RX (0.6MG/ML)
PatentsExpirationPatented Use
Pat. No. 6521212 Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation
Claim Types: Method of use
Nov 13, 2018U-1018: Treatment of pulmonary hypertension by inhalation
Pat. No. 6756033 Method for delivering benzindene prostaglandins by inhalation
Claim Types: Method of use
Nov 13, 2018U-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, 2028U-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) ABACAVIR SULFATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
020977  Prod. No.: 001 RX (EQ 300MG BASE)
PatentsExpirationPatented 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 *PEDU-65: Method of treatment of a patient infected with HIV

ZIAGEN (SOLUTION) ABACAVIR SULFATE [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
020978  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented 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 *PEDU-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) ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
021205  Prod. No.: 001 RX (EQ 300MG BASE;150MG;300MG)
PatentsExpirationPatented 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 *PEDU-65: Method of treatment of a patient infected with HIV

EPZICOM (TABLET) ABACAVIR SULFATE; LAMIVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
021652  Prod. No.: 001 RX (EQ 600MG BASE;300MG)
PatentsExpirationPatented 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 *PEDU-257: Treatment of HIV infection

TRIUMEQ (TABLET) ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
205551  Prod. No.: 001 RX (EQ 600MG BASE;EQ 50MG BASE;300MG)
PatentsExpirationPatented 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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 12, 2018 

NEXIUM (CAPSULE, DELAYED REL PELLETS) 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)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-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 *PEDU-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) 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)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-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 *PEDU-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) 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)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis

NEXIUM (FOR SUSPENSION, DELAYED RELEASE) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
022101  Prod. No.: 001 RX (EQ 10MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis

NEXIUM 24HR (CAPSULE, DELAYED RELEASE) ESOMEPRAZOLE MAGNESIUM [GENERIC OTC]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP      NDA No.:
204655  Prod. No.: 001 OTC (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-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) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP      NDA No.:
207920  Prod. No.: 001 OTC (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-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 *PEDU-1785: Method of treating frequent heartburn by administering an esomeprazole magnesium formulation as claimed

IXEMPRA KIT (INJECTABLE) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.:
022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7125899 DS* DP* Epothilone derivatives
Claim Types: Compound; Method of use; Composition; New polymorph, salt or hydrate
Nov 26, 2018 *PEDU-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 *PEDU-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: Process; Formulation; Method of use
Jul 23, 2022 *PEDU-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: Process; Product-by-process; Formulation; Method of use
Jul 23, 2022 *PEDU-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 *PEDU-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 *PEDU-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
208056  Prod. No.: 001 DISC (30MG)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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: Process; New polymorph, salt or hydrate
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 *PEDU-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: Process; Product-by-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) SILODOSIN [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: ALLERGAN SALES LLC      NDA No.:
022206  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationPatented 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) 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**)
PatentsExpirationPatented 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 *PEDU-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) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.:
205677  Prod. No.: 001 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 5856529 DS* DP* Benzofuran and dihydrobenzofuran melatonergic agents
Claim Types: Compound; Composition; Method of use
Dec 9, 2018U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. 9060995 Treatment of circadian rhythm disorders
Claim Types: Method of improving a treatment
Jan 25, 2033U-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, 2033U-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, 2033U-1486: Treatment of non-24-hour sleep-wake disorder
Pat. No. 9855241 Treatment of circadian rhythm disorders
Claim Types: Method of use
Jan 25, 2033U-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, 2033U-2147: Treatment of non-24 hour sleep-wake disorder by orally administering 20mg of tasimelteon once daily before bedtime
Pat. No. 9730910 Treatment of circadian rhythm disorders
Claim Types: Method of administration
May 17, 2034U-2085: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with rifampin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 31, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityJan 31, 2021ODE-59: Treatment of non-24-hour sleep-wake disorder

OFORTA (TABLET) FLUDARABINE PHOSPHATE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.:
022273  Prod. No.: 001 DISC (10MG)
PatentsExpirationPatented 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, 2022U-944: Treatment of patients with B-cell chronic lymphocytic leukemia (CLL)

MOZOBIL (SOLUTION) PLERIXAFOR
Drug Classes: hematopoietic stem cell mobilizer
NDA Applicant: GENZYME      NDA No.:
022311  Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
PatentsExpirationPatented 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, 2023U-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, 2023U-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) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.:
020835  Prod. No.: 003 RX (35MG)
PatentsExpirationPatented 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 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-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) CALCIUM CARBONATE; RISEDRONATE SODIUM
Drug Classes: tetracycline class antibacterial
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**)
PatentsExpirationPatented 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 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-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) CANGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: CHIESI USA INC      NDA No.:
204958  Prod. No.: 001 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6114313 DP* Pharmaceutical compositions for freeze dryingClaim Types: Formulation; Process; Method of useDec 11, 2018U-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, 2019U-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, 2029U-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, 2029U-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, 2030U-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, 2033U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 22, 2020 

RAPIVAB (SOLUTION) PERAMIVIR
Drug Classes: influenza neuraminidase inhibitor (NAI)
NDA Applicant: BIOCRYST      NDA No.:
206426  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationPatented 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, 2027U-1627: Treatment of acute uncomplicated influenza in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2019 
Exclusivity Code: NPP - New patient populationSep 20, 2020 

ELIDEL (CREAM) PIMECROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VALEANT BERMUDA      NDA No.:
021302  Prod. No.: 001 RX (1%)
PatentsExpirationPatented 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) 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)
PatentsExpirationPatented Use
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, 2018U-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 
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 22, 2019M-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 populationMay 3, 2021 

VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) NALTREXONE
Drug Classes: opioid antagonist
NDA Applicant: ALKERMES      NDA No.:
021897  Prod. No.: 001 RX (380MG/VIAL)
PatentsExpirationPatented 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: Process;Device; Product-by-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: Process; Product-by-process
Nov 12, 2019 
Pat. No. 6713090 DP* Apparatus and method for preparing microparticles
Claim Types: Process; Product-by-process
Nov 12, 2019 
Pat. No. 6939033 DP* Method and apparatus for preparing microparticles using in-line solvent extraction
Claim Types: Process; Product-by-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, 2029U-1123: Treatment of alcohol dependence
U-1124: Prevention of relapse to opioid dependence, following opioid detoxification

LYRICA (SOLUTION) PREGABALIN
NDA Applicant: PF PRISM CV      NDA No.:
022488  Prod. No.: 001 RX (20MG/ML)
PatentsExpirationPatented Use
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, 2018U-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 
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 22, 2019M-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 populationMay 3, 2021 

LYRICA CR (TABLET, EXTENDED RELEASE) PREGABALIN
NDA Applicant: PFIZER INC      NDA No.:
209501  Prod. No.: 001 RX (82.5MG); 002 RX (165MG); 003 RX (330MG)
PatentsExpirationPatented Use
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. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-2136: Treatment of neuropathic pain associated with diabetic peripheral neuropathy
U-2137: Treatment of postherpetic neuralgia
Pat. No. 8945620 DP* Solid pharmaceutical compositions containing pregabalin
Claim Types: Formulation; Method of use
Nov 2, 2026U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 11, 2020 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
Last edited: 25 July 2018
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