Patent Expiration View
Products whose first patent expiration is in 2018

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.


IONSYS (SYSTEM) FENTANYL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: THE MEDICINES CO      NDA No.:
021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
PatentsExpirationPatented Use
Pat. No. 6169920 DP* Iontophoretic drug delivery apparatus
Claim Types: Device; Process
Jan 2, 2018U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 6195582 DP* Electrotransport device electrode assembly having lower initial resistance
Claim Types: Device
Jan 28, 2019U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 6181963 DP* Transdermal electrotransport delivery device including a cathodic reservoir containing a compatible antimicrobial agent
Claim Types: Device; Process; Method of administration
Nov 2, 2019 
Pat. No. 6881208 Method and device for transdermal electrotransport delivery of fentanyl and sufentanil
Claim Types: Method of administration
Apr 19, 2022U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Claim Types: Device; Drug in a container
Apr 1, 2024 
Pat. No. 8301238 DP* Two-part electrotransport device
Claim Types: Device
Sep 30, 2031 
Pat. No. 9364656 Method of storing an electrotransport drug delivery device
Claim Types: Process
Sep 30, 2031U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9731121 DP* Switch validation circuit and method
Claim Types: Device
Oct 17, 2031 
Pat. No. 8781571 DP* Switch validation circuit and method
Claim Types: Device; Method of improving a treatment
Mar 31, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428708 Self-test for analgesic product
Claim Types: Method of improving a treatment
May 21, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428709 DP* Current control for electrotransport drug delivery
Claim Types: Device; Method of administration
Jun 11, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9095706 DP* Self-test for analgesic product
Claim Types: Device
Feb 3, 2033 

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

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 

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 

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 

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 

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 

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 

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 

ALLI (CAPSULE) ORLISTAT
Drug Classes: intestinal lipase inhibitor
NDA Applicant: GLAXOSMITHKLINE CONS      NDA No.:
021887  Prod. No.: 001 OTC (60MG)
PatentsExpirationPatented Use
Pat. No. 6004996 DP* Tetrahydrolipstatin containing compositions
Claim Types: Formulation
Jan 6, 2018 

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 BCISE (SUSPENSION, EXTENDED RELEASE) EXENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
209210  Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
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-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. 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. 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
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. 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. 8895033 DP* Sustained release formulations using non-aqueous carriers
Claim Types: Formulation; Method of use; Kit
Oct 4, 2030U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
U-2157: Treating Type 2 diabetes mellitus by stimulating insulin release
U-2158: Decreasing gastric motility or delaying gastric emptying by using a sustained-release composition
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 20, 2020 

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

BYETTA (INJECTABLE) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
021773  Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
PatentsExpirationPatented Use
Pat. No. 6956026 Use of exendins for the reduction of food intake
Claim Types: Method of use
Jan 7, 2018U-1074: Use of exenatide may result in reduction in body weight
U-1623: Use of exenatide may result in reduction in appetite.
U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4
Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity
Claim Types: Method of use
Jan 7, 2018U-1074: Use of exenatide may result in reduction in body weight
U-1108: Treating Type 2 diabetes mellitus with exenatide by stimulating insulin release
U-653: Stimulating insulin release by administering exenatide
Pat. No. 6872700 Methods for glucagon suppression
Claim Types: Method of use
Jan 14, 2020U-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. 6902744 DP* Exendin agonist formulations and methods of administration thereof
Claim Types: Formulation
Jan 14, 2020 

PULMICORT FLEXHALER (POWDER, METERED) BUDESONIDE
Drug Classes: corticosteroid
NDA Applicant: ASTRAZENECA      NDA No.:
021949  Prod. No.: 001 RX (0.08MG/INH); 002 RX (0.16MG/INH)
PatentsExpirationPatented Use
Pat. No. 6027714 DP* Formulation for inhalation
Claim Types: Formulation; Process; Method of use
Jan 9, 2018U-787: Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older, including patients requiring oral corticosteroid therapy for asthma
Pat. No. 6287540 DP* Formulation for inhalation
Claim Types: Formulation; Process
Jan 9, 2018 
Pat. No. 7143764 DP* Inhalation device
Claim Types: Device
Mar 13, 2018 
Pat. No. 6142145 DP* Inhalation device
Claim Types: Device
May 8, 2018 

TRICOR (TABLET) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE INC      NDA No.:
021203  Prod. No.: 001 DISC (54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 003 DISC (160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6074670 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 6277405 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 6589552 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 6652881 DP* Fenofibrate pharmaceutical composition having high bioavailability
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 7037529 DP* Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation; Process
Jan 9, 2018 
Pat. No. 7041319 DP* Fenofibrate pharmaceutical composition having high bioavailabilty
Claim Types: Formulation
Jan 9, 2018 

TRICOR (TABLET) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE      NDA No.:
021656  Prod. No.: 001 RX (48MG); 002 RX (145MG)
PatentsExpirationPatented Use
Pat. No. 6277405 DS* Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 6652881 DS* Fenofibrate pharmaceutical composition having high bioavailability
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 7037529 DP* Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Claim Types: Formulation; Process
Jan 9, 2018 
Pat. No. 7041319 DP* Fenofibrate pharmaceutical composition having high bioavailabilty
Claim Types: Formulation
Jan 9, 2018 
Pat. No. 6375986 DP* Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Claim Types: Formulation; Process; Method of use
Sep 21, 2020U-615: Adjunctive therapy to diet in adults to reduce LDL-c, total-c, triglycerides and APO B, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)
Pat. No. 7276249 DP* Nanoparticulate fibrate formulations
Claim Types: Formulation
Feb 21, 2023 
Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions
Claim Types: Method of use
Feb 21, 2023U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)

MYTESI (TABLET, DELAYED RELEASE) CROFELEMER
Drug Classes: antidiarrheal
NDA Applicant: NAPO PHARMS INC      NDA No.:
202292  Prod. No.: 001 RX (125MG)
PatentsExpirationPatented Use
Pat. No. 8574634 Compositions and methods of treatment with proanthocyanidin polymer antidiarrheal compositions
Claim Types: Method of use
Jan 11, 2018U-1319: Symptomatic relief of non-infectious diarrhea
Pat. No. 7323195 DP* Enteric formulations of proanthocyanidin polymer antidiarrheal compositions
Claim Types: Formulation
Jun 7, 2018 
Pat. No. 7341744 Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer
Claim Types: Method of use
Jun 16, 2018U-1319: Symptomatic relief of non-infectious diarrhea
Pat. No. 8962680 Methods and compositions for treating HIV-associated diarrhea
Claim Types: Method of use
Oct 31, 2031U-1319: Symptomatic relief of non-infectious diarrhea
Pat. No. 9585868 DS* Methods and compositions for treating HIV-associated diarrhea
Claim Types: Method of administration
Oct 31, 2031U-1319: Symptomatic relief of non-infectious diarrhea

FOLLISTIM AQ (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC      NDA No.:
021211  Prod. No.: 001 RX (300 IU/0.36ML); 002 RX (600 IU/0.72ML); 004 RX (900 IU/1.08ML) NDA No.: 021211  Prod. No.: 003 DISC (150 IU/0.18ML)
PatentsExpirationPatented Use
Pat. No. 5929028 DP* Liquid gonadotropin containing formulations
Claim Types: Drug in a container; Process; Method of use
Jan 14, 2018U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women
U-567: Method of treating infertility
Pat. No. 7446090 DP* FSH formulation
Claim Types: Process; Drug in a container; Formulation
Aug 23, 2019 
Pat. No. 7563763 FSH and FSH variant formulations, products and methods
Claim Types: Method of administration; Method of use; Kit
Aug 23, 2019U-1183: A method for administering follicle stimulating hormone (FSH) for ovarian follicle or testicular stimulation in the human
U-1367: Method of administering FSH for the treatment of infertility through induction of ovulation and pregnancy in anovulatory infertile women
U-993: Method of treating infertility

FOLLISTIM AQ (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC      NDA No.:
021273  Prod. No.: 001 DISC (75 IU/0.5ML); 002 DISC (150 IU/0.5ML)
PatentsExpirationPatented Use
Pat. No. 5929028 DP* Liquid gonadotropin containing formulations
Claim Types: Drug in a container; Process; Method of use
Jan 14, 2018U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women

ECOZA (AEROSOL, FOAM) ECONAZOLE NITRATE
Drug Classes: azole antifungal
NDA Applicant: CHEMO RESEARCH SL      NDA No.:
205175  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 5993830 DP* Cosmetic skin preparation
Claim Types: Formulation; Drug in a container; Process; Method of use
Jan 16, 2018U-1449: Method of alleviating a skin condition

MIRAPEX (TABLET) PRAMIPEXOLE DIHYDROCHLORIDE [GENERIC AB]
Drug Classes: nonergot dopamine agonist
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
020667  Prod. No.: 001 RX (0.125MG); 002 RX (0.25MG); 003 RX (1MG); 005 RX (1.5MG); 006 RX (0.5MG); 007 RX (0.75MG)
PatentsExpirationPatented Use
Pat. No. 6001861 Use of pramipexole in the treatment of restless legs syndrome
Claim Types: Method of use
Jan 16, 2018U-784: Treatment of moderate to severe primary restless legs syndrome (RLS)
Pat. No. 6194445 Use of pramipexole in the treatment of restless legs syndrome
Claim Types: Method of use
Jan 16, 2018U-784: Treatment of moderate to severe primary restless legs syndrome (RLS)

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 

CONCERTA (TABLET, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: JANSSEN PHARMS      NDA No.:
021121  Prod. No.: 001 RX (18MG); 002 RX (36MG); 003 RX (54MG); 004 RX (27MG)
PatentsExpirationPatented Use
Pat. No. 6919373 Methods and devices for providing prolonged drug therapy
Claim Types: Method of use
Jan 31, 2018 *PEDU-666: Method of treating ADHD
Pat. No. 6930129 Methods and devices for providing prolonged drug therapy
Claim Types: Method of use
Jan 31, 2018 *PEDU-666: Method of treating ADHD
Pat. No. 8163798 DP* Methods and devices for providing prolonged drug therapy
Claim Types: Formulation
Jan 31, 2018 *PED 
Pat. No. 8629179 DP* Methods and devices for providing prolonged drug therapy
Claim Types: Formulation
Jan 31, 2018 *PED 
Pat. No. 9000038 Methods and devices for providing prolonged drug therapy
Claim Types: Method of use; Method of administration
Jan 31, 2018 *PEDU-1693: Method of treating adhd in children 6 years of age and older and adolescents
U-666: Method of treating ADHD

OFIRMEV (SOLUTION) ACETAMINOPHEN [GENERIC AP]
Drug Classes: antidote for acetaminophen overdose; mucolytic antidote for acetaminophen overdose
NDA Applicant: MALLINCKRODT IP      NDA No.:
022450  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6028222 DP* Stable liquid paracetamol compositions, and method for preparing same
Claim Types: Formulation
Feb 5, 2018 *PED 
Pat. No. 6992218 DP* Method for obtaining aqueous formulations of oxidation-sensitive active principles
Claim Types: Product-by-process; Process
Dec 6, 2021 *PED 
Pat. No. 9610265 Reduced dose intravenous acetaminophen
Claim Types: Method of administration
Nov 13, 2028U-2263: Modified dosing regimen for the management of moderate to severe pain with adjunctive opioid analgesics
Pat. No. 9987238 Reduced dose intravenous acetaminophen
Claim Types: Method of use
Nov 13, 2028U-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
Pat. No. 9399012 Reduced dose intravenous acetaminophen
Claim Types: Method of use
Mar 11, 2032 *PEDU-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
U-2262: Modified dosing regimen for the reduction of fever
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2020 PEDM-196: Revisions to the package insert based on data from a randomized, placebo controlled, multicenter study of intravenous acetaminophen for the treatment of acute pain in pediatric patients to fulfill the post-marketing requirement 1704-1

CLOBEX (SPRAY) CLOBETASOL PROPIONATE [GENERIC AT]
Drug Classes: corticosteroid
NDA Applicant: GALDERMA LABS LP      NDA No.:
021835  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 5972920 DP* Formulation containing a carrier, active ingredient, and surfactant for treating skin disorders
Claim Types: Formulation
Feb 12, 2018 
Pat. No. 5990100 DP* Composition and method for treatment of psoriasis
Claim Types: Formulation; Method of use
Mar 24, 2018U-742: Twice daily topical treatment of moderate to severe plaque psoriasis.

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 

SOLODYN (TABLET, EXTENDED RELEASE) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: MEDICIS      NDA No.:
050808  Prod. No.: 001 DISC (EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 003 DISC (EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 5908838 Method for the treatment of acne
Claim Types: Method of use
Feb 19, 2018U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Mar 7, 2027U-1078: Treatment of acne

SOLODYN (TABLET, EXTENDED RELEASE) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: MEDICIS      NDA No.:
050808  Prod. No.: 002 DISC (EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 5908838 Method for the treatment of acne
Claim Types: Method of use
Feb 19, 2018U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Mar 7, 2027U-1078: Treatment of acne
Pat. No. 7541347 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of administration
Apr 2, 2027U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7544373 DP* Minocycline oral dosage forms for the treatment of acne
Claim Types: Formulation; Kit
Apr 2, 2027 

SOLODYN (TABLET, EXTENDED RELEASE) MINOCYCLINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: tetracycline class drug
NDA Applicant: MEDICIS      NDA No.:
050808  Prod. No.: 004 RX (EQ 65MG BASE); 005 RX (EQ 115MG BASE)
PatentsExpirationPatented Use
Pat. No. 5908838 Method for the treatment of acne
Claim Types: Method of use
Feb 19, 2018U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Mar 7, 2027U-1078: Treatment of acne
Pat. No. 9192615 DP* Method for the treatment of acne and certain dosage forms thereof
Claim Types: Formulation
Nov 17, 2031 

SOLODYN (TABLET, EXTENDED RELEASE) MINOCYCLINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: tetracycline class drug
NDA Applicant: MEDICIS      NDA No.:
050808  Prod. No.: 006 RX (EQ 105MG BASE); 007 RX (EQ 80MG BASE); 008 RX (EQ 55MG BASE)
PatentsExpirationPatented Use
Pat. No. 5908838 Method for the treatment of acne
Claim Types: Method of use
Feb 19, 2018U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8722650 Extended-release minocycline dosage forms
Claim Types: Method of use
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Mar 7, 2027U-1078: Treatment of acne

XIMINO (CAPSULE, EXTENDED RELEASE) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: SUN PHARM INDS LTD      NDA No.:
201922  Prod. No.: 001 RX (EQ 45MG BASE); 003 RX (EQ 90MG BASE); 005 RX (EQ 135MG BASE)
PatentsExpirationPatented Use
Pat. No. 5908838 Method for the treatment of acne
Claim Types: Method of use
Feb 19, 2018U-1376: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Jun 24, 2025U-124: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Mar 7, 2027U-124: Treatment of acne
Pat. No. 7541347 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of administration
Apr 2, 2027U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7544373 DP* Minocycline oral dosage forms for the treatment of acne
Claim Types: Formulation; Kit
Apr 2, 2027 

SPRITAM (TABLET, FOR SUSPENSION) LEVETIRACETAM
NDA Applicant: APRECIA PHARMS      NDA No.:
207958  Prod. No.: 001 RX (250MG); 002 RX (500MG); 003 RX (750MG); 004 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 6471992 DP* Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
Claim Types: Formulation
Feb 20, 2018 
Pat. No. 9463160 DP* Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
Claim Types: Formulation
Feb 20, 2018 
Pat. No. 9339489 DP* Rapid disperse dosage form containing levetiracetam
Claim Types: Formulation; Method of use
Mar 14, 2034U-1850: Method of administering levetiracetam
Pat. No. 9669009 Rapid disperse dosage form containing levetiracetam
Claim Types: Method of use
Mar 14, 2034U-1850: Method of administering levetiracetam
U-2021: Method of administering levetiracetam under fasted conditions
U-2022: Method of administering levetiracetam under fed conditions

UROXATRAL (TABLET, EXTENDED RELEASE) ALFUZOSIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: CONCORDIA PHARMS INC      NDA No.:
021287  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6149940 Tablet with controlled release of alfuzosine chlorhydrate
Claim Types: Formulation
Feb 22, 2018 *PED 

MYFORTIC (TABLET, DELAYED RELEASE) MYCOPHENOLIC ACID [GENERIC AB]
Drug Classes: antimetabolite immunosuppressant
NDA Applicant: NOVARTIS      NDA No.:
050791  Prod. No.: 001 RX (180MG); 002 RX (360MG)
PatentsExpirationPatented Use
Pat. No. 6306900 DP* Enteric coated pharmaceutical compositions
Claim Types: Formulation
Feb 27, 2018 

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

ULTIVA (INJECTABLE) REMIFENTANIL HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: MYLAN INSTITUTIONAL      NDA No.:
020630  Prod. No.: 001 RX (EQ 1MG BASE/VIAL); 002 RX (EQ 2MG BASE/VIAL); 003 RX (EQ 5MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 5866591 DP* Stable formulations of remifentanil
Claim Types: Formulation
Mar 10, 2018 *PED 

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

NIASPAN (TABLET, EXTENDED RELEASE) NIACIN [GENERIC AB]
Drug Classes: nicotinic acid
NDA Applicant: ABBVIE      NDA No.:
020381  Prod. No.: 002 RX (500MG); 003 RX (750MG); 004 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 6469035 Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acid
Claim Types: Method of use
Mar 15, 2018U-1142: Treatment of primary and mixed dyslipidemia by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirin
U-1143: Reduction in risk of recurrent nonfatal myocardial infarction by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirin
U-1144: Reduction in elevated TC and LDL-C by dosing once per day in the evening or at night, with pretreatment with a flush inhibitin agent such as aspirin
U-1145: Reduction in TG by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirin
U-768: A method of reducing the capacity of extended release nicotinic acid to provoke a flushing reaction by pretreating an individual with a flush inhibiting agent prior to the administration of the extended release nicotinic acid

GLUCOPHAGE XR (TABLET, EXTENDED RELEASE) METFORMIN HYDROCHLORIDE [GENERIC AB1]
Drug Classes: biguanide
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.:
021202  Prod. No.: 001 RX (500MG); 004 RX (750MG)
PatentsExpirationPatented Use
Pat. No. 6475521 Biphasic controlled release delivery system for high solubility pharmaceuticals and method
Claim Types: Formulation; Process; Product-by-process
Mar 19, 2018 
Pat. No. 6660300 Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method
Claim Types: Method of use
Mar 19, 2018U-542: Method of treating patient with Type 2 diabetes by once daily administration

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 

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 

REBETOL (CAPSULE) RIBAVIRIN [GENERIC AB]
Drug Classes: nucleoside analog antiviral
NDA Applicant: MERCK SHARP DOHME      NDA No.:
020903  Prod. No.: 002 RX (200MG) NDA No.: 020903  Prod. No.: 001 DISC (200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**)
PatentsExpirationPatented Use
Pat. No. 6172046 Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Claim Types: Method of use
Mar 21, 2018 *PEDU-1014: Method of using ribavirin in combination with interferon alpha-2b(pegylated and nonpegylated) to treat patients with chronic hepatitis C
U-377: Method of treating pt with chronic hepatitis C having HCV genotype 1 and viral load greater than 2 million copies/ml to eradicate detectable HCV-RNA by admin combination of ribavirin and interferon alfa-2b for a least 24 weeks
Pat. No. 6472373 Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Claim Types: Method of use
Mar 21, 2018 *PEDU-1014: Method of using ribavirin in combination with interferon alpha-2b(pegylated and nonpegylated) to treat patients with chronic hepatitis C
U-479: Method of using PEG-INTRON/REBETOL combination therapy and INTRON/REBETOL combination therapy

REBETOL (SOLUTION) RIBAVIRIN
Drug Classes: nucleoside analog antiviral
NDA Applicant: SCHERING      NDA No.:
021546  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 6172046 Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Claim Types: Method of use
Mar 21, 2018 *PEDU-1014: Method of using ribavirin in combination with interferon alpha-2b(pegylated and nonpegylated) to treat patients with chronic hepatitis C
U-521: Method of using RIBAVIRIN in combination with INTRON A (interferon
Pat. No. 6472373 Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Claim Types: Method of use
Mar 21, 2018 *PEDU-521: Method of using RIBAVIRIN in combination with INTRON A (interferon
Pat. No. 6790837 DP* Ribavirin syrup formulations
Claim Types: Formulation
Oct 5, 2023 *PED 

TOPICORT (SPRAY) DESOXIMETASONE [GENERIC AT]
Drug Classes: corticosteroid
NDA Applicant: TARO PHARMS      NDA No.:
204141  Prod. No.: 001 RX (0.25%)
PatentsExpirationPatented Use
Pat. No. 5990100 DP* Composition and method for treatment of psoriasis
Claim Types: Formulation; Method of use
Mar 24, 2018U-1408: Treatment of plaque psoriasis in patients 18 years of age or older
Pat. No. 8715624 DP* Stable liquid desoximethasone compositions with reduced oxidized impurity
Claim Types: Formulation; Method of use; Process
May 26, 2026U-1408: Treatment of plaque psoriasis in patients 18 years of age or older
Pat. No. 8277780 DP* Stable liquid desoximethasone compositions with reduced oxidized impurity
Claim Types: Formulation; Method of use; Process
Sep 1, 2028U-1408: Treatment of plaque psoriasis in patients 18 years of age or older

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

PEPCID COMPLETE (TABLET, CHEWABLE) CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE [GENERIC OTC]
Drug Classes: anticholinergic; histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC      NDA No.:
020958  Prod. No.: 001 OTC (800MG;10MG;165MG)
PatentsExpirationPatented Use
Pat. No. 5989588 DP* Methods and compositions for preventing and treating heartburn
Claim Types: Method of use; Formulation
Mar 30, 2018 *PEDU-349: Method of use which is subject of the application
Pat. No. 6814978 DP* Process for preparing a soft tablet
Claim Types: Formulation; Process
Feb 26, 2022 *PED 

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.

TECFIDERA (CAPSULE, DELAYED RELEASE) DIMETHYL FUMARATE
NDA Applicant: BIOGEN IDEC INC      NDA No.:
204063  Prod. No.: 001 RX (120MG); 002 RX (240MG)
PatentsExpirationPatented Use
Pat. No. 8524773 Utilization of dialkylfumarates
Claim Types: Method of use
Apr 1, 2018U-1384: Method of treating multiple sclerosis
Pat. No. 8759393 DP* Utilization of dialkylfumarates
Claim Types: Formulation
Jul 4, 2018 
Pat. No. 6509376 DP* Utilization of dialkyfumarates
Claim Types: Formulation
Apr 1, 2019 
Pat. No. 7619001 Utilization of dialkylfumarates
Claim Types: Method of use
Apr 1, 2019U-1384: Method of treating multiple sclerosis
Pat. No. 7803840 Utilization of dialkylfumarates
Claim Types: Method of use
Apr 1, 2019U-1385: Method of treating an autoimmune disease selected from autoimmune polyarthritis and multiple sclerosis but not treating psoriatic arthritis
Pat. No. 7320999 Dimethyl fumarate for the treatment of multiple sclerosis
Claim Types: Method of use
Oct 20, 2019U-1384: Method of treating multiple sclerosis
Pat. No. 8399514 Treatment for multiple sclerosis
Claim Types: Method of use
Feb 7, 2028U-1384: Method of treating multiple sclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 27, 2018 

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 

NUVARING (RING) ETHINYL ESTRADIOL; ETONOGESTREL
Drug Classes: estrogen; progestin
NDA Applicant: ORGANON SUB MERCK      NDA No.:
021187  Prod. No.: 001 RX (0.015MG/24HR;0.12MG/24HR)
PatentsExpirationPatented Use
Pat. No. 5989581 Drug delivery system for two or more active substances
Claim Types: Device
Apr 8, 2018 

FAZACLO ODT (TABLET, ORALLY DISINTEGRATING) CLOZAPINE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: JAZZ PHARMS III      NDA No.:
021590  Prod. No.: 001 RX (25MG); 002 RX (100MG); 004 RX (12.5MG); 005 RX (150MG); 006 RX (200MG) NDA No.: 021590  Prod. No.: 003 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

FLUXID (TABLET, ORALLY DISINTEGRATING) FAMOTIDINE
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: UCB INC      NDA No.:
021712  Prod. No.: 001 DISC (20MG); 002 DISC (40MG)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

KEMSTRO (TABLET, ORALLY DISINTEGRATING) BACLOFEN
Drug Classes: GABA A agonist
NDA Applicant: UCB INC      NDA No.:
021589  Prod. No.: 001 DISC (10MG); 002 DISC (20MG)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

NIRAVAM (TABLET, ORALLY DISINTEGRATING) ALPRAZOLAM
Drug Classes: benzodiazepine
NDA Applicant: UCB INC      NDA No.:
021726  Prod. No.: 001 DISC (0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 002 DISC (0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 003 DISC (1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 004 DISC (2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

REGLAN ODT (TABLET, ORALLY DISINTEGRATING) METOCLOPRAMIDE HYDROCHLORIDE [Has competitive generic]
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: MEDA PHARMS      NDA No.:
021793  Prod. No.: 001 DISC (EQ 5MG BASE); 002 DISC (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation; Process; Drug in a container
Apr 9, 2018 
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form
Claim Types: Formulation
Apr 9, 2018 

APRISO (CAPSULE, EXTENDED RELEASE) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL      NDA No.:
022301  Prod. No.: 001 RX (375MG)
PatentsExpirationPatented Use
Pat. No. 6551620 DS* DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Apr 20, 2018U-907: For the maintenance of remission of ulcerative colitis in subjects 18 years of age and older
Pat. No. 8337886 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation; Method of use
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8496965 DP* Pellet formulation for the treatment of the intenstinal tract
Claim Types: Formulation
Apr 20, 2018 
Pat. No. 8911778 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018U-1310: For the maintenance of remission of ulcerative colitis
Pat. No. 8940328 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018 
Pat. No. 8956647 DP* Pellet formulation for the treatment of the intestinal tract
Claim Types: Formulation
Apr 20, 2018 
Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine
Claim Types: Method of use
May 1, 2030U-1310: For the maintenance of remission of ulcerative colitis

LAZANDA (SPRAY, METERED) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: ELEFSEE PHARMS INTL      NDA No.:
022569  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.4MG BASE)
PatentsExpirationPatented Use
Pat. No. 6432440 DP* Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces
Claim Types: Formulation; Kit; Method of use; Process; Method of administration
Apr 20, 2018U-1169: Management of breakthrough pain in cancer patients 18 years of age and older who are receiving and tolerant to opioid therapy for their underlying persistent cancer pain
Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Drug in a container
Jan 8, 2024 
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Jan 8, 2024 
Pat. No. 8889176 Method of managing or treating pain
Claim Types: Method of administration
Jan 16, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8216604 Method of managing or treating pain
Claim Types: Method of use
Oct 3, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Jan 26, 2032 

LEVULAN (SOLUTION) AMINOLEVULINIC ACID HYDROCHLORIDE
Drug Classes: porphyrin precursor
NDA Applicant: DUSA      NDA No.:
020965  Prod. No.: 001 RX (20%)
PatentsExpirationPatented Use
Pat. No. 6709446 Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light
Claim Types: Device; Method of use
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 8216289 Illuminator for photodynamic therapy
Claim Types: Diagnostic or surgical method
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 8758418 Illuminator for photodynamic therapy
Claim Types: Method of use
May 1, 2018U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 7723910 Method of photodynamically diagnosing or treating a contoured surface
Claim Types: Method of use
Jun 17, 2019U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 9, 2021I-766: Treatment of minimally to moderately thick actinic keratosis of the upper extremities in conjunction with a blue light photodynamic therapy illuminator

KALETRA (CAPSULE) LOPINAVIR; RITONAVIR
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.:
021226  Prod. No.: 001 DISC (133.3MG;33.3MG)
PatentsExpirationPatented Use
Pat. No. 6232333 Pharmaceutical composition
Claim Types: Formulation
May 7, 2018 *PED 
Pat. No. 6458818 Pharmaceutical composition
Claim Types: Formulation
May 7, 2018 *PED 
Pat. No. 6521651 DP* Pharmaceutical composition
Claim Types: Formulation
May 7, 2018 *PED 
Pat. No. 7141593 DP* Pharmaceutical formulations
Claim Types: Formulation
Nov 22, 2020 *PED 
Pat. No. 7432294 DP* Pharmaceutical formulations
Claim Types: Formulation
Nov 22, 2020 *PED 

NORVIR (CAPSULE) RITONAVIR
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE      NDA No.:
020945  Prod. No.: 001 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 6232333 Pharmaceutical composition
Claim Types: Formulation
May 7, 2018 *PED 
Pat. No. 7141593 DP* Pharmaceutical formulations
Claim Types: Formulation
Nov 22, 2020 *PED 
Pat. No. 7432294 DP* Pharmaceutical formulations
Claim Types: Formulation
Nov 22, 2020 *PED 

EMSAM (FILM, EXTENDED RELEASE) SELEGILINE
Drug Classes: monoamine oxidase inhibitor (MAOI); monoamine oxidase type B (MAO-B) inhibitor
NDA Applicant: SOMERSET      NDA No.:
021336  Prod. No.: 001 RX (6MG/24HR); 002 RX (9MG/24HR); 003 RX (12MG/24HR)
PatentsExpirationPatented Use
Pat. No. 7070808 DS* DP* Adhesive mixture for transdermal delivery of highly plasticizing drugs
Claim Types: Formulation
May 10, 2018 
Pat. No. 7638140 DP* Adhesive mixture for transdermal delivery of highly plasticizing drugs
Claim Types: Formulation; Process
May 10, 2018 
Pat. No. 7150881 DS* DP* Adhesive mixture for transdermal delivery of highly plasticizing drugs
Claim Types: Formulation
Jun 12, 2018 

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 

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 

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

SKLICE (LOTION) IVERMECTIN
Drug Classes: antiparasitic; pediculicide
NDA Applicant: ARBOR PHARMS LLC      NDA No.:
202736  Prod. No.: 001 RX (0.5%)
PatentsExpirationPatented Use
Pat. No. 6103248 DP* Topical preparation and therapy for head lice
Claim Types: Formulation
May 22, 2018 
Pat. No. 8791153 DP* Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment-resistant strains of head lice
Claim Types: Formulation
Oct 12, 2027 
Pat. No. 8927595 Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment resistant strains of head lice
Claim Types: Method of use
Oct 12, 2027U-1782: For head lice infestations

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021704  Prod. No.: 002 OTC (180MG;240MG)
PatentsExpirationPatented Use
Pat. No. RE39069 DP* Multi-layered osmotic device
Claim Types: Device
May 29, 2018 
Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist
Claim Types: Device; Method of use
Dec 25, 2020U-1159: Relief of symptoms associated with respiratory allergies, swelling of the nasal passages and sinus congestion and pressure in adults and children 12 years of age and older

OSMOLEX ER (TABLET, EXTENDED RELEASE) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: OSMOTICA PHARM      NDA No.:
209410  Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE); 003 RX (EQ 258MG BASE)
PatentsExpirationPatented Use
Pat. No. RE39069 DP* Multi-layered osmotic device
Claim Types: Device
May 29, 2018 
Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation; Method of use
Nov 28, 2025U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation
Mar 13, 2030 

CLARITIN (SYRUP) LORATADINE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAYER HEALTHCARE LLC      NDA No.:
020641  Prod. No.: 002 OTC (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 6132758 DP* Stabilized antihistamine syrup
Claim Types: Formulation
Jun 1, 2018 

VFEND (INJECTABLE) VORICONAZOLE [GENERIC AP]
Drug Classes: azole antifungal
NDA Applicant: PF PRISM CV      NDA No.:
021267  Prod. No.: 001 RX (200MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6632803 DP* Pharmaceutical formulations containing voriconazole
Claim Types: Formulation; Product-by-process
Jun 2, 2018 

FLO-PRED (SUSPENSION) PREDNISOLONE ACETATE
Drug Classes: corticosteroid
NDA Applicant: TARO      NDA No.:
022067  Prod. No.: 001 DISC (EQ 5MG BASE/5ML); 002 DISC (EQ 15MG BASE/5ML)
PatentsExpirationPatented Use
Pat. No. 6071523 DP* Spill resistant pharmaceutical compositions in semi-solid form
Claim Types: Formulation; Drug in a container
Jun 3, 2018 
Pat. No. 6399079 DP* Spill resistant pharmaceutical compositions in semi-solid form
Claim Types: Drug in a container; Formulation
Jun 3, 2018 
Pat. No. 6656482 DP* Spill resistant pharmaceutical system
Claim Types: Drug in a container; Method of use; Formulation
Jun 3, 2018 
Pat. No. 7799331 DP* Oral suspension of prednisolone acetate
Claim Types: Formulation
Oct 11, 2028U-1068: Treatment of asthma
U-139: Treatment of allergic reactions

HUMALOG KWIKPEN (SOLUTION) INSULIN LISPRO RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: ELI LILLY AND CO      NDA No.:
205747  Prod. No.: 001 RX (200 UNITS/ML)
PatentsExpirationPatented Use
Pat. No. 6034054 DP* Stable insulin formulations
Claim Types: Formulation; Method of Use; Method of administration
Jun 11, 2018U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 6551992 DP* Stable insulin formulations
Claim Types: Formulation; Method of use; Method of administration
Jun 11, 2018U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7291132 DP* Medication dispensing apparatus with triple screw threads for mechanical advantage
Claim Types: Device
Aug 9, 2024 

GANIRELIX ACETATE (INJECTABLE) GANIRELIX ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) antagonist
NDA Applicant: ORGANON USA INC      NDA No.:
021057  Prod. No.: 001 RX (EQ 250MCG BASE/0.5ML)
PatentsExpirationPatented Use
Pat. No. 6653286 Gonadotropin releasing hormone antagonist
Claim Types: Method of use
Jun 16, 2018U-1354: Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH

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 

EXTRANEAL (SOLUTION) ICODEXTRIN
NDA Applicant: BAXTER HLTHCARE      NDA No.:
021321  Prod. No.: 001 RX (7.5GM/100ML)
PatentsExpirationPatented Use
Pat. No. 6248726 Method of peritoneal dialysis using glucose polymer solutions
Claim Types: Method of use
Jun 19, 2018U-495: Peritoneal dialysis solution

MULTAQ (TABLET) DRONEDARONE HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: SANOFI AVENTIS US      NDA No.:
022425  Prod. No.: 001 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 7323493 DP* Solid pharmaceutical composition containing benzofuran derivatives
Claim Types: Formulation
Jun 19, 2018 
Pat. No. 8318800 DP* Solid pharmaceutical compositions containing benzofuran derivatives
Claim Types: Formulation
Jun 19, 2018 
Pat. No. 8410167 Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
Claim Types: Method of use
Apr 16, 2029U-1387: Reduction in risk of hospitalization in patients with a history of paroxysmal or persistent AF without severe heart failure and with one or more risk factors by administration twice a daily with morning and evening meals
U-1388: Treatment of patients with a history of paroxysmal or persistent AF without severe heart failure and with one or more risk factors by administration twice a day with morning and evening meals
Pat. No. 9107900 Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of morality
Claim Types: Method of use
Apr 16, 2029U-1726: Reduction in risk of hospitalization in patients with coronary heart disease and a history of paroxysmal or persistent AF and with one or more risk factors by administration twice a day with morning and evening meals
U-1728: Reduction in risk of hospitalization in patients with stable NYHA class iii heart failure and a history of paroxysmal or persistent af and with one or more risk factors by administration twice a day with morning and evening meals
Pat. No. 8602215 Methods for reducing the risk of an adverse dronedarone/beta-blockers interaction in a patient suffering from atrial fibrillation
Claim Types: Method of administration
Jun 30, 2031U-1473: Management of risk of dronedarone/beta-blocker interaction in patients in sinus rythm with a history of paroxysmal or persistent AF

ADVAIR HFA (AEROSOL, METERED) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.:
021254  Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/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 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. 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 

ADVAIR HFA (AEROSOL, METERED) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.:
021254  Prod. No.: 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/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. 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 

FLOVENT HFA (AEROSOL, METERED) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD      NDA No.:
021433  Prod. No.: 001 RX (0.22MG/INH); 003 RX (0.044MG/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. 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 

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 

VENTOLIN HFA (AEROSOL, METERED) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020983  Prod. No.: 001 RX (EQ 0.09MG BASE/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. 7107986 DP* Dispenser with doses' counter
Claim Types: Device
Dec 6, 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. 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. 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

MIDOL LIQUID GELS (CAPSULE) IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BIONPHARMA INC      NDA No.:
021472  Prod. No.: 001 OTC (200MG)
PatentsExpirationPatented Use
Pat. No. 6251426 Ibuprofen-containing softgels
Claim Types: Formulation
Jun 25, 2018 

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 (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 

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 

ZYRTEC, CHILDREN'S ALLERGY; ZYRTEC, CHILDREN'S HIVES RELIEF (TABLET, CHEWABLE) CETIRIZINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: J AND J CONSUMER INC      NDA No.:
021621  Prod. No.: 003 DISC (5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 004 DISC (10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 005 DISC (5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 006 DISC (10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6455533 DP* Pharmaceutical compositions for oral administration, comprising an active substance and a cyclodextrin
Claim Types: Formulation; Process; Method of administration
Jul 2, 2018U-295: Treatment of seasonal and perennial allergic rhinitis symptoms

XENICAL (CAPSULE) ORLISTAT
Drug Classes: intestinal lipase inhibitor
NDA Applicant: CHEPLAPHARM      NDA No.:
020766  Prod. No.: 001 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 6004996 Tetrahydrolipstatin containing compositions
Claim Types: Formulation
Jul 6, 2018 *PED 

CENTANY (OINTMENT) MUPIROCIN [Has competitive generic]
Drug Classes: RNA synthetase inhibitor antibacterial
NDA Applicant: PERRIGO NEW YORK      NDA No.:
050788  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 6013657 DP* Pharmaceutical compositions containing mupirocin
Claim Types: Formulation
Jul 8, 2018 

ULTANE (LIQUID) SEVOFLURANE [GENERIC AN]
Drug Classes: general anesthetic
NDA Applicant: ABBVIE      NDA No.:
020478  Prod. No.: 001 RX (100%)
PatentsExpirationPatented Use
Pat. No. 6074668 Container for an inhalation anesthetic
Claim Types: Drug in a container
Jul 9, 2018 *PED 

CLOLAR (SOLUTION) CLOFARABINE [GENERIC AP]
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: GENZYME      NDA No.:
021673  Prod. No.: 001 RX (20MG/20ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 5661136 [Extended 1237 days (3.4 years)]
2-halo-2'-fluoro ARA adenosines as antinoplastic agents
Claim Types: Method of use
Jul 14, 2018 *PEDU-626: CLOLAR is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens

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 

ILEVRO (SUSPENSION/DROPS) NEPAFENAC
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
203491  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 6403609 DP* Ophthalmic compositions containing galactomannan polymers and borate
Claim Types: Formulation; Method of use
Jul 17, 2018 
Pat. No. 7947295 DP* Ophthalmic compositions containing a synergistic combination of two polymers
Claim Types: Formulation
Jun 8, 2024 
Pat. No. 9662398 DP* Carboxylvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Dec 1, 2030 
Pat. No. 8921337 DP* Carboxyvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Mar 31, 2032 

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 

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 

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 

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 

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

SUPRENZA (TABLET, ORALLY DISINTEGRATING) PHENTERMINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: sympathomimetic amine anorectic
NDA Applicant: CITIUS PHARMS      NDA No.:
202088  Prod. No.: 001 DISC (15MG); 002 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 6149938 DP* Process for the preparation of a granulate suitable to the preparation of rapidly disintegrable mouth-soluble tablets and compositions obtained thereby
Claim Types: Process; Formulation
Jul 23, 2018 
Pat. No. 8440170 DP* Orally disintegrating tablets with speckled appearance
Claim Types: Formulation
Mar 14, 2029 

SUPRENZA (TABLET, ORALLY DISINTEGRATING) PHENTERMINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: sympathomimetic amine anorectic
NDA Applicant: CITIUS PHARMS      NDA No.:
202088  Prod. No.: 003 DISC (37.5MG)
PatentsExpirationPatented Use
Pat. No. 6149938 DP* Process for the preparation of a granulate suitable to the preparation of rapidly disintegrable mouth-soluble tablets and compositions obtained thereby
Claim Types: Process; Formulation
Jul 23, 2018U-1243: With dry hands, gently remove the SUPRENZA (phentermine hydrochloride ODT) tablet from the bottle. immediately place the SUPRENZA tablet on top of the tongue where it will dissolve, then swallow with or without water
Pat. No. 8440170 DP* Orally disintegrating tablets with speckled appearance
Claim Types: Formulation
Mar 14, 2029 

VIADUR (IMPLANT) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ORTHO MCNEIL JANSSEN      NDA No.:
021088  Prod. No.: 001 DISC (EQ 65MG BASE)
PatentsExpirationPatented Use
Pat. No. 6113938 Beneficial agent delivery system with membrane plug and method for controlling delivery of beneficial agents
Claim Types: Device; Process; Method of administration
Jul 24, 2018 
Pat. No. 6375978 Rate controlling membranes for controlled drug delivery devices
Claim Types: Excipient as product-by-process; Process
Dec 17, 2018 

XERESE (CREAM) ACYCLOVIR; HYDROCORTISONE
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor; corticosteroid
NDA Applicant: VALEANT BERMUDA      NDA No.:
022436  Prod. No.: 001 RX (5%;1%)
PatentsExpirationPatented Use
Pat. No. 6514980 DP* Nucleoside analogs in combination therapy of herpes simplex infections
Claim Types: Formulation; Method of use
Jul 24, 2018U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older)
U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older)
Pat. No. 7223387 DP* Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Claim Types: Formulation; Method of use
Nov 13, 2022U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older)
U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older)

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

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.

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

AMPYRA (TABLET, EXTENDED RELEASE) DALFAMPRIDINE [GENERIC AB]
Drug Classes: potassium channel blocker
NDA Applicant: ACORDA      NDA No.:
022250  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 5540938 Formulations and their use in the treatment of neurological diseases
Claim Types: Method of use
Jul 30, 2018U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 9918973 Sustained release aminopyridine composition
Claim Types: Method of use
Dec 13, 2024U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8663685 Sustained release aminopyridine composition
Claim Types: Method of use
Jan 18, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8440703 Methods of using sustained release aminopyridine compositions
Claim Types: Method of administration
Apr 8, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8354437 Method of using sustained release aminopyridine compositions
Claim Types: Method of use
Dec 22, 2026U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8007826 Sustained release aminopyridine composition
Claim Types: Method of administration
May 26, 2027U-1030: Improvement of walking in patients with multiple sclerosis (MS)

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 

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: SANOFI AVENTIS US      NDA No.:
020786  Prod. No.: 002 OTC (60MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6039974 DP* Pharmaceutical composition for combination of piperidinoalkanol-decongestant
Claim Types: Formulation
Jul 31, 2018 

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

CADUET (TABLET) AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; HMG CoA-reductase inhibitor
NDA Applicant: PFIZER      NDA No.:
021540  Prod. No.: 001 RX (EQ 5MG BASE;EQ 10MG BASE); 002 RX (EQ 5MG BASE;EQ 20MG BASE); 003 RX (EQ 5MG BASE;EQ 40MG BASE); 004 RX (EQ 5MG BASE;EQ 80MG BASE); 005 RX (EQ 10MG BASE;EQ 10MG BASE); 006 RX (EQ 10MG BASE;EQ 20MG BASE); 007 RX (EQ 10MG BASE;EQ 40MG BASE); 008 RX (EQ 10MG BASE;EQ 80MG BASE); 009 RX (EQ 2.5MG BASE;EQ 10MG BASE); 010 RX (EQ 2.5MG BASE;EQ 20MG BASE); 011 RX (EQ 2.5MG BASE;EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6455574 Therapeutic combination
Claim Types: Method of use
Aug 11, 2018U-552: Treatment of hypertension and hyperlipidemia with a single composition

TRILEPTAL (TABLET) OXCARBAZEPINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: NOVARTIS      NDA No.:
021014  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (600MG)
PatentsExpirationPatented Use
Pat. No. 7037525 Oxacarbazepine film-coated tablets
Claim Types: Method of use
Aug 12, 2018 *PEDU-724: Method of treating seizures

TRILEPTAL (SUSPENSION) OXCARBAZEPINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: NOVARTIS      NDA No.:
021285  Prod. No.: 001 RX (300MG/5ML)
PatentsExpirationPatented Use
Pat. No. 7037525 Oxacarbazepine film-coated tablets
Claim Types: Method of use
Aug 12, 2018 *PEDU-724: Method of treating seizures
Pat. No. 8119148 DP* Suspension comprising oxcarbazepine
Claim Types: Formulation; Method of use; Drug in a container
Jun 19, 2021 *PEDU-724: Method of treating seizures

PICATO (GEL) INGENOL MEBUTATE
Drug Classes: inducer of cell death
NDA Applicant: LEO LABS      NDA No.:
202833  Prod. No.: 001 RX (0.015%)
PatentsExpirationPatented Use
Pat. No. 6432452 Anti-cancer compounds
Claim Types: Method of use
Aug 19, 2018U-68: Treatment of actinic keratosis
Pat. No. 6787161 Anti-cancer compounds
Claim Types: Method of use
Aug 19, 2018U-68: Treatment of actinic keratosis
Pat. No. 6844013 Methods of stimulating the immune system
Claim Types: Method of use
Dec 13, 2018U-1221: To stimulate the immune system to induce T cell proliferation
Pat. No. 7410656 Anti-cancer compounds
Claim Types: Method of use
Oct 10, 2020U-1222: To inhibit the proliferative activity of neoplastic cells
Pat. No. 8372827 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8372828 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8377919 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8536163 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8716271 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8735375 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 9820959 DP* Therapeutic compositions
Claim Types: Formulation; Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 9833428 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 9833429 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 9861603 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8278292 DP* Therapeutic compositions
Claim Types: Formulation
Jul 6, 2027 
Pat. No. 9789078 Method of topically treating actinic keratosis with ingenol mebutate cycle therapy
Claim Types: Method of use
May 15, 2033U-2138: Topical treatment of actinic keratosis of the face or scalp using more than one treatment course of ingenol mebutate
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 19, 2018M-169: Updates to labeling describing response to a repeat course of PICATO gel 0.015% on the face or scalp if an incomplete response is observed at a follow-up examination.

PICATO (GEL) INGENOL MEBUTATE
Drug Classes: inducer of cell death
NDA Applicant: LEO LABS      NDA No.:
202833  Prod. No.: 002 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 6432452 Anti-cancer compounds
Claim Types: Method of use
Aug 19, 2018U-68: Treatment of actinic keratosis
Pat. No. 6787161 Anti-cancer compounds
Claim Types: Method of use
Aug 19, 2018U-68: Treatment of actinic keratosis
Pat. No. 6844013 Methods of stimulating the immune system
Claim Types: Method of use
Dec 13, 2018U-1221: To stimulate the immune system to induce T cell proliferation
Pat. No. 7410656 Anti-cancer compounds
Claim Types: Method of use
Oct 10, 2020U-1222: To inhibit the proliferative activity of neoplastic cells
Pat. No. 8372827 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8372828 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8377919 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 8536163 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8716271 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8735375 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 9820959 DP* Therapeutic compositions
Claim Types: Formulation; Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 9833428 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 9833429 DP* Therapeutic compositions
Claim Types: Formulation
Dec 18, 2026 
Pat. No. 9861603 Therapeutic compositions
Claim Types: Method of use
Dec 18, 2026U-1440: Use of ingenol mebutate to treat actinic keratosis
Pat. No. 8278292 DP* Therapeutic compositions
Claim Types: Formulation
Jul 6, 2027 

COMBIVENT RESPIMAT (SPRAY, METERED) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist; anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021747  Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
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, 2020 
Pat. No. 7988001 DP* Container provided with a pressure equalization opening
Claim Types: Device
Aug 4, 2021 
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
Aug 26, 2024 
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
May 26, 2025 
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Oct 10, 2026 
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 

POMALYST (CAPSULE) POMALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE      NDA No.:
204026  Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (3MG); 004 RX (4MG)
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
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-1361: Use of pomalidomide while preventing the exposure of a fetus or other contraindicated individual to pomalidomide
Pat. No. 8673939 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Claim Types: Method of use
May 15, 2023U-1360: Use of pomalidomide for the treatment of multiple myeloma
U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy
Pat. No. 8735428 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Claim Types: Method of use
May 15, 2023U-1360: Use of pomalidomide for the treatment of multiple myeloma
U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy
Pat. No. 8198262 Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Claim Types: Method of administration
Jun 17, 2025U-1360: Use of pomalidomide for the treatment of multiple myeloma
U-2254: Use of pomalidomide with dexamethasone for patients with multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or within 60 days of completing the last therapy
Pat. No. 8828427 DS* DP* Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Claim Types: Formulation
Jun 21, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 23, 2018I-707: Pomalyst, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least 2 prior therapies and have demonstrated disease progression on or within 60 days of completion of the last therapy
Exclusivity Code: NCE - New chemical entityFeb 8, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 8, 2020ODE-43: Treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

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 

THALOMID (CAPSULE) THALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE      NDA No.:
020785  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 7874984 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-1109: Treatment of cutaneous manifestations of erythema nodosum leprosum (ENL) in connection with a special program approved by FDA called "system for thalidomide education and prescribing safety" (S.T.E.P.S.)
U-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-442: Method for delivering a drug to a patient in need of the drug, while avoiding the occurence of an adverse side effect known or suspected of being caused by said drug
U-732: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL)
U-733: Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
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-1465: Use of thalidomide while preventing the exposure of a fetus or other contraindicated individual to thalidomide
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-442: Method for delivering a drug to a patient in need of the drug, while avoiding the occurence of an adverse side effect known or suspected of being caused by said drug
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 6869399 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 use
Oct 23, 2020U-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
U-732: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL)
U-733: Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
Pat. No. 7141018 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-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
U-732: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL)
U-733: Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
Pat. No. 7959566 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 use
Oct 23, 2020U-1155: Use of thalidomide in treatment of cutaneous manifestations of erythema nodosum leprosum (ENL)
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-1465: Use of thalidomide while preventing the exposure of a fetus or other contraindicated individual to thalidomide
Pat. No. 7230012 DP* Pharmaceutical compositions and dosage forms of thalidomide
Claim Types: Formulation
Dec 9, 2023 

THALOMID (CAPSULE) THALIDOMIDE
Drug Classes: thalidomide analog
NDA Applicant: CELGENE      NDA No.:
020785  Prod. No.: 004 RX (150MG)
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 7874984 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-1109: Treatment of cutaneous manifestations of erythema nodosum leprosum (ENL) in connection with a special program approved by FDA called "system for thalidomide education and prescribing safety" (S.T.E.P.S.)
U-371: Approval for marketing only under a special restriction program approved by FDA called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.)
U-442: Method for delivering a drug to a patient in need of the drug, while avoiding the occurence of an adverse side effect known or suspected of being caused by said drug
U-732: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL)
U-733: Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
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-1465: Use of thalidomide while preventing the exposure of a fetus or other contraindicated individual to thalidomide
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 6869399 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 use
Oct 23, 2020U-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 7141018 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-731: Use in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma
Pat. No. 7959566 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 use
Oct 23, 2020U-1155: Use of thalidomide in treatment of cutaneous manifestations of erythema nodosum leprosum (ENL)
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-1465: Use of thalidomide while preventing the exposure of a fetus or other contraindicated individual to thalidomide

LYBREL (TABLET) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: estrogen; progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: WYETH PHARMS INC      NDA No.:
021864  Prod. No.: 001 DISC (0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 6500814 Hormonal contraceptive
Claim Types: Method of use
Sep 3, 2018U-1: Prevention of pregnancy

CICLOPIROX (GEL) CICLOPIROX [GENERIC AB]
NDA Applicant: CNTY LINE PHARMS      NDA No.:
020519  Prod. No.: 001 RX (0.77%)
PatentsExpirationPatented Use
Pat. No. 7018656 DP* Antimycotic gel with high active substance release
Claim Types: Formulation
Sep 5, 2018 

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 

RAPAMUNE (TABLET) SIROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: PF PRISM CV      NDA No.:
021110  Prod. No.: 001 RX (1MG); 002 RX (2MG); 004 RX (0.5MG) NDA No.: 021110  Prod. No.: 003 DISC (5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
PatentsExpirationPatented Use
Pat. No. 5989591 DP* Rapamycin formulations for oral administration
Claim Types: Formulation; Process
Sep 11, 2018 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 28, 2022ODE-92: Treatment of lymphangioleiomyomatosis (LAM)

COMTAN (TABLET) ENTACAPONE [GENERIC AB]
Drug Classes: catechol o-methyl transferase (COMT) inhibitor
NDA Applicant: ORION PHARMA      NDA No.:
020796  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6599530 DP* Oral compacted composition comprising catechol derivatives
Claim Types: Formulation; Process; Method of use
Sep 14, 2018U-219: Treatment of Parkinson's disease

NITROSTAT (TABLET) NITROGLYCERIN [GENERIC AB]
Drug Classes: nitrate vasodilator
NDA Applicant: PFIZER PHARMS      NDA No.:
021134  Prod. No.: 001 RX (0.3MG); 002 RX (0.4MG); 003 RX (0.6MG)
PatentsExpirationPatented Use
Pat. No. 6500456 Compressed nitroglycerin tablet and its method of manufacture
Claim Types: Formulation
Sep 16, 2018 

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 

EXPAREL (INJECTABLE, LIPOSOMAL) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Process; Formulation; Method of use
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Process; Product-by-process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

EXPAREL (INJECTABLE, LIPOSOMAL) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Process; Formulation; Method of use
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9205052 Sustained-release liposomal anesthetic compositions
Claim Types: Method of use; Method of administration
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Process; Product-by-process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

SOOLANTRA (CREAM) IVERMECTIN
Drug Classes: antiparasitic; pediculicide
NDA Applicant: GALDERMA LABS LP      NDA No.:
206255  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 5952372 Method for treating rosacea using oral or topical ivermectin
Claim Types: Method of use
Sep 18, 2018U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 6133310 Method of treatment of rosacea
Claim Types: Method of administration
Apr 26, 2019U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 7550440 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8080530 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8093219 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation; Method of use
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8415311 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8470788 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8815816 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9089587 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233117 Treatment of inflammatory lesions of rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233118 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9782425 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.

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 

DAYTRANA (FILM, EXTENDED RELEASE) METHYLPHENIDATE
Drug Classes: central nervous system stimulant
NDA Applicant: NOVEN PHARMS INC      NDA No.:
021514  Prod. No.: 001 RX (10MG/9HR (1.1MG/HR)); 002 RX (15MG/9HR (1.6MG/HR)); 003 RX (20MG/9HR (2.2MG/HR)); 004 RX (30MG/9HR (3.3MG/HR))
PatentsExpirationPatented Use
Pat. No. 6210705 DP* Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate
Claim Types: Formulation; Method of use
Sep 30, 2018U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 6348211 DP* Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate
Claim Types: Formulation; Method of use
Sep 30, 2018U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 8632802 DP* Device for transdermal administration of drugs including acrylic polymers
Claim Types: Formulation
Oct 7, 2025 
Pat. No. 9034370 DP* Device for transdermal administration of drugs including acrylic polymers
Claim Types: Formulation; Method of administration
Oct 7, 2025 
Pat. No. 9668981 Device for transdermal administration of drugs including acrylic based polymers
Claim Types: Method of administration
Oct 7, 2025U-2024: Method for transdermally delivering a drug to a user in need thereof

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.

CRESTOR (TABLET) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.:
021366  Prod. No.: 002 RX (5MG); 003 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 20, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.:
021366  Prod. No.: 004 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 27, 2019I-732: Treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia to reduce LDL-C, total C, NonHDL-C and APOB as an adjunct to diet, either alone or with other lipid-lowering treatments
Exclusivity Code: NPP - New patient populationNov 20, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.:
021366  Prod. No.: 005 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

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

ZEMPLAR (SOLUTION) PARICALCITOL [GENERIC AP]
Drug Classes: vitamin D3 analog
NDA Applicant: ABBVIE      NDA No.:
020819  Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))
PatentsExpirationPatented Use
Pat. No. 6136799 Cosolvent formulations
Claim Types: Formulation; Process
Oct 8, 2018 *PED 
Pat. No. 6361758 DP* Cosolvent formulations
Claim Types: Formulation
Oct 8, 2018 *PED 

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 

EXTINA (AEROSOL, FOAM) KETOCONAZOLE [GENERIC AT]
Drug Classes: azole antifungal
NDA Applicant: MYLAN PHARMS INC      NDA No.:
021738  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 7553835 DP* Topical antifungal composition
Claim Types: Method of use; Formulation
Oct 19, 2018U-245: Treatment of seborrhea dermatitis in humans
Pat. No. 8026238 DP* Topical antifungal composition
Claim Types: Method of use; Formulation
Oct 19, 2018U-1213: Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older

MYDAYIS (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE DEV LLC      NDA No.:
022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts