Orange Book Companion®
Products that had a patent expiration last month

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.


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 

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 

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 

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 

EMEND (CAPSULE) APREPITANT [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK      NDA No.:
021549  Prod. No.: 001 RX (80MG); 002 RX (125MG)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-1744: Prevention of post-operative nausea and vomiting
U-745: Treatment or prevention of emesis
U-745: Treatment or prevention of emesis
Pat. No. 6096742 Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018 
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

EMEND (CAPSULE) APREPITANT [GENERIC AB]
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MERCK      NDA No.:
021549  Prod. No.: 003 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-1744: Prevention of post-operative nausea and vomiting
U-745: Treatment or prevention of emesis
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1743: For the prevention of nausea and vomiting associated with chemotherapy
U-901: Prevention of postoperative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

EMEND (FOR SUSPENSION) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: MSD MERCK CO      NDA No.:
207865  Prod. No.: 001 RX (125MG/KIT)
PatentsExpirationPatented Use
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Jul 1, 2018U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)
Pat. No. 8258132 DP* Pharmaceutical composition of a tachykinin receptor antagonist
Claim Types: Formulation; Method of use
Sep 26, 2027U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAug 28, 2018 

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 

VALTURNA (TABLET) ALISKIREN HEMIFUMARATE; VALSARTAN
Drug Classes: renin inhibitor; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.:
022217  Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
Claim Types: Composition
Jul 3, 2026 

TEKAMLO (TABLET) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker
NDA Applicant: NOVARTIS      NDA No.:
022545  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE); 002 DISC (EQ 150MG BASE;EQ 10MG BASE); 003 DISC (EQ 300MG BASE;EQ 5MG BASE); 004 DISC (EQ 300MG BASE;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8613949 DP* Galenical formulations of organic compounds
Claim Types: Formulation; Process
Dec 21, 2029 

AMTURNIDE (TABLET) ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant: NOVARTIS      NDA No.:
200045  Prod. No.: 001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jul 21, 2018U-3: Treatment of hypertension
Pat. No. 8618174 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Composition; Formulation
Nov 15, 2021 
Pat. No. 8183295 DP* Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Claim Types: Formulation
May 16, 2023 

HEPSERA (TABLET) ADEFOVIR DIPIVOXIL [GENERIC AB]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD      NDA No.:
021449  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6451340 DS* DP* Nucleotide analog compositions
Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation
Jul 23, 2018U-470: Therapy in chronic hepatitis B virus infection

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

LETAIRIS (TABLET) AMBRISENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: GILEAD      NDA No.:
022081  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. RE42462 DS* Carboxylic acid derivatives, their preparation and use
Claim Types: Compound
Jul 29, 2018 
Pat. No. 8377933 Method for treating a pulmonary hypertension condition
Claim Types: Method of administration; Method of use
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9474752 Method for treating a pulmonary hypertension condition
Claim Types: Method of use
Dec 11, 2027U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil
Pat. No. 9549926 Compositions and methods of treating pulmonary hypertension
Claim Types: Method of use
Oct 14, 2031U-1965: For the treatment of pulmonary arterial hypertension (PAH) in combination with tadalafil, wherein the weight ratio of ambrisentan to tadalafil is about 1:2 to about 1:3
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 2, 2018I-716: Revised indication to include language about the benefits of using LETAIRIS in combination with tadalafil to reduce the risk of disease progression and hospitalization for worsening PAH and to improve exercise ability, based on the ambition study

GILOTRIF (TABLET) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
201292  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-1067: Treatment of cancer
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound
Jan 22, 2022 
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases
Claim Types: Method of use
Nov 9, 2026U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds
Claim Types: Process; New polymorph, salt or hydrate
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 12, 2021I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test
Exclusivity Code: NCE - New chemical entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

GILOTRIF (TABLET) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
201292  Prod. No.: 003 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6251912 DS* DP* Substituted quinazoline derivatives
Claim Types: Compound; Method of use; Composition
Jul 29, 2018U-1067: Treatment of cancer
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound
Jan 22, 2022 
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases
Claim Types: Method of use
Nov 9, 2026U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds
Claim Types: Process; New polymorph, salt or hydrate
Oct 10, 2029 
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992
Claim Types: Intermediate; Formulation; Process; Product-by-process
Dec 19, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 15, 2019I-730: New indication for the treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: I - New IndicationJan 12, 2021I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test
Exclusivity Code: NCE - New chemical entityJul 12, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2023ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityJul 12, 2020ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

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 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
Last edited: 5 August 2018
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