Patents whose numbers are in italics have been extended under 35 USC
156. All expiration dates include applicable Sec. 156 and pediatric
(PED) extensions.
Products tagged as GENERIC have had a generic equivalent
approved for at least one strength of the product.
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5914331
DS* [Extended 642 days (1.8 years)] Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition |
Jan 2, 2018 *PED | |
Pat.
No. 5922695
DS* Antiviral phosphonomethyoxy nucleotide analogs having
increased oral bioavarilability Claim Types: Compound; Method of use; Process |
Jan 25, 2018 *PED | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 5935946
DS* DP* Nucleotide analog composition and
synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process |
Jan 25, 2018 *PED | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 5977089
DS* DP* Antiviral phosphonomethoxy nucleotide
analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use |
Jan 25, 2018 *PED | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 6043230
Antiviral phosphonomethoxy nucleotide analogs having increased oral
bioavailability Claim Types: Method of use |
Jan 25, 2018 *PED | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 6939964
DS* Crystal forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Jul 20, 2018 *PED | |
Pat.
No. 6639071
DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-
trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Aug 14, 2018 *PED | |
Pat.
No. 6642245
Antiviral activity and resolution of
2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use |
May 4, 2021 *PED | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 6703396
DS* DP* Method of resolution and antiviral
activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation |
Sep 9, 2021 *PED | |
Pat.
No. 8592397
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use |
Jan 13, 2024 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 8716264
DP* Compositions and methods for combination antiviral
therapy Claim Types: Method of use |
Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat.
No. 9457036
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use |
Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat.
No. 9744181
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use |
Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat.
No. 9018192
Unitary pharmaceutical dosage form Claim Types: Method of use |
Jun 13, 2026 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 9545414
DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Method of use; Drug in a container; Method of administration |
Jun 13, 2026 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of hiv-1 infection in adults |
Pat.
No. 8598185
DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Drug in a container |
Apr 28, 2029 |
TECFIDERA
(CAPSULE, DELAYED
RELEASE) DIMETHYL FUMARATE
NDA Applicant:
BIOGEN IDEC
INC NDA No.: 204063 Prod. No.:
001 RX (120MG); 002 RX (240MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8524773
Utilization of dialkylfumarates Claim Types: Method of use |
Apr 1, 2018 | U-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, 2019 | U-1384: Method of treating multiple sclerosis |
Pat.
No. 7803840
Utilization of dialkylfumarates Claim Types: Method of use |
Apr 1, 2019 | U-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, 2019 | U-1384: Method of treating multiple sclerosis |
Pat.
No. 8399514
Treatment for multiple sclerosis Claim Types: Method of use |
Feb 7, 2028 | U-1384: Method of treating multiple sclerosis |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Mar 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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6170717
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6315173
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6510969
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6966467
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6161724
DP* Indicating device Claim Types: Device |
Jul 16, 2018 *PED | |
Pat.
No. 6435372
DP* Delivery system for a medicament and method for the
assembly thereof Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6938796
DP* Indicating device Claim Types: Device; Process; Method of administration |
Jul 16, 2018 *PED | |
Pat.
No. 6997349
DP* Indicating device Claim Types: Device; Kit; Process |
Jul 16, 2018 *PED | |
Pat.
No. 7143908
DP* Indicating device Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6170717
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6315173
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6510969
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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6170717
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6315173
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6510969
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6966467
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6161724
DP* Indicating device Claim Types: Device |
Jul 16, 2018 *PED | |
Pat.
No. 6435372
DP* Delivery system for a medicament and method for the
assembly thereof Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6938796
DP* Indicating device Claim Types: Device; Process; Method of administration |
Jul 16, 2018 *PED | |
Pat.
No. 6997349
DP* Indicating device Claim Types: Device; Kit; Process |
Jul 16, 2018 *PED | |
Pat.
No. 7143908
DP* Indicating device Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6431168
DP* Dispenser with doses' counter Claim Types: Device; Method of administration; Drug in a container |
Dec 8, 2018 *PED | |
Pat.
No. 7107986
DP* Dispenser with doses' counter Claim Types: Device |
Dec 8, 2018 *PED | |
Pat.
No. 7350676
DP* Valve for aerosol container Claim Types: Device |
Feb 24, 2019 *PED | |
Pat.
No. 9861771
DP* Device housing for an aerosol container Claim Types: Device |
Oct 11, 2020 | |
Pat.
No. 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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6170717
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6315173
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6510969
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6966467
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6161724
DP* Indicating device Claim Types: Device |
Jul 16, 2018 *PED | |
Pat.
No. 6435372
DP* Delivery system for a medicament and method for the
assembly thereof Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6938796
DP* Indicating device Claim Types: Device; Process; Method of administration |
Jul 16, 2018 *PED | |
Pat.
No. 6997349
DP* Indicating device Claim Types: Device; Kit; Process |
Jul 16, 2018 *PED | |
Pat.
No. 7143908
DP* Indicating device Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6431168
DP* Dispenser with doses' counter Claim Types: Device; Method of administration; Drug in a container |
Dec 8, 2018 *PED | |
Pat.
No. 7107986
DP* Dispenser with doses' counter Claim Types: Device |
Dec 8, 2018 *PED | |
Pat.
No. 7350676
DP* Valve for aerosol container Claim Types: Device |
Feb 24, 2019 *PED | |
Pat.
No. 9861771
DP* Device housing for an aerosol container Claim Types: Device |
Oct 11, 2020 | |
Pat.
No. 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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6170717
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6315173
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6510969
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6966467
DP* Valve for aerosol container Claim Types: Device |
Jun 23, 2018 *PED | |
Pat.
No. 6161724
DP* Indicating device Claim Types: Device |
Jul 16, 2018 *PED | |
Pat.
No. 6435372
DP* Delivery system for a medicament and method for the
assembly thereof Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6938796
DP* Indicating device Claim Types: Device; Process; Method of administration |
Jul 16, 2018 *PED | |
Pat.
No. 6997349
DP* Indicating device Claim Types: Device; Kit; Process |
Jul 16, 2018 *PED | |
Pat.
No. 7143908
DP* Indicating device Claim Types: Device; Process |
Jul 16, 2018 *PED | |
Pat.
No. 6431168
DP* Dispenser with doses' counter Claim Types: Device; Method of administration; Drug in a container |
Dec 8, 2018 *PED | |
Pat.
No. 7107986
DP* Dispenser with doses' counter Claim Types: Device |
Dec 8, 2018 *PED | |
Pat.
No. 7350676
DP* Valve for aerosol container Claim Types: Device |
Feb 24, 2019 *PED | |
Pat.
No. 9861771
DP* Device housing for an aerosol container Claim Types: Device |
Oct 11, 2020 | |
Pat.
No. 6743413
Suspension aerosol formulations Claim Types: Composition; Device; Method of use |
Dec 1, 2021 *PED | U-581: Method of treating a condition capable of treatment by inhalation, e.g. asthma, comprising administration of a formulation claimed in US Patent No. 6743413 |
Pat.
No. 7832351
DP* Actuation indicator for a dispensing device Claim Types: Device |
Dec 19, 2023 *PED | |
Pat.
No. 7500444
DP* Actuation indicator for a dispensing device Claim Types: Device |
Aug 26, 2026 *PED |
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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6096742
DS* DP* Polymorphic form of a tachykinin receptor
antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use |
Jul 1, 2018 | U-1743:
For the prevention of nausea and vomiting associated with chemotherapy U-1744: Prevention of post-operative nausea and vomiting U-745: Treatment or prevention of emesis U-745: Treatment or prevention of emesis |
Pat.
No. 6096742
Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use |
Jul 1, 2018 | |
Pat.
No. 8258132
DP* Pharmaceutical composition of a tachykinin receptor
antagonist Claim Types: Formulation; Method of use |
Sep 26, 2027 | U-1743:
For the prevention of nausea and vomiting associated with chemotherapy U-901: Prevention of postoperative nausea and vomiting |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
EMEND
(CAPSULE) APREPITANT [GENERIC AB]
Drug Classes:
substance P/neurokinin-1
(NK-1) receptor antagonist
NDA Applicant:
MERCK NDA No.:
021549 Prod. No.:
003 RX (40MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6096742
DS* DP* Polymorphic form of a tachykinin receptor
antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use |
Jul 1, 2018 | U-1743:
For the prevention of nausea and vomiting associated with chemotherapy U-1744: Prevention of post-operative nausea and vomiting U-745: Treatment or prevention of emesis |
Pat.
No. 8258132
DP* Pharmaceutical composition of a tachykinin receptor
antagonist Claim Types: Formulation; Method of use |
Sep 26, 2027 | U-1743:
For the prevention of nausea and vomiting associated with chemotherapy U-901: Prevention of postoperative nausea and vomiting |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
EMEND
(FOR SUSPENSION)
APREPITANT
Drug Classes:
substance P/neurokinin-1
(NK-1) receptor antagonist
NDA Applicant:
MSD MERCK
CO NDA No.: 207865 Prod. No.:
001 RX (125MG/KIT)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6096742
DS* DP* Polymorphic form of a tachykinin receptor
antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use |
Jul 1, 2018 | U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV) |
Pat.
No. 8258132
DP* Pharmaceutical composition of a tachykinin receptor
antagonist Claim Types: Formulation; Method of use |
Sep 26, 2027 | U-1916: Prevention of nausea and vomiting associated with chemotherapy (CINV) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Aug 28, 2018 |
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**)
Patents | Expiration | Patented 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, 2018 | U-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)
Patents | Expiration | Patented 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%)
Patents | Expiration | Patented 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%)
Patents | Expiration | Patented 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))
Patents | Expiration | Patented 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 *PED | U-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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6251910
DS* 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor
antagonists Claim Types: Compound; Composition; Method of use; Process |
Jul 15, 2018 | |
Pat.
No. 6525060
DS* DP* Triazolo(4,5-d)pyrimidine compounds Claim Types: Compound; Composition; Method of use |
Dec 2, 2019 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1862: Treatment of post-myocardial infarction U-1863: Treatment of stroke |
Pat.
No. 7250419
DS* DP* Trisubstituted triazolopyrimidines for use
in platelet aggregation inhibition Claim Types: Compound; Composition; Method of use |
Dec 2, 2019 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1864: Treatment of myocardial infarction U-1865: Treatment of thrombotic stroke U-1866: Treatment of stable and unstable angina U-1867: Method of inhibiting platelet aggregation |
Pat.
No. 7265124
DS* DP* Cristalline and amorphous form of a
triazolo (4,5-D) pyridimine compound Claim Types: New polymorph, salt or hydrate; Process; Method of use |
Jul 9, 2021 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarction U-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease |
Pat.
No. RE46276
DS* DP* Triazolo(4,5-D)pyrimidine compounds Claim Types: Compound; Composition; Process; Method of use |
Oct 30, 2024 | U-1935:
Reduction of the rate of cardiovascular death, myocardial infarction,
and stroke in patients with a history of myocardial infarction U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction |
Pat.
No. 8425934
DP* Pharmaceutical compositions Claim Types: Formulation |
Apr 17, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Sep 3, 2018 | I-714: Extends the 2011 approval of BRILINTA for use beginning with ACS to use beginning more remote from myocardial infarction |
BRILINTA
(TABLET) TICAGRELOR
Drug Classes:
P2Y12 platelet inhibitor
NDA Applicant:
ASTRAZENECA
PHARMS NDA No.: 022433 Prod. No.:
002 RX (60MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6251910
DS* 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor
antagonists Claim Types: Compound; Composition; Method of use; Process |
Jul 15, 2018 | |
Pat.
No. 6525060
DS* DP* Triazolo(4,5-d)pyrimidine compounds Claim Types: Compound; Composition; Method of use |
Dec 2, 2019 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1862: Treatment of post-myocardial infarction U-1863: Treatment of stroke |
Pat.
No. 7250419
DS* DP* Trisubstituted triazolopyrimidines for use
in platelet aggregation inhibition Claim Types: Compound; Composition; Method of use |
Dec 2, 2019 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1864: Treatment of myocardial infarction U-1865: Treatment of thrombotic stroke U-1866: Treatment of stable and unstable angina U-1867: Method of inhibiting platelet aggregation |
Pat.
No. 7265124
DS* DP* Cristalline and amorphous form of a
triazolo (4,5-D) pyridimine compound Claim Types: New polymorph, salt or hydrate; Process; Method of use |
Jul 9, 2021 | U-1171:
Reduction of the rate of thrombotic events in patients with acute
coronary syndrome U-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarction U-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease |
Pat.
No. RE46276
DS* DP* Triazolo(4,5-D)pyrimidine compounds Claim Types: Compound; Composition; Process; Method of use |
Oct 30, 2024 | U-1935:
Reduction of the rate of cardiovascular death, myocardial infarction,
and stroke in patients with a history of myocardial infarction U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction |
Pat.
No. 8425934
DP* Pharmaceutical compositions Claim Types: Formulation |
Apr 17, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NS - New strength | Sep 3, 2018 |
PAXIL
(CAPSULE)
PAROXETINE HYDROCHLORIDE
Drug Classes:
selective serotonin
reuptake inhibitor (SSRI)
NDA Applicant:
APOTEX
TECHNOLOGIES NDA No.: 020885 Prod. No.:
001 DISC (EQ 10MG BASE **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy reasons**);
002 DISC (EQ 20MG BASE **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy reasons**);
003 DISC (EQ 30MG BASE **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy reasons**);
004 DISC (EQ 40MG BASE **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6172233
Process for making paroxetine Claim Types: Product-by-process; Process |
Jul 15, 2018 *PED | |
Pat.
No. 6063927
Paroxetine derivatives Claim Types: Composition; Product-by-process |
Oct 23, 2019 *PED |
ILEVRO
(SUSPENSION/DROPS)
NEPAFENAC
Drug Classes:
nonsteroidal
anti-inflammatory drug
NDA Applicant:
NOVARTIS PHARMS
CORP NDA No.: 203491 Prod. No.:
001 RX (0.3%)
Patents | Expiration | Patented 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**)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6939964
DS* Crystal forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Jul 20, 2018 *PED | |
Pat.
No. 6639071
DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-
trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Aug 14, 2018 *PED | |
Pat.
No. 6238695
DP* Formulation of fast-dissolving efavirenz capsules or
tablets using super-disintegrants Claim Types: Formulation; Process |
Oct 6, 2019 *PED | |
Pat.
No. 6555133
Formulation of fast-dissolving efavirenz capsules or tablets using
super-disintegrants Claim Types: Method of use |
Oct 6, 2019 *PED | U-248: Treatment of HIV |
SUSTIVA
(TABLET) EFAVIRENZ [GENERIC AB]
Drug Classes:
HIV nonnucleoside analog
reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant:
BRISTOL MYERS
SQUIBB NDA No.: 021360 Prod. No.:
002 RX (600MG)
NDA No.: 021360 Prod. No.:
001 DISC (300MG **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6939964
DS* Crystal forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Jul 20, 2018 *PED | |
Pat.
No. 6639071
DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-
trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate |
Aug 14, 2018 *PED |
VALTURNA
(TABLET) ALISKIREN
HEMIFUMARATE; VALSARTAN
Drug Classes:
renin inhibitor;
angiotensin II receptor blocker
NDA Applicant:
NOVARTIS NDA No.:
022217 Prod. No.:
001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5559111
DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use |
Jul 21, 2018 | U-3: Treatment of hypertension |
Pat.
No. 8168616
DP* Combination comprising a renin inhibitor and an
angiotensin receptor inhibitor for hypertension Claim Types: Composition |
Jul 3, 2026 |
TEKAMLO
(TABLET) ALISKIREN
HEMIFUMARATE; AMLODIPINE BESYLATE
Drug Classes:
renin inhibitor;
dihydropyridine calcium channel blocker
NDA Applicant:
NOVARTIS NDA No.:
022545 Prod. No.:
001 DISC (EQ 150MG BASE;EQ 5MG BASE); 002 DISC (EQ 150MG BASE;EQ 10MG
BASE); 003 DISC (EQ 300MG BASE;EQ 5MG BASE); 004 DISC (EQ 300MG BASE;EQ
10MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5559111
DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use |
Jul 21, 2018 | U-3: Treatment of hypertension |
Pat.
No. 8613949
DP* Galenical formulations of organic compounds Claim Types: Formulation; Process |
Dec 21, 2029 |
AMTURNIDE
(TABLET) ALISKIREN
HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes:
renin inhibitor;
dihydropyridine calcium channel blocker; thiazide diuretic
NDA Applicant:
NOVARTIS NDA No.:
200045 Prod. No.:
001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC (EQ 300MG BASE;EQ
5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ 5MG BASE;25MG); 004 DISC
(EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005 DISC (EQ 300MG BASE;EQ 10MG
BASE;25MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5559111
DS* DP* [Extended 1204 days (3.3 years)] .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides Claim Types: Compound; Composition; Method of use |
Jul 21, 2018 | U-3: Treatment of hypertension |
Pat.
No. 8618174
DP* Synergistic combinations comprising a renin inhibitor
for cardiovascular diseases Claim Types: Composition; Formulation |
Nov 15, 2021 | |
Pat.
No. 8183295
DP* Pharmaceutical composition comprising a renin
inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation |
May 16, 2023 |
HEPSERA
(TABLET) ADEFOVIR
DIPIVOXIL [GENERIC AB]
Drug Classes:
HBV nucleoside analog
reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant:
GILEAD NDA No.:
021449 Prod. No.:
001 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6451340
DS* DP* Nucleotide analog compositions Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation |
Jul 23, 2018 | U-470: Therapy in chronic hepatitis B virus infection |
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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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 | U-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)
Patents | Expiration | Patented 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%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6514980
DP* Nucleoside analogs in combination therapy of herpes
simplex infections Claim Types: Formulation; Method of use |
Jul 24, 2018 | U-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, 2022 | U-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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5968979
DS* DP* Triglycerides and ethyl esters of
phenylalkanoic acid and phenylalkenoic acid useful in treatment of
various disorders Claim Types: Method of use; Compound; Formulation; Composition |
Jul 28, 2018 | U-1378: Treatment of a nitrogen metabolism disorder |
Pat.
No. 8642012
Methods of treatment using ammonia-scavenging drugs Claim Types: Method of use; Method of administration |
Sep 22, 2030 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat.
No. 9561197
Methods of therapeutic monitoring of phenylacetic acid prodrugs Claim Types: Method of use |
Sep 22, 2030 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat.
No. 9962359
Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use |
Sep 22, 2030 | U-1816: Treatment of a urea cycle disorder |
Pat.
No. 8404215
Methods of therapeutic monitoring of nitrogen scavenging Claim Types: Method of administration |
Mar 9, 2032 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat.
No. 9095559
Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of improving a treatment; Method of use |
Mar 9, 2032 | U-1383: Dosage adjustment of a nitrogen scavenging drug in the treatment of a urea cycle disorder |
Pat.
No. 9254278
Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use; Method of administration |
Mar 9, 2032 | U-1816: Treatment of a urea cycle disorder |
Pat.
No. 9326966
Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of administration |
Mar 9, 2032 | U-1816: Treatment of a urea cycle disorder |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Apr 28, 2020 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-157: For use as a nitrogen-binding agent for chronic management of pediatric patients >=2 months and < 2 years of age with urea cycle disorders (ucds) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 1, 2020 | ODE-42: Use as a nitrogen-binding adjunctive therapy for chronic mgmt of adult and pediatric patients at least 2 yrs with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone |
LETAIRIS
(TABLET) AMBRISENTAN
Drug Classes:
endothelin receptor
antagonist
NDA Applicant:
GILEAD NDA No.:
022081 Prod. No.:
001 RX (5MG); 002 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE42462
DS* Carboxylic acid derivatives, their preparation and use Claim Types: Compound |
Jul 29, 2018 | |
Pat.
No. 8377933
Method for treating a pulmonary hypertension condition Claim Types: Method of administration; Method of use |
Dec 11, 2027 | U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil |
Pat.
No. 9474752
Method for treating a pulmonary hypertension condition Claim Types: Method of use |
Dec 11, 2027 | U-1754: For the treatment of pulmonary hypertension (PAH) in combination with tadalafil |
Pat.
No. 9549926
Compositions and methods of treating pulmonary hypertension Claim Types: Method of use |
Oct 14, 2031 | U-1965: For the treatment of pulmonary arterial hypertension (PAH) in combination with tadalafil, wherein the weight ratio of ambrisentan to tadalafil is about 1:2 to about 1:3 |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Oct 2, 2018 | I-716: Revised indication to include language about the benefits of using LETAIRIS in combination with tadalafil to reduce the risk of disease progression and hospitalization for worsening PAH and to improve exercise ability, based on the ambition study |
GILOTRIF
(TABLET) AFATINIB
DIMALEATE
Drug Classes:
kinase inhibitor
NDA Applicant:
BOEHRINGER
INGELHEIM NDA No.: 201292 Prod. No.:
001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6251912
DS* DP* Substituted quinazoline derivatives Claim Types: Compound; Method of use; Composition |
Jul 29, 2018 | U-1067: Treatment of cancer |
Pat.
No. RE43431
DS* Quinazoline derivatives and pharmaceutical
compositions containing them Claim Types: Compound |
Jan 22, 2022 | |
Pat.
No. 9539258
Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use |
Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
Pat.
No. 8426586
DS* Process for preparing amino crotonyl compounds Claim Types: 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 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
Exclusivity Code: NCE - New chemical entity | Jul 12, 2018 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
GILOTRIF
(TABLET) AFATINIB
DIMALEATE
Drug Classes:
kinase inhibitor
NDA Applicant:
BOEHRINGER
INGELHEIM NDA No.: 201292 Prod. No.:
003 RX (EQ 40MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6251912
DS* DP* Substituted quinazoline derivatives Claim Types: Compound; Method of use; Composition |
Jul 29, 2018 | U-1067: Treatment of cancer |
Pat.
No. RE43431
DS* Quinazoline derivatives and pharmaceutical
compositions containing them Claim Types: Compound |
Jan 22, 2022 | |
Pat.
No. 9539258
Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use |
Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
Pat.
No. 8426586
DS* Process for preparing amino crotonyl compounds Claim Types: 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 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Apr 15, 2019 | I-730: New indication for the treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
Exclusivity Code: NCE - New chemical entity | Jul 12, 2018 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
AMPYRA
(TABLET, EXTENDED
RELEASE) DALFAMPRIDINE [GENERIC AB]
Drug Classes:
potassium channel blocker
NDA Applicant:
ACORDA NDA No.:
022250 Prod. No.:
001 RX (10MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5540938
Formulations and their use in the treatment of neurological diseases Claim Types: Method of use |
Jul 30, 2018 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
Pat.
No. 9918973
Sustained release aminopyridine composition Claim Types: Method of use |
Dec 13, 2024 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
Pat.
No. 8663685
Sustained release aminopyridine composition Claim Types: Method of use |
Jan 18, 2025 | U-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, 2025 | U-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, 2026 | U-1030: Improvement of walking in patients with multiple sclerosis (MS) |
Pat.
No. 8007826
Sustained release aminopyridine composition Claim Types: Method of administration |
May 26, 2027 | U-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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE39820
DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition |
Jul 30, 2018 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
Pat.
No. 6777423
DS* DP* Crystalline tiotropium bromide
monohydrate, processes for the preparation thereof, and pharmaceutical
compositions Claim Types: New polymorph, salt or hydrate; Process |
Mar 24, 2022 *PED | |
Pat.
No. 6908928
DS* DP* Crystalline tiotropium bromide
monohydrate, processes for the preparation thereof,and pharmaceutical
compositions Claim Types: Composition; Product-by-process; Method of use |
Mar 24, 2022 *PED | U-566:
For the long-term, once-daily, maintenance treatment of bronchospasm
associated with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema U-762: Treatment of chronic obstructive pulmonary disease |
Pat.
No. 7309707
DS* DP* Crystalline micronisate, process for the
manufacture thereof and use thereof for the preparation of a medicament Claim Types: New polymorph, salt or hydrate; Process |
Mar 24, 2022 *PED | |
Pat.
No. 7642268
DS* DP* Crystalline micronisate, process for the
manufacture thereof and use thereof for the preparation of a medicament Claim Types: Composition; Formulation |
Mar 24, 2022 *PED | |
Pat.
No. RE38912
DP* Process for preparing powder formulations Claim Types: 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 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
Pat.
No. 8022082
DP* Method for the administration of an anticholinergic by
inhalation Claim Types: Method of administration; Kit |
Jul 19, 2026 *PED | U-1186: Administration of an inhalable powder comprising tiotropium via device |
Pat.
No. 7694676
DP* Dry powder inhaler Claim Types: Device |
Sep 12, 2027 *PED | |
Pat.
No. 9010323
DP* Inhaler and sieve for an inhaler Claim Types: Device |
Apr 19, 2030 |
SPIRIVA RESPIMAT (SPRAY, METERED)
TIOTROPIUM BROMIDE
Drug Classes:
anticholinergic
NDA Applicant:
BOEHRINGER
INGELHEIM NDA No.: 021936 Prod. No.:
001 RX (EQ 0.0025MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE39820
DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition |
Jul 30, 2018 *PED | U-1593: Maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, and reduction of exacerbations in COPD patients. |
Pat.
No. 6846413
DP* Microstructured filter Claim Types: Device |
Feb 28, 2019 *PED | |
Pat.
No. 6977042
DP* Microstructured filter Claim Types: Device |
Feb 28, 2019 *PED | |
Pat.
No. 7802568
DP* Cartridge for a liquid Claim Types: Device |
Aug 26, 2019 *PED | |
Pat.
No. 6988496
DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container |
Aug 23, 2020 *PED | |
Pat.
No. 7988001
DP* Container provided with a pressure equalization opening Claim Types: Device |
Feb 4, 2022 *PED | |
Pat.
No. 7284474
DP* Piston-pumping system having o-ring seal properties Claim Types: Device |
Feb 26, 2025 *PED | |
Pat.
No. 7896264
DP* Microstructured high pressure nozzle with built-in
filter function Claim Types: Device; Process |
Nov 26, 2025 *PED | |
Pat.
No. 7396341
DP* Blocking device for a locking stressing mechanism
having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration |
Apr 10, 2027 *PED | |
Pat.
No. 9027967
DP* Device for clamping a fluidic component Claim Types: Device; Process |
Oct 1, 2027 *PED | |
Pat.
No. 7837235
DP* Device for clamping a fluidic component Claim Types: Device |
Sep 13, 2028 *PED | |
Pat.
No. 8733341
DP* Atomizer and method of atomizing fluid with a nozzle
rinsing mechanism Claim Types: Device; Method of administration |
Apr 16, 2031 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Mar 24, 2018 PED | |
Exclusivity Code: NPP - New patient population | Aug 15, 2020 PED |
SPIRIVA RESPIMAT (SPRAY, METERED)
TIOTROPIUM BROMIDE
Drug Classes:
anticholinergic
NDA Applicant:
BOEHRINGER
INGELHEIM NDA No.: 021936 Prod. No.:
002 RX (EQ 0.00125MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE39820
DS* DP* [Extended 1421 days* (3.9 years)] Esters of thienyl carboxylic acids and amino alcohols and their quaternization products Claim Types: Compound; Method of use; Composition |
Jul 30, 2018 *PED | |
Pat.
No. 6846413
DP* Microstructured filter Claim Types: Device |
Feb 28, 2019 *PED | |
Pat.
No. 6977042
DP* Microstructured filter Claim Types: Device |
Feb 28, 2019 *PED | |
Pat.
No. 7802568
DP* Cartridge for a liquid Claim Types: Device |
Aug 26, 2019 *PED | |
Pat.
No. 6988496
DP* Cartridge for a liquid Claim Types: Method of administration; Drug in a container |
Aug 23, 2020 *PED | |
Pat.
No. 7988001
DP* Container provided with a pressure equalization opening Claim Types: Device |
Feb 4, 2022 *PED | |
Pat.
No. 7284474
DP* Piston-pumping system having o-ring seal properties Claim Types: Device |
Feb 26, 2025 *PED | |
Pat.
No. 7896264
DP* Microstructured high pressure nozzle with built-in
filter function Claim Types: Device; Process |
Nov 26, 2025 *PED | |
Pat.
No. 7396341
DP* Blocking device for a locking stressing mechanism
having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration |
Apr 10, 2027 *PED | |
Pat.
No. 9027967
DP* Device for clamping a fluidic component Claim Types: Device; Process |
Oct 1, 2027 *PED | |
Pat.
No. 7837235
DP* Device for clamping a fluidic component Claim Types: Device |
Sep 13, 2028 *PED | |
Pat.
No. 8733341
DP* Atomizer and method of atomizing fluid with a nozzle
rinsing mechanism Claim Types: Device; Method of administration |
Apr 16, 2031 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Mar 15, 2019 PED | |
Exclusivity Code: NPP - New patient population | Aug 15, 2020 PED |
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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented 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)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6268489
DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process |
Jul 31, 2018 |
ZMAX
(FOR SUSPENSION,
EXTENDED RELEASE) AZITHROMYCIN
Drug Classes:
macrolide antimicrobial
NDA Applicant:
PF PRISM
CV NDA No.: 050797 Prod. No.:
001 DISC (EQ 2GM BASE/BOT)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6268489
DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process |
Jul 31, 2018 | |
Pat.
No. 6984403
DP* Azithromycin dosage forms with reduced side effects Claim Types: Formulation; Method of use |
Feb 14, 2024 | U-282: Method of treating bacterial infections |
Pat.
No. 7887844
DP* Multiparticulate crystalline drug compositions having
controlled release profiles Claim Types: Formulation; Process |
Feb 14, 2024 |