Orange Book Companion (R)
What's New for Vol. 42, Supp. 10
Changes to patent and exclusivity information

In the What's New that logged-in subscribers see, the tradename of each drug is a link to the full patent/exclusivity portfolio of the drug. If you would like that have that very useful feature, please subscribe! It is only $295/year for your whole company or organization! Click the link at the top of this page for more info.

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


AEMCOLO (TABLET, DELAYED RELEASE) (ORAL) RIFAMYCIN SODIUM
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == rifamycin antibacterial
NDA Applicant: REDHILL      NDA No.:
210910  Prod. No.: 001 RX (EQ 194MG BASE)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Nov 16, 2028 GAINNew exclusivity for this product

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX      NDA No.:
210583  Prod. No.: 001 RX (30MG/ML (30MG/ML))
PatentsExpirationChange
Pat. No. 11458145
Methods of administering intravenous meloxicam in a bolus dose
Pat. Sub. Date(s): 001: Oct 25, 2022
Claim Types: Method of use
Use Code: U-3318: Management of moderate-to-severe pain by injection
Mar 8, 2039New patent for this product

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.:
207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationChange
Pat. No. 11446318
Methods for treating pulmonary non-tuberculous mycobacterial infections
Pat. Sub. Date(s): 001: Oct 14, 2022
Claim Types: Method of use
Use Code: U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
May 15, 2035New patent for this product

AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
PatentsExpirationChange
Pat. No. 11446291
Methods for the treatment of abnormal involuntary movement disorders
Pat. Sub. Date(s): All strengths: Oct 13, 2022
Claim Types: Dosaage regimen
Use Code: U-1995: Treatment of tardive dyskinesia
Mar 7, 2036New patent for this product

BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: Antiemetics:Antiemetics, Other == dopamine-2 (D2) antagonist
NDA Applicant: ACACIA      NDA No.:
209510  Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))
PatentsExpirationChange
Pat. No. 9084765
Use of amisulpride as an anti-emetic
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Claim Types: Method of use
Use Code: U-1744: Prevention of post-operative nausea and vomiting
Use Code: U-2754: Treatment of post-operative nausea and vomiting
Use Code: U-3467: Prevention and treatment of post-operative nausea and vomiting
Feb 26, 2034New expiration date. Was previously Mar 10, 2031; New Use Code

CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: EXELIXIS INC      NDA No.:
208692  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE)
PatentsExpirationChange
Pat. No. 11141413 DLR*
Method of treating renal cell carcinoma using N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropa- ne-1,1-dicarboxamide, (2S)-hydroxybutanedioate
Pat. Sub. Date(s): All strengths: Nov 5, 2021
Claim Types: Method of use
Use Code: U-3239: Treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy
Apr 17, 2037New Delisting Request flag

CALCIUM GLUCONATE (SOLUTION) (INTRAVENOUS) CALCIUM GLUCONATE [GENERIC AP]
NDA Applicant: NIVAGEN PHARMS INC      NDA No.:
213071  Prod. No.: 001 RX (1GM/10ML (100MG/ML))
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy May 5, 2023New product in Orange Book

CERDELGA (CAPSULE) (ORAL) ELIGLUSTAT TARTRATE [GENERIC AB]
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == glucosylceramide synthase inhibitor
NDA Applicant: GENZYME CORP      NDA No.:
205494  Prod. No.: 001 RX (EQ 84MG BASE)
PatentsExpirationChange
Pat. No. 11458119 DS* DP*
Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Pat. Sub. Date(s): 001: Nov 2, 2022
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Nov 24, 2030New patent for this product

CETRORELIX ACETATE (POWDER) (SUBCUTANEOUS) CETRORELIX ACETATE [GENERIC AP]
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == Infertility Agents == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: AKORN      NDA No.:
215737  Prod. No.: 001 RX (EQ 0.25MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Apr 22, 2023New exclusivity for this product

DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: OCULAR THERAPEUTIX      NDA No.:
208742  Prod. No.: 001 RX (0.4MG)
PatentsExpirationChange
Pat. No. 11458041
Punctal plug and bioadhesives
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Method of use
Use Code: U-1680: Treatment of ocular itching associated with allergic conjunctivitis
Use Code: U-3455: Treatment of ocular inflammation and pain following ophthalmic surgery
Nov 16, 2037New patent for this product

DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.:
216285  Prod. No.: 001 RX (3.5MG)
PatentsExpirationChange
Pat. No. 11478487 DP*
Synthetic Progestogens And Pharmaceutical Compositions Comprising The Same
Pat. Sub. Date(s): 001: Nov 4, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
Jun 28, 2031New patent for this product

ELUCIREM (SOLUTION) (INTRAVENOUS) GADOPICLENOL
NDA Applicant: GUERBET      NDA No.:
216986  Prod. No.: 001 RX (1.4553GM/3ML (485.1MG/ML)); 002 RX (3.63825GM/7.5ML (485.1MG/ML)); 003 RX (4.851GM/10ML (485.1MG/ML)); 004 RX (7.2765GM/15ML (485.1MG/ML)); 005 RX (14.553GM/30ML (485.1MG/ML)); 006 RX (24.255GM/50ML (485.1MG/ML)); 007 RX (48.51GM/100ML (485.1MG/ML))
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 21, 2027New exclusivity for this product

EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: NEXUS PHARMS      NDA No.:
213407  Prod. No.: 001 RX (50MG/10ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11464752 DP*
Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Pat. Sub. Date(s): 001: Oct 17, 2022
Claim Types: Formulation claimed by its inherent performace characteristics; Product-by-process
May 16, 2040New patent for this product

ESTRADIOL (GEL) (TRANSDERMAL) ESTRADIOL [GENERIC AB]
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant: CHEMO RESEARCH SL      NDA No.:
211783  Prod. No.: 001 RX (0.1%)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Apr 8, 2023New exclusivity for this product

FERRIPROX (TABLET) (ORAL) DEFERIPRONE [Has competitive generic]
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral/Metal Modifiers == iron chelator
NDA Applicant: CHIESI      NDA No.:
212269  Prod. No.: 001 RX (1GM)
PatentsExpirationChange
Pat. No. 11458103 DP*
Delayed release deferiprone tablets and methods of using the same
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
Oct 25, 2038New patent for this product

FIRDAPSE (TABLET) (ORAL) AMIFAMPRIDINE PHOSPHATE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other == potassium channel blocker
NDA Applicant: CATALYST PHARMS      NDA No.:
208078  Prod. No.: 001 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 10793893
Methods of administering 3,4-diaminopyridine
Pat. Sub. Date(s): 001: Oct 7, 2020
Claim Types: Method of use
Use Code: U-2956: Method of treating Lambert-Eaton myasthenic syndrome with amifampridine
May 26, 2034New expiration date. Was previously Apr 7, 2034

FUROSCIX (SOLUTION) (SUBCUTANEOUS) FUROSEMIDE
Drug Classes: Cardiovascular Agents:Diuretics, Loop == loop diuretic
NDA Applicant: SCPHARMACEUTICALS      NDA No.:
209988  Prod. No.: 001 RX (80MG/10ML (8MG/ML))
PatentsExpirationChange
Pat. No. 9884039
Pharmaceutical formulations for subcutaneous administration of furosemide
Pat. Sub. Date(s): 001: Nov 2, 2022
Claim Types: Method of use
Use Code: U-3462: Use of a liquid formulation comprising furosemide to treat congestion due to fluid overload (edema) in adults with NYHA Class II/III chronic heart failure
Apr 3, 2034New product in Orange Book
Pat. No. 10272064 DP*
Pharmaceutical formulations for subcutaneous administration of furosemide
Pat. Sub. Date(s): 001: Nov 2, 2022
Claim Types: Formulation
Apr 3, 2034New product in Orange Book
Pat. No. 11433044
Pharmaceutical formulations for subcutaneous administration of furosemide
Pat. Sub. Date(s): 001: Nov 2, 2022
Claim Types: Method of use
Use Code: U-3462: Use of a liquid formulation comprising furosemide to treat congestion due to fluid overload (edema) in adults with NYHA Class II/III chronic heart failure
Apr 3, 2034New product in Orange Book

GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: AMICUS THERAP US      NDA No.:
208623  Prod. No.: 001 RX (EQ 123MG BASE)
PatentsExpirationChange
Pat. No. 11458128
Methods of treating Fabry patients having renal impairment
Pat. Sub. Date(s): 001: Oct 13, 2022
Claim Types: Method of use
Use Code: U-2371: The treatment of Fabry patients
May 30, 2038New patent for this product

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.:
201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-280: Revisions to the pediatric use subsection of labeling to include the results from clinical studies E7389-G000-223 and E7389-G000-213, conducted to fulfill a pediatric written requestMar 13, 2026 PEDNew exclusivity for this product

IBSRELA (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
NDA Applicant: ARDELYX INC      NDA No.:
211801  Prod. No.: 001 RX (EQ 50MG BASE)
PatentsExpirationChange
Pat. No. 8541448 DS* DP*
Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Pat. Sub. Date(s): 001: Oct 10, 2019
Claim Types: Compound; Composition
Aug 1, 2033New expiration date. Was previously Dec 30, 2029

IHEEZO (GEL) (OPHTHALMIC) CHLOROPROCAINE HYDROCHLORIDE
Drug Classes: ester local anesthetic
NDA Applicant: SINTETICA SA      NDA No.:
216227  Prod. No.: 001 RX (3%)
PatentsExpirationChange
Pat. No. 10792271 DP*
Topical formulations of chloroprocaine and methods of using same
Pat. Sub. Date(s): 001: Oct 26, 2022
Claim Types: Method of use
Use Code: U-3457: Method of inducing ocular anesthesia
Sep 15, 2038New patent for this product

KATERZIA (SUSPENSION) (ORAL) AMLODIPINE BENZOATE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.:
211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)
PatentsExpirationChange
Pat. No. 11471409
Amlodipine formulations
Pat. Sub. Date(s): 001: Oct 18, 2022
Claim Types: Method of use
Use Code: U-3447: A method of treating coronary artery disease
Use Code: U-3448: A method of treating hypertension
Oct 6, 2037New patent for this product
Pat. No. 11484498 DP*
Amlodipine Formulations
Pat. Sub. Date(s): 001: Nov 4, 2022
Claim Types: Product-by-process
Oct 6, 2037New patent for this product

KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: AZURITY      NDA No.:
213593  Prod. No.: 001 RX (2MG/ML;84MG/ML)
PatentsExpirationChange
Pat. No. 10751333 DP*
Compositions and kits for omeprazole suspension
Pat. Sub. Date(s): 001: Oct 21, 2022
Claim Types: Excipient; Formulation; Formulation claimed by its inherent performace characteristics; Kit
Jul 16, 2039New patent for this product
Pat. No. 11103492 DP*
Compositions and kits for omeprazole suspension
Pat. Sub. Date(s): 001: Oct 21, 2022
Claim Types: Excipient
Jul 16, 2039New patent for this product

KYPROLIS (POWDER) (INTRAVENOUS) CARFILZOMIB [GENERIC AP]
Drug Classes: proteasome inhibitor
NDA Applicant: ONYX THERAP      NDA No.:
202714  Prod. No.: 001 RX (60MG/VIAL); 002 RX (30MG/VIAL); 003 RX (10MG/VIAL)
PatentsExpirationChange
Pat. No. RE47954
Combination therapy with peptide epoxyketones
Pat. Sub. Date(s): All strengths: Oct 18, 2022
Claim Types: Method of use
Use Code: U-3449: Use in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Oct 21, 2029New patent for this product

LYTGOBI (TABLET) (ORAL) FUTIBATINIB
NDA Applicant: TAIHO ONCOLOGY      NDA No.:
214801  Prod. No.: 001 RX (4MG)
PatentsExpirationChange
Pat. No. 9108973 DS* DP*
3,5-disubstituted alkynylbenzene compound and salt thereof
Pat. Sub. Date(s): 001: Oct 24, 2022
Claim Types: Compound; Composition; Method of use
Use Code: U-3456: Method of treating intrahepatic cholangiocarcinoma
Feb 23, 2033New patent for this product
Pat. No. 10434103 DS* DP*
Crystal of 3,5-disubstituted benzene alkynyl compound
Pat. Sub. Date(s): 001: Oct 24, 2022
Claim Types: New polymorph, salt or hydrate; Composition; Process
Mar 31, 2036New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 30, 2027New exclusivity for this product

MAKENA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) HYDROXYPROGESTERONE CAPROATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: COVIS      NDA No.:
021945  Prod. No.: 004 RX (275MG/1.1ML (250MG/ML))
PatentsExpirationChange
Pat. No. 11446440 DP*
Needle assisted injection device having reduced trigger force
Pat. Sub. Date(s): 004: Oct 17, 2022
Claim Types: Device
Aug 21, 2031New patent for this product
Pat. No. 11446441 DP*
Prefilled syringe injector
Pat. Sub. Date(s): 004: Oct 17, 2022
Claim Types: Device
Jan 24, 2026New patent for this product

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: NEVAKAR INJECTABLES      NDA No.:
214628  Prod. No.: 001 RX (EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)); 003 RX (EQ 16MG BASE/250ML (EQ 64MCG BASE/ML))
PatentsExpirationChange
Pat. No. 10159657 DP*
Norepinephrine compositions and methods therefor
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Formulation
Jan 30, 2038New product in Orange Book
Pat. No. 10226436 DP*
Norepinephrine compositions and methods therefor
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Use Code: U-3461: Indicated to raise blood pressure in adult patients with severe, acute hypotension
Jan 30, 2038New product in Orange Book
Pat. No. 10420735 DP*
Norepinephrine compositions and methods therefor
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Method of use; Method of administration
Use Code: U-3461: Indicated to raise blood pressure in adult patients with severe, acute hypotension
Jan 30, 2038New product in Orange Book
Pat. No. 10568850 DP*
Norepinephrine compositions and methods therefor
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Drug in a container
Jan 30, 2038New product in Orange Book
Pat. No. 11413259 DP*
Norepinephrine compositions and methods therefor
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Process; Formulation claimed by its inherent performace characteristics
Use Code: U-3461: Indicated to raise blood pressure in adult patients with severe, acute hypotension
Jan 30, 2038New product in Orange Book

OMLONTI (SOLUTION) (OPHTHALMIC) OMIDENEPAG ISOPROPYL
NDA Applicant: SANTEN      NDA No.:
215092  Prod. No.: 001 RX (0.002%)
PatentsExpirationChange
Pat. No. RE48183 DP*
Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Formulation; Method of use
Use Code: U-3454: Method of treating open-angle glaucoma or ocular hypertension in patients
Jan 8, 2035New patent for this product
Pat. No. 8648097 DS* DP*
Pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Compound; Composition
Oct 13, 2029New patent for this product
Pat. No. 8685986 DP*
Medical composition for treatment or prophylaxis of glaucoma
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Composition
Oct 13, 2029New patent for this product
Pat. No. 9415038 DP*
Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Formulation; Method of use
Use Code: U-3454: Method of treating open-angle glaucoma or ocular hypertension in patients
Jan 8, 2035New patent for this product
Pat. No. 10179127 DP*
Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Composition; Method of use
Use Code: U-3454: Method of treating open-angle glaucoma or ocular hypertension in patients
Jan 8, 2035New patent for this product
Pat. No. 10702511 DP*
Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Composition; Method of use
Use Code: U-3454: Method of treating open-angle glaucoma or ocular hypertension in patients
Jan 8, 2035New patent for this product
Pat. No. 10765750 DP*
Pharmaceutical composition containing pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Formulation; Process
Jan 8, 2035New patent for this product
Pat. No. 10774072 DS*
Crystal of N-substituted sulfonamide compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: New polymorph, salt or hydrate
Jun 10, 2035New patent for this product
Pat. No. 11197849 DP*
Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Pat. Sub. Date(s): 001: Oct 20, 2022
Claim Types: Formulation; Method of use
Use Code: U-3454: Method of treating open-angle glaucoma or ocular hypertension in patients
Jan 8, 2035New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 22, 2027New exclusivity for this product

ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == cystic fibrosis transmembrane conductance regulator (CFTR) potentiator
NDA Applicant: VERTEX PHARMS INC      NDA No.:
211358  Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Sep 2, 2025New exclusivity for this product

ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == cystic fibrosis transmembrane conductance regulator (CFTR) potentiator
NDA Applicant: VERTEX PHARMS INC      NDA No.: 211358  Prod. No.: 003 RX (94MG/PACKET;75MG/PACKET)
ExclusivityExpirationChange
Exclusivity Code: NS - New strength Sep 2, 2025New exclusivity for this product

OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: Antineoplastics:Antineoplastics, Other == Immunological Agents:Immunosuppressants == folate analog metabolic inhibitor
NDA Applicant: OTTER PHARMS      NDA No.:
204824  Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML)); 002 RX (15MG/0.4ML (15MG/0.4ML)); 003 RX (20MG/0.4ML (20MG/0.4ML)); 004 RX (25MG/0.4ML (25MG/0.4ML)); 006 RX (12.5MG/0.4ML (12.5MG/0.4ML)); 007 RX (17.5MG/0.4ML (17.5MG/0.4ML)); 008 RX (22.5MG/0.4ML (22.5MG/0.4ML)) NDA No.: 204824  Prod. No.: 005 DISC (7.5MG/0.4ML (7.5MG/0.4ML))
PatentsExpirationChange
Pat. No. 11446441 DP*
Prefilled syringe injector
Pat. Sub. Date(s): All strengths: Oct 19, 2022
Claim Types: Device
Jan 24, 2026New patent for this product

OXBRYTA (TABLET) (ORAL) VOXELOTOR
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: GLOBAL BLOOD THERAPS      NDA No.:
213137  Prod. No.: 001 RX (500MG)
PatentsExpirationChange
Pat. No. 11452720
Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Pat. Sub. Date(s): 001: Oct 27, 2022
Claim Types: Method of use; Composition
Use Code: U-3459: Treating sickle cell disease by administering voxelotor and another active agent
Feb 6, 2035New patent for this product

OXBRYTA (TABLET) (ORAL) VOXELOTOR
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: GLOBAL BLOOD THERAPS      NDA No.: 213137  Prod. No.: 002 RX (300MG)
PatentsExpirationChange
Pat. No. 11452720
Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Pat. Sub. Date(s): 002: Oct 27, 2022
Claim Types: Method of use; Composition
Use Code: U-3459: Treating sickle cell disease by administering voxelotor and another active agent
Feb 6, 2035New strength or variation of this product

OXBRYTA (TABLET, FOR SUSPENSION) (ORAL) VOXELOTOR
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: GLOBAL BLOOD THERAPS      NDA No.: 216157  Prod. No.: 001 RX (300MG)
PatentsExpirationChange
Pat. No. 11452720
Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Pat. Sub. Date(s): 001: Oct 27, 2022
Claim Types: Method of use; Composition
Use Code: U-3459: Treating sickle cell disease by administering voxelotor and another active agent
Feb 6, 2035New patent for this product

OXLUMO (SOLUTION) (SUBCUTANEOUS) LUMASIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
214103  Prod. No.: 001 RX (EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE))
PatentsExpirationChange
Pat. No. 11446380 DS* DP*
Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
Pat. Sub. Date(s): 001: Oct 19, 2022
Claim Types: Compound; Composition; Cell
Oct 9, 2035New patent for this product

PEDMARK (SOLUTION) (INTRAVENOUS) SODIUM THIOSULFATE
NDA Applicant: FENNEC PHARMS INC      NDA No.:
212937  Prod. No.: 001 RX (12.5GM/100ML (125MG/ML))
PatentsExpirationChange
Pat. No. 10596190
Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy
Pat. Sub. Date(s): 001: Oct 6, 2022
Claim Types: Method of use
Use Code: U-3443: A method of reducing ototoxicity in a human pediatric patient about 5 years of age or under with localized medulloblastoma comprising administering sodium thiosulfate about six hours after administration of cisplatin
Jan 5, 2038New patent for this product
Pat. No. 11291728 DP*
Anhydrous sodium thiosulfate and formulations thereof
Pat. Sub. Date(s): 001: Oct 6, 2022
Claim Types: Formulation
Jul 1, 2039New patent for this product

PEMAZYRE (TABLET) (ORAL) PEMIGATINIB
Drug Classes: kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.:
213736  Prod. No.: 001 RX (4.5MG); 002 RX (9MG); 003 RX (13.5MG)
PatentsExpirationChange
Pat. No. 11466004
Solid forms of an FGFR inhibitor and processes for preparing the same
Pat. Sub. Date(s): All strengths: Nov 7, 2022
Claim Types: Method of use; Dosaage regimen
Use Code: U-3464: Treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement by administering once daily a tablet containing about 0.5 mg to about 10 mg of pemigatinib
Use Code: U-3465: Treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement by administering pemigatinib qd for 14 days then not administering pemigatinib for 7 days in a 21-day cycle
Use Code: U-3466: Treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement by administering pemigatinib in a daily dose of about 5 mg to about 20 mg
May 3, 2039New patent for this product

PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: MANKIND PHARMA      NDA No.:
216859  Prod. No.: 001 RX (2.5%)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Apr 5, 2023New exclusivity for this product

RECORLEV (TABLET) (ORAL) LEVOKETOCONAZOLE
Drug Classes: cortisol synthesis inhibitor
NDA Applicant: STRONGBRIDGE      NDA No.:
214133  Prod. No.: 001 RX (150MG)
PatentsExpirationChange
Pat. No. 11478471
Methods And Compositions For Treating Diabetes, Metabolic Syndrome And Other Conditions
Pat. Sub. Date(s): 001: Oct 31, 2022
Claim Types: Method of use
Use Code: U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing's syndrome for whom surgery is not an option or has not been curative
Jan 10, 2026New patent for this product

RELYVRIO (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE; TAURURSODIOL
NDA Applicant: AMYLYX      NDA No.:
216660  Prod. No.: 001 RX (3GM/PACKET; 1GM/PACKET)
PatentsExpirationChange
Pat. No. 9872865
Compositions for improving cell viability and methods of use thereof
Pat. Sub. Date(s): 001: Oct 28, 2022
Claim Types: Method of use
Use Code: U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Dec 24, 2033New patent for this product
Pat. No. 10251896
Compositions for improving cell viability and methods of use thereof
Pat. Sub. Date(s): 001: Oct 28, 2022
Claim Types: Method of use
Use Code: U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Dec 24, 2033New patent for this product
Pat. No. 10857162
Compositions for improving cell viability and methods of use thereof
Pat. Sub. Date(s): 001: Oct 28, 2022
Claim Types: Method of use
Use Code: U-3460: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Dec 24, 2033New patent for this product
Pat. No. 11071742 DP*
Compositions for improving cell viability and methods of use thereof
Pat. Sub. Date(s): 001: Oct 28, 2022
Claim Types: Composition; Formulation
Dec 24, 2033New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 29, 2027New exclusivity for this product

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.:
213246  Prod. No.: 001 RX (40MG)
PatentsExpirationChange
Pat. No. 10137124
Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Pat. Sub. Date(s): 001: Jun 5, 2020
Claim Types: Method of use
Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer
Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2037New Use Code
Pat. No. 10172851
Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Pat. Sub. Date(s): 001: Jun 5, 2020
Claim Types: Method of use
Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer
Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2037New Use Code
Pat. No. 10584124 DS*
Crystalline forms
Pat. Sub. Date(s): 001: Jun 5, 2020
Claim Types: New polymorph, salt or hydrate; Method of use
Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer
Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2038New Use Code
Pat. No. 10786489 DP*
Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile
Pat. Sub. Date(s): 001: Oct 26, 2020
Claim Types: Formulation; Method of use
Use Code: U-2971: The treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
Use Code: U-2972: The treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2973: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is papillary thyroid cancer
Use Code: U-2974: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is medullary thyroid cancer
Use Code: U-2975: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is differentiated thyroid cancer
Use Code: U-2976: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is recurrent thyroid cancer
Use Code: U-2977: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive refractory differentiated thyroid cancer who require systemic therapy and are radioactive iodine-refractory
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2038New Use Code

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 213246  Prod. No.: 002 RX (80MG)
PatentsExpirationChange
Pat. No. 10137124
Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Pat. Sub. Date(s): 002: Jun 5, 2020
Claim Types: Method of use
Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer
Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2037New Use Code
Pat. No. 10584124 DS*
Crystalline forms
Pat. Sub. Date(s): 002: Jun 5, 2020
Claim Types: New polymorph, salt or hydrate; Method of use
Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer
Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2038New Use Code
Pat. No. 10786489 DP*
Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile
Pat. Sub. Date(s): 002: Oct 26, 2020
Claim Types: Formulation; Method of use
Use Code: U-2971: The treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
Use Code: U-2972: The treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
Use Code: U-2973: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is papillary thyroid cancer
Use Code: U-2974: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is medullary thyroid cancer
Use Code: U-2975: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is differentiated thyroid cancer
Use Code: U-2976: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is recurrent thyroid cancer
Use Code: U-2977: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive refractory differentiated thyroid cancer who require systemic therapy and are radioactive iodine-refractory
Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Oct 10, 2038New Use Code

ROFLUMILAST (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Phosphodiesterase Inhibitors, Airways Disease == phosphodiesterase 4 inhibitor
NDA Applicant: MSN      NDA No.:
208256  Prod. No.: 001 RX (250MCG)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Apr 18, 2023New exclusivity for this product

SEGLENTIS (TABLET) (ORAL) CELECOXIB; TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: KOWA PHARMS      NDA No.:
213426  Prod. No.: 001 RX (56MG;44MG)
PatentsExpirationChange
Pat. No. 11478488
Co-crystals Of Tramadol And Coxibs
Pat. Sub. Date(s): 001: Nov 7, 2022
Claim Types: Method of use
Use Code: U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Apr 19, 2030New patent for this product

SLYND (TABLET) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.:
211367  Prod. No.: 001 RX (4MG)
PatentsExpirationChange
Pat. No. 11478487 DP*
Synthetic Progestogens And Pharmaceutical Compositions Comprising The Same
Pat. Sub. Date(s): 001: Nov 4, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
Jun 28, 2031New patent for this product

SPRAVATO (SPRAY) (NASAL) ESKETAMINE HYDROCHLORIDE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: JANSSEN PHARMS      NDA No.:
211243  Prod. No.: 001 RX (EQ 28MG BASE)
PatentsExpirationChange
Pat. No. 11446260
Pharmaceutical composition of S-ketamine hydrochloride
Pat. Sub. Date(s): 001: Oct 14, 2022
Claim Types: Method of administration
Use Code: U-3444: Treatment of depressive symptoms in adults with mdd with acute suicidal ideation or behavior by nasally administering 56mg or 84mg of esketamine as a pharmaceutical composition twice per week in conjunction with an oral antidepressant
Use Code: U-3445: Treatment of treatment-resistant depression in adults by nasally administering 56mg or 84mg of esketamine twice per week as a pharmaceutical composition in conjunction with an oral antidepressant
Use Code: U-3446: Treatment of treatment-resistant depression in adults by nasally administering 56mg or 84mg of esketamine as a pharmaceutical composition in conjunction with an oral antidepressant
Mar 14, 2034New patent for this product

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: AXSOME MALTA      NDA No.:
211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 11439597 DP*
Formulations of (R)-2-amino-3-phenylpropyl carbamate
Pat. Sub. Date(s): All strengths: Oct 13, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
Nov 5, 2034New patent for this product

TERLIVAZ (POWDER) (INTRAVENOUS) TERLIPRESSIN ACETATE
NDA Applicant: MALLINCKRODT IRELAND      NDA No.:
022231  Prod. No.: 001 RX (EQ 0.85MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 14, 2027New exclusivity for this product

TRIKAFTA (COPACKAGED) (TABLET) (ORAL) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == cystic fibrosis transmembrane conductance regulator (CFTR) potentiator
NDA Applicant: VERTEX PHARMS INC      NDA No.:
212273  Prod. No.: 001 RX (100MG,75MG,50MG; 150MG); 002 RX (50MG,37.5MG,25MG; 75MG)
PatentsExpirationChange
Pat. No. 11453655 DS* DP*
Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Pat. Sub. Date(s): All strengths: Oct 21, 2022
Claim Types: New polymorph, salt or hydrate; Composition
Dec 8, 2037New patent for this product

TRINTELLIX (TABLET) (ORAL) VORTIOXETINE HYDROBROMIDE
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
204447  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 204447  Prod. No.: 003 DISC (EQ 15MG BASE**)
PatentsExpirationChange
Pat. No. 11458134 DP*
1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Pat. Sub. Date(s): All strengths: Nov 2, 2022
Claim Types: Formulation; Method of use
Use Code: U-3463: Use of TRINTELLIX for the treatment of major depressive disorder (MDD) in adults
Jun 15, 2027New patent for this product

TURALIO (CAPSULE) (ORAL) PEXIDARTINIB HYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: DAIICHI SANKYO INC      NDA No.:
211810  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 7893075 DS*
Compounds modulating c-fms and/or c-kit activity and uses therefor
Pat. Sub. Date(s): 001: Aug 28, 2019
Claim Types: Compound; Composition; Kit
May 4, 2033New expiration date. Was previously Oct 13, 2028

VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-hepatitis B (HBV) Agents == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
208464  Prod. No.: 001 RX (EQ 25MG BASE)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Oct 17, 2025New exclusivity for this product

YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic
NDA Applicant: MYLAN IRELAND LTD      NDA No.:
210598  Prod. No.: 001 RX (175MCG/3ML)
PatentsExpirationChange
Pat. No. 11484531
Methods For Treating Chronic Obstructive Pulmonary Disease
Pat. Sub. Date(s): 001: Nov 2, 2022
Claim Types: Method of use
Use Code: U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Oct 23, 2039New patent for this product

ZONISADE (SUSPENSION) (ORAL) ZONISAMIDE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: AZURITY      NDA No.:
214273  Prod. No.: 001 RX (100MG/5ML)
PatentsExpirationChange
Pat. No. 11478456
Oral Pharmaceutical Composition Comprising Zonisamide And Process Of Preparation Thereof
Pat. Sub. Date(s): 001: Oct 26, 2022
Claim Types: Method of use
Use Code: U-3458: A method of treating seizures
Aug 18, 2038New patent for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 16 November 2022
© 2001-2022 Bruce A. Pokras, All rights reserved worldwide