Generic Ogsiveo Availability
Last updated on Aug 7, 2024.
Ogsiveo is a brand name of nirogacestat, approved by the FDA in the following formulation(s):
OGSIVEO (nirogacestat hydrobromide - tablet;oral)
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Manufacturer: SPRINGWORKS
Approval date: November 27, 2023
Strength(s): EQ 50MG BASE [RLD] -
Manufacturer: SPRINGWORKS
Approval date: April 4, 2024
Strength(s): EQ 100MG BASE [RLD], EQ 150MG BASE [RLD]
Has a generic version of Ogsiveo been approved?
No. There is currently no therapeutically equivalent version of Ogsiveo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ogsiveo. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Patent 10,590,087
Issued: March 17, 2020
Inventor(s): Greer Elaine & Anderson Stephen & Maloney Mark & Yu Shu & Albert Ekaterina & Rigsbee Emily
Assignee(s): Pfizer Inc.The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
Patent expiration dates:
- August 9, 2039✓
- August 9, 2039
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Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Patent 10,710,966
Issued: July 14, 2020
Inventor(s): Greer Elaine & Anderson Stephen & Maloney Mark & Yu Shu & Albert Ekaterina & Rigsbee Emily
Assignee(s): Pfizer Inc.The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
Patent expiration dates:
- August 9, 2039✓✓
- August 9, 2039
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Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Patent 10,941,118
Issued: March 9, 2021
Inventor(s): Greer Elaine & Anderson Stephen & Maloney Mark & Yu Shu & Albert Ekaterina & Rigsbee Emily
Assignee(s): Pfizer Inc.The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
Patent expiration dates:
- August 9, 2039✓✓
- August 9, 2039
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Patent 11,504,354
Patent expiration dates:
- July 8, 2042✓
- July 8, 2042
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Patent 11,612,588
Patent expiration dates:
- July 8, 2042✓✓
- July 8, 2042
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Patent 11,807,611
Patent expiration dates:
- September 8, 2042✓✓
- September 8, 2042
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Patent 11,820,748
Patent expiration dates:
- August 9, 2039✓
- August 9, 2039
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Patent 11,844,780
Patent expiration dates:
- September 8, 2042✓✓
- September 8, 2042
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Patent 11,845,732
Patent expiration dates:
- August 9, 2039✓✓
- August 9, 2039
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Patent 11,872,211
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 11,884,634
Patent expiration dates:
- August 9, 2039✓
- August 9, 2039
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Patent 11,884,635
Patent expiration dates:
- August 9, 2039✓
- August 9, 2039
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Patent 11,905,255
Patent expiration dates:
- August 9, 2039✓
- August 9, 2039
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Patent 11,925,619
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 11,925,620
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 11,938,116
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 11,951,096
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 11,957,662
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 12,011,434
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 12,011,435
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 12,036,207
Patent expiration dates:
- May 19, 2043✓
- May 19, 2043
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Patent 7,342,118
Patent expiration dates:
- August 18, 2025✓
- August 18, 2025
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Patent 7,795,447
Patent expiration dates:
- August 18, 2025✓
- August 18, 2025
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Patent 7,951,958
Patent expiration dates:
- March 11, 2025✓
- March 11, 2025
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- November 27, 2028 - NEW CHEMICAL ENTITY
- November 27, 2030 - FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT
- November 27, 2030 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
More about Ogsiveo (nirogacestat)
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- Drug class: miscellaneous antineoplastics
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.