Generic Ogsiveo Availability

Last updated on Apr 10, 2025.

Ogsiveo is a brand name of nirogacestat, approved by the FDA in the following formulation(s):

OGSIVEO (nirogacestat hydrobromide - tablet;oral)

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]

Is there a generic version of Ogsiveo available?

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.

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.

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
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  Drug substance
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
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  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
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  Drug substance
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
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
  ✓
  Drug substance
Chlorinated tetralin compounds and pharmaceutical compositions
Patent 11,504,354
Issued: November 22, 2022
Inventor(s): Patterson; Kristin et al.
The present disclosures are directed to chlorinated tetralin compounds and pharmaceutical compositions.
Patent expiration dates:
- July 8, 2042
  ✓
  Drug product
Chlorinated tetralin compounds and pharmaceutical compositions
Patent 11,612,588
Issued: March 28, 2023
Inventor(s): Patterson; Kristin et al.
Assignee(s): Spring Works Therapeutics, Inc. (Stamford, CT)
The present disclosures are directed to chlorinated tetralin compounds and pharmaceutical compositions.
Patent expiration dates:
- July 8, 2042
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
  ✓
  Drug product
Chlorinated tetralin compounds and pharmaceutical compositions
Patent 11,807,611
Issued: November 7, 2023
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosures are directed to chlorinated tetralin compounds and pharmaceutical compositions.
Patent expiration dates:
- September 8, 2042
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
  ✓
  Drug product
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 11,820,748
Issued: November 21, 2023
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Drug product
Chlorinated tetralin compounds and pharmaceutical compositions
Patent 11,844,780
Issued: December 19, 2023
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosures are directed to chlorinated tetralin compounds and pharmaceutical compositions.
Patent expiration dates:
- September 8, 2042
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
  ✓
  Drug product
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 11,845,732
Issued: December 19, 2023
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
  ✓
  Drug substance
Treatments with nirogacestat
Patent 11,872,211
Issued: January 16, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Compositions of solid 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
Patent 11,884,634
Issued: January 30, 2024
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Drug product
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 11,884,635
Issued: January 30, 2024
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Drug product
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 11,905,255
Issued: February 20, 2024
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Drug product
Treatments with nirogacestat
Patent 11,925,619
Issued: March 12, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 11,925,620
Issued: March 12, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 11,938,116
Issued: March 26, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 11,951,096
Issued: April 9, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 11,957,662
Issued: April 16, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 12,011,434
Issued: June 18, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 12,011,435
Issued: June 18, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Treatments with nirogacestat
Patent 12,036,207
Issued: July 16, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Synthesis of nirogacestat
Patent 12,110,277
Issued: October 8, 2024
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosures are directed to processes for synthesizing (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 (“nirogacestat”).
Patent expiration dates:
- July 8, 2042
  ✓
  Drug product
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 12,116,347
Issued: October 15, 2024
Inventor(s): Greer; Elaine et al.
Assignee(s): PFIZER INC. (New York, NY)
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
  ✓
  Drug product
Treatments with nirogacestat
Patent 12,138,246
Issued: November 12, 2024
Inventor(s): Lim; Allison et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosure relates to improved methods of treatment with nirogacestat.
Patent expiration dates:
- May 19, 2043
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Synthesis of nirogacestat
Patent 12,234,210
Issued: February 25, 2025
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosures are directed to processes for synthesizing (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 (“nirogacestat”).
Patent expiration dates:
- July 8, 2042
  ✓
  Drug product
Synthesis of nirogacestat
Patent 12,247,012
Issued: March 11, 2025
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)
The present disclosures are directed to processes for synthesizing (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 (“nirogacestat”).
Patent expiration dates:
- July 8, 2042
  ✓
  Drug product
Imidazole compounds for the treatment of neurodegenerative disorders
Patent 7,342,118
Issued: March 11, 2008
Inventor(s): Brodney; Michael A. et al.
Assignee(s): Pfizer Inc (New York, NY)
The present invention relates to compounds of the Formula I ##STR00001## wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.6, R.sup.7 and A are as defined. Compounds of the Formula I have activity inhibiting production of A.beta.-peptide. The invention also relates to pharmaceutical compositions and methods for treating diseases and disorders, for example, neurodegenerative and/or neurological disorders, e.g., Alzheimer's disease, in a mammal comprising compounds of the Formula I.
Patent expiration dates:
- August 18, 2025
  ✓
  Drug substance
Imidazole compounds for the treatment of neurodegenerative disorders
Patent 7,795,447
Issued: September 14, 2010
Inventor(s): Brodney; Michael A. et al.
Assignee(s): Pfizer Inc (New York, NY)
The present invention relates to compounds of the Formula I ##STR00001## wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.6, R.sup.7 and A are as defined. Compounds of the Formula I have activity inhibiting production of A.beta.-peptide. The invention also relates to pharmaceutical compositions and methods for treating diseases and disorders, for example, neurodegenerative and/or neurological disorders, e.g., Alzheimer's disease, in a mammal comprising compounds of the Formula I.
Patent expiration dates:
- August 18, 2025
  ✓
  Drug substance
Imidazole compounds for the treatment of neurodegenerative disorders
Patent 7,951,958
Issued: May 31, 2011
Inventor(s): Brodney; Michael A. et al.
Assignee(s): Pfizer Inc. (New York, NY)
The present invention relates to compounds of the Formula I ##STR00001## wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.6, R.sup.7 and A are as defined. Compounds of the Formula I have activity inhibiting production of A.beta.-peptide. The invention also relates to pharmaceutical compositions and methods for treating diseases and disorders, for example, neurodegenerative and/or neurological disorders, e.g., Alzheimer's disease, in a mammal comprising compounds of the Formula I.
Patent expiration dates:
- March 11, 2026
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  Drug substance

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 - 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
- November 27, 2030 - FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT

More about Ogsiveo (nirogacestat)

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Glossary

Term	Definition
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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill 150 is Ogsiveo 150 mg — Ogsiveo 150 mg (150)