You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 27, 2024

~ Buy the OGSIVEO (nirogacestat hydrobromide) Drug Profile, 2024 PDF Report in the Report Store ~

OGSIVEO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Ogsiveo patents expire, and what generic alternatives are available?

Ogsiveo is a drug marketed by Springworks and is included in one NDA. There are sixteen patents protecting this drug.

This drug has sixty-eight patent family members in forty-four countries.

The generic ingredient in OGSIVEO is nirogacestat hydrobromide. One supplier is listed for this compound. Additional details are available on the nirogacestat hydrobromide profile page.

DrugPatentWatch® Generic Entry Outlook for Ogsiveo

Ogsiveo will be eligible for patent challenges on November 27, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 27, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Summary for OGSIVEO
International Patents:68
US Patents:16
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for OGSIVEO
What excipients (inactive ingredients) are in OGSIVEO?OGSIVEO excipients list
DailyMed Link:OGSIVEO at DailyMed
Drug patent expirations by year for OGSIVEO
Drug Prices for OGSIVEO

See drug prices for OGSIVEO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OGSIVEO
Generic Entry Date for OGSIVEO*:
Constraining patent/regulatory exclusivity:
FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for OGSIVEO

OGSIVEO is protected by sixteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OGSIVEO is ⤷  Try a Trial.

This potential generic entry date is based on FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OGSIVEO

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 Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS

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 Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting OGSIVEO

FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OGSIVEO

When does loss-of-exclusivity occur for OGSIVEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Iceland

Patent: 50
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OGSIVEO around the world.

Country Patent Number Title Estimated Expiration
El Salvador 2006002055 COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS REF. PC32054A ⤷  Try a Trial
Dominican Republic P2005000040 COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS ⤷  Try a Trial
Peru 20221252 FORMAS EN ESTADO SOLIDO DE (S)-2-(((S)-6,8-DIFLUOR-1,2,3,4-TETRAHIDRONAFTALEN-2-IL)AMINO)-N-(1-(2-METIL-1-(NEOPENTILAMINO) PROPAN-2-IL)-1H-IMIDAZOL-4-IL) PENTANAMIDA Y USOS DE LA MISMA ⤷  Try a Trial
Netherlands 1028598 Imidazoolverbindingen voor de behandeling van neurodegeneratieve ziekten. ⤷  Try a Trial
Croatia P20080375 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.