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Last Updated: June 4, 2024

Nirogacestat hydrobromide - Generic Drug Details


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What are the generic sources for nirogacestat hydrobromide and what is the scope of freedom to operate?

Nirogacestat hydrobromide is the generic ingredient in one branded drug marketed by Springworks and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nirogacestat hydrobromide has seventy-two patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for nirogacestat hydrobromide
International Patents:72
US Patents:19
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:nirogacestat hydrobromide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nirogacestat hydrobromide
Generic Entry Date for nirogacestat hydrobromide*:
Constraining patent/regulatory exclusivity:
FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT
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 nirogacestat hydrobromide

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 nirogacestat hydrobromide

Country Patent Number Title Estimated Expiration
China 114555562 (S)-2-(((S)-6,8-二氟-1,2,3,4-四氢萘-2-基)氨基)-N-(1-(2-甲基-1-(新戊基氨基)丙-2-基)-1H-咪唑-4-基)戊酰胺的固态形式及其用途 (Solid state forms of (s)-2-(((s)-6, 8-difluoro-1, 2, 3, 4-tetrahydronaphthalene-2-yl) amino)-n-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1h-imidazol-4-yl) pentanamide and uses thereof) ⤷  Sign Up
Canada 3237521 COMPOSITIONS ET TRAITEMENTS A BASE DE NIROGACESTAT (COMPOSITIONS AND TREATMENTS WITH NIROGACESTAT) ⤷  Sign Up
Georgia, Republic of P20084420 USE OF IMIDAZOLE COMPOUNDS FOR THE TREATMENT OF NEURODEGENERATIVE DISORDERS ⤷  Sign Up
Canada 3230422 COMPOSES DE TETRALINE CHLOREE ET COMPOSITIONS PHARMACEUTIQUES (CHLORINATED TETRALIN COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005092864 ⤷  Sign Up
Argentina 049875 COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.