NIROGACESTAT HYDROBROMIDE - Generic Drug Details

What are the generic drug 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 sixty-eight patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for NIROGACESTAT HYDROBROMIDE

International Patents:	68
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

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

International Patents for NIROGACESTAT HYDROBROMIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2022553479	（Ｓ）－２－（（（Ｓ）－６，８－ジフルオロ－１，２，３，４－テトラヒドロナフタレン－２－イル）アミノ）－Ｎ－（１－（２－メチル－１－（ネオペンチルアミノ）プロパン－２－イル）－１Ｈ－イミダゾール－４－イル）ペンタンアミドの固体状態形態およびその使用
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)
Mexico	2022001743	FORMAS EN ESTADO SOLIDO DE (S)-2-(((S)-6,8-DIFLUOR-1,2,3,4-TETRAHI DRONAFTALEN-2-IL)AMINO)-N-(1-(2-METIL-1-(NEOPENTILAMINO)PROPAN-2- IL)-1H-IMIDAZOL-4-IL)PENTANAMIDA Y USOS DE LA MISMA. (SOLID STATE FORMS OF (S)-2-(((S)-6,8-DIFLUORO-1,2,3,4-TETRAHYDRON APHTHALEN-2-YL)AMINO)-N-(1-(2-METHYL-1-(NEOPENTYLAMINO)PROPAN-2- YL)-1H-IMIDAZOL-4-YL)PENTANAMIDE AND USES THEREOF.)
World Intellectual Property Organization (WIPO)	2021029854
Israel	290428	צורות מוצקות של (s)-2-(((s)-8,6-דיפלואורו-4,3,2,1-טטראהידרונפתלן-2-איל)אמינו)-n-(1-(2-מתיל-1-(ניופנטילאמינו)פרופאן-2-איל)-1h-אימידאזול-4-איל)פנטאמיד ושימושים שלהן (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)
Colombia	2022002731	Formas en estado sólido de (s)-2-(((s)-6,8-diflúor-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