NIROGACESTAT HYDROBROMIDE - Generic Drug Details
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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 twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nirogacestat hydrobromide has eighty-five patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for NIROGACESTAT HYDROBROMIDE
| International Patents: | 85 |
| US Patents: | 24 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 3 |
| 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 | 217677-003 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-002 | Apr 4, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-003 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-001 | Nov 27, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-003 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-003 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-001 | Nov 27, 2023 | RX | Yes | No | ⤷ 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 |
|---|---|---|---|
| Ecuador | SP066879 | COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS | ⤷ Sign Up |
| Guatemala | 200500060 | COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS | ⤷ Sign Up |
| South Africa | 200606957 | IMIDAZOLE COMPOUNDS FOR THE TREATMENT OF NEURODEGENERATIVE DISORDERS | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2021029854 | ⤷ Sign Up | |
| Colombia | 2024002891 | Compuestos clorados de tetralina y composiciones farmacéuticas | ⤷ Sign Up |
| Japan | 2007530525 | ⤷ Sign Up | |
| Norway | 20064726 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
