OGSIVEO Drug Patent Profile
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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
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 |
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 | ||||
>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 |
>Country | >Patent Number | >Title | >Estimated Expiration |