Details for New Drug Application (NDA): 217677
✉ Email this page to a colleague
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.
Summary for 217677
Tradename: | OGSIVEO |
Applicant: | Springworks |
Ingredient: | nirogacestat hydrobromide |
Patents: | 24 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217677
Generic Entry Date for 217677*:
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.
Suppliers and Packaging for NDA: 217677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-050 | 82448-050-18 | 180 TABLET, FILM COATED in 1 BOTTLE (82448-050-18) |
OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-100 | 82448-100-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Nov 27, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 27, 2030 | ||||||||
Regulatory Exclusivity Use: | FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT | ||||||||
Regulatory Exclusivity Expiration: | Nov 27, 2028 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 9, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? |
Complete Access Available with Subscription