Details for New Drug Application (NDA): 217677
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NDA 217677 describes OGSIVEO, which is a drug marketed by Springworks and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the OGSIVEO profile page.
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.
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: | 19 |
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: | ⤷ Try a Trial | Patent Expiration: | Aug 9, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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