Details for New Drug Application (NDA): 217677
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 twenty-nine patents protecting this drug. Additional details are available on the OGSIVEO profile page.
The generic ingredient in OGSIVEO is nirogacestat hydrobromide. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. 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: | 29 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217677
Generic Entry Date for 217677*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 217677
| Mechanism of Action | Cytochrome P450 2C19 Inducers Cytochrome P450 3A Inhibitors Gamma Secretase Inhibitors |
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. | 82448-100 | 82448-100-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) |
| OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-150 | 82448-150-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-150-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | 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: | ⤷ Start Trial | Patent Expiration: | Aug 9, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 217677
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-002 | Apr 4, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-003 | Apr 4, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-001 | Nov 27, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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