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Last Updated: November 8, 2024

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 twenty-four 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.
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:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 27, 2023TE: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 UpPatent Expiration:Aug 9, 2039Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.