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Last Updated: January 31, 2023

Details for New Drug Application (NDA): 212950

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NDA 212950 describes RUKOBIA, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the RUKOBIA profile page.

The generic ingredient in RUKOBIA is fostemsavir tromethamine. One supplier is listed for this compound. Additional details are available on the fostemsavir tromethamine profile page.
Summary for 212950
Applicant:Viiv Hlthcare
Ingredient:fostemsavir tromethamine
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212950
Generic Entry Date for 212950*:
Constraining patent/regulatory exclusivity:

*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: 212950
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950 NDA ViiV Healthcare Company 49702-250 49702-250-18 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 600MG BASE
Approval Date:Jul 2, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 2, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:See Plans and PricingPatent Expiration:Nov 19, 2027Product Flag?Substance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Feb 25, 2025Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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