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FDA Orange Book · active-ingredient family

Fostemsavir tromethamine

Fostemsavir tromethamine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RUKOBIA · NDA 212950

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, extended release

ProductApplicantApplicationTEApproved
RUKOBIARLDVIIV HLTHCARENDA 212950—Jul 02, 2020

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7745625Nov 19, 2027in 1 yr 5 mo
Substance
8168615Jul 13, 2029in 3 yr 1 mo
Product

Fostemsavir tromethamine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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