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FDA Orange Book · active-ingredient family

Vemurafenib

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

Reference-listed drug:ZELBORAF · NDA 202429

1

Brand (NDA)

0

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ZELBORAFRLDHOFFMANN LA ROCHENDA 202429—Aug 17, 2011

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8143271Jun 21, 2026in 2 d
SubstanceProduct
8470818Aug 02, 2026in 1 mo
U-2164
7504509Oct 22, 2026in 4 mo
SubstanceProduct
7863288Jun 20, 2029in 3 yr 1 mo
SubstanceProduct
8741920Jul 27, 2030in 4 yr 2 mo
SubstanceProduct
9447089Jun 06, 2032in 6 yr 1 mo
Product

Vemurafenib — 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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