Assyro AI

FDA Orange Book · active-ingredient family

Vismodegib

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

Reference-listed drug:ERIVEDGE · NDA 203388

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
ERIVEDGERLDGENENTECHNDA 203388Jan 30, 2012

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7888364Nov 11, 2028in 2 yr 5 mo
SubstanceProduct
9278961Dec 15, 2028in 2 yr 6 mo
U-1825

Vismodegib — 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.