FDA Orange Book

Is there a generic for Erivedge?

Erivedge contains vismodegib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Erivedge (vismodegib). The Orange Book shows its last listed patent expires December 15, 2028.

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Erivedge products in the Orange Book

Erivedge products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral150MGMarketed (Rx)None0None

NDA 203388, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Erivedge patents

Patents listed for Erivedge
PatentExpiresCoversUse codeNDA
7888364November 11, 2028Drug substance, Drug productNone203388
9278961December 15, 2028Method of useU-1825203388

Erivedge NDC codes

Questions

Is there a generic for Erivedge?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Erivedge (vismodegib). The Orange Book shows its last listed patent expires December 15, 2028.

What is the generic name for Erivedge?

The active ingredient in Erivedge is vismodegib, per the FDA Orange Book.

When does the Erivedge patent expire?

The last patent listed for Erivedge in the Orange Book expires December 15, 2028. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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