FDA Orange Book

Is there a generic for Zokinvy?

Zokinvy contains lonafarnib. 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 Zokinvy (lonafarnib). The Orange Book shows its last listed patent expires July 26, 2029 and its last listed exclusivity ends November 20, 2027.

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Zokinvy products in the Orange Book

Zokinvy products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral50MGMarketed (Rx)None0None
capsule, oral75MGMarketed (Rx)None0None

NDA 213969, held by SENTYNL THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Zokinvy patents

Patents listed for Zokinvy
PatentExpiresCoversUse codeNDA
7838531July 26, 2029Method of useU-3070213969

Zokinvy exclusivity

Exclusivity listed for Zokinvy
CodeMeaningExpiresNDA
ODE-324Orphan drug exclusivityNovember 20, 2027213969

Zokinvy NDC codes

Questions

Is there a generic for Zokinvy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Zokinvy (lonafarnib). The Orange Book shows its last listed patent expires July 26, 2029 and its last listed exclusivity ends November 20, 2027.

What is the generic name for Zokinvy?

The active ingredient in Zokinvy is lonafarnib, per the FDA Orange Book.

When does the Zokinvy patent expire?

The last patent listed for Zokinvy in the Orange Book expires July 26, 2029. 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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