FDA Orange Book

Is there a generic for Lyrfigtu?

Lyrfigtu contains lirafugratinib. 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 Lyrfigtu (lirafugratinib).

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Lyrfigtu products in the Orange Book

Lyrfigtu products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 20MG BASEMarketed (Rx)None0None
capsule, oralEQ 30MG BASEMarketed (Rx)None0None

NDA 220425, held by ELEVAR THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Lyrfigtu?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lyrfigtu (lirafugratinib).

What is the generic name for Lyrfigtu?

The active ingredient in Lyrfigtu is lirafugratinib, per the FDA Orange Book.

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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