FDA Orange Book

Is there a generic for Lisraya?

Lisraya contains brepocitinib. 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 Lisraya (brepocitinib). The Orange Book shows its last listed patent expires August 19, 2035 and its last listed exclusivity ends August 27, 2031.

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Lisraya products in the Orange Book

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

NDA 220106, held by PRIOVANT THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Lisraya patents

Patents listed for Lisraya
PatentExpiresCoversUse codeNDA
9663526August 19, 2035Drug substance, Drug productNone220106
11197867August 19, 2035Drug substance, Drug productNone220106

Lisraya exclusivity

Exclusivity listed for Lisraya
CodeMeaningExpiresNDA
NCENew chemical entityAugust 27, 2031220106

Lisraya NDC codes

Questions

Is there a generic for Lisraya?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lisraya (brepocitinib). The Orange Book shows its last listed patent expires August 19, 2035 and its last listed exclusivity ends August 27, 2031.

What is the generic name for Lisraya?

The active ingredient in Lisraya is brepocitinib, per the FDA Orange Book.

When does the Lisraya patent expire?

The last patent listed for Lisraya in the Orange Book expires August 19, 2035. 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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