FDA Orange Book

Is there a generic for Jideytro?

Jideytro contains zidesamtinib. 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 Jideytro (zidesamtinib). The Orange Book shows its last listed patent expires September 30, 2042 and its last listed exclusivity ends July 22, 2031.

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Jideytro products in the Orange Book

Jideytro products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral100MGMarketed (Rx)None0None
tablet, oral25MGMarketed (Rx)None0None

NDA 220185, held by NUVALENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Jideytro patents

Patents listed for Jideytro
PatentExpiresCoversUse codeNDA
12054498May 5, 2041Method of useU-4579220185
11542278May 5, 2041Drug substance, Drug productNone220185
12630560September 30, 2042Method of useU-4579220185
12043626September 30, 2042Drug substance, Drug productNone220185

Jideytro exclusivity

Exclusivity listed for Jideytro
CodeMeaningExpiresNDA
NCENew chemical entityJuly 22, 2031220185

Jideytro NDC codes

Questions

Is there a generic for Jideytro?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Jideytro (zidesamtinib). The Orange Book shows its last listed patent expires September 30, 2042 and its last listed exclusivity ends July 22, 2031.

What is the generic name for Jideytro?

The active ingredient in Jideytro is zidesamtinib, per the FDA Orange Book.

When does the Jideytro patent expire?

The last patent listed for Jideytro in the Orange Book expires September 30, 2042. 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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