FDA Orange Book

Is there a generic for Vevye?

Vevye contains cyclosporine. 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 Vevye (cyclosporine). The Orange Book shows its last listed patent expires April 1, 2042 and its last listed exclusivity ends May 30, 2026.

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Vevye products in the Orange Book

Vevye products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, ophthalmic0.1%Marketed (Rx)None0None

NDA 217469, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Vevye patents

Patents listed for Vevye
PatentExpiresCoversUse codeNDA
8614178December 13, 2030Drug productNone217469
12496326September 29, 2036Method of useU-3627217469
10813976September 22, 2037Drug productNone217469
11413323October 11, 2039Method of useU-3627217469
12059449April 1, 2042Drug productU-1483217469

Vevye exclusivity

Exclusivity listed for Vevye
CodeMeaningExpiresNDA
NPNew productMay 30, 2026217469

Vevye NDC codes

Questions

Is there a generic for Vevye?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Vevye (cyclosporine). The Orange Book shows its last listed patent expires April 1, 2042 and its last listed exclusivity ends May 30, 2026.

What is the generic name for Vevye?

The active ingredient in Vevye is cyclosporine, per the FDA Orange Book.

When does the Vevye patent expire?

The last patent listed for Vevye in the Orange Book expires April 1, 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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