FDA Orange Book

Is there a generic for Verkazia?

Verkazia 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 Verkazia (cyclosporine). The Orange Book shows its last listed patent expires June 2, 2029 and its last listed exclusivity ends June 23, 2028.

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Verkazia products in the Orange Book

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

NDA 214965, 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.

Verkazia patents

Patents listed for Verkazia
PatentExpiresCoversUse codeNDA
11612658January 27, 2026Method of useU-3560214965
9220694January 27, 2026Drug productNone214965
9956289January 27, 2026Drug productNone214965
7973081January 27, 2026Drug productNone214965
8524779January 27, 2026Drug productNone214965
8298568November 3, 2027Drug productNone214965
9132071June 2, 2029Drug productNone214965

Verkazia exclusivity

Exclusivity listed for Verkazia
CodeMeaningExpiresNDA
ODE-358Orphan drug exclusivityJune 23, 2028214965

Verkazia NDC codes

Questions

Is there a generic for Verkazia?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Verkazia (cyclosporine). The Orange Book shows its last listed patent expires June 2, 2029 and its last listed exclusivity ends June 23, 2028.

What is the generic name for Verkazia?

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

When does the Verkazia patent expire?

The last patent listed for Verkazia in the Orange Book expires June 2, 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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