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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, ophthalmic | 0.1% | Marketed (Rx) | None | 0 | None |
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
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8614178 | December 13, 2030 | Drug product | None | 217469 |
| 12496326 | September 29, 2036 | Method of use | U-3627 | 217469 |
| 10813976 | September 22, 2037 | Drug product | None | 217469 |
| 11413323 | October 11, 2039 | Method of use | U-3627 | 217469 |
| 12059449 | April 1, 2042 | Drug product | U-1483 | 217469 |
Vevye exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | May 30, 2026 | 217469 |
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.
More on Vevye and Cyclosporine
- What is Vevye used for?FDA label uses
- Is Vevye a controlled substance?Federal schedule
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
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