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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, ophthalmic | 0.1% | Marketed (Rx) | None | 0 | None |
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
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11612658 | January 27, 2026 | Method of use | U-3560 | 214965 |
| 9220694 | January 27, 2026 | Drug product | None | 214965 |
| 9956289 | January 27, 2026 | Drug product | None | 214965 |
| 7973081 | January 27, 2026 | Drug product | None | 214965 |
| 8524779 | January 27, 2026 | Drug product | None | 214965 |
| 8298568 | November 3, 2027 | Drug product | None | 214965 |
| 9132071 | June 2, 2029 | Drug product | None | 214965 |
Verkazia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-358 | Orphan drug exclusivity | June 23, 2028 | 214965 |
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.
More on Verkazia and Cyclosporine
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
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- Verkazia Medicare Part D coverageBy plan and state
- NDC 65086-001Verkazia NDC record
- NDC 82667-014Verkazia NDC record