FDA Orange Book
Is there a generic for Cequa?
Cequa 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 Cequa (cyclosporine). The Orange Book shows its last listed patent expires February 28, 2037.
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Cequa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, ophthalmic | 0.09% | Marketed (Rx) | None | 0 | None |
NDA 210913, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cequa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8980839 | August 23, 2033 | Drug product | U-1483 | 210913 |
| 9937225 | August 23, 2033 | Drug product | U-1483 | 210913 |
| 10441630 | August 23, 2033 | Drug product | None | 210913 |
| 11951153 | February 28, 2037 | Method of use | U-1483 | 210913 |
| 10918694 | February 28, 2037 | Drug product | None | 210913 |
Cequa NDC codes
Questions
Is there a generic for Cequa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cequa (cyclosporine). The Orange Book shows its last listed patent expires February 28, 2037.
What is the generic name for Cequa?
The active ingredient in Cequa is cyclosporine, per the FDA Orange Book.
When does the Cequa patent expire?
The last patent listed for Cequa in the Orange Book expires February 28, 2037. 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 Cequa and Cyclosporine
- What is Cequa used for?FDA label uses
- Is Cequa a controlled substance?Federal schedule
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
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- Cequa Medicare Part D coverageBy plan and state
- NDC 47335-506Cequa NDC record
- NDC 47335-507Cequa NDC record