FDA Orange Book
Is there a generic for Xiidra?
Xiidra contains lifitegrast. 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 Xiidra (lifitegrast). The Orange Book shows its last listed patent expires December 18, 2033.
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Xiidra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 5% | Marketed (Rx) | None | 0 | None |
NDA 208073, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xiidra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8592450 | May 17, 2026 | Method of use | U-1880 | 208073 |
| 8084047 | May 17, 2026 | Drug substance, Drug product | None | 208073 |
| 9447077 | April 15, 2029 | Method of use | U-1900 | 208073 |
| 8367701 | April 15, 2029 | Drug product | U-1880 | 208073 |
| 8168655 | May 9, 2029 | Method of use | U-1880 | 208073 |
| 7314938 | June 25, 2029 | Drug substance, Drug product | None | 208073 |
| 9890141 | October 21, 2030 | Drug substance | None | 208073 |
| 9353088 | October 21, 2030 | Drug product | None | 208073 |
| 8927574 | November 12, 2030 | Drug product | None | 208073 |
| 9085553 | July 25, 2033 | Drug product | None | 208073 |
| 11058677 | December 18, 2033 | Drug product | None | 208073 |
Xiidra NDC codes
Questions
Is there a generic for Xiidra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xiidra (lifitegrast). The Orange Book shows its last listed patent expires December 18, 2033.
What is the generic name for Xiidra?
The active ingredient in Xiidra is lifitegrast, per the FDA Orange Book.
When does the Xiidra patent expire?
The last patent listed for Xiidra in the Orange Book expires December 18, 2033. 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.