FDA Orange Book
Is there a generic for Xdemvy?
Xdemvy contains lotilaner. 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 Xdemvy (lotilaner). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends July 24, 2028.
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Xdemvy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.25% | Marketed (Rx) | None | 0 | None |
NDA 217603, held by TARSUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xdemvy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8383659 | January 17, 2030 | Drug substance, Drug product | None | 217603 |
| 11690827 | December 14, 2038 | Method of use | U-3674 | 217603 |
| 11690826 | December 14, 2038 | Method of use | U-3674 | 217603 |
| 11197847 | December 14, 2038 | Method of use | U-3674 | 217603 |
| 10835517 | December 14, 2038 | Method of use | U-3674 | 217603 |
| 12171750 | December 14, 2038 | Method of use | U-3674 | 217603 |
| 11752137 | December 14, 2038 | Drug product | None | 217603 |
| 12213964 | December 14, 2038 | Drug product | None | 217603 |
| 12364685 | December 14, 2038 | Drug product | None | 217603 |
Xdemvy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 24, 2028 | 217603 |
Xdemvy NDC codes
Questions
Is there a generic for Xdemvy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xdemvy (lotilaner). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends July 24, 2028.
What is the generic name for Xdemvy?
The active ingredient in Xdemvy is lotilaner, per the FDA Orange Book.
When does the Xdemvy patent expire?
The last patent listed for Xdemvy in the Orange Book expires December 14, 2038. 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.