FDA Orange Book
Is there a generic for Klisyri?
Klisyri contains tirbanibulin. 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 Klisyri (tirbanibulin). The Orange Book shows its last listed patent expires September 7, 2038 and its last listed exclusivity ends June 7, 2027.
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Klisyri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 213189, held by ALMIRALL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Klisyri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10323001 | December 28, 2027 | Drug product | None | 213189 |
| 7851470 | February 2, 2029 | Drug substance, Drug product | U-3015 | 213189 |
| 7300931 | December 28, 2030 | Drug substance, Drug product | None | 213189 |
| 10617693 | March 12, 2038 | Method of use | U-3015 | 213189 |
| 11497750 | March 12, 2038 | Method of use | U-3015 | 213189 |
| 12667576 | March 12, 2038 | Method of use | U-4577 | 213189 |
| 10669236 | September 7, 2038 | Drug substance, Drug product | None | 213189 |
Klisyri exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-192 | New dosing schedule | June 7, 2027 | 213189 |
Klisyri NDC codes
Questions
Is there a generic for Klisyri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Klisyri (tirbanibulin). The Orange Book shows its last listed patent expires September 7, 2038 and its last listed exclusivity ends June 7, 2027.
What is the generic name for Klisyri?
The active ingredient in Klisyri is tirbanibulin, per the FDA Orange Book.
When does the Klisyri patent expire?
The last patent listed for Klisyri in the Orange Book expires September 7, 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.