FDA Orange Book
Is there a generic for Licart?
Licart contains diclofenac epolamine. 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 Licart (diclofenac epolamine). The Orange Book shows its last listed patent expires February 20, 2035 and its last listed exclusivity ends March 27, 2029.
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Licart products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, topical | 1.3% | Marketed (Rx) | None | 0 | None |
NDA 206976, held by IBSA INSTITUT BIOCHIMIQUE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Licart patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11351133 | February 20, 2035 | Method of use | U-3393 | 206976 |
| 11344520 | February 20, 2035 | Method of use | U-3393 | 206976 |
Licart exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | March 27, 2029 | 206976 |
Licart NDC codes
Questions
Is there a generic for Licart?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Licart (diclofenac epolamine). The Orange Book shows its last listed patent expires February 20, 2035 and its last listed exclusivity ends March 27, 2029.
What is the generic name for Licart?
The active ingredient in Licart is diclofenac epolamine, per the FDA Orange Book.
When does the Licart patent expire?
The last patent listed for Licart in the Orange Book expires February 20, 2035. 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.