FDA Orange Book
Is there a generic for Xcopri?
Xcopri contains cenobamate. 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 Xcopri (cenobamate). The Orange Book shows its last listed patent expires June 16, 2039.
Run it in Rivvi
Map Xcopri and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Xcopri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 12.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 212839, held by SK LIFE SCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xcopri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7598279 | October 30, 2032 | Drug substance | None | 212839 |
| 11654133 | June 16, 2039 | Method of use | U-3610 | 212839 |
Xcopri NDC codes
Questions
Is there a generic for Xcopri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xcopri (cenobamate). The Orange Book shows its last listed patent expires June 16, 2039.
What is the generic name for Xcopri?
The active ingredient in Xcopri is cenobamate, per the FDA Orange Book.
When does the Xcopri patent expire?
The last patent listed for Xcopri in the Orange Book expires June 16, 2039. 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.