FDA Orange Book
Is there a generic for Xocova?
Xocova contains ensitrelvir. 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 Xocova (ensitrelvir). The Orange Book shows its last listed patent expires May 1, 2042 and its last listed exclusivity ends May 29, 2031.
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Xocova products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 125MG | Marketed (Rx) | None | 0 | None |
NDA 220442, held by SHIONOGI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xocova patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9150546 | December 12, 2030 | Drug substance, Drug product | None | 220442 |
| 12559474 | May 1, 2042 | Drug substance, Drug product | U-4553 | 220442 |
| 11814368 | May 1, 2042 | Drug substance, Drug product | U-4553 | 220442 |
Xocova exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 29, 2031 | 220442 |
Xocova NDC codes
Questions
Is there a generic for Xocova?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xocova (ensitrelvir). The Orange Book shows its last listed patent expires May 1, 2042 and its last listed exclusivity ends May 29, 2031.
What is the generic name for Xocova?
The active ingredient in Xocova is ensitrelvir, per the FDA Orange Book.
When does the Xocova patent expire?
The last patent listed for Xocova in the Orange Book expires May 1, 2042. 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.