FDA Orange Book
Is there a generic for Zolinza?
Zolinza contains vorinostat. 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 Zolinza (vorinostat). The Orange Book shows its last listed patent expires March 18, 2028.
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Zolinza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 021991, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zolinza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8093295 | May 16, 2026 | Drug product | None | 021991 |
| 7456219 | March 11, 2027 | Drug substance | None | 021991 |
| 8450372 | March 18, 2028 | Method of use | U-892 | 021991 |
Zolinza NDC codes
Questions
Is there a generic for Zolinza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zolinza (vorinostat). The Orange Book shows its last listed patent expires March 18, 2028.
What is the generic name for Zolinza?
The active ingredient in Zolinza is vorinostat, per the FDA Orange Book.
When does the Zolinza patent expire?
The last patent listed for Zolinza in the Orange Book expires March 18, 2028. 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.