FDA Orange Book
Is there a generic for Beleodaq?
Beleodaq contains belinostat. 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 Beleodaq (belinostat). The Orange Book shows its last listed patent expires October 27, 2027.
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Beleodaq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 500MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 206256, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Beleodaq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6888027 | August 10, 2026 | Drug substance, Drug product | U-1544 | 206256 |
| 8835501 | October 27, 2027 | Drug product | None | 206256 |
Beleodaq NDC codes
Questions
Is there a generic for Beleodaq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Beleodaq (belinostat). The Orange Book shows its last listed patent expires October 27, 2027.
What is the generic name for Beleodaq?
The active ingredient in Beleodaq is belinostat, per the FDA Orange Book.
When does the Beleodaq patent expire?
The last patent listed for Beleodaq in the Orange Book expires October 27, 2027. 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.