FDA Orange Book · active-ingredient family
Belinostat
Belinostat: 1 brand, 0 generics; first approved Jul 03, 2014; on patent until Aug 10, 2026.
On patent
Generic status & protection
Protected until Aug 10, 2026 (earliest listed patent expiry).
Earliest patent expiry Aug 10, 2026
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Aug 10, 2026
in 28 d
Originator applications
Brand (NDA) products
ACROTECH BIOPHARMANDA 2062562014
ACROTECH BIOPHARMANDA 2062562014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 500MG/VIAL | POWDER | INTRAVENOUS | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Orange Book patent file
Listed patents
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6888027 | Aug 10, 2026 | in 28 d | SubstanceProductU-1544 |
| 8835501 | Oct 27, 2027 | in 1 yr 4 mo | Product |
FDA approval span
Approval history
First approval
Jul 03, 2014
12 yr 2 mo ago
Most recent approval
Jul 03, 2014
12 yr 2 mo ago
All 1 application were approved in 2014.
Brand (NDA) 1100%
Generic (ANDA) 00%
Belinostat — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
