Prescription medicine

Belinostat Brand names: Beleodaq

Belinostat (Beleodaq) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the belinostat FDA label on DailyMed (effective April 7, 2025, Acrotech Biopharma Inc); the NDA 206256 record on Drugs@FDA; every belinostat label on DailyMed.

Highlights of the record

FDA label of April 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Forms and strengths

500 mg/10ml

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: July 3, 2014 Beleodaq, Acrotech Biopharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 27, 2027 Beleodaq injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 347 through July 30, 2026

What is belinostat used for?

From the label: indications and usage
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). […]

Conditions named in the indications of belinostat's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

FDA pharmacologic class: Histone Deacetylase Inhibitor.

Source: FDA drug label (Beleodaq), Acrotech Biopharma Inc, effective April 7, 2025 (SPL set 2e8ef36b-71fa-4492-a16f-577d5f7d111d), via openFDA; the full label on DailyMed

Is there a generic for belinostat (Beleodaq)?

No generic belinostat is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 2 patents for Beleodaq injection: the compound patent runs to August 10, 2026, and the last listed entry to October 27, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2014 earliest approval on file
2027 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for belinostat?

The FDA Adverse Event Reporting System holds 347 reports that list belinostat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 116 are coded as a death and 153 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Disease Progression (a use or a product term, not a reaction)73
Nausea (named in the label)58
Anaemia (named in the label)46
Vomiting (named in the label)42
Death (an outcome recorded in the report)41
Dyspnoea (named in the label)35
Fatigue (named in the label)32
Platelet Count Decreased32

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as belinostat?

36 other medicines are given the same way (intravenous) and in the same FDA class as belinostat or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Romidepsin	Leukemia, lymphoma and myeloma	1 labeler	n/a	No current entry
Cyclophosphamide	Leukemia, lymphoma and myeloma	15 labelers	n/a	No current entry
Doxorubicin	Leukemia, lymphoma and myeloma	16 labelers	n/a	No current entry
Bortezomib	Leukemia, lymphoma and myeloma	22 labelers	n/a	No current entry
Arsenic trioxide	Leukemia, lymphoma and myeloma	16 labelers	n/a	A presentation being discontinued
Bendamustine	Leukemia, lymphoma and myeloma	4 labelers	n/a	A presentation being discontinued
Nelarabine	Leukemia, lymphoma and myeloma	12 labelers	n/a	No current entry
Idarubicin	Leukemia, lymphoma and myeloma	2 labelers	n/a	No current entry

Every medicine labeled for the same conditions as belinostat

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to belinostat: 36 medicines for the same use
Other histone deacetylase inhibitors: the pharmacologic class, with prices and generics
Belinostat side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other