Is Beleodaq still available?

Yes. Beleodaq (NDA 206256) is listed with marketing status Prescription in the FDA Orange Book.

Does Beleodaq have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Beleodaq's active ingredient (Belinostat).

When do Beleodaq's patents expire?

The FDA Orange Book lists 2 patents against Beleodaq, with the last listed patent expiring Oct 27, 2027. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Beleodaq's FDA application number?

Beleodaq is approved under NDA 206256, held by Acrotech Biopharma.

Orange Book product · Brand (NDA)

Beleodaq

Belinostat

Brand (NDA)NDA 206256RLD Acrotech Biopharma

Approved

Jul 03, 2014

Application

Brand (NDA)

TE code

Not listed

Listed patents

Beleodaq (Belinostat) is Acrotech Biopharma's brand-name drug, approved by the FDA under NDA 206256 in 2014. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 2 patents against it, the last expiring 2027.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Jul 03, 2014
12 yr 2 mo ago
Today
Patent 6888027 expires
Listed drug substance patent expiration.
Aug 10, 2026
in 29 d
Patent 8835501 expires
Listed drug product patent expiration.
Oct 27, 2027
in 1 yr 4 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

BELINOSTAT

Strength

500MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 206256

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Belinostat family

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6888027	Aug 10, 2026	in 29 d	SubstanceProductU-1544
8835501	Oct 27, 2027	in 1 yr 4 mo	Product

Beleodaq — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Belinostat active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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