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BELEODAQ

NDA

BELINOSTAT | N206256 | ACROTECH BIOPHARMA INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

Today

6888027

Aug. 10, 2026

8835501

Oct. 27, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Acrotech Biopharma, LLC et al v. Fresenius Kabi USA, LLC et al 1:2018cv01533 2 patentsANDA 211485belinostat	D. Del.	2018-10-03	Terminated 2020-12-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Beleodaq (2023)

Total Spending

$10.5M

Total Claims

1,056

Beneficiaries

ASP Price

—

HCPCS: J9032 — Injection, belinostat, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

ACROTECH BIOPHARMA INCBELINOSTAT DRUG SUBSTANCE

DMF 269262013

TIANJIN WEIJIE PHARMACEUTICAL CO LTDBELINOSTAT

DMF 311342016

FRESENIUS KABI ONCOLOGY LTDBELINOSTAT

DMF 322602018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBELINOSTAT

DMF 324052018

MSN LABORATORIES PRIVATE LTDBELINOSTAT

DMF 326602018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 21, 2024	SUPPL -6	View Letter (PDF)
Apr 22, 2022	SUPPL -4	View Letter (PDF)
Jan 9, 2020	SUPPL -3	View Letter (PDF)
Apr 14, 2017	SUPPL -2	View Letter (PDF)
Jul 3, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/VIAL

RLD

2 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jul 3, 2014

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
6888027	Aug 10, 2026	—	Yes	Yes		—
8835501	Oct 27, 2027	—	—	Yes	—	—