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BENDAMUSTINE HYDROCHLORIDE

NDA

BENDAMUSTINE HYDROCHLORIDE | N216078 | BAXTER HEALTHCARE CORP

1 strength0 unique patents0 unique exclusivities

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Eagle Pharmaceuticals, Inc. v. Baxter Healthcare Corporation 1:2025cv00079 2 patentsbendamustine hydrochloride	D. Del.	2025-01-17	Active	—

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

API Supply Chain14 active DMFs3 inactive

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

CHEMPACIFIC CORPBENDAMUSTINE HYDROCHLORIDE

DMF 226262009

DR REDDYS LABORATORIES LTDBENDAMUSTINE HYDROCHLORIDE USP

DMF 248232011

HERAEUS PRECIOUS METALS GMBH AND CO KGBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 255122011

HETERO LABS LTDBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP

DMF 258002012

EMCURE PHARMACEUTICALS LTDBENDAMUSTINE HYDROCHLORIDE USP

DMF 258072012

NERPHARMA SRLBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE

DMF 261422012

NATCO PHARMA LTDBENDAMUSTINE HYDROCHLORIDE

DMF 267042012

LABORCHEMIE APOLDA GMBHBENDAMUSTINE HYDROCHLORIDE

DMF 267212014

SUN PHARMACEUTICAL INDUSTRIES LTDBENDAMUSTINE HYDROCHLORIDE

DMF 267232013

MSN LABORATORIES PRIVATE LTDBENDAMUSTINE HYDROCHLORIDE USP [ROUTE CODE - "BH"]

DMF 272052013

NAVINTA LLCBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 272722013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 274832013

FUXIN LONG RUI PHARMACEUTICAL CO LTDBENDAMUSTINE HYDROCHLORIDE

DMF 333802018

INTAS PHARMACEUTICALS LTDBENDAMUSTINE HYDROCHLORIDE

DMF 386852023

EUTICALS SPAInactiveBENDAMUSTINE HYDROCHLORIDE HYDRATE

DMF 253942011

FRESENIUS KABI ONCOLOGY LTDInactiveBENDAMUSTINE HYDROCHLORIDE

DMF 266562012

ITF CHEMICAL LTDAInactiveBENDAMUSTINE HYDROCHLORIDE

DMF 284182014

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 12, 2024	SUPPL -2	View Letter (PDF)
Jul 15, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/4ML (25MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 15, 2022

No patent or exclusivity listings for this strength.