Last Updated: June 22, 2026

BENDAMUSTINE Drug Patent Profile


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When do Bendamustine patents expire, and what generic alternatives are available?

Bendamustine is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Avyxa Holdings, Baxter Hlthcare Corp, and Hospira. and is included in twelve NDAs.

The generic ingredient in BENDAMUSTINE is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bendamustine

A generic version of BENDAMUSTINE was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.

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Summary for BENDAMUSTINE
US Patents:0
Applicants:11
NDAs:12
Drug Prices: Drug price information for BENDAMUSTINE
DailyMed Link:BENDAMUSTINE at DailyMed

US Patents and Regulatory Information for BENDAMUSTINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 205574-001 Dec 7, 2022 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Avyxa Holdings BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride SOLUTION;INTRAVENOUS 219014-001 Jul 3, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 205376-001 Dec 7, 2022 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 204230-002 Jun 5, 2023 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Meitheal BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 211001-002 Jun 5, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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