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Last Updated: May 27, 2024

Bendamustine hydrochloride - Generic Drug Details

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What are the generic drug sources for bendamustine hydrochloride and what is the scope of patent protection?

Bendamustine hydrochloride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Kindos, Mylan Labs Ltd, Nang Kuang Pharm Co, Cephalon, Eagle Pharms, Baxter Hlthcare Corp, Hospira, and Slayback Pharma Llc, and is included in fifteen NDAs. There are twenty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has one hundred and fifty-two patent family members in thirty-two countries.

There are sixteen drug master file entries for bendamustine hydrochloride. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.

Recent Clinical Trials for bendamustine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Philippe Armand, MD, PhDPhase 2
GenmabPhase 2
Cancer Research UKPhase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bendamustine hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BELRAPZO Injection bendamustine hydrochloride 100 mg/4 mL (25 mg/mL) multiple-dose vials 205580 1 2018-07-17
BENDEKA Injection bendamustine hydrochloride 100 mg/4 mL (25 mg/mL) multiple-dose vials 208194 1 2017-05-04
TREANDA Injection bendamustine hydrochloride 90 mg/mL, 0.5 mL and 2 mL in single- dose vials 022249 1 2014-06-19
TREANDA Injection bendamustine hydrochloride 25 mg/vial and 100 mg/vial 022249 10 2013-06-04

US Patents and Regulatory Information for bendamustine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-003 Sep 13, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kindos BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;IV (INFUSION) 211001-002 Jun 5, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nang Kuang Pharm Co BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;IV (INFUSION) 206554-002 Jun 7, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride SOLUTION;INTRAVENOUS 215033-001 Dec 7, 2022 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for bendamustine hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2024037915 低減された投与容量を必要とする患者におけるベンダムスチン応答性症状の治療方法 ⤷  Sign Up
South Korea 20170096221 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) ⤷  Sign Up
Taiwan 200944508 Novel solid forms of bendamustine hydrochloride ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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