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Last Updated: June 29, 2022

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 three branded drugs marketed by Cephalon and Eagle Pharms, and is included in three NDAs. There are twenty-five 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 thirty patent family members in thirty-two countries.

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

Recent Clinical Trials for bendamustine hydrochloride

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

SponsorPhase
Kite, A Gilead CompanyPhase 3
Fondazione Italiana Linfomi ONLUSPhase 1/Phase 2
Roche S.p.aPhase 1/Phase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MG/VIALPOWDER;IV (INFUSION)
See Plans and PricingSee Plans and Pricing25MG/VIALPOWDER;IV (INFUSION)
See Plans and PricingSee Plans and Pricing100MG/VIALPOWDER;IV (INFUSION)

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 Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes 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
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 6738376 See Plans and Pricing
Singapore 158870 BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION See Plans and Pricing
Croatia P20210915 See Plans and Pricing
Serbia 55491 FORMULACIJE BENDAMUSTINA (FORMULATIONS OF BENDAMUSTINE) See Plans and Pricing
Argentina 072777 FORMAS SOLIDAS DE CLORHIDRATO DE BENDAMUSTINA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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