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Generated: April 30, 2017

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Bendamustine hydrochloride - Generic Drug Details

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

Bendamustine hydrochloride
is the generic ingredient in three branded drugs marketed by Breckenridge Pharm, Cephalon, Glenmark Pharms Ltd, Accord Hlthcare, Innopharma Licensing, Hospira Inc, and Eagle Pharms, and is included in seven NDAs. There are twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has sixty patent family members in twenty-four countries.

There are twenty-two drug master file entries for bendamustine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: bendamustine hydrochloride

Drug Master File Entries: see list22
Suppliers / Packagers: see list2
Bulk Api Vendors: see list73
Clinical Trials: see list1,101
Patent Applications: see list618
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bendamustine hydrochloride at DailyMed

Pharmacology for Ingredient: bendamustine hydrochloride

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity


Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE; INJECTION100MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes8,445,524*PED► SubscribeY► Subscribe
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes8,344,006*PED► SubscribeY► Subscribe
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes8,669,279*PED► SubscribeY► Subscribe
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes8,445,524*PED► SubscribeY► Subscribe
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes8,791,270*PED► SubscribeY► Subscribe
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