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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Fish and Richardson
Moodys
Farmers Insurance
Federal Trade Commission
Julphar
Chubb
Teva

Generated: September 22, 2018

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Bendamustine hydrochloride - Generic Drug Details

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What are the generic drug 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 Accord Hlthcare, Breckenridge Pharm, Glenmark Pharms Ltd, Mylan Labs Ltd, Cephalon, and Eagle Pharms, and is included in seven NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for bendamustine hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial100MGINJECTABLE; INJECTION

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 POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Glenmark Pharms Ltd BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;IV (INFUSION) 204771-002 Mar 24, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Eagle Pharms BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Fish and Richardson
Moodys
Farmers Insurance
Federal Trade Commission
Julphar
Chubb
Teva

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