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Serving leading biopharmaceutical companies globally:

Accenture
Federal Trade Commission
Boehringer Ingelheim
Cantor Fitzgerald
QuintilesIMS
Dow
Covington
Baxter
Deloitte
Johnson and Johnson

Generated: February 25, 2018

DrugPatentWatch Database Preview

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

Bendamustine hydrochloride has seventy-nine patent family members in thirty-one 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 bendamustine hydrochloride
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
➤ Sign Up➤ Sign Up100MGINJECTABLE; 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) 022249-002 May 1, 2009 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hospira Inc BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;IV (INFUSION) 204086-002 May 20, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 AP 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

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Non-Orange Book US Patents for bendamustine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,461,350 Bendamustine pharmaceutical compositions ➤ Sign Up
9,572,888 Formulations of bendamustine ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for bendamustine hydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
AstraZeneca
McKesson
Daiichi Sankyo
Colorcon
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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