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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Queensland Health
Deloitte
Accenture
Colorcon
Fuji
Cerilliant
US Army
Harvard Business School

Generated: December 11, 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 Accord Hlthcare, Breckenridge Pharm, Glenmark Pharms Ltd, Hospira Inc, Innopharma Licensing, Cephalon, and Eagle Pharms, and is included in seven NDAs. There are twenty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has seventy-eight 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.

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
u► Subscribe100MGINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eagle PharmsBENDEKAbendamustine hydrochlorideSOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Eagle PharmsBENDEKAbendamustine hydrochlorideSOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Accord HlthcareBENDAMUSTINE HYDROCHLORIDEbendamustine hydrochloridePOWDER;IV (INFUSION)205574-001May 19, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eagle PharmsBENDEKAbendamustine hydrochlorideSOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,461,350Bendamustine pharmaceutical compositions► Subscribe
9,572,888Formulations of bendamustine► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bendamustine hydrochloride

Country Document Number Estimated Expiration
San MarinoT201700043► Subscribe
TaiwanI472515► Subscribe
European Patent Office2271315► Subscribe
European Patent Office2574334► Subscribe
Mexico2010010398► Subscribe
Taiwan200944508► Subscribe
Japan2015510939► Subscribe
European Patent Office3150197► Subscribe
Spain2605205► Subscribe
Malaysia157661► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
US Army
Express Scripts
UBS
Federal Trade Commission
Citi
AstraZeneca
Teva
Daiichi Sankyo

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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