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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Fuji
UBS
US Army
Farmers Insurance
US Department of Justice
Express Scripts
Merck
Harvard Business School

Generated: October 21, 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-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.

Summary for Generic Name: bendamustine hydrochloride

US Patents:21
Tradenames:3
Applicants:7
NDAs:7
Drug Master File Entries: see list22
Suppliers / Packagers: see list2
Bulk Api Vendors: see list73
Clinical Trials: see list2,484
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

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 Product Substance Delist Req. Exclusivity Expiration
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► SubscribeY ► Subscribe
Eagle Pharms
BENDEKA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Breckenridge Pharm
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
POWDER;IV (INFUSION)205447-002Dec 29, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Eagle Pharms
BENDEKA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Eagle Pharms
BENDEKA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Accord Hlthcare
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
POWDER;IV (INFUSION)205574-001May 19, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► 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
9,572,888Formulations of bendamustine► Subscribe
8,461,350Bendamustine pharmaceutical compositions► 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
Mexico339878► Subscribe
European Patent Office2271315► Subscribe
Denmark2528602► Subscribe
Japan2011515472► Subscribe
China103550159► Subscribe
South Korea20070094848► Subscribe
Cyprus1118769► Subscribe
World Intellectual Property Organization (WIPO)2013142359► Subscribe
Canada2867343► Subscribe
BrazilPI0606332► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Medtronic
US Army
Harvard Business School
Boehringer Ingelheim
Cipla
Baxter
Moodys
Argus Health
Queensland Health

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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