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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Generated: June 27, 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-nine patent family members in twenty-nine 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

Tradenames:3
Patents:22
Applicants:7
NDAs:7
Drug Master File Entries: see list22
Suppliers / Packagers: see list2
Bulk Api Vendors: see list73
Clinical Trials: see list2,438
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
► Subscribe► Subscribe100MGINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge Pharm
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
POWDER;IV (INFUSION)205447-002Dec 29, 2016APRXNoNo► Subscribe► Subscribe
Hospira Inc
BENDAMUSTINE HYDROCHLORIDE
bendamustine hydrochloride
POWDER;IV (INFUSION)204086-002May 20, 2016APRXNoNo► Subscribe► Subscribe
Eagle Pharms
BENDEKA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes9,597,398► Subscribe ► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes8,791,270*PED► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes9,533,955► 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
Denmark2528602► Subscribe
Spain2405611► Subscribe
Japan5688195► Subscribe
World Intellectual Property Organization (WIPO)2013142359► Subscribe
South Africa200705793► 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 500+ biopharmaceutical companies globally:

Cipla
Cerilliant
Teva
QuintilesIMS
Fish and Richardson
Accenture
Chinese Patent Office
Fuji
Moodys
Chubb

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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