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Serving 500+ biopharmaceutical companies globally:

Dow
Johnson and Johnson
Queensland Health
Federal Trade Commission
Healthtrust
UBS
QuintilesIMS
Daiichi Sankyo
Chinese Patent Office
AstraZeneca

Generated: August 17, 2017

DrugPatentWatch Database Preview

BENDEKA Drug Profile

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Which patents cover Bendeka, and what generic Bendeka alternatives are available?

Bendeka is a drug marketed by Eagle Pharms and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-nine countries.

The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for Tradename: BENDEKA

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list35
Patent Applications: see list356
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BENDEKA at DailyMed

Pharmacology for Tradename: BENDEKA

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
BENDEKA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► 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
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► SubscribeY► Subscribe
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Paragraph IV activity for: BENDEKA

Drugname Dosage Strength RLD Submissiondate
bendamustine hydrochlorideInjection100 mg/4 mL (25 mg/mL) multiple-dose vialsBendeka5/4/2017

Non-Orange Book Patents for Tradename: BENDEKA

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
8,436,190Bendamustine pharmaceutical compositions► Subscribe
8,609,863Bendamustine pharmaceutical compositions► Subscribe
8,461,350Bendamustine pharmaceutical compositions► Subscribe
8,895,756Bendamustine 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 Tradename: BENDEKA

Country Document Number Estimated Expiration
Japan2013518130► Subscribe
World Intellectual Property Organization (WIPO)2011094565► Subscribe
European Patent Office3158991► Subscribe
Singapore158870► Subscribe
Eurasian Patent Organization013324► 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 500+ biopharmaceutical companies globally:

Covington
Boehringer Ingelheim
Daiichi Sankyo
Fish and Richardson
US Army
Express Scripts
Chinese Patent Office
Federal Trade Commission
AstraZeneca
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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