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Serving leading biopharmaceutical companies globally:

Queensland Health
Dow
Medtronic
Chinese Patent Office
Colorcon
AstraZeneca
UBS
Express Scripts
US Department of Justice
Cantor Fitzgerald

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,791,270

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Which drugs does patent 8,791,270 protect, and when does it expire?


Patent 8,791,270 protects TREANDA and BENDEKA and is included in two NDAs. There have been zero Paragraph IV challenges on Bendeka and Treanda

Protection for TREANDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in twenty-one countries.

Summary for Patent: 8,791,270

Title:Bendamustine pharmaceutical compositions
Abstract: The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Inventor(s): Brittain; Jason Edward (El Cajon, CA), Franklin; Joe Craig (Tulsa, OK)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/969,724
Patent Claim Types:
see list of patent claims
Composition; Compound; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Eagle PharmsBENDEKAbendamustine hydrochlorideSOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Patent: 8,791,270

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
8,895,756Bendamustine pharmaceutical compositions► Subscribe
8,609,863Bendamustine pharmaceutical compositions► 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 Patent: 8,791,270

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan5726833► Subscribe
China101119708► Subscribe
China102078305► Subscribe
Eurasian Patent Organization200701511► Subscribe
Eurasian Patent Organization013324► Subscribe
European Patent Office1863452► Subscribe
European Patent Office2574334► Subscribe
Spain2405611► Subscribe
Hong Kong1116073► Subscribe
Israel184394► 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:

Teva
AstraZeneca
Deloitte
Moodys
Colorcon
UBS
Dow
Citi
Healthtrust
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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