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Serving leading biopharmaceutical companies globally:

Queensland Health
Covington
Colorcon
Chinese Patent Office
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Accenture
US Department of Justice
Medtronic
Julphar
Cerilliant

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,609,707

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Which drugs does patent 8,609,707 protect, and when does it expire?


Patent 8,609,707 protects BENDEKA and is included in one NDA. There has been one Paragraph IV challenge on Bendeka.

This patent has fourteen patent family members in fifteen countries.

Summary for Patent: 8,609,707

Title:Formulations of bendamustine
Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response ("PAR") basis as determined by high performance liquid chromatography ("HPLC") at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5.degree. C. to about 25.degree. C.
Inventor(s): Palepu; Nagesh R. (Southampton, PA), Buxton; Philip Christopher (Great Dunmow, GB)
Assignee: Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)
Application Number:13/016,473
Patent Claim Types:
see list of patent claims
Composition; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Eagle PharmsBENDEKAbendamustine hydrochlorideSOLUTION;IV (INFUSION)208194-001Dec 7, 2015RXYesYes► Subscribe► Subscribe► SubscribeYFOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
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Non-Orange Book Patents for Patent: 8,609,707

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
9,265,831Formulations of bendamustine► Subscribe
9,572,797Formulations of bendamustine► Subscribe
9,572,796Formulations 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 Patent: 8,609,707

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
San MarinoT201700043► Subscribe
Slovenia2528602► Subscribe
Serbia55491► Subscribe
Portugal2528602► Subscribe
Poland2528602► Subscribe
Lithuania2528602► Subscribe
Japan6133943► Subscribe
Japan2016020365► Subscribe
Japan5795600► Subscribe
Japan2013518130► 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:

Daiichi Sankyo
Teva
AstraZeneca
Dow
Chubb
Chinese Patent Office
Harvard Business School
Mallinckrodt
Cantor Fitzgerald
Colorcon

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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