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Details for Patent: 9,265,831

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Which drugs does patent 9,265,831 protect, and when does it expire?

Patent 9,265,831 protects BENDEKA and is included in one NDA.

This patent has fourteen patent family members in fifteen countries.

Summary for Patent: 9,265,831

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:	14/031,879
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,265,831
Patent Claim Types: see list of patent claims	Composition;

Drugs Protected by US Patent 9,265,831

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
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes			Y

Non-Orange Book US Patents Family Members for Patent 9,265,831

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
8,609,707	Formulations of bendamustine
9,572,797	Formulations of bendamustine
9,572,796	Formulations of bendamustine

International Family Members for US Patent 9,265,831

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
San Marino	T201700043
Slovenia	2528602
Serbia	55491
Portugal	2528602