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Details for Patent: 10,010,533

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Which drugs does patent 10,010,533 protect, and when does it expire?

Patent 10,010,533 protects BALRAPZO and BENDEKA and is included in two NDAs.

This patent has nineteen patent family members in fifteen countries.

Summary for Patent: 10,010,533

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:	15/432,335
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,010,533
Patent Claim Types: see list of patent claims

Drugs Protected by US Patent 10,010,533

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eagle Pharms	BALRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes			Y

International Family Members for US Patent 10,010,533

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2787568
Cyprus	1118769
Denmark	2528602