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Last Updated: October 16, 2019

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Details for Patent: 10,010,533

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

International Family Members for US Patent 10,010,533

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2787568   See Pricing
Cyprus 1118769   See Pricing
Denmark 2528602   See Pricing
European Patent Office 2528602   See Pricing
European Patent Office 3158991   See Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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