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Last Updated: March 29, 2024

Details for Patent: 11,103,483


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Summary for Patent: 11,103,483
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 (Uxbridge, GB)
Assignee: Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)
Application Number:16/509,920
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 11,103,483

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;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Try a Trial
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA ⤷  Try a Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Try a Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA ⤷  Try a Trial
>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 11,103,483

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2787568 ⤷  Try a Trial
Cyprus 1118769 ⤷  Try a Trial
Cyprus 1124262 ⤷  Try a Trial
Denmark 2528602 ⤷  Try a Trial
Denmark 3158991 ⤷  Try a Trial
European Patent Office 2528602 ⤷  Try a Trial
European Patent Office 3158991 ⤷  Try a Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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