Claims for Patent: 11,872,214

Summary for Patent: 11,872,214

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° C. to about 25° C.
Inventor(s):	Nagesh R. Palepu, Philip Christopher Buxton
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US18/081,251
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,872,214
Patent Claims:	1. A sterile vial containing a liquid bendamustine-containing composition comprising about 100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, wherein the bendamustine concentration in the composition is from about 25 mg/mL; a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and a stabilizing amount of an antioxidant, wherein the total impurities resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. to about 25° C. 2. The sterile vial of claim 1, wherein the antioxidant is monothioglycerol. 3. The sterile vial of claim 1, wherein the antioxidant is monothioglycerol in a concentration of about 5 mg/mL. 4. The composition of claim 1, wherein the composition is stable for at least about 15 months at 5° C. or for at least about 15 months at 25° C. 5. The sterile vial of claim 1, wherein the liquid bendamustine-containing composition further comprises ethanol. 6. A liquid bendamustine-containing composition comprising 100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, and a stabilizing amount of an antioxidant, in a pharmaceutically acceptable fluid; wherein the pharmaceutically acceptable fluid consists of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and wherein the bendamustine concentration in the pharmaceutically acceptable fluid is from about 25 mg/mL, wherein the total impurities resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. to about 25° C. 7. The composition of claim 6, wherein the antioxidant is monothioglycerol. 8. The composition of claim 6, wherein the antioxidant is monothioglycerol in a concentration of about 5 mg/mL. 9. The composition of claim 6, further comprising ethanol.