Claims for Patent: 9,572,796

Summary for Patent: 9,572,796

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:	15/013,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,572,796
Patent Claims:	1. A non-aqueous liquid composition comprising: bendamustine, or a pharmaceutically acceptable salt thereof; a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol, wherein the ratio of polyethylene glycol to propylene glycol in the pharmaceutically acceptable fluid is from about 95:5 to about 50:50; and a stabilizing amount of an antioxidant; wherein the composition has less than about 5% total impurities after 15 months of storage at about 5.degree. C., as calculated on a normalized peak area response basis as determined by high performance liquid chromatography at a wavelength of 223 nm. 2. The non-aqueous liquid composition of claim 1, wherein the bendamustine concentration is from about 10 mg/mL to about 100 mg/mL. 3. The non-aqueous liquid composition of claim 1, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL. 4. The non-aqueous liquid composition of claim 1, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL. 5. The non-aqueous liquid composition of claim 1, wherein the bendamustine concentration is about 25 mg/mL. 6. The non-aqueous liquid composition of claim 1, wherein the concentration of the antioxidant is from about 2.5 mg/mL to about 35 mg/mL. 7. The non-aqueous liquid composition of claim 1, wherein the concentration of the antioxidant is from about 5 mg/mL to about 20 mg/mL. 8. The non-aqueous liquid composition of claim 1, wherein the concentration of the antioxidant is from about 10 mg/mL to about 15 mg/mL. 9. The non-aqueous liquid composition of claim 1, comprising bendamustine hydrochloride. 10. A method of treating leukemia, Hodgkin's disease, or multiple myeloma in a mammal comprising administering to the mammal an effective amount of the composition of claim 1. 11. The method of claim 10, for the treatment of leukemia. 12. The method of claim 10, for the treatment of Hodgkin's disease. 13. The method of claim 10, for the treatment of multiple myeloma. 14. A non-aqueous liquid composition comprising: bendamustine, or a pharmaceutically acceptable salt thereof; a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol, wherein the ratio of polyethylene glycol to propylene glycol in the pharmaceutically acceptable fluid is from about 95:5 to about 50:50; and a stabilizing amount of an antioxidant; wherein the composition has less than about 5% total impurities after storage for 15 days at 25.degree. C., as calculated on a normalized peak area response basis as determined by high performance liquid chromatography at a wavelength of 223 nm. 15. The non-aqueous liquid composition of claim 14, wherein the bendamustine concentration is from about 10 mg/mL to about 100 mg/mL. 16. The non-aqueous liquid composition of claim 14, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL. 17. The non-aqueous liquid composition of claim 14, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL. 18. The non-aqueous liquid composition of claim 14, wherein the bendamustine concentration is about 25 mg/mL. 19. The non-aqueous liquid composition of claim 14, wherein the concentration of the antioxidant is from about 2.5 mg/mL to about 35 mg/mL. 20. The non-aqueous liquid composition of claim 14, wherein the concentration of the antioxidant is from about 5 mg/mL to about 20 mg/mL. 21. The non-aqueous liquid composition of claim 14, wherein the concentration of the antioxidant is from about 10 mg/mL to about 15 mg/mL. 22. The non-aqueous liquid composition of claim 14, comprising bendamustine hydrochloride. 23. A method of treating leukemia, Hodgkin's disease, or multiple myeloma in a mammal comprising administering to the mammal an effective amount of the composition of claim 14. 24. The method of claim 23, for the treatment of leukemia. 25. The method of claim 23, for the treatment of Hodgkin's disease. 26. The method of claim 23, for the treatment of multiple myeloma.