Claims for Patent: 9,493,470

Summary for Patent: 9,493,470

Title:	Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Abstract:	Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyljbenzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methyl piperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein. The instant application is directed to novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl}phenyl}benzamide and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, compositions comprising such crystalline forms, and to methods of their preparation and use.
Inventor(s):	Murray; Christopher K. (Lexington, MA), Rozamus; Leonard W. (Andover, MA), Chaber; John J. (Westford, MA), Sharma; Pradeep (Westford, MA)
Assignee:	ARIAD PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:	14/651,577
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,493,470
Patent Claims:	1. Crystalline Form A of ponatinib hydrochloride characterized by an x-ray powder diffraction pattern comprising at least five 2.theta. values (.+-.0.3) chosen from 5.9, 7.1, 10.0, 12.5, 16.4, 19.3, 21.8, 23.8, and 26.1. 2. Crystalline ponatinib hydrochloride of which more than 90% is the crystalline Form A of ponatinib hydrochloride of claim 1. 3. The crystalline Form A of ponatinib hydrochloride of claim 1 characterized by an x-ray powder diffraction pattern substantially as shown in FIG. 4. 4. Crystalline Form A ponatinib hydrochloride characterized by an x-ray powder diffraction pattern comprising at least five 2.theta. values (.+-.0.3) chosen from 5.9, 7.1, 10.0, 12.5, 13.6, 14.1, 15.0, 16.4, 17.7, 18.6, 19.3, 20.4, 21.8, 22.3, 23.8, 24.9, 26.1, 27.0, 28.4, 30.3, 31.7, and 35.1. 5. A pharmaceutical composition comprising crystalline Form A ponatinib hydrochloride according to claim 1 and at least one pharmaceutically acceptable carrier, vehicle or excipient. 6. A pharmaceutical composition comprising crystalline Form A ponatinib hydrochloride according to claim 2 and at least one pharmaceutically acceptable carrier, vehicle or excipient. 7. A pharmaceutical composition consisting essentially of the crystalline Form A of ponatinib hydrochloride of claim 1. 8. A method for treating chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition of claim 5. 9. A method for treating chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition of claim 6. 10. A pharmaceutical composition comprising crystalline Form A ponatinib hydrochloride according to claim 3 and at least one pharmaceutically acceptable carrier, vehicle or excipient. 11. A method for treating chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition of claim 10. 12. Crystalline ponatinib hydrochloride of which more than 90% is the crystalline Form A of ponatinib hydrochloride of claim 4. 13. A pharmaceutical composition comprising crystalline Form A ponatinib hydrochloride according to claim 4 and at least one pharmaceutically acceptable carrier, vehicle or excipient. 14. A pharmaceutical composition comprising crystalline Form A ponatinib hydrochloride according to claim 12 and at least one pharmaceutically acceptable carrier, vehicle or excipient. 15. A pharmaceutical composition consisting essentially of the crystalline Form A of ponatinib hydrochloride of claim 4. 16. A method for treating chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition of claim 13. 17. A method for treating chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition of claim 14.