Claims for Patent: 8,415,363

Summary for Patent: 8,415,363

Title:	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide
Abstract:	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide free base and salts thereof are prepared by various processes.
Inventor(s):	Manley; Paul W (Arlesheim, CH), Shieh; Wen-Chung (Berkeley Heights, NJ), Sutton; Paul Allen (Parsippany, NJ), Karpinski; Piotr "Peter" H (Lincoln Park, NJ), Wu; Raeann R (Pine Brook, NJ), Monnier; Stephanie M (Raedersheim, FR), Brozio; Jorg (Basel, CH)
Assignee:	Novartis AG (Basel, CH)
Application Number:	13/565,913
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,415,363
Patent Claims:	1. A crystalline form B of the hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide as a monohydrate, characterized by an x-ray powder diffraction pattern having at least one maxima selected from about 7.2.degree., 9.2.degree., 11.4.degree., 12.0.degree., 12.3.degree., 14.6.degree., 14.8.degree., 15.7.degree., 17.6.degree., 19.2.degree., 19.5,.degree. 20.5.degree., 22.0.degree., 23.4.degree., 23.9.degree., 25.0.degree., 25.5.degree., 25.9.degree., 27.0.degree. (2.theta. degrees) as shown in FIG. 8. 2. The crystalline form of claim 1, characterized by an x-ray powder diffraction pattern having maxima at about 7.2.degree., 9.2.degree., 11.4.degree., 12.0.degree., 12.3.degree., 14.6.degree., 14.8.degree., 15.7.degree., 17.6.degree., 19.2.degree., 19.5,.degree. 20.5.degree., 22.0.degree., 23.4.degree., 23.9.degree., 25.0.degree., 25.5.degree., 25.9.degree., 27.0.degree. (2.theta. degrees). 3. A pharmaceutical composition comprising: (a) a therapeutically effective amount of crystalline form B of the hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl -pyrimidin-2-ylamino)-benzamide as a monohydrate according to claim 1; and (b) at least one pharmaceutically acceptable carrier, diluent or excipient. 4. A method of treating chronic myelogenous leukemia comprising the step of administering to a subject in need thereof, a therapeutically effective amount of crystalline form B of the hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide as a monohydrate according to claim 1. 5. A crystalline form B' of the anhydrous hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide, characterized by an x-ray powder diffraction pattern having at least one maxima selected from about 7.2.degree., 9.2.degree., 11.5.degree., 12.0.degree., 13.9.degree., 14.3.degree., 15.4.degree., 17.6.degree., 18.6.degree., 20.3.degree., 21.7.degree., 22.5.degree., 23.2.degree., 24.7.degree., 24.9.degree., 25.2.degree., 26.0.degree., 26.6.degree., 27.5.degree., 28.2.degree., 29.2.degree. and 30.0.degree. (2.theta. degrees) as shown in FIG. 9. 6. The crystalline form of claim 5, characterized by an x-ray powder diffraction pattern having maxima at about 7.2.degree., 9.2.degree., 11.5.degree., 12.0.degree., 13.9.degree., 14.3.degree., 15.4.degree., 17.6.degree., 18.6.degree., 20.3.degree., 21.7.degree., 22.5.degree., 23.2.degree., 24.7.degree., 24.9.degree., 25.2.degree., 26.0.degree., 26.6.degree., 27.5.degree., 28.2.degree., 29.2.degree. and 30.0.degree. (2.theta. degrees). 7. A pharmaceutical composition comprising: (a) a therapeutically effective amount of crystalline form B' of the anhydrous hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl -pyrimidin-2-ylamino)-benzamide according to claim 5; and (b) at least one pharmaceutically acceptable carrier, diluent or excipient. 8. A method of treating chronic myelogenous leukemia comprising the step of administering to a subject in need thereof, a therapeutically effective amount of crystalline form B' of the anhydrous hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide according to claim 5.