Claims for Patent: 9,458,107

Summary for Patent: 9,458,107

Title:	Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-- ethylpyridie-carboxamide, its salts and monohydrate
Abstract:	The present invention relates to a process for preparing 4-(4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluo- rophenoxy)-N-methylpyridine-2-carboxamide, its salts and monohydrate.
Inventor(s):	Stiehl; Juergen (Sprockhovel, DE), Heilmann; Werner (Wuppertal, DE), Logers; Michael (Wuppertal, DE), Rehse; Joachim (Leichlingen, DE), Gottfried; Michael (Wuppertal, DE), Wichmann; Saskia (Berlin, DE)
Assignee:	BAYER INTELLECTUAL PROPERTY GMBH (DE)
Application Number:	14/252,850
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,458,107
Patent Claims:	1. The compound of the formula (I) ##STR00010## which is contaminated with one or more anilinic substances, each in an amount equal to or less than 0.05% by weight based on the weight of the compound of the formula (I). 2. The compound of claim 1 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide each in an amount equal to or less than 0.05% by weight based on the weight of the compound of the formula (I). 3. A composition comprising the compound of the formula (I) ##STR00011## the monohydrate of the compound of formula (I) or a combination thereof, which comprises one or more anilinic substances, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula (I) within the composition, wherein the amount of the compound of formula (I) within the composition comprises the combined weight of the compound of formula (I) and the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I) within the composition. 4. The composition of claim 3 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula (I) within the composition. 5. A composition comprising a combination of the compound of formula (I) ##STR00012## and the monohydrate of the compound of formula (I), which comprises one or more anilinic substances, each in an amount equal to or less than 0.05% by weight based on the amount of the compound of formula (I) within the composition wherein the amount of the compound of formula (I) within the composition comprises the combined weight of the compound of formula (I) and the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I) within the composition. 6. The composition of claim 5 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula (I) within the composition. 7. A combination of a compound of formula (I) ##STR00013## and its monohydrate contaminated with one or more anilinic substances, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of the formula (I) within the combination, wherein the amount of the compound of formula (I) within the combination comprises the combined weight of the compound of formula (I) and the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I) within the combination. 8. A combination of claim 7 contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide each in an amount equal to or less than 0.05% by weight based on the amount of the compound of the formula (I). 9. The compound of the formula (I) ##STR00014## which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine-2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.05% by weight, based on the weight of the compound of the formula (I). 10. The compound of the formula (I) of claim 9 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.025% by weight, based on the weight of the compound of the formula (I). 11. The compound of the formula (I) ##STR00015## which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine-2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.01% by weight, based on the weight of the compound of the formula (I). 12. A composition comprising the compound of the formula (I) ##STR00016## which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.05% by weight, based on the weight of the compound of the formula (I) within the composition. 13. A composition of claim 12 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.025% by weight, based on the weight of the compound of the formula (I) within the composition. 14. A composition comprising the compound of the formula (I) ##STR00017## which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.01% by weight, based on the weight of the compound of the formula (I) within the composition. 15. A composition comprising a combination of the compound of the formula (I) ##STR00018## and the monohydrate of the compound of formula (I), which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.05% by weight, based on the amount of the compound of the formula (I) within the composition, wherein the amount of the compound of formula (I) within the composition comprises the combined weight of the compound of formula (I) and the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I) within the composition. 16. A composition of claim 15 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.025% by weight, based on the amount of the compound of the formula (I) within the composition. 17. A composition comprising a combination of the compound of the formula (I) ##STR00019## and the monohydrate of the compound of formula (I), which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide each in an amount of from 0.0001% to a maximum of 0.01% by weight based on the amount of the compound of the formula (I), wherein the amount of the compound of formula (I) within the composition comprises the combined weight of the compound of formula (I) and the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I). 18. A composition comprising the compound of the formula (I) ##STR00020## the monohydrate of the compound of formula (I), a salt of the compound of formula (I) or a combination thereof which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.05% by weight based on the amount of the compound of the formula (I) within the composition, wherein the amount of the compound of formula (I) within the composition comprises the combined weight of the compound of formula (I), the calculated weight of the compound of formula I from the monohydrate of the compound of formula (I) and from the salts of the compound of formula (I) within the composition. 19. A composition of claim 18 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.025% by weight, based on the amount of the compound of the formula (I) within the composition. 20. A composition of claim 18 which comprises 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount 0.0001% to a maximum of 0.01% by weight, based on the amount of the compound of the formula (I) within the composition. 21. The monohydrate of the compound of the formula (I) ##STR00021## which is contaminated with one or more anilinic substances, each in an amount equal to or less than 0.05% by weight, based on the amount of compound of formula (I), within the composition wherein the amount of the compound of formula (I) is the calculated weight of the compound of formula I calculated from the amount of monohydrate of the compound of formula (I) within the composition. 22. The monohydrate of claim 21 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine 2-carboxylic acid methylamide, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula (I). 23. The monohydrate of claim 21 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.05% by weight, based on the amount of the compound of formula (I). 24. The monohydrate of claim 21 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, an amount of from 0.0001% to a maximum of 0.025% by weight, based on the amount of the compound of formula I. 25. The monohydrate of claim 21 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.01% by weight, based on the amount of the compound of formula I. 26. A salt of the compound of the formula (I) ##STR00022## which is contaminated with one or more anilinic substances, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula I within the composition, wherein the amount of the compound of formula (I) is the calculated weight of the compound of formula I calculated from the amount of salt of the compound of formula (I) within the composition. 27. A salt of claim 26 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine 2-carboxylic acid methylamide, each in an amount equal to or less than 0.05% by weight, based on the amount of the compound of formula (I). 28. A salt of claim 26 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.05% by weight, based on the amount of the compound of formula (I). 29. A s alt of claim 26 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.025% by weight, based on the amount of the compound of formula (I). 30. A s alt of claim 26 which is contaminated with 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy)pyridine2-carboxylic acid methylamide, each in an amount of from 0.0001% to a maximum of 0.01% by weight, based on the amount of the compound of formula (I).