Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-11-27
2004-12-14
Desai, Rita (Department: 1626)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C548S213000
Reexamination Certificate
active
06831091
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to salt forms of 3-(4-bromo-2,6-difluoro-benzyloxy)-5-[3-(4-pyrrolidin-1-yl-butyl)-ureido]-isothiazole-4-carboxylic acid amide having the formula:
Formula I in its free base form is described in co-pending U.S. Ser. No. 09/316,837, filed May 21, 1999, the disclosure of which is hereby incorporated herein by reference in its entirety. The foregoing application is assigned in common with the present application. The free base of formula I is useful in the treatment of hyperproliferative diseases, such as cancers.
The present invention provides the hydrochloride, hydrobromide, hemi-citrate, acetate, p-tosylate, L-tartrate, hemi-succinate, and mesylate salt forms of 3-(4-bromo-2,6-difluoro-benzyloxy)-5-[3-(4-pyrrolidin-1-yl-butyl)-ureido]-isothiazole-4-carboxylic acid amide.
The present invention further relates to methods of making the hydrochloride, hydrobromide, hemi-citrate, acetate, p-tosylate, L-tartrate, hemi-succinate, and mesylate salt forms of 3-(4-bromo-2,6-difluoro-benzyloxy)-5-[3-(4-pyrrolidin-1-yl-butyl)-ureido]-isothiazole-4-carboxylic acid amide. The invention also relates to pharmaceutical compositions containing the hydrochloride, hydrobromide, hemi-citrate, acetate, p-tosylate, L-tartrate, hemi-succinate, and mesylate salts of the compound of formula I. The salts of the present invention are useful in the treatment of hyperproliferative diseases, such as cancers, in mammals, especially humans. The invention also relates to methods of administering the salts of formula I to treat hyperproliferative diseases.
REFERENCES:
patent: 6235764 (2001-05-01), Larson et al.
Gant Thomas George
Williams Glenn R.
Banerjee Krishna G.
Butterfield Garth
Desai Rita
Pfizer Inc.
Richardson Peter C.
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