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Watson Confirms Welchol® Oral Suspension Patent Challenge
Date:1/25/2011

MORRISTOWN, N.J., Jan. 25, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Colesevelam HCI powder for oral suspension, 1.875 gm/packet and 3.75 gm/packet.  Watson's Colesevelam HCI powder for oral suspension is a generic version of Daiichi Sankyo, Inc.'s Welchol ® oral suspension, which is indicated to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutarylcoenzyme A (HMG CoA) reductase inhibitor (statin); to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy; and to improve glycemic control in adults with type 2 diabetes mellitus.

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Daiichi Sankyo and Genzyme Corporation filed suit against Watson on January 21, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,693,675.  Daiichi Sankyo's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until June 19, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company.  The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialize
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