Published on February 12, 2013 at 3:14 AM
Sucampo Pharmaceuticals, Inc. ("Sucampo") announced that it, together with R-Tech Ueno, Ltd., Sucampo AG, and Takeda Pharmaceutical Company Limited ("Takeda") and certain affiliates of Takeda, has filed a patent infringement lawsuit against Anchen Pharmaceuticals, Inc. ("Anchen"), which had filed Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA® (lubiprostone) oral capsules, and certain affiliates of Anchen.
As a result of Sucampo's filing of the said lawsuit, final FDA approval of Anchen's ANDA will be stayed up to 30 months from January 2, 2013.
The said filing will have no impact on the forecast of business results for the fiscal year ending March 2013.
Source: R-Tech Ueno, Ltd.