IMPAX Sued Based on ANDA for Generic Flomax®

The following is excerpted from a July 22, 2008 IMPAX press release at Business Wire:

IMPAX Laboratories, Inc. today announced Boehringer Ingelheim Pharmaceuticals Inc. (“Boehringer”) and Astellas Pharma Inc. (“Astellas”) have filed suit for patent infringement in the United States District Court for the Northern District of California based on the Company’s submission of Abbreviated New Drug Application (“ANDA”) for tamsulosin hydrochloride capsules (0.4 mg), generic of Flomax®, to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice to Boehringer and Astellas that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid or enforceable claim of U.S. Patent No. 4,703,063.

Flomax® capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of Flomax® capsules were approximately $1.5 billion in the 12 months ended May 2008.

See the full press release here.