Depomed Receives Notice of Paragraph IV Certification Against Patents for Zipsor®

Depomed, Inc.

today announced that it has received a Paragraph IV certification notice from Banner Pharmacaps Inc. advising Depomed that Banner has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Zipsor® (diclofenac potassium) liquid filled capsules, 25 mg. Banner's certification notice alleges that the five U.S. Patents listed in the FDA Orange Book for Zispor, will not be infringed by Banner's proposed product, or are invalid and/or are unenforceable. Four of the patents expire in 2029 and one expires in 2019. According to Banner's certification notice, Banner has granted to Watson Laboratories, Inc. the exclusive right to sell, market, distribute, or otherwise commercialize Banner's ANDA product. Depomed is evaluating the Paragraph IV certification, and intends to vigorously enforce its intellectual property rights. Depomed has 45 days from the receipt of the Paragraph IV certification to commence a patent infringement lawsuit against Banner that would automatically stay, or bar, the FDA from approving the ANDA for 30 months after Depomed's receipt of the Paragraph IV certification or until a district court decision that is adverse to the company, whichever is earlier.