POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it and AstraZeneca filed a lawsuit against Dr. Reddy's Laboratories (Dr. Reddy's) in the United States District Court for the District of New Jersey, for infringement of U.S. Patent No. 6,926,907 relating to VIMOVO™ (naproxen / esomeprazole magnesium) delayed-release tablets. In a Notice Letter sent to AstraZeneca and POZEN in March 2011 (Notice Letter), Dr. Reddy's informed AstraZeneca and POZEN that it submitted an Abbreviated New Drug Application (ANDA) seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of VIMOVO prior to expiration of U.S. Patent No. 6,926,907, which is one of seven patents listed in the FDA's Orange Book for VIMOVO. The patent expires in 2023. Under the terms of its agreement with POZEN, AstraZeneca has exercised its first right to defend the patent at issue and will take the leading role in prosecuting the infringement suit against Dr. Reddy's.
The filing of this patent infringement lawsuit by AstraZeneca and POZEN within forty-five days of receipt of Dr. Reddy's Notice Letter will result in the FDA automatically instituting a stay, or bar, of final approval of Dr. Reddy's ANDA for up to 30 months or until a final court decision is entered in the infringement suit in favor of Dr. Reddy's, whichever occurs first. VIMOVO currently has regulatory exclusivity through April 30, 2013.
POZEN and AstraZeneca have full confidence in and will vigorously defend and enforce its intellectual property protecting VIMOVO.