POZEN Inc. and
AstraZeneca have 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(TM) (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.
