Appeals Court Denies Bid to Block Mylan’s Generic Nexium

August 10, 2015

The Federal Circuit appeals court has denied AstraZeneca’s effort to block Mylan’s launch of a generic version of the acid reflux blockbuster Nexium, paving the way for additional competition for the drug.

AZ filed a motion for an emergency injunction pending appeal after the U.S. District Court for the District of New Jersey denied its request to block Mylan’s release. The Federal Circuit determined AZ did not establish that it is entitled to an emergency injunction.

The FDA gave tentative approval to Mylan’s ANDA for generic Nexium (esomeprazole magnesium) in February, but denied final approval until after Aug. 3 when exclusivity protections on pediatric indications expired. That left Teva with the only approved ANDA for Nexium.

Mylan notified AZ of its intent to manufacture generic Nexium in January 2012. AZ filed suit against Mylan in March of that year, claiming infringement of three patents for methods, compounds and compositions.

Mylan declined to comment on the ruling. AZ could not be reached for comment by press time. — Jonathon Shacat