Second Circuit Court to Hear Actavis’ Appeal on Namenda Decision

March 10, 2015

The U.S. Court of Appeals for the Second Circuit agreed to hear as soon as possible Actavis’ appeal of a lower court decision requiring it to keep an older formulation of its Alzheimer’s drug Namenda on shelves.

In December, a judge for the New York southern district ordered Actavis and partner Forest Laboratories to make Namenda IR (memantine) available until Aug. 10, despite attempts to switch patients to newer extended-release Namenda XR.

New York Attorney General Eric Schneiderman sued Actavis last September, claiming the switch was meant to prolong market exclusivity since Namenda XR has patent protection through 2016. The patent covering the IR formulation runs in July of this year.

Actavis insists, however, that Namenda XR is superior, requiring once-a-day administration rather than the original formulation’s twice daily.

The drugmaker did not return requests for comment by press time.

Read Actavis’ appeal request at www.fdanews.com/03-04-15-appealetter.pdf and the judge’s assent at www.fdanews.com/03-04-15-expediteappeal.pdf. — Lena Freund