Second Circuit Stops Actavis From Replacing Namenda

A federal appeals court Friday affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July.

The decision by the Second Circuit upholds a preliminary injunction granted by the U.S. District Court for the Southern District of New York requiring Actavis and partner Forest Laboratories to make Namenda IR (memantine) available until Aug. 11 nationwide.

New York Attorney General Eric Schneiderman sued Actavis last year, claiming the drugmaker intended to pull Namenda IR from pharmacy shelves and replace it with extended-release Namenda XR to hinder generic competition and prolong exclusivity. The IR formulation faces generic competition from five generics makers beginning July 11, while Namenda XR has patent protection until 2026.

Both drugs are currently available throughout the U.S. While New York’s substitution law will require pharmacists to fill prescriptions for Namenda IR with generic versions as they become available, patients there and in about 30 other states prescribed Namenda XR can’t be automatically switched to generics of the IR version.

Elizabeth DeBold, a spokeswoman for Schneiderman, saysthe injunction will allow generics makers to get a foothold in the market before Actavis pulls Namenda IR.

Actavis maintains that Namenda XR is superior to Namenda IR because it requires once daily as opposed to twice daily administration. The company did not respond to a request for comment on the ruling in People of the State of New York v. Actavis Plc and Forest Laboratories LLC by press time. — Jonathon Shacat