Actavis Prohibited From Pulling Older Namenda Formulation

A federal judge has ordered Actavis to keep the original version of its blockbuster Alzheimer’s therapy Namenda on the market while the court hears an ongoing antitrust lawsuit that claims the drugmaker wants to pull the older version to hinder generic competition.

The preliminary order represents a win for New York Attorney General Eric Schneiderman, who sued Activis and its subsidiary Forest Laboratories after they announced plans in February to phase out the original tablet version of Namenda (memantine) while continuing to produce it as an oral solution and in a newer, extended-release version. 

The ruling by the U.S. District Court for the Southern District of New York did not dissuade Actavis from continuing to move patients to the newer version of Namenda XR, the company said last week.

Schneiderman contends that switching patients to the new drug and then completely pulling the older version would deny customers the ability to purchase a cheaper generic alternative. While patents on the original Namenda expire next year, the Orange Book lists patents for Namenda XR extending well into the next decade.

But Actavis has hit back at the claims. The company asserts that Namenda XR is a superior product as it needs only to be taken once a day, rather than twice-daily as the original formulation required.

Experts say the Namenda antitrust lawsuit appears to be the first of its kind brought by a state attorney general prior to the switch. Most such cases are brought by private payers years afterward.

Namenda generated $1.5 billion in sales in fiscal year 2014. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.