Forest Laboratories Namenda Alzheimer’s Drug Antitrust Class Action

This antitrust class action alleges that Forest Laboratories, LLC attempted to retain its monopoly on its $1.5 billion-per-year drug, Namenda IR by preventing less expensive generics from coming to market. Namenda IR is prescribed to treat moderate to severe dementia in Alzheimer’s patients. It was approved by the Food and Drug Administration (FDA) in 2003.

The complaint claims that several generic drug companies have filed Abbreviated New Drug Applications (ANDAs) with the FDA for a generic version of Namenda IR. According to the complaint, “The ANDA is a ‘piggyback’ application process allowing a generic manufacturer to rely on a branded company’s initial drug application and therefore avoid lengthy and costly efficacy studies. An FDA-approved ‘bioequivalent’ or ‘AB-rated’ generic is every bit as safe and effective as the branded product because it contains the same active pharmaceutical ingredients and provides the same therapeutic benefits.” These generic drugs are usually considerably cheaper than the original, branded drug.

However, the complaint alleges that “Forest engaged in a two-part anticompetitive scheme to insulate Namenda IR from competition from less-expensive generic versions and preserve its Namenda monopoly profits.”

The first part of the scheme, the complaint asserts, was to file “sham litigations against several generic pharmaceutical companies each of which filed ANDAs with the FDA to manufacture, market and sell an AB-rated generic version of Namenda IR.”

The complaint claims that, after a year, “Forest ended the litigations against the generic manufacturers by entering into anticompetitive settlement agreements that included payments to the generic manufacturers in exchange for promises to delay their market entry.” According to the complaint, at least five companies agreed not to compete with Forest or each other with a generic form of Namenda IR until July 2015. Forest therefore had locked in its monopoly-priced sales until that time.

The second part of the scheme, the complaint claims, occurred when Forest performed a “product hop.” That is, it came out with a “new” product which it called Namenda XR, with the same active ingredient and therapeutic effect as the original Namenda IR, and then removed the original drug from the market, forcing users to switch. This meant that even though Namenda IR was no longer protected, Namenda XR was, and generic drugmakers could not have their products sold in place of the “new” drug.

By preventing a less expensive generic from entering the market, the complaint alleges, Forest maintained its monopoly on the drug and kept prices for it high.

The class for this action is all persons and entities in the US and its territories, except Indian and Ohio, who indirectly bought, paid for, or provided reimbursement for some of all of the purchase price for branded Namenda IR 5 or 10 mg. tablets, or Namenda XR capsules, for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, at any time between April 14, 2010 and the time when Forest’s anticompetitive conduct stops.

Article Type: Lawsuit
Topic: Antitrust
Tags: Antitrust, Drugs and Generics