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AbbVie Reaches $54.4 Million Settlement Over Its Alzheimer’s Drug

AbbVie Reaches $54.4 Million Settlement Over Its Alzheimer’s Drug

AbbVie has agreed to a $54.4 million settlement for alleged anticompetitive abuse of the generic pharmaceutical approval process involving Namenda (memantine hydrochloride), an FDA-approved drug to treat Alzheimer’s.

The class action complaint was originally filed in August 2015 and was settled on the eve of the trial, according to the judge’s ruling, “after years of hard-fought litigation.”

“Trial in this matter would have required a jury to distill and resolve a thicket of conflicting facts in dense legal frameworks at the intersection of antitrust law, Hatch-Waxman drug approval laws and regulations, drug manufacturing concepts, contract interpretation, patent law, and principles of economics,” wrote U.S. District Judge Colleen McMahon.

The company says the settlement is not an admission of wrongdoing and the defendants deny all allegations associated with this lawsuit. A hearing on final approval by potential class members is scheduled for March 13, 2023.

AbbVie and lawyers for the plaintiffs did not immediately respond to requests for comment. AbbVie did not admit wrongdoing.

The 2015 lawsuit accused Forest Laboratories, which is now part of AbbVie, and generic manufacturers of entering into anti-competitive settlements under which the generic companies agreed to refrain from launching their own versions of Namenda until mid-2015 in exchange for payment. The lawsuit claims the settlements were so-called "pay for delay" deals that violated competition laws in 30 states and resulted in higher prices.

Forest was acquired in June 2014 by Actavis Plc, which changed its name to Allergan in June 2015. Allergan was acquired by AbbVie in 2019.

Allergan previously reached a $750 million settlement of antitrust allegations brought by direct purchasers of Namenda, such as drug distributors.

November 16, 2022

https://www.reuters.com/

https://www.fdanews.com/

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