US: EpiPen makers must face antitrust claims, judge rules

The lawsuit alleges Pfizer and Mylan engaged in “an illegal scheme to monopolize the market” for epinephrine auto-injectors. The scheme allegedly involved raising the price of EpiPen and then using the higher margins to offer larger rebates and discounts to pharmacy benefit managers (PBMs) in exchange for better or exclusive formulary positions.

Plaintiffs also claimed the companies abused patent law and regulatory processes to delay competitor products from coming to market. For example, they argue the defendants entered an “unlawful settlement agreement” in 2012 by which Teva postponed the launch of its EpiPen generic until mid-2015. Yet six months before that launch time, Mylan filed a Food and Drug Administration Citizen Petition, calling into question whether the copycat product was equivalent to EpiPen and thereby further stalling its market entry.

The suit in the US District Court for the District of Kansas will continue despite Mylan and Pfizer’s protests. While Judge Daniel Crabtree dismissed several of the plaintiffs’ claims, he found there was adequate support behind the rest.

Full Content: Biopharma Dive