Endo, Impax face class-action over antitrust claims

Endo International and Amneal Pharmaceuticals’ subsidiary, Impax Laboratories, have failed to prevent antitrust claims over a patent settlement from going to trial.

The District Court for the Northern District of Illinois handed down the decision on Friday, June 4, holding that the class action lawsuit should proceed.

Judge Harry Leinenweber formally certified the consolidated case as a class action and rejected a summary judgment bid by the pharmaceutical companies.

According to buyers of pain reliever Opana ER (oxymorphone hydrochloride), the companies allegedly delayed generic versions of Endo’s drug.

In January, the US Federal Trade Commission sued the companies, alleging that a 2017 agreement between Endo and Impax violated US antitrust laws by eliminating competition in the market.

The FTC had previously sued Endo and Impax in January 2017 for engaging in similar anticompetitive conduct concerning the same drug product.

According to the FTC’s complaint, Endo’s Opana ER generated nearly $160 million in revenues in 2016 alone.

In June 2017, the FDA asked Endo to voluntarily withdraw its drug from the market because of safety concerns about the reformulated version of Opana ER that Endo launched in 2012. The withdrawal of Endo’s drug left Impax’s generic version of the original formulation of Opana ER as the only extended-release oxymorphone drug on the market.

After deciding to withdraw its reformulated Opana ER, Endo explored bringing another oxymorphone ER drug to the market or partnering with a third-party generic company as a way to replace its Opana ER revenues.

But ultimately, the FTC alleged that Endo reached an agreement in August 2017 with Impax, the only other authorised seller of an oxymorphone ER product.

The agreement eliminated potential competition from Endo by sharing Impax’s monopoly profits, with Endo in the role of a potential entrant paid to stay out of the market. This agreement allowed Impax to exercise and maintain monopoly power in the market for FDA-approved oxymorphone ER tablets, according to the FTC’s complaint.

The FTC previously found that the 2010 agreement between Endo and Impax was an illegal reverse-payment settlement. The 2017 agreement was made during the pendency of the FTC’s litigation over the 2010 agreement. The Commission’s decision in the matter of the 2010 agreement is being appealed.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox