U.S. FTC sues Endo, Impax for 2017 agreement regarding pain drug

WASHINGTON (Reuters) – The U.S. Federal Trade Commission said on Monday it has filed a lawsuit against Endo Pharmaceuticals and Impax Laboratories that alleges a 2017 agreement eliminated competition between the companies for the pain medicine oxymorphone ER.

In addition to Endo Pharmaceuticals Inc and Impax Laboratories LLC, the lawsuit names as defendants Endo International Plc and Impax’s owner, Amneal Pharmaceuticals Inc, the agency said.

The U.S. Food and Drug Administration had asked Endo in June 2017 to pull its extended-release oxymorphone product off the market because of concerns that it was vulnerable to intravenous abuse, the FTC said.

That left Impax’s generic extended-release version of the medicine alone on the market. Rather than reformulate its drug, Endo struck a deal with Impax in August 2017 to refrain from re-entering the market, the FTC said.

“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,” the FTC said in a statement.

Endo said in a statement that the lawsuit was “meritless” and that its agreement with Impax “had no adverse impact on actual or potential competition.”

“Significantly, as Endo has explained to the FTC, the company has not launched or licensed any new opioid product(s) since that time, and the FTC’s theory that Endo would do so in the current litigation environment but for the agreement is preposterous,” Endo Executive Vice President Matthew Maletta said in a statement. “The company will vigorously defend itself against the FTC’s claims.”

The agency has previously filed a lawsuit against the two companies regarding the same drug, it said.

The five-member commission voted 3-2 to authorize the lawsuit. The “yes” votes were acting Chair Rebecca Slaughter, Democrat Rohit Chopra, who has been nominated to head the Consumer Financial Protection Bureau, and outgoing former chairman Joseph Simons.

Reporting by Diane Bartz in Washington; Editing by Matthew Lewis and Leslie Adler


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