Endo, Impax defeat FTC's latest antitrust case over opioid

Signage is seen at the Federal Trade Commission headquarters in Washington, D.C., U.S. REUTERS/Andrew Kelly

(Reuters) - A federal judge on Thursday tossed a lawsuit by the U.S. Federal Trade Commission accusing Endo International Plc and Impax Laboratories of violating antitrust laws by striking a deal that stifled competition in the market for an opioid pain medication.

The reasons for U.S. District Judge Royce Lamberth's decision were not immediately clear, as the Washington, D.C.-based judge filed his opinion under seal to allow the parties five days to address whether anything should be redacted.

But the decision marks a major setback for FTC antitrust enforcers, who had pursued a successful, earlier case in 2017 against both drugmakers over the same drug, Opana ER.

The companies argued the deal at the center of the FTC's latest case was not anticompetitive but a lawful licensing agreement that allowed both companies to compete.

Endo, represented by George Gordon of Dechert, and Amneal Pharmaceuticals Inc, which now owns Impax and was represented by Devora Allon of Kirkland & Ellis, did not respond to requests for comment. The FTC declined to comment.

Opana ER is Endo's brand-name version of extended release oxymorphone, a semi-synthetic opioid. The U.S. Food and Drug Administration approved the drug in 2006, and Endo introduced a reformulated version in 2012.

In 2016, the drug generated almost $159 million in revenue for Endo, the FTC said.

But in June 2017, amid the opioid epidemic, the FDA asked Endo to pull Opana ER off the market because of concerns it was vulnerable to intravenous abuse. That left Impax's generic extended-release version of the medicine alone on the market.

In a lawsuit filed in January 2021, the FTC said Endo in 2017 settled a breach-of-contract case with Impax over royalties owed under a licensing agreement they struck in 2010 to settle patent litigation over the drug. The FTC said that under the 2017 settlement, Impax agreed to share in its profits with Endo in exchange for it staying out of the market.

The FTC's lawsuit followed an earlier case the agency filed in 2017 against the companies, which accused Endo of paying $112 million to push back the launch of Impax's generic to 2013, delaying competition.

Endo settled that case, and the 5th U.S. Circuit Court of Appeals in April 2021 upheld an administrative ruling by the commission against Impax. The U.S. Supreme Court in December declined to review the case.

The case is Federal Trade Commission v. Endo Pharmaceuticals Inc, et al, U.S. District Court for the District of Columbia, No. 21-cv-00217.

For the FTC: James Weingarten of the FTC

For Endo: George Gordon of Dechert

For Impax: Devora Allon of Kirkland & Ellis

Read more:

5th Circuit upholds FTC ruling against Impax, Endo in reverse-payment case

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

Our Standards: The Thomson Reuters Trust Principles.

Thomson Reuters

Nate Raymond reports on the federal judiciary and litigation. He can be reached at nate.raymond@thomsonreuters.com.