Endo International and the U.S. Federal Trade Commission have resolved charges that the company entered into illegal “pay-for-delay” patent infringement settlements intended to block lower-cost generic versions of its two top-selling drugs, Opana® ER (oxymorphone hydrochloride extended release) and Lidoderm® (lidocaine patch 5%).
Endo will pay no fines and admit no wrongdoing under an agreement with the FTC that both parties yesterday submitted for approval in the U.S. District Court for the Northern District of California. The company and the agency filed a joint motion asking the court to approve a 10-year Stipulated Order resolving all disputes relating to the patent infringement settlements.
The proposed order bars Endo and its subsidiaries from entering into pay-for-delay patent settlements eliminating the risk of generic competition. As a result, the proposed order frees Endo from liability for its use of such settlement agreements concerning another branded drug, AndroGel® (testosterone gel).
Endo is extremely pleased with the FTC settlement,” Matthew J. Maletta, evp and chief legal officer, Endo, said in a statement. “We believe the absence from the Stipulated Order of any requirement that Endo make payment to the FTC, as well as the absence of any admissions of liability by Endo, are consistent with the Company's position that the Lidoderm and Opana ER settlements fully complied with the law both at the time they were executed and today.”
The FTC sued Endo, entity Endo Pharmaceuticals, and two partners last year in U.S. District Court for the Eastern District of Pennsylvania, the first time the agency challenged an agreement not to market an authorized generic drug, or “no-AG commitment.”
The FTC alleged that Endo violated the Federal Trade Commission Act by offering Watson Laboratories $250 million in payments and incentives, in return for not marketing a generic version of Lidoderm in 2011. That year, Endo generated more than 30% of total revenue from Lidoderm, or more than $825 million.
The agency also accused Endo of paying Impax Laboratories more than $112 million to hold off on introducing a generic Opana ER.
The FTC voluntarily dismissed its lawsuit in October 2016 but said it would refile its complaint elsewhere. Endo later sought a declaratory judgment in its favor from the U.S. District Court for the Eastern District of Pennsylvania.
Yesterday the FTC issued an administrative complaint against Impax and refiled charges against Watson and its former parent Allergan in U.S. District Court for the Northern District of California.
Lidoderm is a topical patch indicated for relief of pain associated with postherpetic neuralgia. Opana ER is an extended-release opioid agonist indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate used to relieve moderate to severe pain.