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Endo, FTC settle pay-for-delay charges over 2 drugs


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Endo, FTC settle pay-for-delay charges over 2 drugs

The Federal Trade Commission refiled a complaint and filed a proposed stipulated order in U.S. District Court for the Northern District of California to resolve charges that Endo Pharmaceuticals Inc. and Endo International PLC broke antitrust laws by using pay-for-delay settlements to block access to generic versions of Lidoderm and Opana ER.

Lidoderm is a topical patch used to relieve pain associated with a complication of shingles known as post-herpetic neuralgia and Opana ER is an extended-release opioid used to relieve moderate to severe pain.

The complaint alleges that Endo delayed access to the generic versions of the drugs to preserve its monopoly profits.

The proposed order prohibits Endo and its units from entering into the type of anticompetitive patent settlements that the FTC charged Endo used to eliminate the risk of generic competition, including its use of no-authorized generic, where a brand company agrees not to compete with an authorized generic version of a drug for a period of time.

As Endo is now prohibited from entering into pay-for-delay settlements, the order also releases Endo from liability for its use of reverse-payment settlement agreements concerning the branded drug AndroGel.

Under the stipulated order, Endo will make no monetary payment to the FTC and will dismiss its claims in the declaratory judgment actions. It made no admission of liability in the order and agreed to certain covenants relating to the future settlement of patent infringement litigation for a period of 10 years.

The order also requires the FTC to consider in good faith any requested modifications proposed by Endo in case of a material change in the law governing the antitrust implications of patent infringement settlements.

In addition, the FTC refiled charges against Watson Laboratories Inc. and its former parent, Allergan plc, for illegally blocking a lower-cost generic version of Lidoderm when it entered into a pay-for-delay agreement with Endo. In the new complaint, the FTC is seeking an order permanently barring the defendants from engaging in similar anticompetitive behavior in the future and disgorgement of the defendants’ ill-gotten gains.

The agency further filed an administrative complaint against Impax Laboratories Inc. for being involved in similar conduct regarding Opana ER. The FTC claims the companies allegedly agreed that Impax would delay the entry of its generic version of the drug till January 2013, and in exchange Endo paid Impax more than $112 million.

The re-filed case relates to charges filed by the FTC in federal court in Philadelphia in March 2016 that Endo and certain generic companies were parties to Lidoderm and Opana ER reverse-payment settlements designed to eliminate generic competition. The FTC had voluntarily dismissed its complaint in November 2016 after the court granted the defendants' severance motion.