Endo International, a specialty pharmaceutical and generic-drug company, and the US Federal Trade Commission (FTC) have filed a joint motion in federal court to resolve litigation surrounding two of Endo’s pain medications, Opana ER (oxymorphone hydrochloride) and Lidoderm (lidocaine).

The motion was filed in the US District Court for the Northern District of California for a proposed 10-year stipulated order for permanent injunction. The stipulated order resolves all disputes between Endo and the FTC relating to patent-infringement settlements that Endo entered into for Opana ER and Lidoderm. It also resolves the FTC’s claims against Endo’s subsidiary, Par Pharmaceutical, in the action, FTC v. Actavis, Inc., et al. pending in the US District Court for the Northern District of Georgia.

The FTC asserted claims in March 2016 that Endo violated antitrust laws by using pay-for-delay settlements with certain generic manufacturers to block access to lower-cost generic versions of Opana ER and Lidoderm, which had 2015 sales of $176 million and $125 million, respectively. Opana ER is an opioid agonist indicated for managing pain severe enough to require daily, around-the-clock, long-term treatment. Lidoderm is indicated for providing relief of pain associated with post-herpetic neuralgia, a complication of shingles.

The FTC’s claims, filed in the US District Court for the Eastern District of Pennsylvania, pointed out that certain aspects of the Opana ER and Lidoderm settlements constituted unfair methods of competition in violation of federal law, and the agency sought injunctive and declaratory relief as well as other remedies, including restitution and disgorgement. The FTC later voluntarily dismissed its lawsuit in October 2016 but stated its intention to refile elsewhere.

Endo subsequently filed declaratory judgment actions against the FTC in the US District Court for the Eastern District of Pennsylvania seeking rulings on, among other things, whether the FTC has the statutory authority to initiate litigation against Endo in federal court with respect to the settlements and whether the FTC is able to seek disgorgement.

The FTC refiled claims against Endo and other defendants on January 23, 2017 in the US District Court for the Northern District of California and also filed the stipulated order dismissing the claims against Endo. Under the stipulated order, Endo will make no monetary payment to the FTC and will dismiss its claims in the declaratory judgment actions. In exchange, the FTC has agreed that the prior dismissal of its claims against Endo will be treated as being with prejudice, that it will bring no other claims against Endo arising from the Opana ER and Lidoderm settlements, and that it will also dismiss with prejudice its claims against Par in the litigation FTC v. Actavis, Inc., et al. In addition, the FTC is to consider in good faith any requested modifications proposed by Endo in the event of a material change in the law governing the antitrust implications of patent-infringement settlements.

In addition, Endo made no admission of liability in the stipulated order and agreed to certain covenants relating to future settlement of patent infringement litigation for a period of 10 years. These covenants include a prohibition on agreements that prevent the marketing of authorized generic products, or that involve payments to generics manufacturers in connection with delaying the market entry of their products. The stipulated order also requires the FTC to consider in good faith any requested modifications proposed by Endo in the event of a material change in the law governing the antitrust implications of patent-infringement settlements.

In a related matter, the FTC refiled charges against Watson Laboratories and its former parent, Allergan, for illegally blocking a lower-cost generic version of Lidoderm when it entered into a pay-for-delay agreement with Endo. The agency also issued an administrative complaint against Impax Laboratories, a Hayward, California-headquartered specialty pharmaceutical company, for engaging in similar conduct with regard to Opana ER.

Source: Endo and Federal Trade Commission