Endo resolves FTC allegations over Lidoderm and Opana ER
Endo Pharmaceuticals yesterday settled charges brought by the Federal Trade Commission (FTC) by abandoning anti-competitive pay-for-delay agreements.
Endo and the FTC filed a joint motion in the US District Court for the Northern District of California seeking the entry of a ten-year stipulated order for a permanent injunction.
The stipulated order resolves all disputes between the FTC and Endo relating to patent infringements concerning pain relief drugs Lidoderm (Lidocaine patch 5%) and Opana ER (oxymorphone hydrochloride).
The settlement came after the FTC filed a complaint alleging that Endo had violated competition laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Lidoderm and Opana ER.
In a related matter, the FTC refiled a complaint against Watson Laboratories, and its former parent company Allergan, for blocking a lower-cost generic version of Lidoderm by entering into a pay-for-delay agreement with Endo.
Impax Laboratories was also accused on similar grounds in relation to Opana ER.
Matthew Maletta, executive vice president of Endo, said in a statement: “Endo is extremely pleased with the FTC settlement.
“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’s refiled claim against Watson and Allergan was issued at the US District Court for the Northern District of California, while its complaint against Impax was filed at the commission.
Originally, the FTC filed a complaint against Endo and the other companies in March 2016 for reverse payment settlements which were allegedly designed to eliminate generic competition. But the FTC dismissed the case in November 2016 after the court granted the companies a severance motion, giving them the opportunity to have separate jury trials on the different charges.
The FTC said in a statement: “The proposed Endo order prohibits Endo and its subsidiaries from entering into the type of anti-competitive patent settlements that the FTC charged Endo used to eliminate the risk of generic competition.”
The order also resolves the FTC’s claims against Endo’s subsidiary Par Pharmaceutical in the action FTC v Actavis, which is pending in the US District Court for the Northern District of Georgia.
