FTC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

As part of an FTC agreement announced Monday, Endo pledged to swear off pay-for-delay agreements for 10 years.

As part of a proposed FTC settlement announced Monday, Endo International has pledged to swear off pay-for-delay agreements. But even as the government moves to wrap up its case against Endo, authorities continue to pursue claims against Watson and Allergan.

The lawsuit centers around a pay-for-delay deal on Lidoderm, according to a U.S. Federal Trade Commission release. According to the feds, Watson “illegally” delayed a cheaper Lidoderm “when it entered into a pay-for-delay agreement with Endo.” The FTC announced it has refiled charges against Watson and former parent company Allergan on Monday.

According to the FTC complaint, Lidoderm was an important product for Endo back in 2011. That year, the company made $825 million in sales off the lidocaine patch, or 30% of its annual sales haul, meaning generic competition would pose "significant financial risks" to the company. All told, Endo paid Watson at least $250 million to delay that competition, according to the feds.

Through an “administrative complaint,” authorities are also going after Impax Laboratories, which they say received $112 million back in 2010 to delay a generic competitor to Endo’s Opana ER.

Endo’s 10-year Stipulated Order for Permanent Injunction would resolve all claims by the FTC against Endo and its Par subsidiary related to Opana ER and Lidoderm. The drugmaker made no admission of liability and doesn't have to cough up a monetary payment to the government. In exchange, it stipulated it would not strike any agreements that would prevent the marketing of authorized generics of its products or make any payments to other drugmakers to delay the marketing of any of their generics.

The agency first brought the claims back in March 2016. Then, in October, the feds dismissed the original complaint after a federal court ruling that didn't go its way. The FTC, however, said it would refile, according to an Endo release on Monday, which led to this week's settlement agreement.