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

EndoOffice
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.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

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.

Read more on

Suggested Articles

Acadia's knew it had a winner in psychosis when it called off a trial for its Nuplazid. Now analysts are seeing a blockbuster in the making.

Sandoz would still consider acquisitions, as long as they fit the Novartis unit's focus on generics and biosimilars, CEO Richard Saynor said.

Novartis is planning 80 major drug submissions in key markets over the next three years, and 25 of those could be blockbuster opportunities.