Categories & Search

The FTC Sues Endo and Impax Over Opana ER Agreement . . . Again

Stop me if you’ve heard this one before: the FTC is suing pharmaceutical manufacturers Endo and Impax over an alleged “reverse payment” agreement to reduce competition in the market for Opana ER, an oxymorphone extended release product.  In fact, the FTC’s complaint follows quickly on the heels of the Commission’s decision that a 2010 agreement between the same manufacturers to settle Impax’s patent litigation against Endo for a $112 million payment constituted an illicit “reverse payment” that delayed the entry of Impax’s generic version of Opana ER.  (Click here for background on that decision.)  Oral argument on Impax’s appeal of the FTC’s decision happened six months ago; the Fifth Circuit’s decision will mark the first time a Circuit Court weighs in on the FTC’s interpretation of the Supreme Court’s 2013 decision in FTC v. Actavis.  (Click here for analysis of the oral argument).

Yesterday, the FTC sued Endo and Impax again.  This time, however, it was Impax that allegedly paid Endo to stay out of the market.  In May 2016, Endo sued Impax for failing to abide by the terms of the 2010 settlement agreement between Endo and Impax, and about a year later, in August 2017, the parties settled that breach-of-contract case.  All this occurred while the FTC’s enforcement action concerning that 2010 settlement was ongoing.

The FTC now alleges that the August 2017 settlement agreement violated federal antitrust law.   Before Impax’s generic version of Opana ER launched in January 2013, Endo discontinued the distribution of its original formulation of Opana ER and launched a reformulated product.  On June 8, 2017, the FDA asked Endo to voluntarily withdraw reformulated Opana ER from the market because the product was associated with an outbreak of HIV and hepatitis C stemming from its intravenous abuse.  On July 6, 2017, Endo agreed to remove the reformulated product from the market.  With that decision, Impax’s generic version of the original Opana ER formulation became the only available extended release oxymorphone product.

According to the FTC, Endo considered bringing another extended release oxymorphone product to the market or partnering with a third-party generic company to do so, but instead it entered into the August 2017 agreement with Impax to settle the breach-of-contract claim it filed in 2016 and no extended release product was introduced.  The FTC alleges that these two events were not a coincidence.  It alleges that this agreement “eliminated potential competition from Endo by sharing Impax’s monopoly profits, with Endo in the role of a potential entrant paid to stay out of the market.”

We will continue to monitor this suit and the appeal filed by Impax in the first FTC action concerning this product market.