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• #Ftc suit against endo pharma license#

The FTC brought separate actions against Endo and Impax alleging that the settlement was an unfair method of competition under the FTC Act and an unreasonable restraint on trade under the Sherman Act. As predicted, the market for original Opana ER shrank and Endo had to pay Impax $102 million in credits. The settlement effectively allowed Endo to execute the product hop – in March 2012, Endo introduced the new reformulated drug and withdrew the original drug, publicly stating the original drug was unsafe (which the FDA later disagreed with). Finally, Endo and Impax agreed to collaboratively develop a new Parkinson’s disease treatment, with Endo paying Impax $10 million immediately and up to $30 million in additional payments contingent on achieving sufficient development and marketing progress.

#Ftc suit against endo pharma license#

Endo also agreed to pay a credit to Impax if sales revenues for the original formulation of Opana ER fell by more than 50% between the dates of settlement and Impax’ entry.Įndo also provided Impax with a broad license to Endo’s existing and future patents covering extended-release oxymorphone. Under the terms of the settlement, Impax would delay launching its generic drug until Januand Endo agreed to not market its own generic version of ER oxymorphone until Impax’ 180-day Hatch-Waxman exclusivity period ended in July 2013. Therefore, Endo restarted settlement negotiations with Impax three days after the FDA tentatively approved the generic drug and the parties settled the patent litigation in June 2010. However, this transition would take time, and Endo was facing the imminent expiration of the 30-month delay period. While Impax’ generic drug would still reach the market under Plan B, it would not be therapeutically equivalent to Endo’s new branded drug, and therefore, pharmacies would not be able to automatically substitute the generic when filling prescriptions. When an agreement wasn’t reached, Endo seemingly moved to Plan B: remove Opana ER from the market and move consumers to a new brand-name drug that would benefit from an exclusivity period, a crush-resistant version. However, delaying Impax’ entry beyond the June 2010 stay period would save Endo millions, as the company projected that generic entry would reduce Opana ER sales by 85% within three months and cost it $100 million in revenue within six months. The patent infringement lawsuit delayed any potential FDA approval of the generic for 30 months (until June 2010) – or until the litigation concluded.Įndo and Impax then entered settlement talks, which ultimately failed. In January 2008, Endo sued Impax for patent infringement. However, the application did not result in immediate approval of the generic because Endo held patents for Opana ER that did not expire until 2013. Then, in late 2007, Impax filed the first application to market generic ER oxymorphone.

At that time, Opana ER was the only ER version of oxymorphone. In 2006, Endo (the branded drug manufacturer) started selling an extended-release formulation of oxymorphone, Opana ER.

The FTC held an administrative hearing that included testimony from 37 witnesses and more than 1,200 exhibits before it conducted a rule-of-reason analysis and unanimously found that Impax violated antitrust law. In the first post- Actavis reverse payment settlement case, the FTC charged Impax with antitrust violations for accepting reverse payments worth more than $100 million to delay the entry of its generic opioid drug, oxymorphone, for more than two years. Actavis, which found that reverse payment settlements are not automatically considered invalid, though they can extend the branded drug’s monopoly and have anticompetitive effects that violate antitrust laws, but they are subject to the rule of reason. Readers likely remember the 2013 Supreme Court decision in FTC v. On April 13, 2021, the United States Court of Appeals for the Fifth Circuit denied a Petition for Review filed by Impax Laboratories, Inc., in response to a Federal Trade Commission (FTC) Order finding that Impax should be charged with antitrust violations for accepting payments of about $100 million to delay the entry of a generic opioid for more than two years.