The US Federal Trade Commission (FTC) announced its finding against Impax Laboratories regarding whether it had entered a pay-for-delay agreement with Endo Pharmaceuticals, concluding that the former had violated Section 5 of the Federal Trade Commission Act.
As a result of the decision, the FTC has barred Impax, now a part of Amneal Pharmaceuticals, from entering into any type of reverse payment deal (another term for pay-for-delay) that defers or restricts generic entry, as well as certain business transactions with the branded pharmaceutical manufacturer within 45 days of patent settlement.
The case relates to Endo’s extended-release opioid pain relief product, Opana ER (oxymorphone). The FTC found that, in return for remuneration by Endo, Impax delayed the release of an authorised generic during its 180-day exclusivity, granted through the Hatch-Waxman Act. In total, Endo was found to have paid Impax $112m (€100m), as of January 2017.
Such action, the FTC stated, would eliminate the risk of competition and therefore constitutes anticompetitive harm to consumers.
In a statement, the FTC said, “[it] found that Endo possessed market power in the market for branded and generic oxymorphone ER. The Commission found that Impax received a large and unjustified payment.”
The Commission voted 5-0 in making the decision, but Impax can request a review of this through the US Circuit Court of Appeals.
In May 2018, the case had been dismissed because the Complaint Counsel had failed to prove that the agreement violated the Federal Trade Commission Act.
Opana ER’s troubled history
Endo’s Opana ER became a particularly significant product in the unfolding of the opioid crisis in North America when the US Food and Drug Administration (FDA) requested that the company pull its product.
This was the first such example of the FDA taking direct action against the abuse of approved opioid painkillers by requesting their removal from the market.
Endo complied with the request and removed Opana ER from the market in July 2017. The product generated sales of $159m in its last full year on the market in 2016.