Endo accused of Opana pay-for-delay

Generics and biosimilars Initiative

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Endo accused of Opana pay-for-delay

INICIO/Políticas y legislación | Posted 31/10/2014 0 Post your comment

Specialty drugmaker Endo Health Solutions (Endo) has been accused of paying Impax Laboratories (Impax) more than US$112 million to keep their generic version of its powerful painkiller, Opana ER (oxymorphone), off the market from June 2010 to January 2013.

The Farmingdale, New York-based construction workers’ health and welfare fund filed a class-action anti-trust lawsuit against Endo in the Illinois Northern District Court on 4 October 2014.

Oxymorphone is a potent opioid, which is prone to abuse. To try to combat this Endo created a crush-resistant formula, Opana ER CRF, which was approved by the US Food and Drug Administration (FDA) on 9 December 2011. Endo subsequently stopped sale of the original formula Opana ER, for which patents expired in September 2013.

The fund accuses Endo of using the time to switch patients to its abuse-resistant formulation, Opana ER CRF. The fund is seeking unspecified monetary damages on behalf of patients that had to pay for brand-name Opana during that period.

In May 2013, FDA rejected a petition by Endo to stop generics of Opana ER. Endo had petitioned FDA to confirm that the original formula was withdrawn for safety reasons and therefore FDA should not approve any abbreviated new drug applications (ANDAs). At the time both Actavis and Impax had already had ANDAs for their generic versions of the drug approved by FDA and were already marketing their versions in the US [1].

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Endo petition to stop Opana ER generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Generics/News/FDA-rejects-Endo-petition-to-stop-Opana-ER-generics

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