FTC Makes Double Reverse Payment Case Against Endo And Impax
The generic firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.
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Agreeing a deal that it would not face an authorized generic during its 180-day market exclusivity for generic Opana ER contributed to Amneal's Impax striking an illegal pay-for-delay settlement, the FTC is alleging
Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.
In addition to settling with Endo, FTC refiles charges against Watson (now Teva), Allergan and Impax involving Lidoderm and Opana ER patent litigation settlements.