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21 July 2022AmericasStaff writer

Generic maker pays $145m to settle antitrust suit

California company resolves pay-for-delay issue over opioids | Allegations were brought by direct purchasers eight years ago.

Generic drug maker Impax Laboratories has agreed to pay $145 million to resolve claims that the generic drugmaker had engaged in an illegal pay-for-delay scheme with Endo Pharmaceuticals.

The settlement resolves allegations brought by drug distributors Value Drug Co and Meijer Inc, ending “approximately eight years of intense, fully developed litigation”, according to the memorandum of law filed by the direct purchasers.

The memorandum—which was filed Tuesday, July 19 and supports the motion for preliminary approval of the proposed settlement—said that this settlement assures class members of "receiving substantial cash settlement payments”.

It added that the settlement will also help with “putting the litigation against Impax to rest and avoiding the inherent risks of jury trial”.

In June 2014, the first direct purchaser complaint alleging that Impax had violated antitrust laws with respect to pain reliever Opana ER (oxymorphone hydrochloride).

Shortly after, Value Drug and Meijer filed similar complaints in the US District Court for the Northern District of Illinois and these were subsequently consolidated into direct purchaser class actions.

The plaintiffs alleged Impax had agreed to delay the market release of generic Opana ER in a 2010 deal with Endo. As part of the deal, Endo had allegedly paid Impax and promised not to launch a generic during the 180-day exclusivity period that the Hatch-Waxman Act provides to the first generic filer.

In March this year, District Judge Royce Lamberth of the US District Court for the District of Colombia denied antitrust claims brought by the US Federal Trade Commission (FTC) against Endo and Impax.

The FTC had alleged that the companies attempted to block competition in the market for oxymorphone ER, an opioid that treats moderate to severe pain, in a 2017 deal.

This 2017 deal was made while the FTC’s litigation over the 2010 agreement—which the FTC had later found was an illegal reverse-payment settlement—pending.

Earlier this month, Endo secured a victory in the pay for delay dispute, after a federal court in Illinois found that it did not conspire with Impax Laboratories to delay a generic version of Opana ER.

The preliminary settlement is subject to review by District Judge Harry Leinenweber.

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More on this story

Big Pharma
7 June 2021   Endo International and Amneal Pharmaceuticals’ subsidiary, Impax Laboratories, have failed to prevent antitrust claims over a patent settlement from going to trial.
Big Pharma
5 July 2022   The ruling marks the latest development of a long-running dispute over the alleged delay of a generic version of the blockbuster painkiller.

More on this story

Big Pharma
7 June 2021   Endo International and Amneal Pharmaceuticals’ subsidiary, Impax Laboratories, have failed to prevent antitrust claims over a patent settlement from going to trial.
Big Pharma
5 July 2022   The ruling marks the latest development of a long-running dispute over the alleged delay of a generic version of the blockbuster painkiller.