Lupin Settles Glumetza Case For $150M

Lupin will pay US$150 million to resolve antitrust litigation over its alleged role in a scheme to delay generic versions of the blockbuster diabetes treatment Glumetza, 10 days after Bausch Health settled for US$300 million, according to a federal court filing in San Francisco.

The drug distributors leading part of the lawsuit sought preliminary approval for the deal late Monday, September 20, from Judge William Alsup, who’s overseeing the consolidated case in the US District Court for the Northern District of California, where a trial of “direct purchaser” claims is set to start October 4.

Glumetza, an extended-release form of metformin hydrochloride, was approved by the Food and Drug Administration (FDA) in 2005, originally sold by Depomed, now called Assertio. Depomed marketed the drug in partnership with Santarus, which was later acquired by Bausch.

In 2009, Lupin applied to the FDA to make a generic version of the drug, and Depomed sued. In 2012, the companies reached a settlement in which Lupin agreed to delay launch of its product until 2016, and Depomed agreed to pay Lupin’s legal fees and not to offer its own so-called authorized generic that would compete with Lupin’s during Lupin’s legally mandated 180-day period of market exclusivity.

In their 2019 lawsuit, the Glumetza purchasers allege that arrangement was an illegal “reverse payment” or “pay-for-delay” settlement, which courts have held can violate federal antitrust laws. They said Depomed later reached settlements with other generic companies to delay competing products as well, though they are not named as defendants.

The purchasers claim that the illegal monopoly allowed Bausch, then known as Valeant Pharmaceuticals, to hike the drug’s price by 800% in 2015. Though generic versions have since come on the market, prices remain higher than they would be without the 2012 settlement, the purchasers say.

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