Bausch, Assertio, Lupin To Face Diabetes Drug Glumetza Antitrust Suit

Bausch Health, Assertio Therapeutics and Lupin Pharmaceuticals Inc must face claims by purchasers of Bausch’s type 2 diabetes drug Glumetza that they conspired to suppress generic competition through an illegal patent settlement, enabling an 800% price hike in 2015, reported Reuters. 

US District Judge William Alsup in San Francisco on Thursday denied the drugmakers’ motion for summary judgment, finding that whether they violated antitrust laws was a question for a jury. He also denied the purchasers’ motion for summary judgment on the issue of whether the defendants had market power.

Bausch, Assertio and Lupin and their attorneys – Daniel Asimow of Arnold & Porter Kaye Scholer, Eric Stock of Gibson Dunn and Meg Slachetka of Lowenstein Sandler, respectively – did not respond to requests for comment. Nor did Steve Shadowen of Hilliard & Shadowen, a lawyer for the plaintiffs.

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

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