Merck, Glenmark Accused of Delaying Generic Alternatives to Zetia

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Merck & Co., Inc., Glenmark Pharmaceuticals, Ltd., and several of their respective subsidiaries are facing a lawsuit that claims the parties unlawfully delayed the launch of generic alternatives to Merck’s brand name high cholesterol drug, Zetia. According to the suit, Glenmark was the first manufacturer to seek approval for a generic version of Zetia and challenged Merck’s patent on the medicine, claiming it was “invalid and/or unenforceable.”

When Glenmark submitted its application to approve generic Zetia, Merck allegedly sued its competitor for patent infringement. After three years, the parties supposedly came to a settlement in which Merck agreed to pay Glenmark “to stay out of the ezetimibe market for almost five years.” In exchange, the suit continues, Merck promised not to launch its own “authorized generic version” of the drug, allowing Glenmark to remain the only generic competitor during the 180-day stay after the approval of its drug – a period during which competitors were allegedly prohibited by law from launching other alternatives.

According to the complaint, this “pay-for-delay” agreement effectively permitted Merck to charge “supracompetitive” prices for Zetia for an additional five years and allowed Glenmark to reap the profits of selling the only generic version of the drug for 180 days. As a result, the case claims, consumers were forced to pay more for the medicine than they would have in a competitive market.