Sanofi, U.S. Facing Antitrust Class Action Over Insulin Product

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A proposed class action has been filed against Sanofi, U.S. and Sanofi GmbH claiming the companies violated federal antitrust laws by allegedly employing anticompetitive tactics to fix the market for insulin glargine for injection. According to the 68-page lawsuit, Sanofi, U.S. and co-defendant Sanofi GmbH engaged in “a variety of anticompetitive practices” as part of a scheme to block “follow-on competition” for its insulin glargine products, Lantus and Lantus SoloSTAR.

The case’s allegations are rooted in the expiration of the exclusive patent for insulin glargine in the U.S. in February 2015. To gain necessary FDA approval to sell insulin glargine in the U.S., the lawsuit alleges, the defendants “erected a regulatory roadblock by unlawfully listing other patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations” that either did not belong there or did not cover all formulations of the medication.

Sanofi then sued a competitor over two patents disclosing different variations of the insulin glargine formulation.

“Sanofi’s suit lacked any reasonable basis,” the complaint alleges. “But merely by bringing the claims, Sanofi caused a 30-month delay of FDA approval of [its competitor’s] NDA for insulin glargine. This 30-month delay of FDA approval, extending beyond the February 2015 expiration of exclusivity from the Sanofi insulin glargine patent, prevented [the competitor] from marketing its own insulin glargine drug product.”