Sanofi-Aventis Sues to Stop Generic Lovenox
Last week, the FDA approved the first generic version of Lovenox (enoxaparin sodium) to be manufactured by Novartis AG’s Sandoz and marketed by Momenta Pharmaceuticals. The maker of the original, Sanofi-Aventis of France, has filed a lawsuit in federal court to force the FDA to suspend its approval, stating the generic isn’t “clinically equivalent” to Lovenox.
According to spokesman Jean-Marc Podvin, the FDA’s approval was not made in accordance with the agency’s statutory obligations. The company believes that the case “poses a number of significant questions regarding the FDA review process for complex pharmaceutical products.”
Sanofi contends that their brand drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions.
Sanofi’s patent to Lovenox was voided last year, according to a ruling by the US Supreme Court, because the company had misled the US Patent and Trademark Office. The Court rejected Sanofi’s appeal seeking reinstatement of the patent that would have prevented competition until 2012.
A federal judge will hear the case, Sanofi-Aventis US LLC v. Food and Drug Administration 10cv1255, on August 17th. Although Sanofi has also asked for a temporary restraining order to stop the generic from hitting the market this week, Momenta Pharmaceuticals has said that the court did not place restrictions on sales.