-Sanofi-Aventis SA was dealt a setback in efforts to protect its best-selling blood thinner Lovenox Wednesday night when a U.S. judge refused to stop sales of a generic version made by a competitor.
In a 33-page opinion, Judge Emmet Sullivan of U.S. District Court in Washington, D.C., declined to issue a preliminary injunction blocking the sales of the generic version made by Sandoz, a unit of Novartis AG, and Momenta Pharmaceuticals Inc.
Sanofi sued the Food and Drug Administration in late July after the FDA gave Sandoz approval to make the generic form of the special heparin, called enoxaparin, which is used in cardiovascular ailments. Sanofi contended in its suit that the FDA had not followed its own regulations in granting the approval, which was announced July 23.
Sanofi argued that the enoxaparin made by Sandoz is not exactly the same drug as Lovenox and therefore should not be approved or marketed as a copycat version of the blockbuster. Lovenox had global sales in 2009 of about $4 billion, according to IMS Health.
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