Judge Throws Out Whistleblower Lawuit over Lovenox

Generics manufacturer Amphastar Pharmaceuticals was silenced by a federal judge in California over its latest whistleblower lawsuit in a 12-year battle over Sanofi’s blockbuster anticoagulant Lovenox.  

Bad blood between the two drugmakers dates back to 2003 when Aventis, now part of Sanofi, sued to stop Amphastar from bringing its generic version of Lovenox (enoxaparin sodium) to market. In 2009, Amphastar filed its whistleblower suit claiming it had discovered that Aventis committed fraud that resulted in false payments from Medicare and Medicaid.

Amphastar eventually received FDA approval in 2011 to sell its version of Lovenox.

In Amphastar Pharmaceuticals v. Aventis Pharma SA, et al., Judge Marvin Garbis of the U.S. District Court for the Central District of California said Amphastar did not have standing to file the suit. Garbis said he did not believe testimony from Amphastar owner Yong Feng Zhang, who claimed knowledge of Sanofi’s potential fraud of the U.S. Patent and Trade Office and the FDA. — John Bechtel