The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX Approval

By Kurt R. Karst –   

As we thought might happen, Sanofi-aventis U.S. L.L.C. (“Sanofi”) sued FDA over the Agency’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection).  (On the same day that FDA approved Sandoz’s ANDA, the Agency responded to a February 2003 Sanofi citizen petition concerning the approval of generic LOVENOX.)  Sanofi filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction the U.S. District Court for the District of Columbia late on July 26th requesting that the  court issue a declaratory judgment that FDA acted unlawfully in approving ANDA No. 77-857, as well as a temporary restraining order and preliminary injunction directing FDA to immediately suspend and withdraw approval of the Sandoz ANDA, and a permanent injunction under the same terms.

Sanofi alleges in its court papers that FDA violated the FDC Act in approving ANDA No. 77-857.  Specifically, according to Sanofi:

By approving Sandoz’s ANDA, FDA has exceeded its authority under Section 505(j) of the [FDCA], ignored its own precedent regarding approval of generic versions of drugs that have not been fully characterized, and has failed to ensure that Sandoz's drug has the same active ingredient as Lovenox, as required by the ANDA provisions of the FDCA.

Furthermore, Sanofi alleges that FDA's approval of Sandoz’s ANDA violated the Administrative Procedure Act (“APA”) and was improper under the FDC Act insofar as “FDA approved Sandoz's ANDA for a fully substitutable generic version of Lovenox notwithstanding the fact that the Agency required Sandoz to submit additional data and information demonstrating the safety and effectiveness of its product.”  According to Sanofi, FDA disregarded FDC Act § 505(j)(2)(A), which concerns the required content of an ANDA and “specifically precludes FDA from requiring the submission of such [safety and effectiveness] information.”  Moreover, requiring or considering such information as part of an ANDA “effectively allows the generic applicant to rely upon the pioneer's confidential commercial information in a manner not contemplated by the statute,” according to Sanofi. 

Sanofi also alleges that FDA violated the APA “by effectively according different treatment to similarly situated products.”  According to Sanofi, “FDA has ignored Agency precedent relating to generic versions of drugs that have not been fully characterized,” and “failed to provide a substantive reason why generic enoxaparin should be treated differently from other drugs that cannot be fully characterized.”  Sanofi detailed a body of precedent in the company’s 2003 citizen petition (and in supplements to that petition) that the company believes should have supported FDA fully granting the company’s petition. 

Finally, Sanofi alleges that FDA has also dismissed, “without any rational justification or analysis, a wealth of scientific evidence establishing that small variations in the manufacturing process used to create low molecular weight heparins (LMWHs) such as Lovenox can result in significant changes to the structure and pharmacological properties of generic versions of the drug,” and that “[b]y allowing generic applicants to deviate from the manufacturing process used by [Sanofi] to produce Lovenox, FDA has failed to ensure that generic versions of enoxaparin have the same active ingredient and the same safety and effectiveness profile as Lovenox, as required by the ANDA provisions of the FDCA.”

We will continue to update our loyal FDA Law Blog readers on this interesting (and not unexpected) lawsuit.  A hearing on Sanofi's motion is currently scheduled for August 17, 2010 at 10:30AM.