Sanofi Loses Court Challenge to FDA Generic Lovenox Approval

Sanofi lost a challenge to the U.S. Food and Drug Administration’s approval for a generic version of Lovenox, the blood-thinning drug that had sales of $3.7 billion in 2010.

U.S. District Judge Amy Berman Jackson today ruled that the FDA acted within its authority when in 2010 the agency approved the lower-cost copy produced by Novartis AG’s Sandoz unit with Momenta Pharmaceuticals Inc.’s technology.

“Not only did FDA support its approach in a thorough, well-reasoned response to Sanofi’s citizen petition, but it also carefully considered both sides of the argument internally,” the judge said in her 33-page ruling.

Sanofi, France’s leading drugmaker, sought to force the FDA to suspend its approval of the first generic rival to Lovenox, which was the Paris-based company’s second-biggest selling product in 2010.

Another federal judge in Washington in August 2010 denied Sanofi’s bid for a temporary order to stop the generic version from being sold in the U.S.

Jeanne Longo, a Sanofi spokeswoman, said in an e-mail that the company was disappointed with the ruling and is considering its legal options.

Lower-Cost Copy

Novartis, based in Basel, Switzerland, and Momenta Pharmaceuticals, a biotechnology company in Cambridge, Massachusetts, won U.S. approval in 2010 for a lower-cost copy of Lovenox. Sanofi said in its complaint that the generic version isn’t clinically equivalent to Lovenox, and the FDA’s decision may cause Sanofi “irreparable harm.”

The FDA had told the court Sanofi’s challenge was “the latest in a long line of cases in which a manufacturer of a pioneer drug product has attempted to block generic competition by challenging the regulatory and scientific bases” for the agency’s approval.

Sandy Walsh, an FDA spokeswoman, had no immediate comment on the ruling.

The case is Sanofi-Aventis U.S. LLC v. Food and Drug Administration, 10-01255, U.S. District Court, District of Columbia (Washington).

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