Lovenox is an anti-clot drug and Amphastar and Teva are seeking FDA permission to sell a copycat version of the drug. The loss of the patent also paves the way for other generic versions to enter the market.
Sanofi-Aventis said is currently evaluating its options for further legal recourse and will continue to vigorously defend its intellectual property rights. The US patent on Lovenox had been due to expire in 2012.
Sanofi also said that while several companies have requested marketing approval from the FDA for their products alleged to be generic versions of Lovenox, Sanofi-Aventis has not learned to date of any FDA approval of these requests.
Another company, Momenta Pharmaceuticals is developing a version of Lovenox under an agreement with Novartis’s Sandoz unit.