Reuters reported: French drugs group Sanofi-Aventis said on Feb. 9, 07 a California court had ruled against it in a case pitting it against Amphastar and Teva in a Hatch-Waxman case over the best-selling Lovenox drug. Lovenox is Sanofi's best-selling drug, with sales of 2.14 billion euros ($2.75 billion) in 2005. Lovenox is also under attack from Momenta Pharmaceuticals and Sandoz, owned by Switzerland's Novartis.
David Beadle noted a different complexity as to the generic companies getting FDA approval: "To be honest, we don't think generics will get approval, because Lovenox is a quasi-biological product."
Lovenox is a highly complex medicine that must be injected. As a result, generic manufacturers may struggle in the ANDA requirement to prove that their products are bioequivalent to Sanofi's original.