Andrx, Amphastar Reach Agreement Over Marketing Rights for Generic Lovenox

Andrx has signed a deal with Amphastar Pharmaceuticals to purchase partial U.S. marketing rights to a generic version of sanofi-aventis' blockbuster thrombosis treatment Lovenox.

Under terms of the agreement, Andrx will make a $4.5 million initial payment to acquire certain exclusive marketing rights to a generic version of Lovenox (enoxaparin sodium) currently under development by Amphastar. The marketing rights generally extend to the U.S. retail pharmacy market, where approximately 30 percent of Lovenox's annual sales occur, Andrx said. Lovenox generated roughly $1.5 billion in U.S. sales in 2004, according to IMS Health data.

In addition to the initial payment, Andrx will also pay Amphastar $5.5 million after the company achieves certain milestones, including obtaining FDA marketing approval for the generic Lovenox product. The second payment is also contingent on Amphastar favorably resolving pending patent litigation with sanofi-aventis, which filed suit to block the generic product. The 30-month stay imposed under the Hatch-Waxman Act in this case runs through February 2006.

Lovenox is used to prevent deep vein thrombosis in certain patients undergoing abdominal surgery or knee or hip replacement surgery. The drug is also used to prevent some cardiovascular events. Lovenox generated U.S. sales of roughly $1.5 billion in 2004, according to IMS Health data.