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Andrx and Amphastar enter into generic Lovenox alliance

Andrx Corporation has entered into an agreement to obtain certain marketing rights for both strengths of Amphastar Pharmaceuticals' proposed generic version of the Sanofi-Aventis anticoagulant Lovenox.

Lovenox, an enoxaparin sodium injectable product, is indicated for the prevention of deep vein thrombosis in certain patients undergoing abdominal surgery and knee or hip replacement surgery, and for the prevention of certain cardiovascular events.

Amphastar submitted its abbreviated new drug application (ANDA) for generic Lovenox to the FDA in March 2003. Amphastar’s product is the subject of a patent infringement lawsuit filed by Aventis, and the 30-month stay imposed by law, which runs through February 2006.

Andrx’s marketing rights generally extend to the US retail pharmacy market, representing approximately 30% of total Lovenox sales. To obtain these rights, Andrx paid $4.5 million upon execution of the agreement and will make an additional $5.5 million payment to Amphastar once certain milestones are achieved. In exchange, Andrx will receive up to 50% of the net profits, generated from sales of Amphastar’s product in the retail pharmacy market.