Watson, Amphastar get go-ahead for generic Lovenox

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic version of a deep vein thrombosis treatment.

Watson Pharmaceuticals said that Amphastar Pharmaceuticals' abbreviated new drug application for enoxaparin sodium injection in the 100-mg/mL and 150-mg/mL strengths received approval from the FDA. Enoxaparin sodium injection is the generic equivalent of Sanofi's Lovenox.

The generic drug development is part of Watson and Amphastar's exclusive distribution agreement, whereby Amphastar will supply generic Lovenox to Watson, which will market, sell and distribute the product to the U.S. retail pharmacy channel. Additionally, Amphastar will receive between 50% and 55% of Watson's gross profits on product sales, depending on the number of competitors in the market.

Lovenox and its generic equivalents had total U.S. sales of approximately $2.6 billion, according to IMS Health data.