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Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off

Executive Summary

Allegations in Amphastar Pharmaceuticals’ lawsuit over FDA detention of heparin raw ingredient shipments suggest approval of its enoxaparin ANDA, the generic of Sanofi-Aventis’ low-molecular weight heparin Lovenox, is far from imminent.

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Momenta Pharmaceuticals and Sandoz have enjoyed approximately 14 months of de facto generic exclusivity on Sanofi’s anticoagulant Lovenox (enoxaparin), but faced with the imminent threat of competition they are trying to maintain their hold on the market through patent litigation.

Generic Lovenox Battle Heats Up With Amphastar’s ANDA Approval

Momenta Pharmaceuticals and Sandoz have enjoyed approximately 14 months of de facto generic exclusivity on Sanofi’s anticoagulant Lovenox (enoxaparin), but faced with the imminent threat of competition they are trying to maintain their hold on the market through patent litigation.

Amphastar Seeks Court Order Requiring FDA To Approve Its Enoxaparin ANDA

Amphastar’s initial lawsuit against FDA achieved its stated goal: the agency released two shipments of raw heparin material the company is to use in producing generic Lovenox (enoxaparin).

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