Lovenox ANDA filings

Executive Summary

Two generic firms - Amphastar and Teva - have filed Paragraph IV certifications against Lovenox (enoxaparin), Aventis announces. The certifications challenge the product's 5,389,618 patent, which expires in February 2012, but not its 4,692,435 patent, which expires in December 2004. Aventis is seeking a re-issuance of the '618 patent as part of its patent defense of the low-molecular weight heparin (1"The Pink Sheet" May 5, 2003, p. 10). ANDA filings for the product attracted attention in early April when FDA posted, and then removed, Lovenox from the list of products which have Paragraph IV certifications. Amphastar said that its ANDA was approved for filing April 21...