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Andrx Picks Up Lovenox Generic Marketing Rights From Amphastar

This article was originally published in The Pink Sheet Daily

Executive Summary

Under the $10 mil. deal, Andrx obtains rights to market two strengths of the injectable antithrombotic in the U.S. retail pharmacy market. Amphastar will be responsible for ongoing enoxaparin patent litigation with Sanofi-Aventis. The 30-month stay on Amphastar’s ANDA runs through February 2006.

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California court invalidates Sanofi-Aventis’ patent due to inequitable conduct. The court’s ruling will lead to lifting of 30-month stay on ANDA approvals. Amphastar and Teva said they would await FDA approval of their enoxaparin generics before deciding whether to launch prior to an appellate court ruling.

Lovenox Patent Invalidity Ruling Could Open Door To Near-Term Generics

California court invalidates Sanofi-Aventis’ patent due to inequitable conduct. The court’s ruling will lead to lifting of 30-month stay on ANDA approvals. Amphastar and Teva said they would await FDA approval of their enoxaparin generics before deciding whether to launch prior to an appellate court ruling.

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