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Barr’s generic Allegra

This article was originally published in The Tan Sheet

Executive Summary

Barr Labs has received final FDA approval for its generic version of Aventis' Allegra (fexofenadine HCl) 60 mg capsules, the Woodcliff Lake, N.J.-based firm announced July 14. The company is the first to file an ANDA that has a paragraph IV patent challenge on the Allegra capsule patents and will have 180 days of marketing exclusivity on the product, Barr states. Aventis tried to prevent approval of the ANDA until various Allegra patents expired, but a New Jersey federal court ruled in June 2004 that Barr did not infringe on three Allegra composition patents (1"The Tan Sheet" July 5, 2004, In Brief). Barr still has five patent-related issues pending in litigation with Aventis and anticipates the case will go to court in early 2006...
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