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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Allegra patents
Five generic companies do not infringe two composition patents for Allegra (fexofenadine), a Newark, N.J. federal court ruled June 29. The ruling granted Barr, Impax, Teva, Mylan and Dr. Reddy's summary judgment of noninfringement on two patents. Barr also received summary judgment of noninfringement on a third composition patent for Allegra, while Barr, Mylan and Impax were denied summary judgment of noninfringement on an Allegra D composition patent. Barr said a total of seven patents remain at issue in its litigation with Aventis and expects the case to go to trial in mid-2005...
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