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Barr Allegra-D generic

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Executive Summary

Barr is free to launch the first generic version of Sanofi-Aventis' Allegra-D 12 hour tablets (fexofenadine/pseudoephedrine) following final FDA approval announced April 14. A launch would be "at risk" because of ongoing patent litigation. Approval of Barr's ANDA comes shortly after the company and FDA resolved a dispute over the agency's original decision to split the 180-day exclusivity for generic Allegra-D between Barr and Impax. Barr's withdrawal of a Paragraph IV certification against a late-listed Sanofi-Aventis patent (6,399,632) made it eligible for sole exclusivity and nullified the only remaining 30 month stay...

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