Barr Sues FDA Over Exclusivity for Generic Allegra-D

Law360, New York (February 5, 2005, 12:00 AM EST) -- Barr Laboratories has mounted a challenge to the way the U.S. Food and Drug Administration awards marketing exclusivity for new generics with a lawsuit seeking 180 days of exclusivity for its generic version of Aventis' allergy drug Allegra-D.

Under its existing policies, the FDA awards marketing exclusivity based on each patent filed in the Orange book, which can result in multiple companies having to share the exclusivity period when a drug has more than one patent, such as Allegra-D (fexofenadine HCl/pseudoephedrine HCl).

However, Barr's lawsuit, filed...
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