FDA Faces Barr Lawsuit Over Exclusivity for Generic Allegra-D

Barr Laboratories has filed a lawsuit against the FDA in federal court to obtain 180 days of marketing exclusivity for its generic version of Aventis' Allegra-D allergy drug.

Barr's lawsuit, filed in the U.S. District Court for the District of Columbia, is challenging the FDA's policy of awarding generic exclusivity on a patent-by-patent basis. The agency currently 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).

Barr contends that the rule is inconsistent with the Hatch-Waxman Act, and that the FDA should award marketing rights solely to the first company to submit an abbreviated new drug application with a Paragraph IV certification challenging a listed patent.

"We believe that the exclusivity provisions of Hatch-Waxman are clear and the first company to file a patent challenge is entitled to the 180-day incentive," Barr Chairman and CEO Bruce Downey said in a statement. "We will seek all remedies to ensure that the incentive of 180 days of generic exclusivity is preserved as Congress intended."