Barr Pharmaceuticals Inc. sued the U.S. Food and Drug Administration in the U.S. District Court for the District of Columbia, seeking exclusive rights to sell a generic version of Sanofi-Aventis’ Allegra-D allergy drug. In the suit, Barr is challenging the FDA’s policy of awarding generic exclusivity on a patent-by-patent basis rather than solely to the first company to file an application to sell a generic version of a branded drug. Allegra-D had U.S. sales of about $444 million last year.
Barr in July won tentative approval to sell generic Allegra-D, known by the chemical names fexofenadine hydrochloride and pseudoephedrine hydrochloride, pending resolution of its challenge to Aventis’s patent but fears the FDA will try to force it to share the 180-day marketing exclusivity period.
Sanofi-Aventis holds patents that do not expire until between 2012 and 2019 and in 2002, Aventis obtained and listed an additional Allegra-D patent, extending its patent protection, which Barr believes that another generic company filed the first application based on the subsequently listed patent.
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