The suit challenges the FDA’s policy of awarding generic exclusivity on a patent-by-patent basis. Barr believes that this policy is contrary to the Hatch-Waxman Act, and that it is entitled to sole exclusivity for its generic Allegra-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) product.
Barr filed an abbreviated new drug application (ANDA) for fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in September 2001 but, in 2002, Aventis obtained and listed an additional patent for the drug. Barr believes that the FDA will conclude that another company filed the first paragraph IV certification to that subsequently listed patent and, on that basis, attempt to force Barr to “share” its exclusivity with that other company.
“We believe that the exclusivity provisions of Hatch-Waxman are clear and that the first company to file a patent challenge is entitled to the 180-day incentive,” said Bruce Downey, Barr’s chairman and CEO. “We will seek all remedies to ensure that the incentive of 180 days of generic exclusivity is preserved as Congress intended.”