WOODCLIFF LAKE, NJ - Barr Pharmaceuticals, Inc. announced on Saturday that its subsidiary, Barr Laboratories, Inc., has filed a suit against the US Food and Drug Administration (FDA) in the United States District Court for the District of Columbia.
Barr's suit challenges FDA's policy of awarding generic exclusivity on a patent-by-patent basis, rather than solely to the first company to submit an application containing a paragraph IV certification to a listed patent, a press release by the Company stated.
Barr believes that FDA's policy is contrary to Hatch-Waxman, and that the company is entitled to sole exclusivity for its generic Allegra-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) tablet product.
Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Tablets in September 2001. Barr's ANDA included a paragraph IV certification to patents listed in the Orange Book for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Tablets.
Aventis filed a suit against Barr in United States District Court for the District of New Jersey within the 45-day Hatch-Waxman period. In 2002, Aventis obtained and listed an additional patent in connection with Allegra-D.
Barr believes that 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.
Allegra-D is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Allegra-D had annual sales of approximately $444 million for the twelve months ended November 2004, based on IMS data.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
