Barr Sues FDA to Obtain Sole Exclusivity on Allegra-D(R)

10-Feb-2005

Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has filed suit against the U.S. 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. 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(R) (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 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(R). 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.

"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. We will seek all remedies to ensure that the incentive of 180 days of generic exclusivity is preserved as Congress intended," said Bruce L. Downey, Barr's Chairman and CEO.

https://www.chemeurope.com/en/news/43254/barr-sues-fda-to-obtain-sole-exclusivity-on-allegra-d-r.html