Barr Pharmaceuticals said yesterday that it had won the US Food and Drug Administration green light for its generic capsule version of Aventis Pharmaceuticals’ allergy drug, Allegra (fexofenadine).
The US company said that it is now entitled to 180 days of marketing exclusivity for the medicine, being the first company to file for approval of a copycat version.
Barr originally filed its version of Allegra with the FDA back in May 2001 [[04/07/01b]]. Aventis Pharmaceuticals, which is now part of Sanofi-Aventis, subsequently filed a lawsuit against Barr, seeking to prevent approval until the last of its patents on the drug expires in 2017. In July last year, a US district court judge ruled that it had not infringed three of the patents covering the product [[02/07/04d]], and an additional patent was declared invalid in April this year. The court has yet to rule on five more patents covering the product and, although no trial date has been set, Barr expects the case may be ready for trial early in 2006.