A federal district court dismissed Irvine-based drug maker Allergan Inc.’s lawsuit Friday against the Food and Drug Administration over the reclassification of Restasis, its dry eye drug.
The U.S. District Court’s dismissal backed regulators’ contentions that Restasis is an antibiotic. Allergan sued the FDA in October 2003 in a bid to get three years of marketing exclusivity via having regulators reclassify Restasis as a non-antibiotic drug.
Allergan, in a statement, said it believed the court’s ruling would have a limited effect upon Restasis competition, given that it has a use patent on the drug that expires in 2009 and a formulation patent that doesn’t expire until 2014.
“Fortunately, Restasis has intellectual property protection through a patent estate that extends until May 2013 and thus there should be no practical need for Hatch-Waxman (Act) marketing exclusivity,” said Douglas Ingram, the drug maker’s executive vice president, general counsel and secretary.
Additionally, Allergan also mentioned that cyclosporine, Restasis’ active ingredient, “is a challenging compound to formulate as an eye care product.” The FDA approved Restasis in December 2002.
