Biotechnology company, Allergan, took a knocking on Friday after it revealed that it had failed in its bid get the US Food and Drug Administration to reclassify its dry eye treatment, Restasis (cyclosporine), from an antibiotic to a “non-antibiotic new drug.”
In a statement, Allergan says that a US district court dismissed the lawsuit, ruling that the agency’s designation of the drug as an antibiotic was supported by the FDA’s 1997 modernisation act.
Allergan originally filed the lawsuit in October 2003, noting that the product’s reclassification prevented it from receiving benefits and incentives associated with Hatch-Waxman exclusivity [[04/11/03d]]. Restasis was first approved in December 2002, but was reclassified as an antibiotic in March 2003. Hatch-Waxman exclusivity would have provided three years of marketing exclusivity, but Allergan notes that this would have expired in December 2005, and says “there should be no practical need for separate Hatch-Waxman marketing exclusivity.” It notes that Restasis is covered by a use patent that is not set to expire until August 2009, and a formulation patent also covers the drug until May 2014. Additionally, the firm believes that it would be difficult for a competitor to successfully develop an alternative formulation with the same safety and efficacy profile as Restasis.