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Restasis remains classified as antibiotic, court rules

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IRVINE, Calif. — A federal district court has dismissed Allergan’s lawsuit seeking to have the Food and Drug Administration reclassify its cyclosporine ophthalmic drug, the company announced late last week.

Allergan brought the lawsuit in October 2003 in an effort to have the classification of Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) changed from antibiotic to non-antibiotic, thus obtaining 3 years of market exclusivity on the compound under the Hatch-Waxman Act, according to a company press release. The Hatch-Waxman Act is a 1984 law that allows companies to extend their marketing exclusivity on a drug to make up for time lost during the FDA drug approval process.

The formulation of Restasis is under patent protection until 2014, “and thus there should be no practical need for separate Hatch-Waxman marketing exclusivity,” said Douglas S. Ingram, Allergan’s executive vice president, general counsel and secretary.

The U.S. District Court for the District of Columbia ruled that the FDA classification of Restasis as an antibiotic is supported by the agency’s Modernization Act of 1997, according to the Allergan press release.