Allergan’s Bid to Reclassify Dry-Eye Drug Is Dismissed

Allergan Inc., the maker of Botox, said Friday that a federal court dismissed the company’s lawsuit seeking to win reclassification of its Restasis treatment for dry eyes, which would have prevented the sale of a generic version for three years.

The U.S. District Court in Washington agreed with the Food and Drug Administration’s classification of Restasis as an antibiotic, according to court papers. Allergan sued the FDA in October 2003, hoping that changing the category would give the Irvine company three years of marketing exclusivity.

The ruling won’t affect sales of Restasis, which more than doubled to $24.1 million in the third quarter, because even if the court had ruled in Allergan’s favor, the company’s exclusive rights to sell the drug would have expired in December 2005, said Timothy Chiang, an analyst at New York-based Natexis Bleichroeder Inc.

“It’s kind of a moot decision now,” Chiang said.

Allergan shares fell $1.18 to $77.76 on the New York Stock Exchange.

Allergan said it still had a use patent valid until 2009 and intellectual property patent protection that extended to 2014. The FDA approved Restasis in December 2002.

Allergan said the difficulty of formulating cyclosporine, the active ingredient in Restasis, also protected the company from generic competition.

The company probably sought reclassification to keep competitors from fighting its other patents, Chiang said.