LEO Pharma's Dovonex patent challenged

By Elaine Rigoli

Tampa, Fla., June 29 - LEO Pharma has received a paragraph 4 certification notice from Hi-Tech Pharmacal Co., Inc. advising of the filing of an abbreviated New Drug Application for a generic version of Dovonex solution.

Dovonex solution, which is marketed and sold in the United States by Warner Chilcott, Inc., is protected by U.S. Patent No. 5,763,426, which expires in 2015 and U.S. Patent No. 4,866,048, which expires in 2007.

LEO and Warner Chilcott officials said they are reviewing the detail of the paragraph 4 notice letter from Hi-Tech Pharmacal, and LEO said it continues to have full confidence in its intellectual property protecting Dovonex solution.

LEO Pharma is a research-based pharmaceutical company with headquarters in Copenhagen, Denmark.

Warner Chilcott is a specialty pharmaceutical company located in Fajardo, Puerto Rico.

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