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Published on 5/4/2006 in the Prospect News Biotech Daily.

Barr to challenge Aventis' Nasacort patent

By Elaine Rigoli

Tampa, Fla., May 4 - Barr Laboratories said Thursday it would challenge the patents protecting Aventis Pharmaceuticals, Inc.'s Nasacort AQ (triamcinolone acetonide) nasal spray.

Barr filed its abbreviated New Drug Application for the nasal spray, containing a paragraph 4 certification, with the Food and Drug Administration in December 2005 and received notification of the application's acceptance for filing in March 2006.

Following receipt of the FDA notice, Barr said it notified Aventis Pharmaceuticals, the New Drug Application holder and patent owner.

On May 2, Aventis filed suit in the U.S. District Court of Delaware to prevent Barr from proceeding with the commercialization of its product.

Barr said it developed its triamcinolone acetonide nasal spray product with Perrigo Co. and, under the terms of an agreement, will share in the costs and potential benefits with Perrigo.

Nasacort AQ, indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children six years of age and older, had annual sales of about $346 million for the 12 months ended March 2006, based on IMS sales data.

Aventis is an international pharmaceutical company with U.S. headquarters in Bridgewater, N.J.

Perrigo, based in Allegan, Mich., is a supplier and manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand market.

Barr, based in Woodcliff Lake, N.J., develops, manufactures and markets generic and proprietary pharmaceuticals.


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