Warner Chilcott (WCRX) recently announced that it received a paragraph IV patent certification notice from Zydus Pharmaceuticals USA Inc. regarding its drug Asacol HD (800 mg). The drug is indicated for treating patients suffering from moderately active ulcerative colitis.
The notice informed Warner Chilcott that Zydus Pharmaceuticals had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to manufacture and market a generic version of Asacol HD, 800 mg. The paragraph IV certification implies that the filer believes the relevant patent to be invalid or will not be infringed by the generic version of the drug. Through the notice, Zydus Pharmaceuticals has stated that the "'662 patent" covering the drug is not infringed. The disputed patent expires in November 2021. Warner Chilcott intends to challenge the application.
We note that Asacol HD is not the only drug at Warner Chilcott facing generic threat. Similar threats loom over many leading drugs of the company. The 400 mg version of Asacol is protected by two patents in the US, (170 and 171). Both patents are scheduled to expire in July 2013.
Warner Chilcott headquartered in Dublin, Ireland, targets the women's healthcare, gastroenterology, dermatology and urology markets. The company is entangled in dispute regarding many of its products with other companies also such as Novartis (NVS) and Impax Laboratories (IPXL). We believe that even though Warner Chilcott is facing patent expirations for many of its key drugs, its diversified product base will help withstand the generic threat.
Currently, we have a Neutral stance on Warner Chilcott.
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