Generic Threat for Warner Chilcott - Analyst Blog
October 07 2011 - 10:30AM
Zacks
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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