Zydus Cadila faces patent suit in US over drug Asocol
US based Warner Chilcott Plc has moved court against Zydus Cadila's plan to produce a bowel inflammation drug Asocol.
By ET Bureau | Updated:
AHMEDABAD: US based Warner Chilcott Plc has moved court against Zydus Cadila's plan to produce a bowel inflammation drug Asocol. Chilcott hold exclusive rights over the drug and has filed a patent infringement suit at US’s Delaware court to restrain Zydus from introducing the generic version of Asocol. It said, US drug authorties should not give Zydus the approval until the patent expires in July 2013.
The company said, Zydus Pharmaceuticals USA Inc filed an application in September with the health regulator seeking approval to manufacture and sell the generic version of the drug.
Zydus in its filing to the USFDA sought approval for formulation and methods patent of Asacol. In its court filing last week, Warner said it had the right, title and interest of its patent drug (Asacol) acquired from The Procter & Gamble Company in March, 2010. Thus, being the owner of the patent, it has unlimited and unrestricted right to develop, make, sell, import and dispose of the product in the United States and other territories.
Warner points out in its court filing that the company is also a holder of an approved Asacol drug for a delayed released oral tablet containing 800 mg of mesalamine. The drug was approved by FDA on May 29, 2008. An email sent to Zydus Cadila on Monday remained unanswered.
In the court filing, Warner said that Zydus has submitted to USFDA for mesalamine delayed release tablet that is purportedly bioequivalent to Warner Chilcott’s Asacol tablet. Zydus has applied under paragraph III and paragraph IV certifications to obtain approval of the FDCA to engage in the commercial manufacture and sale of Zydus’s delayed release tablet containing mesalamine before the expiration of Asocal’s patent date. Para IV is for market exclusivity after its approval.
Nasdaq listed $3-billion Warner Chilcott is a leading speciality pharmaceutical company focused on the gastroenterology, women’s healthcare, dermatology and urology segment of the North American and Western European pharmaceuticals markets. The $1-billion Zydus Cadila is India’s fifth largest drug company.
The company said, Zydus Pharmaceuticals USA Inc filed an application in September with the health regulator seeking approval to manufacture and sell the generic version of the drug.
Zydus in its filing to the USFDA sought approval for formulation and methods patent of Asacol. In its court filing last week, Warner said it had the right, title and interest of its patent drug (Asacol) acquired from The Procter & Gamble Company in March, 2010. Thus, being the owner of the patent, it has unlimited and unrestricted right to develop, make, sell, import and dispose of the product in the United States and other territories.
Warner points out in its court filing that the company is also a holder of an approved Asacol drug for a delayed released oral tablet containing 800 mg of mesalamine. The drug was approved by FDA on May 29, 2008. An email sent to Zydus Cadila on Monday remained unanswered.
In the court filing, Warner said that Zydus has submitted to USFDA for mesalamine delayed release tablet that is purportedly bioequivalent to Warner Chilcott’s Asacol tablet. Zydus has applied under paragraph III and paragraph IV certifications to obtain approval of the FDCA to engage in the commercial manufacture and sale of Zydus’s delayed release tablet containing mesalamine before the expiration of Asocal’s patent date. Para IV is for market exclusivity after its approval.
Nasdaq listed $3-billion Warner Chilcott is a leading speciality pharmaceutical company focused on the gastroenterology, women’s healthcare, dermatology and urology segment of the North American and Western European pharmaceuticals markets. The $1-billion Zydus Cadila is India’s fifth largest drug company.
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