Glenmark Confirms ANDA Filing with a Paragraph IV Certification for Zetia (R) Tablets

Glenmark Pharmaceuticals Ltd has announced the Company confirmed that Schering Corporation and MSP Singapore Company LLC ("Schering") filed suit on March 22, 2007 in the U.S. District Court for the District of New Jersey seeking to prevent the Company from proceeding with the commercialization of its Ezetimibe product. Ezetimibe is currently marketed by Schering as Zetia®. The Company filed Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of Ezetimibe on October 25, 2006, the first date on which an ANDA for Ezetimibe could be filed. The Company's ANDA included a paragraph IV certification with respect to patents listed by Schering in the FDA "Orange Book". The Company is the first and believes the only, applicant to have filed an ANDA for Ezetimibe with a paragraph IV certification on October 25, 2006. In the event that the Company successfully challenges Schering’' patent, the Company will be entitled to a 180 day exclusivity period.

Zetia® (Ezetimibe) had sales of approximately $ 1.5 billion in the U.S. based on IMS sales data for the year ending January 2007.

Source : Equity Bulls

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