India’s Lupin has won its patent challenge against King Pharmaceuticals and Sanofi-Aventis for blood pressure drug Altace, which has sales of $700 million in the US alone. A US federal appeals court has ruled that the patent for Altace, chemically known as ramipril, was invalid on grounds of being obvious. Thus, the court overturned a lower court ruling that Lupin had infringed the patent by seeking approval to market a generic version of the drug. Lupin had filed in March 2005, a generic drug application with the US Food and Drug Administration, using the paragraph IV certification pertaining to generics launches for patented drugs. It typically takes up to 15 months for approval and with this latest legal victory, the company is expecting the approval for ramipril any time.

Posted by GEN-ERIC at 12:23:34 am into the following categories: In The News

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