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Lupin wins product patent challenge

September 13, 2007

Lupin Labs has announced that the court of appeals for the federal circuit on 11 September 2007 reversed a district court decision on Ramipril in its favor, finding the Aventis patent on Ramipril invalid. Aventis owns the 722 patent in question and king pharmaceuticals markets Altace.

Ramipril is one of the ACE inhibitors, which are useful for treating high blood pressure and Altace revenues were over US $ 900 million in the US (IMS MAT Jun 2007).

Dr Reddys Laboratories has announced that the U.S. Food and Drug Administration (USFDA) has granted final approval for the company‚Äôs Abbreviated New Drug Application (ANDA) for Ranitidine (Zantac) 150mg tablet (over-the-counter). The company is the only generic manufacturer to receive FDA approval for this product following the expiry of innovator’s patents. This is the first approval for the company’s U.S. OTC business unit following an announcement in mid-May, to launch a store brand OTC division in the U.S.

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