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September, 2006 Pragati Maidan, New Delhi, India |
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Ranbaxy insists on exclusivity period for Pravastatin
A US court ruling notwithstanding, Ranbaxy Laboratories says it is entitled to the 180 day exclusivity period for the cholesterol-lowering agent Pravastatin 80mg, even as it was preparing to make its case for another drug Simvastatin 80 mg.
A US court, on October 21, ruled in favour of Teva Pharmaceuticals’ exclusivity for other strengths (10mg, 20mg, 40mg) of Pravastatin tablets, as a result of which the US FDA is expected to reverse its decision on Pravastatin that the 180 day exclusivity was “triggered and had expired.”
“Irrespective of the decision and independent thereof, Ranbaxy’s position is that it was the first to file a paragraph IV certification for Pravastatin 80 mg and is thus entitled to exclusivity for this particular tablet strength when the product is launched by Ranbaxy,” a company representative was quoted saying in a leading newspaper.
“As a consequence of this decision, it appears that Teva will have exclusivity for 10 mg, 20 mg and 40 mg tablet strengths that will allow for commercialisation at the time that the basic patent expires on April 20, 2006,” the company says.
On another cholesterol-lowering agent Simvastatin, Ranbaxy said: “as anticipated, on October, 24, the US FDA denied Ranbaxy’s citizen petition requesting the relisting of two patents that had been delisted for Simvastatin tablets, or that it maintain its 180 day exclusivity until after it has commercially launched the 80 mg tablet strength.
Ranbaxy’s position is that it believes it is the first company to file a containing paragraph IV certification against the 80 mg strength tablet (Simvastatin), and is thus entitled to market exclusivity for this particular strength.
Prior to the US FDA response, Ranbaxy had brought a suit against the FDA in Washington, DC on September 11, 2005 to resolve the exclusivity question. “A hearing is expected in January, 2006,” the company said.
Ranbaxy vice-president (global intellectual property) Jay Deshmukh said in the same newspaper article: “we are delighted with the situation relating to Pravastatin 80mg tablets, and will now make our case regarding Simvastatin.”
Date: 03-Nov-2005
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