The Hindu Business Line : Ranbaxy hopeful of launching cholesterol drug next year

RANBAXY Laboratories Ltd is hopeful of launching the 80 mg dosage form of Bristol-Myers Squibb's Pravachol (pravastatin) on a 180-day exclusive basis some time next year.

Besides, it will also pursue its litigation against the US Food and Drug Administration (FDA) for resolving the exclusivity issue against Merck's Zocor (simvastatin), according to a company release.

Both pravastatin and simvastatin are cholesterol-lowering drugs available in the US.

Litigation: On the litigation on the status of pravastatin, Ranbaxy said, "In respect to pravastatin 10 mg, 20 mg and 40 mg tablets held by Teva Pharmaceuticals, as a result of an October 21, 2005 court decision, the FDA is likely to reverse its decision that the 180-day exclusivity was triggered and had expired, (assuming affirmance on appeal).

"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 further said that irrespective of the said decision, its 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.

Regarding simvastatin, the company has stated that on October, 24, 2005 the US FDA had 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 an ANDA (abbreviated new drug application) containing a Paragraph IV Certification against the 80 mg strength tablet, and is thus entitled to market exclusivity for this particular strength.

"However, before the 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," it said.

The shares of Ranbaxy, on Monday, closed at Rs 350.85 on the BSE.

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