Ranbaxy for more drugs in US mkt

Ranbaxy Laboratories could grow its kitty of drugs in the lucrative US market by over 50 per cent this year as it awaits the US Food and Dru...

Ranbaxy Laboratories could grow its kitty of drugs in the lucrative US market by over 50 per cent this year as it awaits the US Food and Drug Administration’s (FDA) decision on 33 abbreviated new drug applications (ANDA).

The company currently has 62 ANDA approvals with 33 pending. While the average time for getting ANDA approvals is 18 months, Ranbaxy has usually been able to achieve it in 10-12 months.

This could well mean that within a formidable Ranbaxy portfolio in 2003. The major therapy products are anti-infectives and a few for cardio-vascular system (CVS).

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Ranbaxy filed 23 ANDAs during 2002 alone, surpassing its target of 15-20 ANDA filings annually. Last year also saw 11 approvals coming through, confirmed Ranbaxy’s director (corporate communications) Paresh Chaudhry.

According to analyst reports, 24 ANDAs involve patent challenges while Ranbaxy is first-to-file in nine cases. While not all such patent suits go in a company’s favour, it is such filings that drive the growth of generics companies, according to analysts.

One such filing is for Atorvastatin, a generic version of Pfizer’s Lipitor, which is the largest selling drug in the world with global sales of $8 billion in 2002. Chaudhry confirmed Ranbaxy has been sued by Pfizer for certain patents.

He added that the company is first-to-file an ANDA with a patent challenge for Ganciclovir, a generic for Roche’s Cytovene used in treatment for viral infection. But Ranbaxy has not been sued by Roche for this.

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It has filed two new drug applications in the US for Metformin and Ofloxacin. Ranbaxy has reportedly challenged patents on Glaxo SmithKline’s Sumatriptan with US sales of $924 million (Rs 4,500 crore).

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