The Hindu Business Line : Resolving patent row is bonus for Ranbaxy

That Ranbaxy Laboratories will be able to sell capsules of the generic version of prostate drug Flomax starting March 2, 2010 for eight weeks without competition from other generic drug makers, will give a fillip to the earnings of the domestic pharma major. Flomax is estimated to have annual sales of $1.2 billion (Rs 4,800 crore). The peak sales of this product are likely to be covered in the first and second quarters of 2010.

This follows Ranbaxy resolving the US patent dispute with innovator-company, Astellas and Boehringer Ingelheim, holder of the exclusive marketing rights for the drug in the US.

As per the out-of-court settlement reached by parties involved in the patent dispute, Ranbaxy will enter the US market eight weeks prior to the expiration of the six-month paediatric exclusivity that is likely to be granted to Astellas/Boehringer Ingelheim.

Ranbaxy will be the only generic manufacturer during this period to commercialise this product in the US market. This would allow it to earn higher profits, before other generic versions enter the market and create significant price erosion.

Tentative nod

Ranbaxy has already received tentative approval from the US Foods and Drugs Administration for Tamsulosin, the active ingredient of Flomax, in June.

In a long-drawn battle, a judge on November 8 finally dismissed a patent suit that Astellas and Boehringer Ingelheim lodged against Ranbaxy over Flomax, and dropped the court’s prior decision in February (which went against Ranbaxy).

But after the dispute resolution, the case between Ranbaxy and Astellas/Boehringer Ingelheim has been dismissed.

Patent tussles

Ranbaxy has been particularly successful in US patent tussles and the latest adds to the growing list of exclusive launches that gives the company strong earnings visibility from 2009 onwards.

It will enter the US market in late-2009 with a six-month exclusivity to sell its generic version of herpes drug Valtrex, having annual sales of $1.3 billion. In 2010-11, Ranbaxy might launch generic version of Pfizer’s blockbuster cholesterol drug Lipitor, which recorded revenues of $13 billion annually.

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