Author: Gordon Platt

INDIAN DRUG MAKER SEEKS TO CASH IN ON GENERIC LIPITOR

By Gordon Platt

Ranbaxy Laboratories, India’s largest pharmaceuticals company, has secured a six-month exclusive right to sell a low-cost version of Lipitor, Pfizer’s popular anti-cholesterol drug, in the US market.


Pfizer, the world’s largest drugmaker, says Lipitor has been its best-selling drug in recent years, bringing in annual revenue of $10.7 billion. Lipitor lost its US patent protection on November 30.

Ranbaxy’s Japanese parent, Daiichi Sankyo, is working with the US Food and Drug Administration to resolve problems with two Indian production plants at which the FDA found shortfalls in 2008. If it doesn’t get clearance in time, Ranbaxy plans to use a third facility that is already in operation to produce its copycat version of Lipitor.

Pfizer, in turn, is offering to subsidize co-payments for users of the branded version of Lipitor in an effort to minimize its loss of revenue, among other strategies aimed at protecting its market share.

Ranbaxy produces a range of generic medicines and has a presence in 23 of the top 25 pharmaceutical markets worldwide.

India’s drug regulator has given conditional market approval for Ranbaxy’s anti-malaria drug. This is the first time that an Indian company has discovered and patented a new molecule as the basis of a drug to be sold commercially.

Ranbaxy’s leading products in the US are generic versions of Valtrex, which is used to treat herpes; Aricept, an Alzheimer’s drug; and Zocor, another cholesterol medication.