Patent News | "Lipitor goes off patent today, Pfizer vs Ranbaxy-led Indian pharma's war for blockbuster drugs intensifies"

By: Divya Rajagopal
Category : Patent News

MUMBAI: Indian pharma companies' quest to make millions from the sale of copycat versions of blockbuster drugs may turn out to be a flop show as innovative companies raise defences to protect their turf. The world's biggest-selling drug is going off patent today in the United States and Ranbaxy Laboratories, India's third-largest company, is still struggling to get approvals from the American regulator.

Ranbaxy, which has exclusive rights to the off-patent version of Lipitor, Pfizer's blockbuster cholesterolbusting drug, has built its business model around the generic version of Lipitor and its success rides on how much money it can make on sales of the copycat version of the drug. Till the time of going to the press, there was no word on whether a settlement had been reached and whether Ranbaxy will be able to launch its version of Lipitor soon.

As the clock ticked away on Tuesday, and rumours of Ranbaxy's settlement with the US Food and Drug Administration made the rounds, company executives declined comment and huddled together in last-minute confabulations with the US authorities. Arun Sawhney, MD of Ranbaxy, was defiant in an analyst call last week. "A lot of our plans are ready. The reality will be out soon," he said. ETlearns that officials from the USFDA had re-inspected the pharma major's Tonsa plant in Punjab which supplies key ingredients for atorvastatin, the medical name for Lipitor, indicating a possible settlement.

Failure to launch the generic version of Lipitor will devastate the company, which has spent millions of dollars in product development and legal costs. It will also raise a huge question mark over the Indian pharmaceutical industry's capability to generate big bucks out of high-value products going off patent in the next five years.

"Ranbaxy has lost the plot," said Surjit Pal, analyst at Elara Capital, which on Tuesday cut the company's EPS target to Rs 15 from Rs 25. Its report told investors to sell the stock, the second such recommendation on Tuesday after Deutsche Bank. "There is nothing left for Ranbaxy with regards to Lipitor now," said NR Munjal, managing director, In-Swift.

'Pfizer won't let Bestseller Lipitor go away so easily'

Munjal's company supplies active pharmaceutical ingredients to Pfizer. The anti-cholesterol Lipitor, which contributed close to $10 billion to Pfizer's revenues, is the world's biggest-selling drug and has generated sales of over $131 billion for the American drug giant. No other drug in the history of pharma has achieved similar numbers. "Pfizer will not let this product go away," said the promoter of one of the leading suppliers of Pfizer.