Ranbaxy’s generic Lipitor bid gets US court boost

In a huge boost for Ranbaxy, a federal judge in Washington has dismissed Mylan Inc’s lawsuit seeking to stop the company from launching a generic version of Lipitor, the largest-selling drug in the US market.

US district judge James Boasberg ruled that drugmakers can’t sue over pending applications filed by their competitors. He also said that Mylan’s lawsuit is premature, since an application from its Matrix Laboratories Ltd subsidiary to sell a copy of the cholesterol-lowering drug is still pending.

“Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan’s liking,” Boasberg said in the ruling, quoting an FDA document.
Mylan had sued the US FDA in March to stop the launch saying that Ranbaxy was not eligible because of falsified data from its manufacturing plant in India, from where filing for the drug was made.

Last month, the USFDA had said that it is premature for Mylan to seek action as the regulatory body had not yet given approval to any of the applications for generic Lipitor, while adding that it is in discussions with Ranbaxy over its manufacturing issue.
Now, with this court dismissal, all problems related to the launch seem to have tapered out.

A Ranbaxy spokesperson held the “no comments” approach on this matter, but analysts said this bit of news is a sure positive for the company.

“It strongly goes in favour of Ranbaxy and it remains to be seen as to how the company will be able to capitalise on the forthcoming opportunity,” said Sarabjit Kour Nangra, vice-president, research, Angel Broking.

Ranbaxy managing director Arun Sawhney had earlier said that the firm was confident of monetising its first-to-file (FTF) opportunities.

As per IMS Health estimates, Lipitor grossed $7.27 billion in US sales in 2010. Ranbaxy holds an FTF status on the drug, implying that as it is the first player to successfully challenge the patent, it gets a 180-day period of exclusivity on the product in the US, during which no other player can introduce its generic version.
Some experts see the Gurgaon-based subsidiary of Daiichi Sankyo raking in as much as $500-600 million from sales of the drug during its 180-day exclusivity period, which starts on November 30.

An analyst from a Mumbai-based brokerage, however, said the USFDA is yet to give a nod for the product and any delay in approval could mean heavy losses not just for Ranbaxy, but even Daiichi shareholders. “The key component of Ranbaxy lies in generic Lipitor and any delay in the launch can have repercussions even for its parent company.”