Dr Reddy’s plans Lipitor generic launch in June

Dr Reddy’s Laboratories will hit the US market with its much-hyped Lipitor generic in the first quarter of next fiscal.

The company, which has been working on the copycat version of Pfizer’s anti-cholesterol drug, is said to be ready with a plan to approach the market, though it is restrained for now by the exclusivity granted to Ranbaxy.

Ranbaxy’s 180-day exclusivity started on November 30.

“The exclusivity comes to an end in May 2012 and Dr Reddy’s would time its launch by then,” a source told DNA Money.
Company officials, however, were not willing to “speculate” on the timeline of the launch.

Dr Reddy’s had sought the US drug regulator’s approval to launch the generic Lipitor (atorvastatin calcium) in
2009.

However, Pfizer, being the innovator and the patent holder, sued Dr Reddy’s and sought to stop the generic version from hitting the market at least till one of the patents on the drug lapsed in 2017.
In August 2011, Dr Reddy’s and Pfizer moved ahead with a settlement.

Though the terms of the settlement were not disclosed, it was said that the generic versions of the drug, including those of Dr Reddy’s, would be allowed by the innovator after the expiry of an exclusivity arrangement it had with Ranbaxy in 2008.

Interestingly, Ranbaxy’s profits from the launch are seen coming in below analyst expectations.

Sources suggest toning down expectations for Dr Reddy’s as well.

“It is too early to talk about expectations since there is a price erosion due to the entry of generics and there is a chance of more generic companies entering the market post the expiry of Ranbaxy’s exclusivity,” said a source.

Lipitor is said to have a market of over $1.5 billion in the US alone, at the innovator’s price.

Meanwhile, as part of its strategy to move into newer segments like pain management, Dr Reddy’s has announced the launch of Supamove cream, which helps reduce pain and inflammation in patients with joint pain, arthritis, bursitis, tendinits and lower back pain. The product has been in-licensed from the US-based Cymbiotics Inc and will be available in a 30 gm tube.

Dr Reddy’s also strengthened its emollients and protective product portfolio with the launch of Venusia Soft lotion, which provides sustained relief from dry, itchy skin (Pruritis) and will complete Dr Reddy’s treatment basket in the emollient and protective space which already includes Venusia Cream, Venusia Lotion, Venusia Max and Venusia Bathing Bar. Venusia Soft lotion has also been in-licensed from Cymbiotics and will be available in a 75 ml pack.