Hyderabad based-Natco Pharma has won a patent battle against Israeli drug giant Teva Pharmaceuticals, which could enable it to launch a generic version of the multiple sclerosis drug Copaxone in the US market in 2014.
Copaxone is the largest branded drug sold by Teva, which accounted for almost 20% of its revenue in 2012 and 40% of the multiple sclerosis market. The drug has annual sales worldwide of over $4 billion including $2.2 billion in the US.
The generic opportunity of Copaxone in the US is being chased by only two set of players — Novartis & Momenta Pharmaceuticals and Mylan & Natco Pharma — which will limit the fragmentation of the market and provide a good opportunity for Natco, said analysts.
A senior Natco official said, “The company is anticipating getting US Food and Drug Administration (USFDA) approval to launch generic Copaxone in May 2014 and it will not be affected by any review appeal filed by Teva in the US Supreme Court.” Natco had in June 2008 partnered Mylan to seek USFDA approval for marketing a generic version of Teva’s Copaxone.
On Wednesday, US Supreme Court Judge John Roberts turned down request from Teva Pharma to stay a lower court order that denied patent protection to Copaxone from next year instead of 2015.
Interestingly, in 2009 Natco had successfully blocked Teva’s patent application for the same drug in India and the patent office here had refused to grant a patent to the Israeli drug maker.
According to a report by ICICI Direct, under a bull scenario, “Natco’s sales from Copaxone could touch about R1,300 crore in a year.” Natco has a marketing tie-up with Mylan for sales of the drug in the US markets. The report also states that Teva’s US sales for Copaxone for the June quarter stood at $806 million.
Teva has also sought USFDA approval of a longer-lasting version of the drug, expected to be granted by early 2014, that would be injected three times a week. The company aims to move patients taking its current daily drug to the new offering.
However, appearance of cheaper generic versions of Copaxone before that would give Teva far less time to switch patients to the newer drug before generics of the original become an option. Hence, Teva is likely to continue its legal battle to prevent entry of general players in that segment, said analysts.