Sun Pharmaceutical, which has had its U.S. sales gut-kicked as its deal with FDA concerns at some of its manufacturing plants, has launched in the U.S. its copy of Novartis' blockbuster blood cancer drug Gleevec. With its first-to-file approval, the Sun generic will have the market to itself for 6 months.
It's a dark day at Novartis. Sun Pharma rolled out its copycat version of Novartis' blockbuster cancer drug Gleevec, setting the Swiss drugmaker up for a big hit to 2016 sales.
Switzerland-based Novartis sees Mumbai-based Sun Pharmaceutical Industries meeting its February target start date for sales of generic Gleevec/Glivec (imatinib), putting the Indian drugmaker in the spotlight on the deadline.
After suffering through a year of U.S. Food and Drug Administration warnings over quality lapses, a slumping share price, and falling profits, India's Sun Pharmaceutical Industries was handed an early Christmas gift after the American regulator approved the company's generic version of the expensive cancer drug Gleevec (imatinib).
Sun Pharma said today that the FDA has approved its generic of Novartis' top-selling drug, cancer pill Gleevec, and that it will launch its version in two months, beginning Feb. 1.
Two union funds are suing Novartis, claiming that the Swiss drugmaker used "sham" patent-infringement claims to delay a generic version of its blockbuster leukemia drug Gleevec. Though just the latest in a series of legal battles over drug patent settlements, it's the first attempt by purchasers to block one of those settlements, the plaintiffs' lawyers said.
As blood cancer wonder-drug Gleevec ages, Novartis is trying to build out indications for follow-up Tasigna. After an up-and-down week for the pair, the Swiss pharma is now short a potential Tasigna label expansion, thanks to a snag in Europe. But a change of heart for the U.K.'s cost watchdog on Gleevec may give the franchise a boost.
When it comes to selling big, cancer drugs have a lot going for them. Their targets--deadly diseases that in many cases can kill quickly--put them in high demand, even as they continue to redefine...
After nearly a year of fighting to protect the patent on its blockbuster leukemia drug Gleevec, Novartis has made peace with Indian drugmaker Sun Pharma, reaching a settlement that will keep Sun's generic version off the U.S. market until February 2016, Reuters reports. Novartis' U.S. patent expires in July 2015.
After years of struggling for intellectual property rights over cancer drug Glivec in India, Novartis ($NVS) will now have to fight for patent protection in the U.S. as well.