Remember when GlaxoSmithKline ($GSK) CEO Andrew Witty (photo) assured folks that the company's blockbuster lung drug Advair wouldn't face generic competition as quickly as some feared? Witty figured that Advair--an inhaled drug--would be tough to copy. Well, it appears that he was right.
As Reuters reports, Teva Pharmaceutical Industries disclosed during its respiratory drug update that it won't even try to copy Advair because the hurdles to winning approval for a substitutable drug in the U.S. are much too high. Instead, the Israeli generics maker will develop a branded competitor and file for FDA approval in 2014.
And if Teva can't do it, who will? Novartis' generic unit Sandoz already dropped development of its copycat version. "The world's top generic company has now admitted that there will be no rapid erosion of Advair by generics, which should assuage the fears of even the most skeptical fund manager," Citigroup analyst Kevin Wilson tells the news service.
Europe is a different story, but even there GSK won't face immediate competition when the Advair patent expires next year. Teva says it will ask European regulators to OK a generic form of Advair in 2012, something that could allow the company to launch its copy in 2013 or 2014.
- read the Reuters news