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Related Topics >> GlaxoSmithKline | Advair

GSK's Advair up for dispute in Germany

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GlaxoSmithKline goes to German court next week to defend its asthma drug Advair, whose patent is under seige not only in Germany but other countries as well. A group of generics makers have been pursuing patent challenges against the drug, hoping to capture some of its $7.8 billion in annual sales.

As you know, one Advair patent was already revoked in the U.K. and Ireland, but Glaxo chief Andrew Witty has said that he's not too worried about any IP struggles over the drug. Advair is technically difficult to knock off, he points out: "We are working on the basis of substantial Advair business for the foreseeable future," Witty said back in January during the big J.P. Morgan healthcare conference. "It is very difficult to make a generic."

But that hasn't stopped generics makers from leaping at the possibility. In Germany, four companies have joined to fight Glaxo's patent, including Mylan, a Sandoz unit, and a Teva Pharmaceutical Industries unit. And analysts think a copycat version could be rolled out next year, Reuters reports. "The barriers are a bit lower in Europe and there will probably be more companies that can satisfy the regulatory demands than in the U.S.," Stefan Hamill, an analyst at stockbroker Execution Noble, told the news service.

The company could learn the fate of Advair in Germany as early as Feb. 23, the day of the hearing, or in a written opinion some weeks later. We'll have to wait and see how that--and Advair's other patent challenges--turn out.

- see the Reuters article

Related Articles:
Witty: No rivals coming for Advair
FDA panel votes down two asthma meds
Panel to vote on asthma drugs' fate


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I believe Cipla already has versions of Advair in India, and from all reports, it works very well. Including a discus of 50/250.

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