The difference between a pill and a capsule might not seem big, but it could result in hundreds of millions of dollars in lost sales for Wyeth's top drug.
The Madison, N.J.-based company makes the best-selling antidepressant in the world, Effexor, with sales on pace to exceed $3.7 billion this year. The most common version is an extended-release capsule, Effexor XR.
Until recently, it seemed Wyeth would be the exclusive seller of extended-release Effexor in the United States through July 2010, thanks to its resolution of patent litigation in 2005.
But now Wyeth's market exclusivity is being threatened. Sun Pharmaceutical Industries Ltd., a generics manufacturer in India, has applied for U.S. Food and Drug Administration approval to sell a drug with the same active ingredient as Effexor XR, but with an important difference: It's an extended-release tablet, not a capsule.
FDA approval of what is likely to be a lower-priced drug from Sun might come when patent protection for Effexor's active ingredient, venlafaxine, runs out in June 2008. Patent protection for the capsule formulation expires later. Sun's different formulation should allow it to sidestep Wyeth's patent rights, and Wyeth already has told Sun it won't sue for patent infringement.
READ MORE @ AP
Sunday, December 23, 2007
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