Wyeth shouldn't be facing generic competition for Effexor XR until 2010. It already fought that battle in court, prevailing over patent challenges in 2005. But Sun Pharmaceuticals figured out how to put the drug in pill, rather than capsule, form--and because the active ingredient goes off patent in June, Sun will likely be able to launch its copycat med. Analysts expected Sun's drug to shave off 10 to 15 percent of Effexor XR sales. That's a $500 million-plus hit to Wyeth's top line.
Meanwhile, Wyeth has other problems, too. Generics firms are taking aim at Protonix, its blockbuster heartburn drug. Bifeprunox, its experimental antipsychotic, got a "not approvable" letter from the FDA in August. The agency in July asked for another one-year studyÂ before it will approve Pristiq, an antidepressant Wyeth wants to market for menopausal symptom relief.
And now Wyeth must deal with Sun's Effexor-like pill. The Indian generics maker will have a tough job marketing the new drug, because it's not an exact copy and so can't be automatically substituted for Effexor XR; docs will have to write prescriptions specifically for the Sun product. But that sales challenge isn't likely to help Wyeth execs sleep better at night.
- read the AP report
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