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Sarafem patent ruling

Executive Summary

A Sarafem (fluoxetine) use patent is valid and infringed by Teva's ANDA, an Indianapolis federal judge rules. Patent no. 4,971,998, which claims a method for using fluoxetine to treat disturbances of mood or appetite, depression or carbohydrate craving associated with premenstrual syndrome, is neither anticipated nor obvious, court says. The patent expires in May 2008 following a six-month pediatric extension. Sarafem, a repackaged version of Prozac, was launched by Lilly in August 2000 for the treatment of premenstrual dysphoric disorder; the product was divested to Galen/Warner Chilcott in 2002 (1"The Pink Sheet" Dec. 16, 2002, p. 34). Prozac generics entered the market in 2001...

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