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Lilly Sells Sarafem: Galen Adds Drug To Women’s Health Line For $295 Mil.

Executive Summary

Galen is adding Sarafem to its line of women's health products through a $295 mil. deal with Lilly

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Sarafem patent upheld

D.C. federal appeals court upholds Sarafem (fluoxetine) use patent as valid and infringed by Teva's ANDA in a July 13 FDL-1ruling. The premenstrual dysphoric disorder product, a repackaged version of Prozac, was launched by Lilly in August 2000; the company divested it to Galen/Warner Chilcott in 2002 (1"The Pink Sheet" Dec.16, 2002, p. 34). The appellate court rejected Teva's arguments that the Indianapolis district court erred by construing the patent claim to include dosing regimens "that go on continuously." The court also disagreed with Teva's argument that the lower court improperly ruled the patent invalid for reasons of obviousness (2"The Pink Sheet" Aug. 23, 2004, In Brief)...

Sarafem patent upheld

D.C. federal appeals court upholds Sarafem (fluoxetine) use patent as valid and infringed by Teva's ANDA in a July 13 FDL-1ruling. The premenstrual dysphoric disorder product, a repackaged version of Prozac, was launched by Lilly in August 2000; the company divested it to Galen/Warner Chilcott in 2002 (1"The Pink Sheet" Dec.16, 2002, p. 34). The appellate court rejected Teva's arguments that the Indianapolis district court erred by construing the patent claim to include dosing regimens "that go on continuously." The court also disagreed with Teva's argument that the lower court improperly ruled the patent invalid for reasons of obviousness (2"The Pink Sheet" Aug. 23, 2004, In Brief)...

Sarafem patent ruling

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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