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Wellbutrin SR Generics Multiply As Andrx Relinquishes Exclusivity

Executive Summary

Andrx' agreement to give up its first-to-file ANDA exclusivity on a generic of GlaxoSmithKline's Wellbutrin SR 150 mg tablet means six companies will immediately share in the profits on sales of the generic antidepressant

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Impax/Teva launch first generic version of GlaxoSmithKline's Zyban (bupropion 150 mg) after Andrx relinquishes 180-day marketing exclusivity. Impax' ANDA was approved March 27; under a July 2003 agreement, Andrx will share in the profits of the Impax/Teva product for six months. Andrx also gave up first-to-file rights on the compound for antidepressant use, allowing launch of Wellbutrin SR generics in March (1"The Pink Sheet" March 29, 2004, p. 27)...

Zyban goes generic

Impax/Teva launch first generic version of GlaxoSmithKline's Zyban (bupropion 150 mg) after Andrx relinquishes 180-day marketing exclusivity. Impax' ANDA was approved March 27; under a July 2003 agreement, Andrx will share in the profits of the Impax/Teva product for six months. Andrx also gave up first-to-file rights on the compound for antidepressant use, allowing launch of Wellbutrin SR generics in March (1"The Pink Sheet" March 29, 2004, p. 27)...

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FDA is requesting that the National Institutes of Health conduct pediatric studies on GlaxoSmithKline's bupropion agents Wellbutrin SR and Zyban

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