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Purepac/Teva Generic Gabapentin Approval Stayed By Court

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer’s Neurontin will not face generic competition from the “first filer” on gabapentin capsules until 2005 at the earliest. The stay, however, does not impact approvals Ivax currently holds on gabapentin tablets.

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Apotex Challenge On Neurontin Generic Exclusivity May Be Too Late – Judges

Apotex' attempt to re-open generic exclusivity for Neurontin may be barred because the company failed to challenge FDA's patent-based approach for awarding 180-day exclusivity in earlier gabapentin litigation, appellate judges suggested Dec. 6

Apotex Challenge On Neurontin Generic Exclusivity May Be Too Late – Judges

Apotex' attempt to re-open generic exclusivity for Neurontin may be barred because the company failed to challenge FDA's patent-based approach for awarding 180-day exclusivity in earlier gabapentin litigation, appellate judges suggested Dec. 6

Purepac Free To Launch Neurontin Generic After Court Lifts Stay

The company is not commenting on launch plans but previously said it would "commence commercial sales" if a court stay was lifted. Purepac said it would book revenues from its own gabapentin generic upon launch, but revenues received under an agreement with Teva would not be recorded until patent litigation with Pfizer is resolved.

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