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Teva, Ivax Move Closer To Marketing Generic Gabapentin; Neurontin Litigation Continues

This article was originally published in The Pink Sheet Daily

Executive Summary

Ivax receives full ANDA approval for low dose tablet formulations of gabapentin. Teva licenses Alpharma's generic exclusivity for capsule form and higher dose tablets.

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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.

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.

Ivax Launches Neurontin Generic As User Fee Date For Pfizer's Pregabalin Nears

Non-AB-rated gabapentin tablets launch "at risk" less than two weeks before the estimated Aug. 30 user fee deadline for Pfizer's follow-on drug Lyrica. Pfizer is seeking a temporary restraining order against Ivax.

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