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news.Ivax Corporation and Alpharma have agreed to settle litigation relating to gabapentin, the generic equivalent of Pfizer's Neurontin, meaning Ivax will now be able to market its epilepsy generic earlier than expected.
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Pursuant to the settlement, Alpharma has waived its FDA-awarded 180-day marketing exclusivity, enabling Ivax to begin selling gabapentin capsules from March 23, 2005 and gabapentin tablets from April 29, 2005.
The litigation involved an appeal filed by Ivax seeking to reverse a District Court decision upholding the FDA’s award of marketing exclusivity to Alpharma for gabapentin capsules and tablets.
Ivax’ abbreviated new drug applications (ANDAs) for gabapentin capsules in 100mg, 300mg, and 400mg dosage strengths, and tablets in 600mg and 800mg dosage strengths have received tentative approval from the FDA. Upon final approval, these products will be sold through the company’s wholly owned subsidiary, Ivax Pharmaceuticals.
Ivax is also presently litigating whether its gabapentin products infringe a patent held by Pfizer. A trial in the US District Court of New Jersey has not yet been scheduled.