Ivax Corporation received final approval and confirmation of its first-to-file status from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for gabapentin tablets in 100 mg, 300 mg and 400 mg dosage strengths, for which Ivax will have 180-day exclusivity.
Gabapentin is the active ingredient in Neurontin, which is used to treat epileptic seizures and is marketed by Warner-Lambert, a unit of Pfizer Inc. Neurontin had U.S. sales of approximately $2.4 billion in 2003.
Neurontin is sold by Warner-Lambert in 5 dosage strengths, 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. Tablets in the 100 mg, 300 mg and 400 mg dosage strengths are not currently marketed and Ivax intends to market them through its wholly owned subsidiary, Ivax Pharmaceuticals, Inc. Ivax is able to launch these tablets at any time and is considering a variety of factors in determining when to launch.
Ivax has also just received tentative approval from the FDA for its ANDA for gabapentin tablets in 600 mg and 800 mg dosage strengths, currently marketed by Warner-Lambert, and had previously received a tentative approval from the FDA on its ANDA for the 100 mg, 300 mg, and 400 mg capsules, currently marketed by Warner-Lambert. Ivax is presently litigating whether its gabapentin products infringe a patent held by Pfizer. A trial in the U.S. District Court of New Jersey has not yet been scheduled.
Ivax continues its aggressive program to increase the number of products in its generic portfolio.