Ivax Corporation has entered into a settlement of its litigation with the US FDA and Alpharma Inc. regarding gabapentin, the generic equivalent of Neurontin.
Pursuant to the settlement, Alpharma has waived its FDA awarded 180-day marketing exclusivity in favour of Ivax, effective on March 23, 2005 for gabapentin capsules, and April 29, 2005 for gabapentin tablets. As a result, Ivax will be able to market AB rated generic gabapentin capsules and tablets prior to the expiration of Alpharma's 180-day marketing exclusivity periods, the company announced here.
Neurontin is used to treat epileptic seizures and is marketed by Warner-Lambert, a unit of Pfizer Inc. Ivax is 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.
Ivax previously announced that its ANDAs for gabapentin capsules in 100mg, 300mg, and 400mg dosage strengths, and tablets in 600mg and 800mg dosage strengths received tentative approval from the FDA. Upon final approval, these products will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals, Inc. Ivax currently markets gabapentin tablets in 100mg, 300mg and 400mg dosage strengths, for which Ivax received 180-day marketing exclusivity.