Generic Neurontin Dispute Settled Between Ivax, Alpharma

Ivax has signed a settlement agreement with rival Alpharma that will enable it to launch a generic version of Pfizer's Neurontin before Alpharma's 180 days of marketing exclusivity expires.

The companies have been embroiled in a battle over generic Neurontin (gabapentin) since 2003, when the FDA awarded Alpharma marketing exclusivity for gabapentin capsules in 100-, 300-, and 400-mg dosage strengths, and tablets in 600- and 800-mg dosage strengths.

Ivax appealed the FDA's decision in federal court, but lost the case and appealed the lower court's decision to the U.S. Court of Appeals for the District of Columbia.

As part of the settlement, Ivax has agreed to drop its lawsuit in exchange for early marketing rights to gabapentin. The agreement calls for Alpharma to waive its FDA-awarded 180-day marketing exclusivity in favor of Ivax, effective on March 23 for gabapentin capsules and April 29 for gabapentin tablets.

Alpharma's exclusivity on gabapentin capsules and tablets had been set to expire on April 6 and June 11, respectively.

Ivax currently markets gabapentin tablets in 100-, 300- and 400-mg dosage strengths, for which it received 180-day marketing exclusivity.