U.S. District Court rules on Alpharma FDA submission on gabapentin
Alpharma Inc announced that the U.S. District Court for the District of Columbia ruled that its Purepac division correctly submitted a statement of inapplicable use on one of the Orange book patents for gabapentin. This decision is consistent with Alpharma's belief that Purepac is the first to file on all patents relevant to gabapentin that require a Paragraph IV filing. However, the court did not expressly order other ANDA applicants to change their paragraph IV certifications on this patent to "little viii statements." The FDA has yet to rule on the effect of this court ruling on Alpharma's 180 day exclusivity rights.
Gabapentin is the generic equivalent of Neurontin, a product marketed by Pfizer with annual brand sales of $2 billion and is indicated as adjunctive therapy in the treatment of partial seizures of epilepsy and post-herpetic neuralgia.