Apotex Sues FDA Over Gabapentin ANDAs, Says Purepac Generic Exclusivity For Neurontin Has Run

Under the “one first applicant” approach, Purepac’s exclusivity expired in April 2002, clearing the way for other ANDA approvals, Apotex asserts. The company’s argument is based on a federal judge’s ruling in a dispute over “shared exclusivity” for Paxil generics.