Generic paroxetine exclusivity
Executive Summary
FDA is understood to have completed its analysis of 180-day generic exclusivity for paroxetine (GlaxoSmithKline's Paxil) and will soon notify the ANDA filers that hold shared exclusivity. Agency's review stemmed from GSK's request to delist three paroxetine product-by-process patents, which would remove the 30-month stay of approval on Apotex' ANDA (1"The Pink Sheet" July 7, 2003, p. 21). FDA conducted a similar analysis in the Neurontin case when it awarded Purepac, not Apotex subsidiary TorPharm, 180-day exclusivity on gabapentin capsules following the delisting of a Pfizer patent (2"The Pink Sheet" Feb. 3, 2003, p. 20)...