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)...
You may also be interested in...
GSK Paxil Patent Delistings Open Door For Generic Paroxetine Approvals
GlaxoSmithKline's delisting of three Paxil patents will clear the way for approval of generic versions of the antidepressant, and set up a potential dispute over how 180-day exclusivity will be awarded
Purepac Gabapentin Is “First Generic” After Pfizer Delists Neurontin Patent
Purepac and Ivax will split "first generic" 180-day exclusivity on their versions of Pfizer's antiepileptic Neurontin (gabapentin)
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.