Purepac Gabapentin Is “First Generic” After Pfizer Delists Neurontin Patent
Executive Summary
Purepac and Ivax will split "first generic" 180-day exclusivity on their versions of Pfizer's antiepileptic Neurontin (gabapentin)
You may also be interested in...
Purepac’s Neurontin Generic Exclusivity, FDA’s “Section viii” Policy Affirmed
FDA's position on the appropriate use of "section viii" statements in ANDAs will stand following an appellate court ruling on gabapentin generics
Purepac’s Neurontin Generic Exclusivity, FDA’s “Section viii” Policy Affirmed
FDA's position on the appropriate use of "section viii" statements in ANDAs will stand following an appellate court ruling on gabapentin generics
Neurontin, Rebetol Generics Could Be Affected By “Shared Exclusivity” Ruling
A federal court decision invalidating FDA's "shared exclusivity" policy for first-to-file ANDAs poses another potential complication to the launch of generic versions of Pfizer's Neurontin (gabapentin)