Generic Antiepileptics: Same as Brand Name

Generic formulations may be bioequivalent to the brand but not to each other.

Many doctors and patients wonder whether generic medications are therapeutically equivalent to the brand-name product and to other generics (because patients refilling prescriptions can receive various generics). Some generic antiepileptic drugs (AEDs) have been associated with more medical utilization than the brand-name drug (JW Psychiatry May 17 2010). The FDA requires studies showing bioequivalence between generic formulations and the reference drug (peak concentration [Cmax] and area under the time-concentration curve [AUC], 0.80–1.25). These researchers analyzed 258 FDA bioequivalence studies of 141 approved generic AED formulations; 251 studies had demographic information (7125 participants; mean age, 32; 79% men).

Few generics differ…

Reviewing Author

Jonathan Silver, MD

Disclosures

RoyaltiesTextbook of Traumatic Brain Injury, 2nd and 3rd editions

Editorial BoardsUpToDate; Journal of Neuropsychiatry and Clinical Neuroscience

Leadership Positions in Professional SocietiesNorth American Brain Injury Association (Board Member); National Institute on Disability, Independent Living, and Rehabilitation Research (Chair of Data Monitoring Safety Board for study of donepezil on cognition after traumatic brain injury)

Jonathan Silver, MD

Disclosures

RoyaltiesTextbook of Traumatic Brain Injury, 2nd and 3rd editions

Editorial BoardsUpToDate; Journal of Neuropsychiatry and Clinical Neuroscience