Effective November 13, 2014, the US Food and Drug Administration (FDA) changed the Orange Book rating of Methylphenidate Hydrochloride ER for the manufacturers Mallinckrodt and Kudco. As a result of this change, the FDA no longer recognizes Methylphenidate Hydrocholride ER from these manufacturers as the generic equivalent to Concerta.
Florida Blue and Prime Therapeutics are dependent upon the FDA Orange Book ratings and the national drug reference company MediSpan® (a part of Wolters Kluwer Health), for drug classification on brands and generics. Currently the only available generic product for Methylphenidate Hydrochloride ER is from the manufacturer Janssen. Actavis markets the FDA approved authorized generic version of Janssen’s Concerta which has been classified as a brand by Medispan®.
As a result of the changes listed above, Participating Pharmacies will no longer have the ability to substitute generic Methylphenidate Hydrochloride ER for brand name Concerta, as both manufacturers will both process as brand drugs. Covered Persons may experience a higher co-pay or coinsurance at point-of-sale (POS).
For additional information, please refer to:
http://www.fda.gov/drugs/drugsafety/ucm422569.htm