Amneal Launches AB-Rated Generic for Concerta®

Amneal Launches Methylphenidate Hydrochloride Extended-Release Tablets, USP (CII) AB-Rated Generic for Concerta® Bridgewater, NJ (USA), February 5, 2018 – Amneal Pharmaceuticals has launched methylphenidate hydrochloride extended-release tablets, USP (CII) in 18, 27, 36, and 54 mg strengths. Amneal’s methylphenidate is an AB-rated equivalent to the brand Concerta®. The Amneal ANDA included all bioequivalence metrics recommended by FDA. “We are extremely pleased to add our methylphenidate to the list of therapeutically equivalent generics for Concerta,” commented Amneal EVP – Sales & Marketing Jim Luce. “The entrance of another AB-rated option adds to the choices provided patients, prescribers and payers beyond non-substitutable BX-rated products and the brand.” Methylphenidate hydrochloride ER tablets are now shipping to wholesalers, distributors and direct to the trade. All strengths are available in 90-ct bottles with a 30-ct size available upon request. The product is manufactured in the U.S.A. at the Amneal plant in Brookhaven, New York. Annual U.S. sales of methylphenidate ER were $1.5 billion, according to December 2017 IQVIA® market data. Click here for full prescribing information, including boxed warning and important safety considerations.

The release as fetched from its publisher. amneal.com ↗