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.

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