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.
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