Dr. Reddy’s Laboratories announces the launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, in the U.S. Market

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Hyderabad, India and Princeton, NJ, USA. September 3, 2020 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a therapeutic equivalent generic version of Concerta® (methylphenidate Hydrochloride) Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg, approved by the U.S. Food and Drug Administration (USFDA).

The Concerta® brand and generic market had U.S. sales of approximately $1.159 billion MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.

Please click here for full prescribing information including boxed warning.


Methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.

Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Concerta® is a trademark owned or licensed by Janssen Pharmaceuticals, Inc.

*IQVIA Retail and Non-Retail MAT June 2020