Glenmark to launch generic version of Adderall Tablets in the US market by May 2025
Company announces bioequivalent and therapeutically equivalent version of Mixed Salts of a Single Entity Amphetamine Product across multiple strengths
Glenmark Pharmaceuticals Inc., USA (Glenmark) has announced the upcoming launch of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulphate and Amphetamine Sulphate Tablets—also referred to as Mixed Salts of a Single Entity Amphetamine Product—in strengths of 5 mg, 10 mg, 15 mg, 20 mg and 30 mg.
Glenmark confirmed that its product is bioequivalent and therapeutically equivalent to the reference listed drug, Adderall Tablets, marketed in the same strengths by Teva Women’s Health, Inc. The company stated that distribution will begin in May 2025.
According to IQVIA sales data for the 12-month period ending February 2025, Adderall Tablets across the listed strengths recorded annual sales of approximately $421.7 million.
Commenting on the launch, Marc Kikuchi, President and Business Head, North America, said, “Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is a highly prescribed medication in the United States. Glenmark is very pleased to be able to help alleviate the shortage this country has been facing with this upcoming launch.”