Glenmark Pharmaceuticals Inc., USA and Cediprof, Inc. (a part of the Neolpharma Pharmaceutical Group family of companies) have entered into an exclusive supply and distribution agreement for Cediprof’s FDA-approved 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, the generic version of Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc.
According to a press statement, Glenmark expects to commence distribution of the product in the U.S. during the second half of 2023. This product has long been on FDA’s shortage list.
“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 alleviate the shortage this country is
facing by partnering with Cediprof and Neol,” Brendan O’Grady, Chief Executive Officer – Glenmark Global Formulations Business said in a statement.
According to IQVIATM sales data for the 12-month period ending January 2023, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market achieved annual sales of approximately $389.8 million.
Glenmark’s current portfolio consists of 180 products authorized for distribution in the U.S. marketplace and 48 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.