Glenmark and Cediprof announce exclusive distribution agreement in US for USFDA approved tablets

Glenmark Pharmaceuticals Inc., USA and Cediprof, Inc. 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), as per an exchange filing.

The approved dosage is 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, and is the generic version of Adderall1 Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc.

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.

Commenting on the launch, Brendan O’Grady, Chief Executive Officer – Glenmark Global Formulations Business 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 alleviate the shortage this country is facing by partnering with Cediprof and Neol."

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 market2 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.