The agreement entered between Glenmark Pharmaceuticals Inc USA and Cediprof Inc, a part of the Neolpharma Pharmaceutical Group family of companies, covers supply and distribution agreement for Cediprof’s FDA-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablets of strengths 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, the company said in a statement.
These are the generic versions of Adderal tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc, it added.
Glenmark said it expects to commence distribution of the product in the US during the second half of 2023. The drug is indicated for treatment of attention deficit hyperactivity disorder.
“This product has long been on FDA’s shortage list,” the company said.
Glenmark Global Formulations Business CEO Brendan O’Grady said the tablets which is a mixed salts of a single entity Amphetamine product is a highly prescribed medication in the US.
According to IQVIATM sales data for the 12-month period ending January 2023, Glenmark said the Adderall tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market achieved annual sales of approximately USD 389.8 million.