In a significant effort to alleviate the ongoing shortage of ADHD medications in the United States, the Drug Enforcement Administration (DEA) has authorized a substantial increase in production limits for Takeda Pharmaceutical Co Ltd’s TAK Vyvanse and its generic versions. This decision follows a request from the Food and Drug Administration (FDA) in July. The production of Vyvanse, known chemically as lisdexamfetamine, will see a 24% increase. This move addresses not only the domestic shortage but also the rising international demand for the medication.
The shortage of ADHD drugs, particularly Vyvanse and Adderall (manufactured by Israel-based Teva Pharmaceutical Industries Ltd TEVA), has been exacerbated by manufacturing delays and a surge in demand. Lisdexamfetamine is classified as a Schedule II controlled substance by the DEA, requiring additional prescribing safeguards due to its high potential for abuse.
The DEA’s recent production adjustment includes an additional 6,236 kilograms of lisdexamfetamine, divided into 1,558 kilograms to meet the increased U.S. demand and 4,678 kilograms for international markets. “These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” stated the DEA.
Further bolstering the supply chain, Reuters reported that the FDA last year approved generic versions of Vyvanse from 11 drug manufacturers, including U.S.-based Mallinckrodt Plc MCKPF MNKTQ and Viatris Inc VTRS, UK-based Hikma Pharmaceuticals Plc, HKMPF HKMPY, and Indian drugmaker Sun Pharmaceutical Industries. These approvals followed the expiration of Takeda’s exclusivity on the drug, opening the market to more players and potentially stabilizing supply.
As a result of this news, TAK shares were down by 0.10% to $14.91 at the last check on Friday. This increase in production of Vyvanse and its generic equivalents is expected to have a positive impact on the availability of ADHD medication for patients in need, both domestically and internationally.
