After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff.
The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation.
On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency's regulatory bar with their generics.
It's not clear whether any of the companies have actually launched their copycats in the U.S. Takeda's patents on its branded version expired Aug. 24.
Takeda's Vyvanse shortage emerged after Adderall and its generics began to face similar shortfalls last summer, when top supplier Teva started struggling to keep up with demand.
In Takeda's financial outlook for 2023, the company said it anticipated “significant headwinds” throughout this year because of U.S. generic erosion for Vyvanse.
In Vyvanse’s last quarter of exclusivity, the drug brought in sales of 123 billion Japanese yen (about $880 million), good for 16% growth at constant exchange rates.
Takeda acquired Vyvanse in its 2019 buyout of Shire. The drug won its original FDA approval in 2007.