Several generic drug manufacturers received U.S. Food and Drug Administration (FDA) approval on Aug. 25, 2023, for A-rated generics to Vyvanse® (lisdexamfetamine – Takeda Pharmaceuticals) capsules; and a few companies received approval for generics to Vyvanse’s chewable tablet version. However, no company has exclusivity. The first generic capsules were launched By Mallinckrodt’s subsidiary, SpecGx, on Aug. 26, 2023, and others are expected to follow. Lisdexamfetamine is taken once each morning to treat attention deficit hyperactivity disorder (ADHD) for patients at least six years old and binge eating disorder (BED) for adults. A boxed warning cautions that lisdexamfetamine is a Class II controlled (CII) central nervous system (CNS) stimulant with increased potential for abuse and/or dependence. The cost for the generics is not available.
At a Glance
- Brand (Generic) Name: Vyvanse (lisdexamfetamine – Takeda Pharmaceuticals)
- Generic Manufacturers: Multiple companies including Apotex, Mylan (Viatris), and SpecGx (capsules); and Ascent Pharmaceuticals and Teva Pharmaceuticals (chewable tablets). Sun Pharmaceutical Industries has approval for both dosage forms.
- Indication: ADHD and BED
- Dosage Forms Available: Vyvanse is available in 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg capsules as well as in 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg chewable tablets
- Launch Date: Aug 26, 2023
- Annual U.S. Sales: $2.5 billion
- According to the organization, Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), more than 10% of U.S. children and teens between the ages of six years old and 18 years old (roughly six million individuals) have been diagnosed as having ADHD, which also affects about 4.4% of adults aged 18 years old to 45 years old (around five million).
- The National Eating Disorders Association (NEDA) estimates that as many as 3.5% of American women and 2% of American men will have BED sometime during their lives.
- Recently, shortages of stimulant medications have resulted from high demand and some production problems.
- Brand Vyvanse typically costs about $370 per month.