Vyvanse Generics Approved by FDA
The FDA approval of generic versions of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets will likely ease cost and accessibility barriers to prescription stimulants for ADHD.
September 5, 2023
The U.S. Food and Drug Administration (FDA) has approved several generic forms of Vyvanse (lisdexamfetamine dimesylate), the stimulant medication used to treat ADHD in patients six years or older and moderate-to-severe binge-eating disorder (BED) in adults.1 Drugmakers began shipping generic versions of Vyvanse on August 31, according to Reuters.
Fourteen companies may now manufacture and sell generic versions of Vyvanse capsules and chewable tablets, according to the FDA. Takeda Pharmaceuticals’ U.S. patent for Vyvanse expired on August 24. Generic versions of drugs, which provide the same clinical benefits and risks as their brand-name counterparts, are often available at significant cost savings for patients. The FDA stipulates that generic ADHD medications contain exactly the active ingredients as their name-brand counterparts; however, compounds in generic drugs are allowed to include different binding chemicals, fillers, and colors.
Vyvanse was the most popular prescription stimulant according to a July 2023 ADDitude survey of 11,000 readers on ADHD treatment. Nearly one-quarter of respondents said they (or their child) currently take Vyvanse to treat ADHD symptoms, outnumbering other prescription stimulants used by ADDitude readers, including Adderall (15%), Adderall XR (13%), and Ritalin (10%). It’s estimated that one million Americans regularly take Vyvanse, generating $2.5 billion in sales annually.
Among ADDitude survey respondents taking Vyvanse, 44% said the medication is extremely or very effective at treating their ADHD symptoms.
“Vyvanse has, without exaggeration, changed my life and made me into the kind of person I’ve always wanted to be,” one survey respondent said.
Another reader reported that Vyvanse improved their focus: “I’m less distracted at work. I feel like my working memory is slightly better.”
Barriers to Vyvanse
The FDA announcement comes amid a year-long shortage of stimulant medications, which has left millions of patients and caregivers struggling to fill prescriptions for Adderall XR and many of its alternatives. The FDA first reported a shortage of Adderall (the brand name for the immediate-release formulation of amphetamine mixed salts used to treat ADHD) in October 2022 and that shortage, paired with skyrocketing demand and unmovable quotas from the Drug Enforcement Agency (DEA), has resulted in industry-wide drug availability problems since. Adderall and Vyvanse are both schedule II amphetamine-based central nervous system stimulant medications.
“My sister was on Vyvanse until the [prescription stimulant] shortage. It worked and had the lowest side effects. Now, she can’t get it,” one ADDitude reader reported.
Increased production of lisdexamfetamine dimesylate promises to not only ease accessibility issues but bring financial relief to the more than one million Americans who take Vyvanse to treat ADHD or BED. Bloomberg reported that the cost of the drug has steadily climbed since its introduction in 2007; a 30-day supply of name-brand Vyvanse now costs $369. Generic versions, when available, will cost considerably less.
Several survey respondents noted cost and insurance barriers to receiving the prescription stimulant. “I would like to switch to Vyvanse for longer coverage, but it is too expensive, and my insurance won’t cover the cost,” one reader said.
One reader worried about their long-term ability to pay for Vyvanse. “I am still working and have commercial insurance, but once I am not working and on Medicare, I don’t know if I will be able to afford anything for my ADHD, especially not Vyvanse, even as a generic,” the reader said.
Vyvanse Side Effects
According to information provided by the manufacturer, the side effects associated with Vyvanse include anxiety, anorexia, diminished appetite, dizziness, weight loss, dry mouth, diarrhea, irritability, nausea, insomnia, stomachaches, and vomiting.
The most common Vyvanse side effects experienced by ADDitude survey respondents included loss of appetite (46%), dry mouth (30%), irritability or moodiness (29%), and sleep disturbances (26%).
Eighteen percent of respondents reported no side effects from the medication.
Because lisdexamfetamine dimesylate is an amphetamine and federally controlled substance (CII), the FDA recommends that medical practitioners evaluate the possibility of drug abuse before prescribing the generic medication and watch for signs of misuse and dependency. Prescribing information for lisdexamfetamine dimesylate capsules and chewable tablets contains a Boxed Warning informing providers and patients about the potential risk of abuse and dependence.
Benefits of Prescription Stimulants to Treat ADHD
Medication is the first-line treatment for ADHD. The clinical practice guidelines developed by the American Academy of Child and Adolescent Psychiatry (AACAP) recommend medication as the primary treatment for ADHD in school-age children, citing a formal review of 78 studies on the treatment of ADHD, which “consistently supported the superiority of stimulant over the non-drug treatment.”
Research studies like this one conducted by scientists at McGill University have found that “stimulant medications are most effective, and combined medication and psychosocial treatment is the most beneficial treatment option for most adult patients with ADHD.”2
“Stimulant ADHD medications are among the most effective treatments in all of medicine,” said William Dodson, M.D., LF-APA, a clinician, writer, and consultant on ADHD medicine. “They literally ‘stimulate’ the brain to produce more norepinephrine and dopamine — the key neurotransmitters deficient in patients with ADHD.”
Patients should consult with a licensed medical provider regarding all ADHD treatment decisions.
View Article Sources
1FDA Approves Multiple Generics of ADHD and BED Treatment. FDA. Published August 28, 2023. Accessed August 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment?utm_medium=email&utm_source=govdelivery
2Kolar, D., Keller, A., Golfinopoulos, M., Cumyn, L., Syer, C., Hechtman, L. (2008). Treatment of Adults with Attention-Deficit/Hyperactivity Disorder. Neuropsychiatr Dis Treat. https://doi.org/10.2147/ndt.s6985