FDA Approves Generics of ADHD Medication for Children 6 and Up

A mother helps her daughter with homework on a computer.
The FDA has approved several first generics for Vyvanse, a popular medication used to treat ADHD in children 6 and up. AzmanL/Getty Images
  • The FDA has approved several first generics for the ADHD drug Vyvanse.
  • The announcement comes as the maker of Vyvanse has been experiencing increased demand and delays.
  • Experts say the arrival of generics can help provide more options for patients and help bring down costs.
  • Drug makers in the US, UK, and India have already begun to ship their generic versions of the drug.

In June of 2023, Takeda, the Japanese manufacturer of the ADHD drug Vyvanse (lisdexamfetamine dimesylate) published a statement indicating that they were experiencing low inventory of the medication due to a “manufacturing delay compounded by increased demand.”

However, on August 28, 2023, the U.S. Food and Drug Administration (FDA) announced what could be very good news for those who have been affected by the shortage of the drug. It has approved several first generics.

According to the agency, the term “first generic” means that these are the first approvals by the FDA to allow the manufacture of generics for Vyvanse.

The drug will be available in both capsules and chewable tablets and is approved for the treatment of moderate-to-severe binge-eating disorder (BED) in adults as well as for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 and older.

BED is the most common eating disorder in the U.S., per the National Eating Disorders Association. People with this disorder experience recurring episodes of eating large quantities of food and may feel a sense of being out of control during the binge.

ADHD is a common neurodevelopmental disorder generally diagnosed at a young age, although it often persists into the adult years. It can create symptoms such as inattention, impulsivity, and hyperactivity in those affected, says the U.S. Centers for Disease Control and Prevention.

What generic Vyvanse means for patients

Dr. Stefan Ivantu, a private psychiatrist and a specialist in adult ADHD and complex cases in London, England, said, “This announcement is highly important since the supply chains will become more robust, considering the pandemic period and increased demand for prescribing.”

Ivantu went on to explain that, when a supply chain may fail, having access to generic medications creates more options for patients and prescribers.

“[T]his announcement develops redundancies within a system that is continuously growing and under pressure,” he added.

Ivantu also noted that it can help bring costs down for patients by creating more competition in the marketplace.

Dr. Nicole Garber, chief medical officer with Alsana — a national eating disorder treatment program with locations in California, Alabama, and Missouri — additionally pointed out that this announcement is especially beneficial for those with binge-eating disorder.

“While several other medications are approved for the treatment of ADHD, Vyvanse is the only medication approved for the treatment of binge eating disorder,” she said. 

Garber added that the gold-standard treatment for binge-eating disorder is cognitive behavioral therapy, a type of talk therapy that seeks to modify behavior by helping people recognize their unhelpful ways of thinking.

Additionally, nutritional therapy can help people return to healthy eating patterns.

Medications like Vyvanse can also play a role in helping bring symptoms under control, she noted. However, she cautioned that it doesn’t work for everyone so it’s important that it be a part of a comprehensive treatment program.

How long it will take for generic Vyvanse to become available

Generic drugs can be made available after their patent expires.

Dr. Praveen Guntipalli, Medical Director and Owner of Sanjiva Medical Spa in Dallas, Texas, said, “[The patent for] Vyvanse officially ended on February 24, 2023.” However, he added, Takeda maintained market exclusivity through August 24, 2023, due to its pediatric exclusivity.

Ivantu explained, however, that this does not mean that the generic versions of the drug will be available right away.

“Delays may occur within generic drug manufacturers as the quality checks and distribution processes remain complex,” he said.

It can take months — or even years — according to Ivantu, for generic medications to actually become available, depending on how well-prepared the manufacturers are. It can also depend on where you live since different countries can have different timelines as well.

According to reporting by Reuters, Mallinckrodt and Viatris in the US; Hikma Pharmaceuticals in the UK; and Sun Pharmaceutical Industries in India have all confirmed they have begun shipping their respective versions of the drug.

Ivantu suggests that the best way to become apprised of when the generic drugs will be available to you is to contact a healthcare professional. However, he believes that they will be available by the end of the year.

In the meantime, Takeda expects the shortage of its brand-name drug to continue into September.

The bottom line

With Takeda’s patent on Vyvanse having just expired, the door is now open for generic lisdexamfetamine dimesylate to enter the market.

The medication is commonly used to treat moderate-to-severe binge-eating disorder in adults as well as ADHD in children aged 6 and older.

Having generics available will create more options for patients and can also help bring prices down.

Pharmaceutical companies in the US, UK, and India have already begun to ship generic versions of Vyvanse. A healthcare professional should be able to provide you with more specific details about when they will be available to patients.

The shortage of the brand name drug is expected to continue into September.

Leave a Comment

Your email address will not be published. Required fields are marked *