Since first hitting the market in 2007, Vyvanse, a stimulant medication used primarily to treat attention-deficit/hyperactivity disorder, is a unique and increasingly sought after drug. While expensive, it’s one of the most prescribed and effective alternatives to the widely known Adderall. 

In August 2023, Vyvanse, also known by its pharmaceutical name lisdexamfetamine dimesylate, will lose its market exclusivity. That means generic versions of the now very expensive brand-name drug can soon be produced and marketed, resulting in lower-cost alternatives for people who need it. 

So, when can users expect the cheaper version? And what does this situation mean for people enduring the Adderall shortage?

What is a generic drug?

Like most products you can buy, drugs come in brand-name and generic forms. Brand-name products are typically costlier, so manufacturers make generic versions of the original formula to give the public lower-cost alternatives. 

When pharmaceutical companies create drugs, they secure patents for their formulas. In addition, they establish exclusivity periods that give them sole rights to make and sell the product for a specified timeframe. Once a drug’s exclusivity period expires, other pharmaceutical manufacturers are free to sell generic versions of the original drug for a lower cost. 

What should people taking Vyvanse expect?

If you take Vyvanse now or expect to in the future, it will be a little longer before a more affordable option is available at the pharmacy counter. 

The patent for Vyvanse under Takeda Pharmaceutical expired in February, but the company has a six-month period of exclusivity (until August) as the only lisdexamfetamine manufacturer. 

On August 24, the FDA will consider approving generic lisdexamfetamine formulations from other manufacturers. Until then, Vyvanse will remain the sole drug of its kind on the market. 

When can you expect access to generic forms of Vyvanse? That’s difficult to say: To get a new drug on the market, the FDA says manufacturers must first conduct clinical trials to “validate that it’s safe, effective and can be a substitute for the brand-name” version, and then they can submit it for FDA approval. 

Clinical trials can take years, and though some generic lisdexamfetamine trials are in development, the generic products must still undergo the FDA approval process. 

Once manufacturers have proved a drug is safe and effective, the process to approve an application for a new drug typically takes less than six months. This means that the soonest you can expect new lisdexamfetamine generics to be available for purchase is late 2023 or early 2024. 

The Adderall shortage 

When Vyvanse’s exclusivity period ends, individuals who’ve had to stop taking Adderall because of the shortage and those who’ve had to go without their medication because other products don’t work for them might be able to consider Vyvanse generics now as a low-cost alternative. However, this option will not work for everyone: Adderall and Vyvanse are two different drugs with different ways of working in the body.

For providers and patients alike, Vyvanse’s patent expiration means there will be more accessible and effective options to treat ADHD. The timeline for a generic version is on the horizon, and for many people, that’s enough.