As the U.S. patent for Vyvanse expired August 2023, the FDA cleared 14 manufacturers to produce Vyvanse generics. It might take several months for a significant number of consumers to access these Vyvanse generics.
At that point, we should have a better idea if these generics truly do “work the same as brand.” Then again, we might see these generics much sooner. More details below.
Remember, Vyvanse isn’t the only stimulant containing dextroamphetamine. Other choices include Dexedrine Spansule, Zenzedi, and ProCentra. [I have no business relationship with any pharmaceutical company.]
- Please share any first-hand experiences with the new Vyvanse generics in the comments below.
- When you do, please note which generic you received (it’s written on the bottle); there are at least 14!
- If you experience adverse effects, please consider filing a report through FDA’s Medwatch. “Adverse” can cover a range of differences between brand and generic. It needn’t be life-threatening.
I share this not to send Vyvanse users into a panic—just to be beware. We’ve seen ADHD-medication “goat rodeos” before, and it’s best to be prepared.
For example, since 2014, many brand Concerta users have been caught flat-footed—sometimes with serious repercussions. They learned they’d been switched to an inferior Concerta generic only weeks or months in—and often only after finding my reports.
Until then, many attributed increased symptoms to other causes—such as more stress or a school change. They didn’t think to question the medication, even though it looked different. Why? Because “generics are exactly the same as brand.” Or so they’d been told.
We Might See Positive Changes – Or More Confusion
Like Concerta, Vyvanse (Lisdexamfetamine Dimesylate) is a hugely popular medication for attention deficit hyperactivity disorder (ADHD). With this patent expiration, the flood of Vyvanse generics could significantly reshape the landscape of ADHD treatment. Then again, we might best describe this past year’s landscape of shortages and higher prices as “ravaged.” So, one knows what reshaping might mean.
We might see positive changes, such as more affordable medications. Or, we might face more confusion and less access to brands of any kind.
Concerta marked a major innovation in long-acting stimulant treatment. When Concerta generics turned out to be “not even close to the same”, many people suffered. Still are. That’s why I want to be proactive with these Vyvanse generics.
In this post, I’ll hit the highlights. Look for updates as I learn more.
A Quick Word About Generic Vs. Brand
Contrary to what some physicians and pharmacists tell us, generic is not always “exactly the same as brand.” This is especially true with medications using complex delivery systems. One prime example is Concerta’s patented osmotic capsule called OROS.
In 2014, “Big Generic” started exploiting FDA loopholes on generics for complex-delivery system drugs. Concerta generic manufacturers did not use OROS. Instead, they used more rudimentary means. As a result, no Concerta generic works in the same way that Concerta does.
The FDA downgraded the first three Concerta generics in 2016. But in 2017 a new White House administration and newly appointed FDA chief forced a dramatic reversal. This came over the objections of FDA scientists’ concerns about bio-equivalence.
Below, I’ll share a little conjecture about how “true” these Vyvanse true generics can be. For background: True generics are what we commonly understand as a generic. Authorized generic is what we call the brand medication that’s marketed/sold as a generic. As far as I can tell, we won’t see an authorized generic for Vyvanse.
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You’ll find several background posts on the generic vs. brand issue at the end of this post.
14 Vyvanse Generics Manufacturers Approved
The FDA chart of approved Vyvanse generics currently shows 14 companies with approved Vyvanse generics. Not every company, however, produces all the available dosages — 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg.
No timeline has been announced as to when consumers can access these Vyvanse generics.
To view the FDA chart (3 pages worth), click on this link and enter the search term “lisdex”: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Here is the list of companies:
- Ascent Pharmaceuticals Inc
- Specgzx (subsidiary of Mallinckrodt)
On August 31, Reuters reported that “drugmakers have begun shipping copycat versions of Takeda Pharmaceutical’s drug Vyvanse. Reuters typically has solid reportage so I’m surprised to see “copycat” instead of “generic.”
The article says that U.S.-based drugmakers Mallinckrodt and Viatris, UK-based Hikma Pharmaceuticals, and Indian drugmaker Sun Pharmaceutical Industries confirmed last week that they began shipping their generic versions of the drug.
You can read more here: Generic drugmakers start shipping copies of Takeda’s ADHD drug Vyvanse
Vyvanse Delivery System Cause for Optimism?
Is Vyvanse’s delivery system as sophisticated and precise as Concerta’s OROS delivery system? I’m no pharmacologist but I don’t think so. This might be reason for optimism. A simpler delivery system would be easier to re-create in a generic. If that’s the case, it might up the odds of a Vyvanse generic working similarly to the brand.
In fact, I’ve heard that a Vyvanse generic might improve delivery. But for now, that’s only hearsay and….probably marketing.
An August 31, 2023 Everyday Health report on this topic (FDA Clears First Generics of ADHD Drug Vyvanse) quotes Jack Turban, MD, MHS. He is director of the Gender Psychiatry Program at the University of California, San Francisco (UCSF):
It should be fairly straightforward for anyone already taking Vyvanse for ADHD to switch to generic versions of this drug because they work exactly the same way. [emphasis mine – GP] Some people taking other stimulants might also try generic Vyvanse, especially if this is the only thing they can get while their regular medicines are out of stock at their local pharmacy.
With all due respect, I wonder if Dr. Turban is familiar with the Concerta fiasco—and the fact that generics are not always “exactly the same as brand.” He is not an ADHD specialist. Rather, his specialty is pediatric gender identity and related public health issues. Honestly, UCSF has never been a hotbed of ADHD expertise. In fact, it’s long been the opposite.
The ADHD medical experts I contacted were unwilling to speculate on Vyvanse generics’ bio-equivalence.
Vyvanse is a “Prodrug”
Vyvanse’s marketing claim to fame is being the first “non-abusable” stimulant. (Not exactly true).
It’s called a “prodrug”. What that? Prodrugs are medications that become active only after entering the body and being converted by certain bodily chemicals or enzymes. Until that happens, the medication remains inactive. In other words, it does nothing. (Dr. Goat and I explain this in our 7-part series on gene-testing for ADHD medications. You’ll find the link to the specific post explaining Prodrugs below.)
In the case of Vyvanse, the stimulant medication (lisdexamfetamine dimesylate) is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine. Only then does it become active—and ready to go to work. As a result, it is claimed, this design also makes it harder to crush, snort, or inject the drug for a quick high. Purportedly, this contributes to its reduced abuse potential.
Vyvanse Quick History
Shire Pharmaceuticals introduced Vyvanse to the market in 2007. This new, long-acting amphetamine-class stimulant, along with fiercely aggressive marketing, contributed massively to Shire’s profits for years.
In 2014 alone, Shire’s top-selling drug brought in about $1.5 billion in sales. When the company succeeded in getting Vyvanse FDA-approved as a medication to treat binge-eating, the CEO estimated that alone would contribute an additional $200-300 million Vyvanse annual sales.
Japan-based Takeda acquired Vyvanse from Shire in 2019. Even before that, though, Shire took legal actions to prevent competitors from entering the market until the Vyvanse patent expired in 2023. In the U.S., Vyvanse generated substantial revenue for Takeda—to the tune of $2.53 billion in 2022, showing impressive growth over the previous year.
For more info, see Fierce Pharma’s report: The top 10 drugs losing US exclusivity in 2023
European Patents Expire Later
In Europe, Vyvanse is mostly called Elvanse. European patents were set to expire in the summer of 2024. Vyvanse manufacturer Takeda, however, extended its patent protection in certain countries until February 2028 and March 2029, according to Takeda’s latest annual report.
Vyvanse Maker Takeda’s Frequently Asked Questions
For more information from Takeda, manufacturer of Vyvanse, check out their Frequently Asked Questions
Selected Posts on ADHD Generic Medications
These posts from the ADHD Roller Coaster archives shed light on various aspects of this topic.
Are you concerned about the changes to come? Do you know what your other options might be?
I strongly encourage anyone making decisions about ADHD medications to get educated.
The hard truth is, we cannot rely on the average prescriber—or sometimes even the specialists. Now more than ever.
You’ll find this and more in Course 2 of Solving Your Adult ADHD Puzzle: Physical Strategies
I welcome your comments!