This post reviews events in the news related to ADHD generic medication—as reported here at the ADHD Roller Coaster.
Since 2009, I’ve felt it important to educate readers about generic ADHD medications. That’s when the earliest version of this post appeared. The distinctions between brand and generic—especially with novel delivery system drugs—remain relevant today, in 2023. In fact, they are even more relevant.
To save money, many people with ADHD take generic medications. Is this a good idea?
That depends on the medication—and the person taking it. A medication such as Strattera does not depend on a fancy delivery system. In comparison to novel delivery-system drugs such as Concerta, Strattera lends itself better to a generic (atomoxetine).
Even then, much depends on the generic manufacturer.
In 2023-4, we saw two blockbuster ADHD medications whose novel delivery systems advanced the efficacy of stimulants. This alone would have sent shockwaves through the ADHD community. Unfortunately, that’s not the only assault on both affordability and availability of stimulant medications.
In This Post on ADHD Generic Medications:
I recap events from 2009 to 2023, offering links to my other articles on this topic:
- 2009: Consumer Reports recommends avoiding brand ADHD medications (lest children get “hooked”)
- 2009: Major story questions “bio-equivalence” on a generic of psychiatric medication Wellbutrin
- 2014: I opened an FDA MedWatch complaint about generic Concerta. Readers followed through by reporting adverse events they experienced. The FDA downgraded the first two generics for Concerta.
- 2017: The circus comes to town with a clown car of Concerta generics.
- 2019: Journalist Katherine Eban’s book “Bottle of Lies” exposed practices of modern “Big Generic”
- 2022: Janssen Discontinues Concerta Authorized-Generic
- 2023: Vyvanse Goes Off-Patent — And Disappoints
- Please Report Generic Medication Adverse Effects to FDA
But First: Generic Not Always “Exactly the Same”
Physicians—and pharmacists—tend to assure patients that generics are “exactly the same” as brand. Only cheaper. Unfortunately, that is not always case—sometimes dangerously so. With ADHD medications, in particular, the most effective dosing tends to be precise.
For example, say you do best on 36 mg of Concerta. With the generic version, however, the effective ingredient legally has 20% wiggle room, up or down. That means you could get significantly more than 36 mg. Or significantly less.
To be sure: Some people do perfectly well on generic stimulants and atomoxetine (brand name Strattera). They do well to monitor the manufacturer, though. Pharmacies can change suppliers at any time. One manufacturer’s generic won’t necessarily work as another manufacturer’s generic. Most people—and their prescribers—won’t think about medication as the key variable. Especially if they believe “generic is exactly the same as brand.” They might look to every other factor but that.
Why You Need to Know About ADHD Generic Medications
Here’s a major reason you want to know about these potential differences. If you start ADHD treatment with a generic, to poor response, you cannot know if it was the generic that caused the problem. Perhaps you’d have done better with the brand version. If you never try the brand, you and your prescriber might conclude you can never take that drug. It’s not wise to eliminate options based on faulty data. Yet, I hear about this happening constantly.
1. Consumer Reports Slams ADHD Brand Rx in 2009
I first reported on this topic in 2009: Consumer Reports on Autos? Yes. On ADHD Medications? No!
Fast-forward to 2022: I help readers to stay current with the ongoing search for Concerta’s authorized-generic (the brand marketed at a generic price)—or at least finding ways to get brand more economically. The most recent post: Authorized Generic Concerta Update
Back to 2009: A Consumer Reports press release was the catalyst: Parents: Don’t rush Children to Adderall, Concerta, Strattera.
The magazine known for its reviews of cars and appliances was now issuing medical advice. Bad medical advice. First, i didn’t know any parents who were “rushing” their children to these medications. Most were extremely cautious—some to their child’s detriment.
Even more shocking, though: CR actually warned consumers away from brand-name medications for ADHD. Yes, you read that correctly.
Their rationale? Brand-name medications are too costly and unnecessary. But more importantly: Your child can get “hooked” on these brand medications? (But not the generics of them? Can you believe how ridiculous that is?) I explain more at the post.
2. People’s Pharmacy Tests Wellbutrin Generic
Later in 2009, The New York Times article (Not All Drugs Are the Same After All) backs up the points I made earlier in the year. Some snippets:
- “There is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterpart.”
- “Some specialists, particularly cardiologists and neurologists, are concerned about generic formulations of drugs in which a slight variation could have a serious effect on a patient’s health.”
Hundreds of consumers posted messages about problems with the generic drug Budeprion XL 300 on Joe Graedon’s People’s Pharmacy Web site. In other generic versions, it is called bupropion, the generic name for Wellbutrin. He then worked with an independent laboratory, ConsumerLab.com, to test the drug.
The lab found that Budeprion XL 300 released the active drug at a different rate than the brand name Wellbutrin XL 300. Mr. Graedon and the lab conjecture that the different dissolution rates might be to blame for the reported side effects and lower effectiveness of Budeprion. [That is exactly the issue with the latest clown car of Concerta generics.]
Kudos to Joe Graedon of The People’s Pharmacy for listening to his readers (despite his own longstanding support of generics) and reconsidering!
3. 2014: FDA Downgrades First Two Inferior Concerta Generics
About 6 years later, I opened an FDA MedWatch complaint about the inferior Concerta generics trickling onto the scene.
Two companies, Kudco and Mallinckrodt, had produced their own Concerta generics. When readers started asking questions, so did I. See Sound Off: Users of Downgraded. Generics
I was confused. What was happening? A similar thing was apparent in Canada: Generic Concerta in Canada: Parallel Problems
I called a pharmaceutical patent attorney in hopes of getting an explanation. He said, paraphrasing, “What these two companies have done is genius! They’ve exploited loopholes in FDA guidelines.” I could barely respond, “Genius, if you’re a sociopath,” and hung up.
When I called the FDA, I spoke with a very helpful representative who suggested I open the FDA MedWatch complaint.
The Delivery System: That Makes Concerta, Concerta
We need to understand a bit about drug delivery systems. That is, how the medication gets from the pill into your bloodstream. It can make all the difference in how it works.
Without Concerta’s sophisticated osmotic-release system (OROS™), it’s active ingredient (methylphenidate) operates more like a generic Ritalin pill. The abrupt start and stop can feel like a “Ritalin Roller Coaster. Concerta’s novel delivery system eliminated the ups and downs in a smooth sustained delivery over 6-12 hours.
ADHD Roller Coaster readers and others followed through and filed their MedWatch complaints. In 2014, we won! (Victory! Concerta Generics downgraded.)
Mallinckrodt refused to accept the downgraded status, however, and threatened to sue the FDA. That went nowhere.
For some time after, some consumers were still forced to accept them as legitimately substitutable generics. That is, these pharmacies weren’t playing by the rules, to put it mildly.
You can read the history in this post, where I also detail the difference between “true” and “authorized” generics: Consumer Q&A On Generic Concerta.
4. 2017: A Clown Car of Inferior Concerta Generics
What had been two inferior Concerta generics wreaking havoc soon turned to, oh, about 15 at last count.
How did this happen? What about our hard-earned victory and the FDA admirably protecting consumers?
The Trump administration appointed venture capitalist as FDA chief, Scott Gottlieb, MD. During his short stint, he pushed through dozens of generics.
Gottlieb scorned FDA scientists’ concerns that some generic makers were exploiting loopholes in FDA guidelines. These loopholes allowed drugs with bare-bones formulation to claim bioequivalence for drugs with sophisticated delivery systems. That included Concerta with its proprietary osmotic pump, Alza’s OROS.
5. Bottle of Lies — “Big Generic” in 2019
Journalist Katherine Eban’s book blew the lid off modern generic-manufacturers’ non-savory (to say the least) business practices. Unconscionable stuff. See Bottle of Lies Exposes Generic Drugs
Here is an excerpt from her opinion piece in The New York Times:
My reporting on the generic drug industry over the last decade led me to four continents, and into the overseas plants where America’s generic drugs are made.
Interviews with more than 240 people, including numerous whistle-blowers, helped expose what was going on behind the boardroom doors at generic-drug companies.
Some companies have encouraged data fraud as the most profitable path to securing approvals from regulators, and have used deceit to hold the F.D.A.’s investigators at bay…
6. 2022: Janssen Discontinues Concerta Authorized-Generic
Concerta manufacturer Janssen officially ended availability of its authorized-generic mid-January 2023, through its Patriot subsidiary. I explain what this might mean for Concerta users in this post: Janssen Quietly Ends Concerta Authorized-Generic. In the post I also touch upon the concurrent reported shortages of Adderall.
First of all, let me validate reactions: The elimination of the Concerta authorized-generic (brand sold as a generic) is a shocking announcement. A massive change. Moreover, it comes amidst an overall stimulant shortage. A “perfect storm” of events created this stimulant medication shortage.
- A surge in diagnoses during COVID
- Alleged problems at generic manufacturer Teva’s Adderall plant
- Prescribers over-relying on 2-3 stimulants, being unfamiliar with other choices
- “Big Generic” disrupting the ADHD medication landscape
- Pharmacy Benefit Managers (PBMs) manipulating access and costs—to great (if partially obscured) profit
The reality is, Concerta users accustomed to paying generic prices felt the pinch as early as October, 2022. (I issued the first warning mid-November 2022.). Others are still scrambling to know what’s happening. If that’s you, check the link above.
7. 2023: Vyvanse Goes Off-Patent — Generics Flood Market
The U.S. patent for Vyvanse expired August 2023. The FDA fast-tracked 14 manufacturers to produce Vyvanse generics. It might take several months for a significant number of consumers to access these Vyvanse generics.
Early reports from ADHD Roller Coaster readers suggest these Vyvanse generics truly do not “work the same as brand.” But these reports represent only a handful of the approved manufacturers.
Meanwhile, remember this: 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.]
For more information: Vyvanse Generics Roll Out — And Disappoint
Please Report Generic Medications’ Adverse Effects to the FDA
If you experience adverse effects from any ADHD generic medication, 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 welcome your comments on generic medications and ADHD.
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