Three Concerta generics are slowly making their way into consumer hands, and already I’m hearing negative reports. This post provides a quick run-down. Please leave a comment if you have useful information.
My first thought was, “Here we go again.” In 2014, ADHD Roller Coaster readers and others petitioned the FDA to downgrade the last round of generics for Concerta. We succeeded (see Victory! Concerta Generics Downgraded!). As a result, these inferior generics could no longer be substituted for brand. I wrote a comprehensive Q&A about the two different types of generic medications (authorized and true), why the FDA downgraded those Concerta generics, and more (updated 10/2016): Consumer Q&A on Concerta Generics
Now we face three new generics. None uses the novel OROS delivery technology that gives Concerta its unique release.
The timing is particularly bad: On December 31, 2017, the marketing deal expires between Concerta maker Janssen and generic pharma Actavis—the deal that brought us brand Concerta at generic prices.
Here is a brief Q&A:
1. Bottom line: What do Concerta users need to know?
Chiefly, that not one of these three generics uses the patented OROS delivery system that is central to Concerta’s delivery system. (You’ll know it’s OROS if it says “Alza” on the pill.)
As a result, many people will find the generic doesn’t work as well as the brand. Yet, some people might actually prefer the generic. It all depends on the individual.
If brand Concerta works well for you or your child, however, and you don’t want to risk going off the rails, you might not want to risk it.
Here is a post consisting of first-person stories detailing adverse reactions to the downgraded generics: Sound Off: Users of Downgraded Concerta Generics
2. How many generics and who makes them?
There are three new generics for Concerta on the market within the last year:
1. Trigen Laboratories
2. Mylan (of Epi-Pen infamy)
3. Impax Laboratories
Reports I’ve received so far are not good on the Trigen generic:
- One month of my son being on the Trigen generic made me want to lose my mind, and now we’ve had two glorious weeks back on the authorized generic. [NOTE: this is the brand sold as a generic.] This is so depressing.
- One month of Trigen generic was no good! CVS insisted that it was equivalent and that’s all they stock now, so I had to switch to Walgreens this month since they still carry Actavis generic. [NOTE: this is the brand sold as a generic.) The time release mechanism [OROS] is what it’s all about!
- I’m finding the Trigen generic is horrible.
I received this e-mail from an ADHD specialist familiar to me (meaning, I trust her):
Dear Gina: This is picture of my patient’s generic 18 mg Mylan generic for Concerta.
He agreed to let us look at pills and it is interesting that 8 of remaining 18 pills left in bottle have no obvious drill hole. Never saw that with Concerta tablets.
This is very bad, folks. Not only is Mylan trying to pass off an inferior technology as very similar to OROS, it also seemingly has very lax quality control.
I’ve received no reports on the generic Concerta from Impax.
If you have already experienced negative effects from one of these generics, please consider filing a MedWatch complaint with the FDA.
That’s how we succeeded in downgrading the previous (inferior) Concerta generics. Skip to #9, below, for instructions.
3. But wait, I’ve gotten the Actavis Concerta generic for a while now. Won’t I keep getting that?
No, not unless your pharmacy has some leftover supply.
First, the Actavis Concerta is not a generic per se. Instead, it is an “authorized generic.” That means it is the brand product marketed as a generic.
Years ago, Actavis agreed to delay launching its Concerta generic if Concerta manufacturer Janssen would cut a deal to let Actavis market the brand as a generic. That’s what “authorized generic” means. And that deal expired 12/31/2017.
4. If I prefer brand Concerta to a new generic, what are my options?
Much will depend on your insurance coverage. Many insurers require policyholders to accept a generic if available. Here are some options:
1. Call your pharmacy fulfillment company and ask the price for the generic and the brand.
Also learn the price for home-delivery, typically a 60- to 90-day supply that is cheaper than the monthly cost if purchased at the local drugs store. Yes, you CAN order stimulants via home-delivery. I write about it here: Tip: Home Delivery of Stimulant Medications
2. If the brand is affordable:
Ask your prescriber to request an “exception” based on medical necessity.
A doctor can request by letter that the plan cover the medicine “by exception.” Even though the medicine is not on the plan’s formulary, the physician contends that another medicine will not work as effectively for you. For example, you are allergic to the other medicines on the formulary.
Unfortunately, sometimes it’s necessary to try the generic first. But if the previous Concerta generics have been tried, to poor effect, mention that.
Also explain if other stimulant medications were not satisfactory, including those in the same class as Concerta (methylphenidate products such as Ritalin, Quillivant, Daytrana, etc.) and the amphetamine class (Vyvanse, Adderall, Dexedrine, etc.) . Assuming, of course, that others had been tried before settling on Concerta; it might be that another medication will work better.
3. If the brand cost is prohibitive:
Check to see if you qualify for financial assistance from Concerta’s manufacturer:
You can also look for the best price available at GoodRX
5. How will I know if I have brand Concerta?
Concerta pills will say “Alza”—the name of the company that owns the OROS technology. Here are photos:
A reader kindly sent to me a photo of her recently filled prescriptions for Concerta: two strengths of the Trigen Concerta generic. Notice: The pills do not say “Alza” and they are not the same shape as the brand Concerta.
There does seem to be a hole in each table, but that is not indicative of OROS technology. A reader suggests that this looks like an older technology for osmotic release. See more details at #9 below.
6. Argh! My pharmacy is still substituting the downgraded generics for my Concerta prescription? Isn’t that illegal? What can I do?
Despite the FDA’s ruling, some pharmacies have persisted in foisting the downgraded generics on unsuspecting consumers.
Here are some options:
- Present the pharmacy manager with FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
- Contact your mail-order pharmacy (if applicable): If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask the price of brand Concerta if it is required by the physician (sometimes it costs more if the consumer, rather than the prescribr, requests brand). (Tip: Home Delivery of Stimulant Medications.)
- Complain to your health insurance carrier.
- Ask your physician to write a note to your health insurance company saying that you or your child experienced intolerable side effects to the downgraded generic and you must have brand. (Be prepared to pay the brand price, though.)
- Ask your physician to write “OROS only” on the prescription; OROS is the technology that makes Concerta’s delivery system unique.
- Ask your physician to indicate “no substitutions” on the Rx script.
For more information on these downgraded generics, please read this post: Consumer Q&A: Generic Concerta.
7. Hey, Gina, why are you making this such a big deal? By law, generics are the same as brand. My pharmacist assures me the generic is exactly the same as brand.
No, sorry. Generics are not the same as brand, no matter what some misguided pharmacists (and even physicians) might tell you. The generics are more precisely “bioequivalent” but that’s not “exactly the same.”
There are two key differences, and they are particularly relevant to psychiatric conditions:
1. Variable dose of effective ingredient:
In the U.S., the FDA requires the “bioequivalence” for the generic product to be between 80% and 125% of the original product. Yes, that’s roughly 20 percent up or down—a huge window of variance.
This variability alone can wreak havoc for the many people with ADHD. They might do best with a specific dosage; taking much more or less than that dosage is not as effective—and can even be very problematic. Especially when you’re not expecting it. And especially when you question the pharmacy about the different-looking pill and you’re told that generics are the exact same as brand. Wrong.
For example, you and your prescribing physician have established that 30 mg of medication X is best for you. You’ve tried 40 mg and 20 mg, both to poor effect. It is 30 mg!
Given this allowed ”bioequivalence” generic range of 80 to 125 percent, your generic pill could be anywhere from 24 mg to 37.5. Even that number will not be constant; it might vary each time the prescription is filled, because pharmacies often switcher suppliers.
2. Different dyes, fill material, and binding
Moreover, branded drugs and their generics almost always contain different dyes, fillers, and binders. These are all ingredients to which many people are allergic or have other adverse reactions. (I cannot cite research to support it, but abundant anecdotal reports indicate that people with ADHD might be more prone to these sensitivities.)
Imagine when your physician has no clue that the filler is the problem, not the medication—and not some additional condition, such as bi-polar disorder.
If you or your child is sensitive to dyes, please note (Thanks, Holly!):
TriGen 27mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake.
TriGen 54mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake.
TriGen 72mg tablets contain: FD&C Blue #1 Aluminum Lake.
Mylan 27mg contains Red #40.
Impax 18 mg contains yellow iron oxide (no mention of dyes; iron oxides are used in brand Concerta, too)
Impax 54 mg contains red iron oxide and yellow iron oxide (no mention of dyes; iron oxides are used in brand Concerta, too).
I could find no evidence of FD&C # dyes in Concerta, though perhaps different names are being used.
According to brand Concerta’s FDA-required product insert:
In addition to the active ingredient (Methylphenidate). CONCERTA® also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.
Bottom line: It seems that the Impax generic Concerta tablets contain no FD&C dyes. They do contain iron oxides (as colorants, presumably), but brand Concerta contains iron oxides as well. This is how you can distinguish the various dosages by color (e.g. white, reddish-brown, etc.). You can read the product insert for the Impax generics here. (Thanks, Adam!)
7. But wait, my pharmacist says the Trigen generic DOES have the OROS technology.
Yes, that’s what our home-delivery pharmacist told me, too, and he was wrong.
I had called to complain about my husband’s recent prescription fulfillment, containing round pills rather than oblong and without “Alza.”
You see, the prescribing physician has for years written, “OROS only”. This specifies brand Concerta, whether sold as a brand or the “authorized generic” from Actavis (the brand marketed as a generic).
“Did you read the script?” I asked the pharmacist. “Yes,” he said. “And I checked with the company (Trigen), which confirmed that they do use OROS technology.”
Okay, that’s a bit like asking the fox if he’s doing a good job of guarding the henhouse. But never mind. Did he read the product insert—the paper with all the fine print describing the medication, as required by the FDA?
“Yes,” he said. “The product insert confirmed it is OROS.”
But no, it isn’t. The pharmacist confused the general term “osmotic” with “OROS.” OROS is the trademark name for a novel osmotic delivery system. OROS = Osmotic [Controlled] Release Oral [Delivery] System. “Osmotic” is just…osmotic.
8. So, Trigen uses the term “osmotic” but that’s not the same as Concerta’s OROS technology?
Exactly. The OROS technology is central to the way Concerta pills release the medication (methylphenidate) into the body. It is a proprietary technology, and extremely difficult to mimic.
Trigen seems to be claiming the same delivery method as Concerta’s OROS delivery system (a laser-drilled osmotic pump, proprietary to a company called Alza)—but is very careful never to use the word OROS.
My instincts are that Trigen hoped that sufficient buzzwords (see below, in boldface) would snow the pharmacists and physicians (as it did the CVS/Caremark pharmacist I spoke with).
From the Trigen Concerta generic insert (the paper describing the medication, as per FDA guidelines):
11.1 System Components and Performance
Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the drug layer of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
CONSIDER THIS ILLUSTRATION, below, also from the Trigen product insert. It purports to compare the Trigen generic Concerta to generic Ritalin (Methylphenidate). I say “purports” because if you didn’t know better, you might think that the “methylphehnidate HCI Extended-Release tablet” is the Trigen generic. Which means you might conclude that the Trigen generic Concerta is superior to generic Ritalin—in the same way that brand Concerta is superior to genetic Ritalin, at least insofar as its “profile” (how the medication is released over time). Note the “peaks and valleys” over the first 12 hours; generic Ritalin is obviously more of a “roller coaster”.
Here’s the thing: Trigen simply lifted this illustration from the Concerta product insert. That graph compares brand Concerta to generic Ritalin. It has nothing to do with the Trigen generic.
To go into more detail risks boring you to tears. Suffice it to say, these generic manufacturers put all their resources into exploiting FDA loopholes when it comes to novel delivery systems such as OROS. The previously downgraded generics made a cynical play, and they were shut down. But only after much tumult in real people’s lives. Let’s hope more people are aware now and, if their “Concerta” stops working, they’ll know where to look first.
9. We’ve tried one of the new generics and are very dissatisfied. How do I file a complaint with the FDA?
I encourage everyone who has experienced adverse events with these generics to file a MedWatch complaint with the FDA. This is how the previous generics were downgraded, so please make your voice heard.
Click on this link for “MedWatch Voluntary Report” and select “Consumer/Patient.” Follow the instructions from there.
For More Reading: Pediatrician Kristen Stuppy helped lead the effort to have the FDA downgrade the previous Concerta generics. You can read her post on the new generics here: New 2017 Generics for Concerta