Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends

Update 12/20/22: For years, consumers have been able to get the brand Concerta sold as a generic — that is, an “authorized generic.” That has ended.

With the introduction since 2016 of about 20 cheap generics not using Alza’s OROS technology, access has been more limited but still accessible. No longer. Read more at Janssen Quietly Ends Authorized Generic 

6/10/19: This post still explains details around what constitutes a generic, and you might scan the subheads to learn useful information. But with the introduction of at least four 12 who-the-heck-knows more Concerta generics, I have written a new post (since outdated given the news above): Authorized Generic Concerta Update.

The term authorized generic is used when the brand is sold as a generic, at generic prices.

Original story: 12/31/17

Three Concerta generics are slowly making their way into consumers’ hands.  Already I’m hearing negative reports. This post provides a quick run-down. Please leave a comment if you have useful information.

The timing is 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 (in other words, an authorized generic; more on this below).

Update 6/20/18: This spring, another company (Amneal) introduced a generic Concerta. The pace is dizzying. I will update info as much as I can in the link I provided above: Authorized Generic Concerta Update: Yet Another (6/1/19)

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.

In this post, you’ll find 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 four new generics. None uses the novel OROS delivery technology from Alza that gives Concerta its unique release.

This threatens to send many children and adults with ADHD into a scramble, to either find the authorized generic or risk a trial of the four new generics.

Q&A on Concerta Generics

I’ll answer 10 common questions below.

1. Bottom line: What do Concerta users need to know?

Chiefly, you should know 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 the same OROS technology if it says “Alza” on the pill.)

As a result, many people will find the generic doesn’t work as well as the brand. (Yes, some people might actually prefer the generic. But the point is not consumer preference; the point is that generics should have the same effect as the brand.)

If brand Concerta works well for you or your child, however, and you don’t want to risk going off the rails, you might want to stick with the brand, whether sold as brand or the authorized generic (brand marketed as a generic).

Here is a post consisting of first-person stories detailing adverse reactions to the previous, now downgraded, Concerta generics:  Sound Off: Users of Downgraded Concerta Generics

2. How many generics and who makes them?

There are four new generics for Concerta on the market within the last year:

1. Trigen Laboratories
2. Mylan (of Epi-Pen infamy)
3. Impax Laboratories
4. Amneal

1. Trigen

Reports 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.
  • The first 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 [Alza’s OROS] is what it’s all about!
  • I’m finding the Trigen generic is horrible.

UPDATE 3/27/2018 :  Trigen recalled their 36 mg. generic Concerta because it was considered sub-potent (27 mg).  Generics are allowed a 20% window up or down, compared to brand; 20% would be 28.8, and this generic was 1.8 mg short. It might not seem like much, but typically people with ADHD have a very narrow window of effective dosage; the 20 percent variability is risk enough. More about generics and “bioequivalence” below.

For more information, check this link to the FDA page:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162135

2. Mylan:

I received this e-mail from an ADHD specialist familiar to me (meaning, I trust her):

 Dear Gina: This is a 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 the remaining 18 pills left in the bottle have no obvious drill hole. Never saw that with Concerta tablets. 

 Is Mylan trying to pass off an inferior technology as very similar to the Alza OROS or does it have very lax quality control—or both? I’ve heard that the company explains that the outer coating, which apparently can dispense in uneven thickness, dissolves quickly, revealing the hole.

3. Impax

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 #10, below, for instructions.

Update 8/2021: I’m not optimistic on getting this clown car of Concerta generics downgraded. But what the heck. Maybe it will make you feel better.

3. But, I’ve gotten the Actavis Concerta generic for a while now. Will that stop?

Maybe. But if you do, it will be from Teva generics  Patriot Pharmaceuticals now, not Actavis, until it’s not from Teva but another distributor.

First, neither Actavis nor Teva nor any other distributor manufactures this generic, which is not a generic per se. Instead, it is an “authorized generic.” That means it is the brand product marketed as a generic.  (I know!  I repeat this ad nauseum. But still, some readers remain confused.)

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. That deal expired 12/31/2017.

Sometime thereafter, generics manufacturer Teva purchased Actavis.  Teva refused to share with me any information about any agreement with Janssen, including when it might expire. Very strange.  Now I hear that Patriot Pharmaceuticals is also marketing the authorized generic.

Bottom line: Don’t specify the distributor on the script; specify Concerta authorized generic; Alza OROS

4. If I prefer brand/authorized generic Concerta, 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/authorized generic Concerta?

Simple! Concerta pills will say “Alza”—the name of the company that owns the OROS technology central to Concerta.  Here are photos:

A reader kindly sent to me a photo (below) 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 tablet, but that is not indicative of Alza’s OROS technology.  A reader suggests that this looks like an older technology for osmotic release.

6. Argh! My pharmacy still substitutes the downgraded Concerta generics? Isn’t that illegal? 

Despite the FDA’s ruling, some pharmacies have persisted in foisting the downgraded generics from Kremers-Urban and Mallinckrodt on unsuspecting consumers.

Here are some options:

1. Present the pharmacy manager with the FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
2. 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 prescriber, requests brand).   (Tip: Home Delivery of Stimulant Medications.)
3. Ask your physician to write “Alza OROS only” on the prescription;  Alza’s OROS is the technology that makes Concerta’s delivery system unique. Another option, as referenced in the opening paragraph: The prescriber writes (for the 18 mg): Concerta  Authorized Generic/Alza OROS. 
4. Ask your physician to indicate “no substitutions” on the Rx script.
5. Complain to your health insurance carrier.
6. 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 the brand. (Be prepared to pay the brand price, though.)

For more information on these downgraded generics,  please read this post:  Consumer Q&A: Generic Concerta.

7. Hey, Gina, why are you making a big deal? By law, generics are 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 might be bioequivalent — and even that includes a huge “margin of error” — but that’s not “exactly the same.”

There are three key differences, and they are particularly relevant to psychiatric conditions because the best results typically come within a precise dosing range (the “therapeutic window”):

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. Even that number will not be constant; it might vary each time the prescription is filled because pharmacies often switch suppliers.

This variability alone can wreak havoc for 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.

2. Different dyes, fill material, and binding

Branded drugs and their generics almost always contain different dyes, fillers, and binders. These are all ingredients to which many people have other adverse reactions. (I cannot cite supporting research, but  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 bipolar disorder.

If you or your child is sensitive to dyes, please note:

• • • 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), as does brand Concerta. The various doses are differentiated by color (e.g. white, reddish-brown, etc.).  Read the product insert for the Impax generics here.

3. Different delivery systems—in “true” generic Concerta’s case, no OROS

Concerta and all Concerta generics contain methylphenidate (MPH), the same medication that’s in Ritalin. The difference is the delivery system—that is, how the medication gets from the pill to your nervous system.  (You’ll commonly see the term CNS  Stimulants—for Central Nervous System Stimulants.)  The delivery system can make all the difference, including the rate at which medication is released.

The breakthrough technology behind Concerta is the Alza-patented OROS Osmotic [Controlled] Release Oral [Delivery] System.  This is a laser-drilled osmotic pump in the capsule, proprietary to a company called Alza. You actually excrete the capsule; it does not dissolve, though there is an outer coating of methylphenidate, for faster release.  None of the “true” generics have OROS.

8. Wait! My pharmacist says the Trigen generic does have OROS technology.

Yes, that’s what our home-delivery pharmacist told me, too. 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” and “Actavis”. That specified 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 Alza’s novel osmotic delivery system.

OROS = Osmotic [Controlled] Release Oral [Delivery] System. Osmotic is just…osmotic — a process, not a proprietary delivery system.

9. So, Trigen uses the term “osmotic” but that’s not Concerta’s OROS technology?

Exactly. A company named Alza owns the OROS technology. And that technology is central to the way Concerta pills release the medication (methylphenidate) into the body.  It is a proprietary technology, and extremely difficult if not impossible (so far) to mimic.

Trigen seems to be claiming the same delivery method as Concerta’s OROS delivery system—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).

Let’s Check the Product Insert

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.

Illustrations of Medication “Profiles”

There is something called a medication “profile.” Essentially, it refers to the timeline starting when the medication is taken and ending when all effects have stopped.

Below, see the “profile” that Trigen included in its product insert.   Here’s where things get a little …complex.

If you didn’t know better, you might assume that this compares two profiles:

1. Trigen generic Concerta, and
2. Brand Concerta.

But no, this graph compares the profiles of

1. Brand Concerta (Methylphenidate HCI Extended Release Tablets)
2. Ritalin (Methylphenidate)—three doses of Ritalin.

If you didn’t know better, you might also draw the wrong conclusion from this graph: That is, the Trigen generic Concerta is superior to Ritalin in the same way that brand Concerta is superior to Ritalin. That is, less of a “roller coaster”.

Here’s the thing: Trigen simply lifted this illustration from the Concerta product insert. Again, that graph compares brand Concerta to generic Ritalin. It has nothing to do with the Trigen generic. Welcome to the wacky world of generic medication approval processes.

To go into more detail risks boring you to tears. Suffice it to say, some 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. They were shut down, but only after much tumult in real people’s live and consumers filing complaints.

Let’s hope more people are aware now and, if their “Concerta” stops working, they’ll know where to look first.

10. 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