A Recap: Consumer’s Guide to Generic Concerta

Some of this information is now outdated (though much is not). Please also see my latest comprehensive post on how you can get the authorized-generic Concerta now:  Consumer Q&A on Concerta Generics.

Why the concern about the new generics for Concerta?  I’ll tell you.

It can take much trial and error to find the ADHD medication and dosage that works best for an individual. Once it’s found, you don’t want to monkey with it!  (Especially when you don’t even know you’re monkeying with it!)

So, when long-time Concerta users felt that it had stopped working or was working less effectively, they were understandably alarmed.

• Some worried that they had “habituated” to the medication. With certain exceptions, however, that is not typical for the stimulant medications.
• Others worried that another variable was interfering—extra stress, a flu or cold, a different teacher at school, etc.
• Fortunately for some, they found the ADHD Roller Coaster blog and traced that change to their prescription being filled with one of the new generics.

Do you find it shocking that a pharmacy could change a patient’s medication so drastically with no warning?  I do. What’s worse, when some readers went back to their pharmacy,  pharmacists patted them on the head and assured them that generics are the same as brand. Not so!

It is true that generic medications generally work as well as brand. That does not mean, however, that they are the exact same as brand. Here is an excerpt from a previous post on the topic (share it freely with any doubting pharmacists):

Moreover, as any experienced physician can tell you, generics can wreak havoc with that narrow “therapeutic window” — the dose that works best with the least side effects.

• A few milligrams up or down can mean trouble, and the FDA allows a wide window of efficacy.  
• In the U.S., the FDA  requires the bioequivalence of the generic product to be between 80% and 125% of that of the original product. That’s a bay window, for petesake!
• Bioequivalence does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their original product counterparts. Significant chemical differences may exist, especially when it comes to extended-release medications.

Concerta’s True Generics Vs. Authorized Generics

There’s one big reason, though, why  many people get confused about the Concerta generics: There are at least three generics within two distinct categories of generics. To understand the distinctions, we have to understand how the FDA defines each type of generic.

I’ll try to make this as simple as possible. Stay with me!

In sum:

• The first (the”authorized generic”) isn’t a generic at all, in the common sense of the word. Rather, it is the brand marketed as a generic.
• The second (“true generic”) is a generic in the common sense of the word. Within these “true generics” of Concerta are several manufacturers’ offerings.

1. The One Authorized Concerta Generic: Watson/Actavis

There is only one authorized Concerta generic; the supplier is Watson/Actavis (old name/new name).  Remember: An authorized generic is the brand drug marketed as a generic. The only difference is in price and name. Period.

Backstory: Watson (the company later changed its name to Actavis) struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta. In exchange, Janssen would manufacture and supply Watson with this brand-name Concerta. That would allow Watson to market Concerta at a cheaper-than-brand price and give Janssen a piece of the profits.  This deal should last through 2014. (I wrote about this in detail here.)

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Appearance: exactly the same as Concerta. A capsule imprinted with “alza” (the makers of Concert’s unique delivery-technology called OROS) and featuring a laser-drilled hole. (See photos below; color will vary with dosage strength)

Bottom line: If your generic Concerta is imprinted with “alza,” you have the brand medication. Period. Also, if you have one on hand, look for the little hole at the end; that tells you this capsule contains OROS, the laser-drilled osmotic pump that is the Concerta delivery-system technology.  The word “alza” is followed by the miligram of that pill.

The Two “True Generics”: Mallinckrodt and Kremers-Urban

These two offerings are generic in the traditional sense of the word. That is, a medication that is very similar to the brand and ostensibly works as well but is not the exact same as the brand.

Currently in the U.S., there are two “true generics” for Concerta. (Note: Another is available in Canada, Teva-Methylphenidate ER-C; Toronto-based Dr. Kenny Handelman discusses this generic on his blog.)

These generics are as follows:

1. Mallinckrodt

Mallinckrodt began with only the 27 mg but now also markets its 36 mg and 54 mg generic Concerta.

[Update: Even though the FDA has downgraded this generic as inferior—meaning, you should not have to accept it if nyour insurance requires you to take a generic—Mallinckrodt is fighting it. Pharmacies such as CVS are still routinely filling prescriptions with it.]

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Bottom line: This generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.

2. Kudco (Kremers-Urban)

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Bottom line: As with the Mallinckrodt offering, this generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.

Update: Kudco has complied with the FDA ruling downgrading this generic and withdrawn the product.

The box looks like this (the color varies by dosage strength):

And the pills look like this, in the 18 and 27 milligram dosages:

Dissatisfied with Your “True” Generic?

Here Are Your Options:

It is possible that, for some people, the generics might be preferable to the brand; the slight differences in action might work to your benefit.

If you have tried the “true generics” and found them unsatisfactory—or you’re not willing to gamble with the change—here are your options:

1. ALWAYS check your pills before you pay for them. You typically cannot return them once you pay for them and especially after you leave the store.
2. Ask your pharmacy to carry the Watson/Actavis/OROS authorized generic (same as brand)
3. If the pharmacy refuses, call other pharmacies in your town.
4. If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask if that pharmacy carries the OROS. If not, ask how much more the brand Concerta will be.   (Note: I find the mail-order option much easier; why go through the hassle 12 times annually if you can cut it to four or six? I detailed how it works in this post, Tip: Home Delivery of Stimulant Medications.)
5. Ask your physician to indicate “no substitutions” on the Rx script if the OROS generic is unavailable and you are willing to pay for the brand.
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 generic and you must have brand. (Be prepared to pay the brand price, though.)
7. Ask your physician to write “OROS only” on the prescription; Watson is in the process of changing names to Actavis, so it’s likely that confusion will result if either name is used instead of OROS (the technology that makes Concerta unique).
8. Complain to your health insurance carrier.

FINALLY: Please report any adverse side effects from “true generics”

Above all, if you or your child experienced adverse reactions to the Mallinckrodt or Kudco/Kremers-Urban generics of Concerta (and have not had such reactions to the brand/”authorized generic” Concerta), please do yourself and everyone else a favor:  File a complaint here with the FDA’s MedWatch (scroll down to the box that says “consumer”).

If the FDA receives sufficient data that a medication merits investigating, it will do so. A generic of Wellbutrin XL was recently recalled after such an effort (explained in this previous post).

I hope this answers some questions and settles the confusion!

Please subscribe to this blog to be notified of updates on this continuing saga.

For more background, see this post (“What’s Up with Generic Concerta?”)

Gina Pera, author and Adult ADHD expert

For more information on Adult ADHD and its treatment strategies, including how to get best results from your medication, please consult my book‘s three chapters on the topic.