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A Recap: Consumer’s Guide to Generic Concerta

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This post updates a previous post with more information and photos of the new generic Concerta products.

Why the concern about the new generics for Concerta?  Here’s why.

It can take much trial and error to find the ADHD medication and dosage that works best for an individual. Once it’s found, it’s understandable that we don’t want it monkeyed with. So, when long-time Concerta users found that it had stopped working or was working less effectively, they were understandably alarmed. Some worried that they had “habituated” to the medication, but that is not typical for the stimulant medications. Others worried that something else was interfering—extra stress, a flu or cold, 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.

I find it shocking that a pharmacy could change a patient’s medication so drastically with no warning. 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, but they are not 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. Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their original product counterparts, as chemical differences may exist.

The main reason, though, that many people are confused about the Concerta generics is that there are at least three generics within two distinct categories of generics. I’ll try to make this as simple as possible. Stay with me!

The first isn’t a generic at all but is the brand marketed as a generic (the “authorized generic”). The second is a generic in the true sense of the word (the “true generic”).

1. “Authorized generic” (Concerta offering from Watson/Actavis): An authorized generic is the brand drug marketed as a generic. The only difference is in price and name. Period.

Backstory: Watson struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta if Janssen would manufacture and supply Watson with this brand-name Concerta, allowing it to market 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 “authorized generic” marketed by Watson is the brand-name Concerta. To identify it, look for “alza” followed by the number of milligrams. The color varies by dosage strength, depicted below.

2. “True generic” (from Mallinckrodt and Kudco/Kremers-Urban, and perhaps more to come in the next few years):  This is a generic in the traditional sense, meaning 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:

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

Mallinckrodt’s generic of Concerta depicts an “M” in a square, followed by the milligrams; it does not use the OROS technology and instead appears to be more similar to Ritalin LA, a far less sophisticated delivery system. The color varies by dosage; I have a photo only of the 27 mg.

B. 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.

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

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

Not Satisfied 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?)
  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 most likely 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.

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  1. GloryB’s avatar

    Gina, you are the BEST! Thanks for all you do!!!

    GB

    Reply

  2. Shirley’s avatar

    I didn’t realize my kid was on generic. Thanks.

    Reply

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