Update on generic Methylphenidate HCl ER (name brand = Concerta)

My previous post on Generic Concerta has been very popular, but it has so many updates that it has become difficult to read. I'd like to highlight the important points to make it easier for all.

What makes Concerta unique?

Concerta is the branded formulation of methylphenidate HCl Extended Release that has a unique time release system. This time release technology is called OROS (osmotic controlled release oral delivery system).  Unlike many slow releasing medications that are released as the capsule parts dissolve, the OROS capsule doesn't dissolve. The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. This allows for a consistent drug release. See this photo from Medscape:

The companies that make the OROS pills include the original maker, now Janssen Pharmaceuticals, Inc., and Actavis (formerly Watson). They are marked with "alza" and the number signifying the strength. They have a distinctive marking on one end that is the exit port (as above).

photo source: goodrx.com

see the "exit port"

What generics are available?

There are now several generic extended release Methylphenidate HCl ER formulations approved by the FDA to substitute for Concerta. Generics must have the same active ingredient, but can vary with how it is made and the fillers.

One company, Actavis (formerly Watson), makes an OROS Methylphenidate HCl generic. It is the same OROS pill as the branded pill, but it is sold as an authorized generic. These look identical to the pictures above.

I'm sure more generics will be made, but the two companies that make a non-OROS generic are Mallinkrodt and Kremers Urban. It is easy to see that the pills of each of these are different from the OROS above.

For more information on authorized vs true generics, visit ADHD Rollercoaster's blog on the subject.

From Kremers Urban:

photos from http://www.kremersurban.com/products/Product_Details.aspx?ProdName=MetaT&ProdID=62175-311-37

How will my child react to different formulations?

This is a difficult question because everyone responds to medicines differently. For some people the formulations that are not OROS might work better. For some either might work well. For others they might respond best to the one with OROS. It is important to know which brand is taken so that if there are variances in how it works you can identify if it might be due to a change in the formulation.

What can I do if my child is not tolerating a new formulation?

There are several things to do if your child is not responding well to a new formulation.

• Identify which brand and strength it is and write it down in a place you will remember so you won't buy it again. Keep a list of all medications and general reactions (both good and bad) in case of future issues. 
• Tell the prescribing physician about the reaction and be sure to let them know the brand your child did well with and the one that has negative effects. Your physician might not know about the different generics available, so let them know it is not the OROS pill. Otherwise they might assume a higher strength will fix the issue, and your child might not need that higher strength, just a different time release. Ask your physician to write "OROS only" on the prescription. State laws vary about how they must do this. A nice summary is found on the Epilepsy.com. (We are not specifically taught these things in medical school or residency, so you might need to share state laws with your physician.)
• Tell the pharmacy that the medication they substituted is not working and see if they can exchange for the brand your child was previously doing well on. You might need to go "up the chain" at a big name pharmacy, since the local pharmacists don't have much say in what is purchased for the company. (They likely won't be able to substitute, but after enough phone calls to the pharmacists who might complain to the administrators, and directly to the people responsible for choosing the company through which they order, they might reconsider the substitution.)
• Tell the pharmacy you will take all your business elsewhere because you cannot buy their substitution. Local "mom and pop" pharmacies are more likely to order your preference than any chain pharmacy. You might pay more, but if you can afford it and your child's response is better, it might be worth it.
• Call ahead before picking up prescriptions. Ask the pharmacy which type of methylphenidate HCl ER they have for the strength you need. (It may vary between 18mg, 27mg, 36mg, etc.) Let them know you will or will not be filling at their store based on what they stock. 
• See if your insurance company participates with a mail order pharmacy. Be sure that they use the OROS pills BEFORE getting a 90 day supply. Mail orders are often less expensive options, so it might be helpful if you are unable to find a generic OROS pill and must buy the name brand. Keep in mind that shipping time will delay getting the medicine, so think ahead and schedule your ADHD visits to get new prescriptions about 2 weeks before you need the refill!
• Tell your insurance company about the issue. They are contracting with pharmacies for certain formularies, and if they don't know that their clients don't like a particular brand, they will keep going for the cheapest contract. They still might because money talks, but keep pressuring them!
• Tell your HR department if your insurance through the office requires you to use a certain formulary drug or particular pharmacy that purchases a brand your child does not thrive on. They can take this into consideration when renegotiating contracts. Again, this only works if a big enough number of people complain.
• Ask your physician if he would be willing to write a letter to your insurance company on your behalf.
• Report adverse events to MedWatch. This can help everyone if they hear enough complaints. You can read about the program then click on the consumer - friendly reporting form. From that link click on the "consumer/patient" button on the right. This is how the FDA learns of drug problems. Hopefully if enough people submit reports they will look into the issue. They have looked at data from each of the generic companies prior to approving the distribution of these pills and they found the data supportive that the medicines were equivalent. They need to hear post-marketing concerns from use in real people.
• Share information. Many people are struggling with new formulations and they don't realize why. 
• UPDATE May 1, 2014: I'm excited to see that the FDA has the generics this on their watch list. Gina Pera's "We Did It! Concerta Generics on FDA Watch List" gives a great summary of how the process works and what we can all do to continue the fight. 
• UPDATE Nov. 16, 2014: Generics that are non-OROS will no longer be automatically substituted. They will still be available. See ADHD Roller Coaster's blog on the topic for details.

Generic Concerta Not Working Like the Brand Used To?

Note: there is an update of this post here. It is much easier to follow, since the original post has so many updates.

I used to be a huge fan of generics. They save money, right? They are equivalent to the brand name, right?

That's what I've always been taught and what I teach taught.

I've been jaded by many problems and now disagree with the above.

Generics aren't always cheaper than the brand name.

Some generics are not equivalent to the name brand.

A recent discussion on a psychology/pharmaceutical listserv I follow brought up the issue of generic Methylphenidate HCl not working as well as the brand name Concerta. Several members had some great insight into why this is. The discussion peaked my interest in the issue and I started looking online for information earlier this week.

Ironically today I went to pick up a family member's medicine. We have filled at the same pharmacy previously for generic "Concerta" and have always gotten the equivalent generic. When I looked at the pills in the bottle today, I told the pharmacy tech they weren't OROS (see below). She looked confused. She had no clue what I was talking about.  (Lesson to all: if you have any questions, ask to talk to the pharmacist. Hopefully they will understand the pharmacology better than the tech.)

Generics for Concerta (Methlyphenidate HCl) might have the same active ingredient, but have a completely different time release system, resulting in varying drug peaks in the bloodstream. The original generic for Concerta (from Watson pharmaceuticals) uses a special technology to time-release the active drug. This time release technology is called OROS (osmotic controlled release oral delivery system). There are several other time release methods. The active ingredient may be imbedded in various substances from which the medicine must exit slowly or a gel cap is filled with beads that dissolve at different rates. With the technology used by Concerta, the capsule IS the time release. It doesn't dissolve. The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. See this photo from Medscape.

from http://www.medscape.org/viewarticle/547415_10

I have recently learned that not all generic formulations of Methylphenidate HCl are using this technology. This alters the time-release nature of the active medicine.  For some people this substitute might be just fine, or even preferable. But if it seems like your medicine isn't lasting long enough, has times that it works well followed by times it doesn't until the next peak, or any other problems -- check your pills!

You can tell the difference by closely looking at the capsules. The OROS capsules are a unique shape, a little more blunted than a standard capsule. If you look really closely at the ends, you will find that one has a "dimple" where there is a small hole covered by a thin layer matching the rest of the capsule. I just happen to have at least one of three dosages:

Photos of the Mallinckrodt brand are now listed under "Updates."

So if any medicine doesn't work like it used to, look closely at the pill itself to see if it is the same as previously. If you don't have any left, ask the pharmacy for the company / maker of the medicines you've filled over the past several months. Let your doctor know if you can't use a substitution so they can specify "Watson brand only."  If the new "brand" works better, be sure to ask for that manufacturer.

Better yet, call ahead and see who the manufacturer is of the generic for Concerta sold at your pharmacy. Watson Pharmaceuticals is the one that makes the OROS system. If they don't use that generic and you plan to shop elsewhere, be sure to let them know why!

Let me know your experiences with generics... See the Updates below if you want to report your experience to the FDA.

Update 4/29/13:

Reporting Adverse Events: A pharmacologist from the listserv I mentioned above suggests that if you have an issue with the duration of action of a different brand of Methylphenidate HCl you should report it to the FDA. This will allow them to review cases and possibly stop the substitution of these non-equivocal products. Click on this link for the MedWatch Report. Thank you SS!

Manufacturer Clarification: Watson Pharmaceuticals is authorized to market Concerta in the US for Ortho McNeill Janssen Pharmaceuticals, the original manufacturer.

Teva markets another type (not OROS) in Canada and Mallinckrodt markets another type (not OROS) in the US.

Update 5/27/13:

Photos of the Mallinckrodt pills (from www.mallinckrodt.com):

As a comparison, the pill shape of the OROS pills (Janssen Pharmaceuticals, McNeil, and Watson all look identical -- from www.goodrx.com):

Update 10/5/13:

I just learned another company is making a generic for Concerta. A patient suddenly found the medicine to be not effective. It looked entirely different, so suspected it was the wrong medication. The pharmacist confirmed that it is another generic for Methylphenidate HCl ER from Kremers Urban Pharmaceuticals. The parent sent me this picture of the 18mg pill and I found the 27mg on the Kremers website:

From http://www.kremersurban.com/products/Product_Details.aspx?ProdName=MetaT&ProdID=62175-311-37

If your pharmacist says he can't order a drug because of a shortage, you can check to see predictions of how long the shortage will last at ASHP.org. Be sure to look closely for the generic name and if it is an extended or immediate release form because it can be confusing.

Update 12/12/13:

Watson Pharmaceuticals will now be called Actavis, so ask for the OROS pill instead of a brand. I think I will do a whole new blog on this topic since there are so many updates since April. Watch for it!

This is a great resource on the difference in authorized vs true generics: An Update on Generic Concerta.

Update 5/1/14:

I'm excited to hear that the FDA has this issue on their watch list. Please read Gina Pera's We Did It! Concerta Generics on FDA Watch List.

Update 11/16/14:

Generics that are non-OROS will no longer be automatically substituted. They will still be available. See ADHD Roller Coaster's blog on the topic for details.

Resources:

The Pre-MMA 180-Day Exclusivity Punt? What Gives? A legal blog explaining how medicines lose their exclusivity and can become generically available, specifically the Concerta dispute.

How To Tell The Difference Between Concerta and Generic Concerta A Canadian ADHD blog provided the picture of how to recognize the difference. Generic formulations have been available in Canada years prior to in the US.

Special thanks to the members of the Child-Pharm listserv!