New 2017 Generics for Concerta

Deja vu. I feel like I've been through this before.

Two of my most-read blogs were about generic forms of Concerta available in 2013-14. The FDA had allowed companies to manufacture and sell tablets that were not the same as Concerta. People across the country noticed the change immediately. I started seeing patients who had been well controlled on Concerta for a long time who suddenly were not able to focus, were more angry, and had other focus and behavior problems. Initially I had no idea there was a new generic, but one mother sent me a picture of the new pill and I knew instantly it could not be the same.

Now I've heard there will be new generics from Trigen Laboratories, Mylan and Impax Laboratories that do not use the special delivery system of Concerta once again. I'm worried because it took many many months of people filing reports with the FDA through MedWatch before the FDA finally stopped allowing the substitution. I hope the newly approved versions work better than the previous editions, but am worried not only because they don't use OROS technology, but there are several new versions coming to market and each could be different.

I have heard that the previously available OROS generic (made in the same factory as the name brand Concerta and the same exact pill but with a different label) will no longer be available. If this is true, options will be to pay for the name brand or go with a new version of the medicine.

These are all OROS type methylphenidate HCl ER (Concerta)

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. There is a little active medicine that is released immediately and then 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:

Source: https://www.medscape.org/viewarticle/547415_10

You can tell if you have the OROS tablets if they have a small dimple in one end:

The new generics

The same active ingredient (methylphenidate) is used in the new pills. I have heard that at least one version of the pills is round, so I know they don't use the OROS system. I cannot tell what type of delayed release they will have based on the information in their package inserts.

I find it very frustrating that each of the package inserts appear to be nearly identical to the one for Concerta (including the initial US approval date of 2000, which is not correct for this form). Older warnings, including a contraindication in those with tics, has been found in newer studies to not be a contraindication. The fact that they did not push to remove it makes me wonder if they did not want to have to change other parts of the document.

Figure 1 and Table 6 are identical with the exception of changing the word "CONCERTA" to "methylphenidate hydrochloride extended-release" and Trigen added an easy-to-read table format: 

Concerta

https://www.janssenmd.com/pdf/concerta/concerta_pi.pdf

Trigen's Methylphenidate HCl ER

Impax's Methylphenidate HCl ER

This makes me wonder if they were somehow able to get permission to make their new tablets based on Concerta's data, not their own. 

We'll see how it works in people who have previously taken OROS methylphenidate ER. Sadly, one version might work better than another, so you will have to keep track of which brand you are using.

What's good about the new generics?

If it's true that the currently available generic OROS form of methylphenidate ER is no longer going to be available, it's good that there will be other options to help keep costs down. Maybe. Sometimes insurance companies prefer branded products. It's all how they contract the cost. If you don't know how to use your insurance company's prescription formulary, you should learn. Also check out GoodRx for pricing information.

One might work as well (or better) than the OROS formulation in any individual. You won't know until you try it. 

One benefit I am excited about if these work: 

The Trigen version is available as a 72 mg tablet. The original Concerta is not able to be made at that strength. You can see from the photos above that the pills get bigger with increasing dosages, and the OROS system has limits to how much it can hold. For people who need 72 mg, they must take two of the 36 mg OROS tablets. Since patients pay by the pill and they need 60 pills/month instead of 30, this can be quite a bit more expensive.

What should you do if the pills change - especially if they don't work? 

Check each bottle when you pick up new medicine and ask if you can return unused tablets if they don't work for any reason. 

Keep track of what each pill looks like and the brand (which should be on the label) so you know which versions work and which don't. 

Talk to your kids about how they think and feel on and off their medicine - some will be more in tune with themselves than others.

Keep in touch with teachers as the pills change so you know if there are school-related issues you're not seeing at home.

If the pills don't work or have new or worsening side effects:

• Talk to your HR representative who deals with the insurance company. 
• Call your insurance company directly. Send them e-mails and snail mail. 
• Ask your physician to write a letter on your behalf. 

In each of the above situations, include why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed (if tried). 

• People were able to get the FDA to look into the issue the last time a different tablet was substituted by submitting complaints to MedWatch. It took a long time, but the FDA finally agreed that there are significant differences and the other substitutions were no longer allowed. It's easy and free. Please submit to MedWatch if you have any concerns!

If you need to change medications because the new generics don't work well, it helps to know what other medicines are in the same class so you can look up your formulary coverage. The ADHD Medication Guide has an easy-to-read format of ADHD medicines. Just look for other medicines in the same colored box as Concerta to find similar drugs. (To limit plagiarism of this wonderful chart, you must click on the user agreement in the center of the page. It is free and easy.) Medications have been arranged on the card for ease of display and comparison, but dosing equivalence cannot be assumed. Talk with your doctor about what medicines will be best for your child (or yourself). *The ADHD Medication Guide was created by Dr. Andrew Adesman of the North Shore-LIJ Health System.

Related Posts:

Generic Concerta Not Working Like It Used To?

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

Top 10 Posts of 2013

My last post of 2012 was my Top 10 Posts of 2012. I think I'll keep the tradition going with the Top 10 of 2013.

photo source: Shutterstock

This past year I have written about everything from insurance to illnesses to common parental concerns. My most influential blog has been about the generic formulations of Concerta, with 11,875 readers. It has been shared on ADHD blogs, various Facebook and Twitter feeds, and found on Google searches. I never thought over 1,000 people would read one of my posts, let alone over 10,000! Thank you to all who are reading and sharing!

If you don't want to miss a post, be sure to sign up for an e-mail subscription on the right!

From #10 to #1:

10. My Child's Cough and Breathing Sounds Like… is a collection of videos I compiled to help parents describe their child's cough.

9. Allergy Tips reviews ways to avoid allergens when possible and how to treat symptoms.

8. Flu Vaccine 2013: The Story Unfolds discusses how coding and billing issues impacted our office use of flu vaccines this season.

7. But the Snot Is Green… once again argues why the color of mucus does not make the diagnosis of bacterial sinusitis and gives information on treating colds and coughs.

6. To Tamiflu or Not to Tamiflu  might be a little intense for some readers because it reviews the research on Tamiflu risks and benefits. I am happy it is among the top 10 because I want people to see that Tamiflu isn't that miraculous of a drug for influenza. I get far too many requests for it this time of year. 

5. Flu Shot Information 2013-14 Season explains the different types of influenza vaccine available for the season. 

4. Help! My Child Has ______ Up His Nose! shares a "secret" tip I use to get some unwanted objects out of a child's nose. 

3. Screen Free Week is a challenge to readers to go Screen Free for a week. I have no idea why it is ranked so high. That is a surprise to me. 

2. Cough Medicine: Which One's Best reviews various cough medicines and other treatments of cough.

1. Generic Concerta Not Working Like the Brand Used To?  was read about 10 TIMES as much as any other post. It was found most often by a search engine, not direct shares, which tells me that many families are struggling with this issue. This is the post I am most passionate about. Any of my ADHD patients who are treated with Methylphenidate ER/Concerta know how angry I am that the FDA allows this substitution. I am thankful that the blog can help spread the word so that parents who are concerned about their child's sudden altered response to a medication can learn what might be the cause. I had so many updates to the original post, I wrote a follow up: Update on generic Methylphenidate HCl ER.

Blogs that missed the Top 10 that I wish more people would read include: 

Evolution of Illness - I wish people would read this because we often fall into the trap of wanting a quick fix. Too many parents bring kids into the doctor for a fast remedy only to find that there isn't one.  Resolution of illness takes time. Sometimes kids get worse, only to have the parent accuse a doctor of missing something. It happens to all good docs once in awhile…

First Period Q&A with a Tween - I wish people would find this one because it has questions every young lady thinks about but is often afraid to ask.

It's [Sports, School, Camp, Yearly] Physical Time - I wish people would read this so they understand the value of well exams and the scheduling constraints most pediatricians face. Don't call at the last minute!

Insurance Confusion - I wish people would read this because dealing with insurance is one of the most stressful parts of my job. I want people to learn about insurance to avoid financial surprises and to be responsible with insurance use.

Private Discussions with the Pediatrician - I wish people would read this because I am often uncomfortable (and sad for a child) when a parent wants them to leave the room for us to discuss something privately. Pre-planning with a quick phone call or secure message before the visit can save the child from excess worry.

What kids need to be able to do to leave the nest - This is one of my favorites because it was written at a very emotional point of my life. My kids are growing up and I reflected on what I really want them to know.

New Ideas

While most of my blogs were article-style writings, I introduced a few different types of blog this year. 

My first (and to date only) attempt at a video blog was Nutrition For the Picky Eater. It was born from a talk I gave at an ADHDKC.org parent meeting. 

I also did a picture blog with Lawn Mower Safety. 

I had one guest blogger. Sleep expert, Kerrin Edmonds, wrote Common Sleep Myths. 

Busy times…

April was my busiest month blogging. Seven posts that month. It tends to be a slow month in the office.  Ironically it was also Screen Free Week, a time I should have been off the computer!

• Allergy Tips

• Generic Concerta Not Working Like the Brand Used T...

• Screen Free Week April 29-May 5, 2013

• Help! My child has ___ up his nose!

• Group Teaching With Physicals

• Waiting times...

• Feeding Your Newborn

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!