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Tuesday, December 17, 2013

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.