Certain Generics Are No Longer Equivalent to Brand Name Concerta

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Within the past few years, the FDA has given the okay for generic manufacturers to market generic versions of brand name Concerta (methylphenidate ER).

However, you may or may not know that Concerta is the only ADHD medication with a very unique delivery system referred to as OROS (osmotic controlled-release oral delivery system).

Several manufacturers have been making generic methylphendiate ER, however, the FDA has had some concerns over whether the various generic products are therapeutically equivalent.

To understand the FDA’s concern, it is important to understand the various delivery systems and how they may differ from one another.

Which pharmaceutical companies are manufacturing generic Concerta?

There are three manufacturers currently making generic Concerta: Actavis (formerly Watson), Kremers (Kudco), and Mallinckrodt.

How does the OROS delivery system release Concerta?

The OROS delivery system used in brand name Concerta is similar to the generic Actavis tablets. Concerta uses osmotic pressure to deliver the medication throughout the day at a controlled rate. The tablet consists of 2 layers. The first layer dissolves within 1 hour and releases an initial dose of methylphenidate, while the 2nd layer releases the rest of the medication over another 6 to 7 hours.

What are the different delivery systems for the Mallinckrodt and Kremers generics?

Mallinckrodt tablets use a precisely designed diffusion process (similar, but not identical to the Actavis generic). This delivers the medication throughout the day at a controlled rate. The tablet also consists of 2 layers, and has a similar release time period to the Actavis generic.

Kremers (Kudco) tablets use extended-release bead technology to deliver the medication throughout the day at a controlled rate. The tablet still consists of 2 layers, and the first layer still dissolves within 1 hour and releases an initial dose of methylphenidate. However, the second layer in this generic releases the medication over a duration of 12 hours.

Are the generic products interchangeable with Concerta?

NO. As of November 13, 2014, the FDA has changed the therapeutic equivalence rating for the Mallinckrodt and Kremers (Kudco) generics from AB to BX.

This meant that methylphenidate ER products from both Mallinckrodt and Kremers (Kudco) are still approved and can be prescribed but are NO LONGER recommended as substitutes if a doctor prescribes Concerta or generic equivalent.

The Actavis methylphenidate ER tablets are currently the ONLY generic equivalent available for Concerta.

Check out what the FDA had to say about generic Concerta products here.

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