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Is the first generic release of the ADHD tx Concerta?

By Lee, Tak-Sun | translator Choi HeeYoung

21.10.30 06:00:40

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Generics had not been released until now despite the approval of Alvogen's bioequivalence test Plan and the expiration of patents



Alvogen Korea has begun to develop a generic development of the ADHD treatment Concerta OROS (Methylphenidate, Janssen Korea). Since there is currently no generic for Concerta in Korea, it is expected to be the first generc if approved.

As of the 28th, the MFDS approved AK-D309 54mg's biological equivalence test plan. In this test, Alvogen will conduct a bioequivalence test evaluation with control group on 58 healthy adults.

The target disease is ADHD. It is estimated to be Concerta OROS 54mg. This is because there is only 54 mg formulation for Concerta OROS for ADHD treatment.

Concerta OROS 54mg is a leading product in the ADHD treatment market. Sales amounted to 15.4 bil

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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