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Main | | | | | | | | | | | | |
| Brand Name | Concerta Extended-Release | | | | | | | | | | |
| Generic Name | methylphenidate extended-release | | | | | | | | | | |
| Label | http://www.concerta.net/concerta/assets/prescribing_info.pdf#zoom=56 | | | | | | | | | | |
| Indication | ADHD | | | | | | | | | | |
| Mechanism | Stimulant blocks the reuptake of dopamine and norepinephrine. Same mechanism as Ritalin. | | | | | | | | | | |
| Approved | April 2000 approval. | | | | | | | | | | |
| Competition | Adderall (generic), Adderall XR (Shire), Vyvanse (Shire), Ritalin (generic), Strattera (Lilly), Daytrana. | | | | | | | | | | |
| IP | IPXL and ADRX suing. CP holding up generics? OROS patents are orange-book listed and expire in 2017-2018. | | | | | | | | | | |
| | JNJ filed Citizen Petition 3/19/2004. | | | | | | | | | | |
| | http://www.fda.gov/ohrms/DOCKETS/ | | | | | | | | | | |
| Economics | 1 | | | | | | | | | | |
| Clinical Studies | | | | | | | | | | | |
| | 3 Phase III ADHD Trials - Children vs Placebo. N=416 (3 studies) | | | | | | | | | | |
| | Study 1 - Approx 7 vs 11.5 symptoms Concerta vs Placebo. N=122 | | | | | | | | | | |
| | Study 2 - Approx 5 vs 10.5 " | | | | | | | | | | |
| | Study 3 - Approx 6 vs 10 " | | | | | | | | | | |
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| Rx | | TRx | NRx | | | | | | | | |
| | 6/1/2007 | 132809 | 132496 | | | | | | | | |
| | 5/25/2007 | 158528 | 158166 | | | | | | | | |
| | 6/1/2006 | 130823 | 130410 | | | | | | | | |
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| | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 |
| US | | | | #ERROR_#REF! | #ERROR_#REF! | #ERROR_#REF! | | | | | |
| ROW | | | | #ERROR_#REF! | #ERROR_#REF! | #ERROR_#REF! | | | | | |
| WW | | | | #ERROR_#REF! | #ERROR_#REF! | 774 | 929 | 1027 | 1142.5 | | |