ABCDEFGHIJKLM
1Main
2Brand NameConcerta Extended-Release
3Generic Namemethylphenidate extended-release
4Labelhttp://www.concerta.net/concerta/assets/prescribing_info.pdf#zoom=56
5IndicationADHD
6MechanismStimulant blocks the reuptake of dopamine and norepinephrine. Same mechanism as Ritalin.
7ApprovedApril 2000 approval.
8CompetitionAdderall (generic), Adderall XR (Shire), Vyvanse (Shire), Ritalin (generic), Strattera (Lilly), Daytrana.
9IPIPXL and ADRX suing. CP holding up generics? OROS patents are orange-book listed and expire in 2017-2018.
10JNJ filed Citizen Petition 3/19/2004.
11http://www.fda.gov/ohrms/DOCKETS/
12Economics1
13Clinical Studies
143 Phase III ADHD Trials - Children vs Placebo. N=416 (3 studies)
15Study 1 - Approx 7 vs 11.5 symptoms Concerta vs Placebo. N=122
16Study 2 - Approx 5 vs 10.5 "
17Study 3 - Approx 6 vs 10 "
18
19
20RxTRxNRx
216/1/2007132809132496
225/25/2007158528158166
236/1/2006130823130410
24
25
2620002001200220032004200520062007200820092010
27US#ERROR_#REF!#ERROR_#REF!#ERROR_#REF!
28ROW#ERROR_#REF!#ERROR_#REF!#ERROR_#REF!
29WW#ERROR_#REF!#ERROR_#REF!77492910271142.5