Bupropion / Naltrexone Extended Release Oral Tablet

Brand(s)
Contrave
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2014-09-22)
Oldest Current Product
2014-09-10
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\BUPROPION:NALTREXONE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\BUPROPION HYDROCHLORIDE: NALTREXONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\BUPROPION HYDROCHLORIDE: NALTREXONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\BUPROPION: NALTREXONE

product(s) by strength(s)

12 hr bupropion hydrochloride 90 mg / naltrexone hydrochloride 8 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640890ContraveNDATakeda Pharmaceuticals America, Inc.2014-09-10BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200063ed2da3a6-0614-4bea-8e82-962cbaae6428

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200063CONTRAVETAKEDA PHARMACEUTICALS USA INC2014-09-10p9125868, USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
p8088786, SUBSTANCE
p7375111, SUBSTANCE
p8916195, USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
p7462626, FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
p8318788, USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
p8722085, USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
p8815889, FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
p9107837, USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
NEW COMBINATION [2017-09-10]NDA200063_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200063_001RXNALTREXONE HYDROCHLORIDE (8MG), BUPROPION HYDROCHLORIDE (90MG)ORALTABLET, EXTENDED RELEASETrue2014-09-10CONTRAVE

patent(s)

#idexpiration dateapplication(s)
1p7375111 (view patent)2025-03-26NDA200063
2p7462626 (view patent)2024-07-20NDA200063
3p8088786 (view patent)2029-02-03NDA200063
4p8318788 (view patent)2027-11-08NDA200063
5p8722085 (view patent)2027-11-08NDA200063
6p8815889 (view patent)2024-07-20NDA200063
7p8916195 (view patent)2030-02-02NDA200063
8p9107837 (view patent)2027-06-04NDA200063
9p9125868 (view patent)2027-11-08NDA200063

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ed2da3a6-0614-4bea-8e82-962cbaae6428 (view SPL)These highlights do not include all the information needed to use CONTRAVE safely and effectively.See full prescribing information for CONTRAVE. CONTRAVE (naltrexone HCl and bupropion HCl)Extended-Release TabletsInitial U.S. Approval: 2014prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2014-09-221647640890

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII