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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Delisted patents from the Rx, OTC, and Disc drug lists are displayed in individual tables below.


The following search results are a list of patents that have been DELISTED since the latest Annual Edition of the Orange Book. Search results display delisted patents from drug products on the RX list.

Appl No Prod No Active Ingredient Proprietary Name Delisted Patent
N021539 001 ACETYLCYSTEINE ACETADOTE 8952065
N020998 001 CELECOXIB CELEBREX 5760068
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX RE44048
N020998 001 CELECOXIB CELEBREX 5760068*PED
N020998 001 CELECOXIB CELEBREX RE44048*PED
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX RE44048
N020998 002 CELECOXIB CELEBREX 5760068
N020998 002 CELECOXIB CELEBREX 5760068*PED
N020998 002 CELECOXIB CELEBREX RE44048*PED
N020998 003 CELECOXIB CELEBREX 5760068
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX RE44048
N020998 003 CELECOXIB CELEBREX 5760068*PED
N020998 003 CELECOXIB CELEBREX RE44048*PED
N020998 004 CELECOXIB CELEBREX 5760068
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX RE44048
N020998 004 CELECOXIB CELEBREX 5760068*PED
N020998 004 CELECOXIB CELEBREX RE44048*PED
N203389 001 CYSTEAMINE BITARTRATE PROCYSBI 8129433
N203389 002 CYSTEAMINE BITARTRATE PROCYSBI 8129433
N019955 001 DESMOPRESSIN ACETATE DDAVP 7022340
N019955 002 DESMOPRESSIN ACETATE DDAVP 7022340
N022454 001 IOFLUPANE I-123 DATSCAN 5310912
N202270 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7459428
N202270 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6890898
N202270 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7078381
N202270 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6303661
N202270 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7078381
N202270 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6303661
N202270 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7459428
N202270 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6890898
N202270 003 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7459428
N202270 003 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6890898
N202270 003 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 6303661
N202270 003 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR 7078381
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6303661
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7459428
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N022044 001 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6303661
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7078381
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 7459428
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N022044 002 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET 6890898
N021545 001 OLOPATADINE HYDROCHLORIDE PATADAY 5641805
N021545 001 OLOPATADINE HYDROCHLORIDE PATADAY 5641805*PED
N021654 001 OMEGA-3-ACID ETHYL ESTERS LOVAZA 5656667
N021071 002 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 002 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 002 ROSIGLITAZONE MALEATE AVANDIA 5741803*PED
N021071 003 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 003 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 003 ROSIGLITAZONE MALEATE AVANDIA 5741803*PED
N021071 004 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 004 ROSIGLITAZONE MALEATE AVANDIA 5741803
N021071 004 ROSIGLITAZONE MALEATE AVANDIA 5741803*PED
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 6303661
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 001 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 6890898
N021995 002 SITAGLIPTIN PHOSPHATE JANUVIA 6303661
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 7078381
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 6303661
N021995 003 SITAGLIPTIN PHOSPHATE JANUVIA 6890898



There have been no patent delistings from the Orange Book in the OTC list since the last Annual Edition.





The following search results are a list of patents that have been DELISTED since the latest Annual Edition of the Orange Book. Search results display delisted patents from drug products on the DISC list.

Appl No Prod No Active Ingredient Proprietary Name Delisted Patent
N021700 001 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 001 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 001 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803*PED
N021700 002 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 002 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 002 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803*PED
N021700 003 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 003 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803
N021700 003 GLIMEPIRIDE; ROSIGLITAZONE MALEATE AVANDARYL 5741803*PED
N021410 001 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 001 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 001 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803*PED
N021410 002 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 002 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 002 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803*PED
N021410 003 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 003 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 003 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803*PED
N021410 004 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 004 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 004 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803*PED
N021410 005 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 005 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803
N021410 005 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET 5741803*PED

Return to Electronic Orange Book Home Page


FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through December 2015
Patent and Generic Drug Product Data Last Updated February 09, 2016

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