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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
N021107 001 ALOSETRON HYDROCHLORIDE LOTRONEX 6284770
N021107 002 ALOSETRON HYDROCHLORIDE LOTRONEX 6284770
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
N205755 001 CERITINIB ZYKADIA 8039474
N203389 001 CYSTEAMINE BITARTRATE PROCYSBI 8129433
N203389 002 CYSTEAMINE BITARTRATE PROCYSBI 8129433
N019955 001 DESMOPRESSIN ACETATE DDAVP 7022340
N019955 002 DESMOPRESSIN ACETATE DDAVP 7022340
N021720 001 DONEPEZIL HYDROCHLORIDE ARICEPT ODT 7727548
N021720 001 DONEPEZIL HYDROCHLORIDE ARICEPT ODT 7727552
N021720 002 DONEPEZIL HYDROCHLORIDE ARICEPT ODT 7727548
N021720 002 DONEPEZIL HYDROCHLORIDE ARICEPT ODT 7727552
N022200 001 EXENATIDE SYNTHETIC BYDUREON 8216180
N022200 001 EXENATIDE SYNTHETIC BYDUREON 8439864
N012827 001 GLYCOPYRROLATE ROBINUL 7091236
N012827 002 GLYCOPYRROLATE ROBINUL FORTE 7091236
N022472 001 INSULIN RECOMBINANT HUMAN AFREZZA 8227409
N022472 002 INSULIN RECOMBINANT HUMAN AFREZZA 8227409
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
N202611 001 MIRABEGRON MYRBETRIQ 7750029
N202611 002 MIRABEGRON MYRBETRIQ 7750029
N021545 001 OLOPATADINE HYDROCHLORIDE PATADAY 5641805
N021545 001 OLOPATADINE HYDROCHLORIDE PATADAY 5641805*PED
N021654 001 OMEGA-3-ACID ETHYL ESTERS LOVAZA 5656667
N022307 001 PRASUGREL HYDROCHLORIDE EFFIENT 6693115
N022307 001 PRASUGREL HYDROCHLORIDE EFFIENT 6693115*PED
N022307 002 PRASUGREL HYDROCHLORIDE EFFIENT 6693115
N022307 002 PRASUGREL HYDROCHLORIDE EFFIENT 6693115*PED
N021959 001 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6221392
N021959 001 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6024981
N021959 002 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6221392
N021959 002 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6024981
N021959 003 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6024981
N021959 003 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT 6221392
N020533 001 ROPIVACAINE HYDROCHLORIDE NAROPIN 7857802
N020533 001 ROPIVACAINE HYDROCHLORIDE NAROPIN 8162915
N020533 001 ROPIVACAINE HYDROCHLORIDE NAROPIN 7828787
N020533 001 ROPIVACAINE HYDROCHLORIDE NAROPIN 8118802
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
N020760 001 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE 6194429
N020760 001 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE 6080756
N020760 002 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE 6080756
N020760 002 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE 6194429
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
N022348 001 IBUPROFEN CALDOLOR 9295639
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
N020720 001 TROGLITAZONE REZULIN 6011049
N020720 001 TROGLITAZONE REZULIN 5859037
N020720 002 TROGLITAZONE REZULIN 5859037
N020720 002 TROGLITAZONE REZULIN 6011049
N020720 003 TROGLITAZONE REZULIN 6011049
N020720 003 TROGLITAZONE REZULIN 5859037
N020759 001 TROVAFLOXACIN MESYLATE TROVAN 6187341
N020759 002 TROVAFLOXACIN MESYLATE TROVAN 6187341

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 June 2016
Patent and Generic Drug Product Data Last Updated July 22, 2016

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