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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 from the latest Edition (delistings since January 25, 2013 ) 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
N020213 001 ACETYLCHOLINE CHLORIDE MIOCHOL-E 6261546
N021795 001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 7022340
N021795 002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 7022340
N020690 001 DONEPEZIL HYDROCHLORIDE ARICEPT 6245911
N020690 001 DONEPEZIL HYDROCHLORIDE ARICEPT 6140321
N020690 001 DONEPEZIL HYDROCHLORIDE ARICEPT 5985864
N020690 002 DONEPEZIL HYDROCHLORIDE ARICEPT 6245911
N020690 002 DONEPEZIL HYDROCHLORIDE ARICEPT 5985864
N020690 002 DONEPEZIL HYDROCHLORIDE ARICEPT 6140321
N021027 001 DOXERCALCIFEROL HECTOROL 6903083
N021027 001 DOXERCALCIFEROL HECTOROL 7148211
N021027 002 DOXERCALCIFEROL HECTOROL 7148211
N021437 001 EPLERENONE INSPRA 6863902
N021437 001 EPLERENONE INSPRA 6863902*PED
N021437 002 EPLERENONE INSPRA 6863902
N021437 002 EPLERENONE INSPRA 6863902*PED
N022386 001 METFORMIN HYDROCHLORIDE; REPAGLINIDE PRANDIMET 6677358
N022386 002 METFORMIN HYDROCHLORIDE; REPAGLINIDE PRANDIMET 6677358
N200678 001 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR 6395767
N200678 002 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR 6395767
N200678 003 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR 6395767
N020868 001 METRONIDAZOLE FLAGYL ER 6103262
N021654 001 OMEGA-3-ACID ETHYL ESTERS LOVAZA 7732488
N021849 001 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6489346
N021849 001 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6699885
N021849 001 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6645988
N021849 002 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6489346
N021849 002 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6699885
N021849 002 OMEPRAZOLE; SODIUM BICARBONATE ZEGERID 6645988
N022307 001 PRASUGREL HYDROCHLORIDE EFFIENT 6693115
N022307 002 PRASUGREL HYDROCHLORIDE EFFIENT 6693115
N020741 001 REPAGLINIDE PRANDIN 6677358
N020741 002 REPAGLINIDE PRANDIN 6677358
N020741 003 REPAGLINIDE PRANDIN 6677358
N021346 004 RISPERIDONE RISPERDAL CONSTA 6667061
N021346 004 RISPERIDONE RISPERDAL CONSTA 6110503
N021346 004 RISPERIDONE RISPERDAL CONSTA 6110503*PED
N021346 004 RISPERIDONE RISPERDAL CONSTA 6667061*PED
N022350 001 SAXAGLIPTIN HYDROCHLORIDE ONGLYZA 6395767
N022350 002 SAXAGLIPTIN HYDROCHLORIDE ONGLYZA 6395767
N021148 008 SOMATROPIN RECOMBINANT NORDITROPIN FLEXPRO 6716198
N021148 009 SOMATROPIN RECOMBINANT NORDITROPIN FLEXPRO 6716198
N021148 010 SOMATROPIN RECOMBINANT NORDITROPIN FLEXPRO 6716198
N020898 001 THYROTROPIN ALFA THYROGEN 6365127
N203975 001 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE ANORO ELLIPTA 7361787



The following search results are a list of patents that have been DELISTED from the latest Edition (delistings since January 25, 2013 ) of the Orange Book. Search results display delisted patents from drug products on the OTC list.

Appl No Prod No Active Ingredient Proprietary Name Delisted Patent
N020832 002 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL CHLORAPREP WITH TINT 6991393
N020832 003 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL CHLORAPREP ONE-STEP FREPP 5752363
N020832 005 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL CHLORAPREP WITH TINT 6991393
N020832 007 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL CHLORAPREP WITH TINT 6991393



The following search results are a list of patents that have been DELISTED from the latest Edition (delistings since January 25, 2013 ) 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
N021437 003 EPLERENONE INSPRA 6863902
N021437 003 EPLERENONE INSPRA 6863902*PED
N020545 001 PROCAINAMIDE HYDROCHLORIDE PROCANBID 5656296
N020545 002 PROCAINAMIDE HYDROCHLORIDE PROCANBID 5656296

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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 2014
Patent and Generic Drug Product Data Last Updated July 23, 2014

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