Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Delisted Patents

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No.	Patent Use	Mkt. Status	Submission Date
Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No.	Patent Use	Mkt. Status	Submission Date
N022511	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	VIMOVO	TABLET, DELAYED RELEASE	ORAL	EQ 20MG BASE;500MG	6926907	U-1052 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER	RX
N022511	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	VIMOVO	TABLET, DELAYED RELEASE	ORAL	EQ 20MG BASE;375MG	6926907	U-1052 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER	RX
N021398	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	COMBIGAN	SOLUTION/DROPS	OPHTHALMIC	0.2%;EQ 0.5% BASE	7323463		RX
N201656	DESMOPRESSIN ACETATE	NOCTIVA	SPRAY, METERED	NASAL	0.00083MG/SPRAY	7405203	U-1980 A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS	DISCN	03/31/2017
N201656	DESMOPRESSIN ACETATE	NOCTIVA	SPRAY, METERED	NASAL	0.00166MG/SPRAY	7405203	U-1980 A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS	DISCN	03/31/2017
N201656	DESMOPRESSIN ACETATE	NOCTIVA	SPRAY, METERED	NASAL	0.00083MG/SPRAY	7579321	U-1980 A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS	DISCN	03/31/2017
N201656	DESMOPRESSIN ACETATE	NOCTIVA	SPRAY, METERED	NASAL	0.00166MG/SPRAY	7579321	U-1980 A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS	DISCN	03/31/2017
N022519	FAMOTIDINE; IBUPROFEN	DUEXIS	TABLET	ORAL	26.6MG;800MG	8067033		RX	11/30/2011
N213026	CASIMERSEN	AMONDYS 45	SOLUTION	INTRAVENOUS	100MG/2ML (50MG/ML)	8524880	U-3088 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING	RX	03/23/2021
N213026	CASIMERSEN	AMONDYS 45	SOLUTION	INTRAVENOUS	100MG/2ML (50MG/ML)	8524880	U-3087 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY INDUCING EXON-SKIPPING OF EXON 45	RX	03/23/2021
N022511	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	VIMOVO	TABLET, DELAYED RELEASE	ORAL	EQ 20MG BASE;500MG	8557285		RX	10/29/2013
N022511	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	VIMOVO	TABLET, DELAYED RELEASE	ORAL	EQ 20MG BASE;375MG	8557285		RX	10/29/2013
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	8629111		RX	01/14/2014
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	8633162	U-1479 INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).	RX	01/22/2014
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	8642556		RX	02/04/2014
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	8648048	U-1483 INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).	RX	02/11/2014
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	8685930		RX	04/01/2014
N050790	CYCLOSPORINE	RESTASIS	EMULSION	OPHTHALMIC	0.05%	9248191	U-1479 INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).	RX	02/02/2016
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9539310	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	01/11/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9539310*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9545434	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	01/19/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9545434*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9545435	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	01/19/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9545435*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9555079	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	02/02/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9555079*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9572867	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	02/22/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9572867*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9592273	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	03/27/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9592273*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9592274	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	03/27/2017
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9592274*PED		RX
N210498	BINIMETINIB	MEKTOVI	TABLET	ORAL	15MG	9593100		RX	07/25/2018
N209299	FOSTAMATINIB DISODIUM	TAVALISSE	TABLET	ORAL	EQ 100MG BASE	9737554		RX	05/16/2018
N209299	FOSTAMATINIB DISODIUM	TAVALISSE	TABLET	ORAL	EQ 150MG BASE	9737554		RX	05/16/2018
N211635	DIAZEPAM	VALTOCO	SPRAY	NASAL	10MG/SPRAY	9763876	U-2727 NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER	RX	02/06/2020
N211635	DIAZEPAM	VALTOCO	SPRAY	NASAL	7.5MG/SPRAY	9763876	U-2727 NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER	RX	02/06/2020
N211635	DIAZEPAM	VALTOCO	SPRAY	NASAL	5MG/SPRAY	9763876	U-2727 NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER	RX	02/06/2020
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968655	U-2308 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/23/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968655*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968656	U-2308 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/23/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968656*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968658	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/30/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9968658*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9974835	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/30/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9974835*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9974837	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/30/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9974837*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9981014	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	06/06/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9981014*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9981016	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	05/30/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9981016*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9987334	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	06/06/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9987334*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9987335	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	06/29/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9987335*PED		RX
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9993528	U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT	RX	06/29/2018
N203441	TEDUGLUTIDE RECOMBINANT	GATTEX KIT	POWDER	SUBCUTANEOUS	5MG/VIAL	9993528*PED		RX

View a list of all patent use codes
View a list of all exclusivity codes

Last Updated August 05, 2022.