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Delisted Patents

About This List

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

Additional Information about Patents
  • 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.

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