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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
N203565 FERRIC CARBOXYMALTOSE INJECTAFER SOLUTION INTRAVENOUS 750MG IRON/15ML (50MG IRON/ML) 10519252
RX 01/17/2020
N203565 FERRIC CARBOXYMALTOSE INJECTAFER SOLUTION INTRAVENOUS 500MG IRON/10ML (50MG IRON/ML) 10519252
RX 02/02/2021
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.232MG/INH 10918816
DISCN 03/18/2021
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.055MG/INH 10918816
DISCN 03/18/2021
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.113MG/INH 10918816
DISCN 03/18/2021
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.232MG/INH 10918816*PED
DISCN
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.055MG/INH 10918816*PED
DISCN
N208798 FLUTICASONE PROPIONATE ARMONAIR RESPICLICK POWDER INHALATION 0.113MG/INH 10918816*PED
DISCN
N021903 IBUPROFEN LYSINE NEOPROFEN INJECTABLE INTRAVENOUS EQ 20MG BASE/2ML (EQ 10MG BASE/ML) 6344479
U-794 CLOSURE OF A CLINICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
RX
N021398 BRIMONIDINE TARTRATE; TIMOLOL MALEATE COMBIGAN SOLUTION/DROPS OPHTHALMIC 0.2%;EQ 0.5% BASE 7323463
RX
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 7582621
U-2016 TREATMENT FOR ONYCHOMYCOSIS THAT IS TINEA UNGUIUM
RX 07/21/2014
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 7582621*PED
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 7674799
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 7674800
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 7683072
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 7776314
RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 7776314
RX
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7910605
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7910605
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7910605
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7910605
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
RX 09/11/2019
N021775 ALVIMOPAN ENTEREG CAPSULE ORAL 12MG 8112290
U-1443 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
RX 03/01/2012
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8168209
RX 04/23/2013
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8168209
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8168209
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8168209
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8168209*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8168209*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8168209*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8168209*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8173708
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX 04/23/2013
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8173708
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8173708
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8173708
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8173708*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8173708*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8173708*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8173708*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8283379
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX 04/23/2013
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8283379
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8283379
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8283379
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8283379*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8283379*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8283379*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8283379*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8329752
RX 04/23/2013
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8329752
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8329752
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8329752
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8329752*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8329752*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8329752*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8329752*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8362085
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX 04/22/2013
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8362085
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8362085
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8362085
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 7MG 8362085*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 14MG 8362085*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 21MG 8362085*PED
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8362085*PED
RX
N206488 ETEPLIRSEN EXONDYS 51 SOLUTION INTRAVENOUS 100MG/2ML (50MG/ML) 8486907
U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
RX 10/17/2016
N206488 ETEPLIRSEN EXONDYS 51 SOLUTION INTRAVENOUS 500MG/10ML (50MG/ML) 8486907
U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
RX 10/17/2016
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8598233
RX
N022525 MEMANTINE HYDROCHLORIDE NAMENDA XR CAPSULE, EXTENDED RELEASE ORAL 28MG 8598233*PED
RX
N021775 ALVIMOPAN ENTEREG CAPSULE ORAL 12MG 8645160
U-1485 TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
RX
N202736 IVERMECTIN SKLICE LOTION TOPICAL 0.5% 8791153
OTC 08/27/2014
N202736 IVERMECTIN SKLICE LOTION TOPICAL 0.5% 8927595
U-1782 FOR HEAD LICE INFESTATIONS
OTC 12/17/2015
N213973 RIPRETINIB QINLOCK TABLET ORAL 50MG 8940756
U-2829 TREATMENT OF GASTROINTESTINAL STROMAL TUMORS
RX 06/11/2020
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9549938
U-1951 TREATMENT OF ONYCHOMYCOSIS OF A TOENAIL
RX 02/06/2017
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9549938*PED
RX
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9566289
RX 02/21/2017
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9566289*PED
RX
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9566290
U-1970 TREATMENT OF ONYCHOMYCHOSIS OF A TOENAIL CAUSED BY TRICHOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES
RX 02/21/2017
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9566290*PED
RX
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9572823
U-1970 TREATMENT OF ONYCHOMYCHOSIS OF A TOENAIL CAUSED BY TRICHOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES
RX 03/17/2017
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9572823*PED
RX

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View a list of all exclusivity codes

Last Updated November 26, 2021.

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