Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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 for each of the records below may be found in the links above the search box: CSV, Excel, and Print.
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 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 140MG | 10653696 |
U-1456
TREATMENT OF MANTLE CELL LYMPHOMA
|
RX | 06/12/2020 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 70MG | 10653696 |
U-1456
TREATMENT OF MANTLE CELL LYMPHOMA
|
RX | 06/12/2020 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 140MG | 10653696*PED |
|
RX | |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 70MG | 10653696*PED |
|
RX | |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 10675296 |
|
RX | 11/12/2020 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 10675296*PED |
|
RX | |
| N021225 | LEVONORGESTREL | MIRENA | INTRAUTERINE DEVICE | INTRAUTERINE | 52MG | 10987244 |
|
RX | 05/25/2021 |
| N203159 | LEVONORGESTREL | SKYLA | INTRAUTERINE DEVICE | INTRAUTERINE | 13.5MG | 10987244 |
|
RX | 05/25/2021 |
| N208224 | LEVONORGESTREL | KYLEENA | INTRAUTERINE DEVICE | INTRAUTERINE | 19.5MG | 10987244 |
|
RX | 05/25/2021 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 11266681 |
U-2984
TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG) REQUIRING HOSPITALIZATION
|
RX | 04/04/2022 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 11266681 |
U-3367
TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
|
RX | 04/04/2022 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 11266681 |
U-3249
TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG)
|
RX | 04/04/2022 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 11266681 |
U-3368
TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
|
RX | 04/04/2022 |
| N214787 | REMDESIVIR | VEKLURY | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | 11266681*PED |
|
RX | |
| N209863 | TESTOSTERONE ENANTHATE | XYOSTED (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 75MG/0.5ML (75MG/0.5ML) | 11771646 |
|
RX | 10/12/2023 |
| N209863 | TESTOSTERONE ENANTHATE | XYOSTED (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 50MG/0.5ML (50MG/0.5ML) | 11771646 |
|
RX | 10/12/2023 |
| N209863 | TESTOSTERONE ENANTHATE | XYOSTED (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 100MG/0.5ML (100MG/0.5ML) | 11771646 |
|
RX | 10/12/2023 |
| N021454 | TESTOSTERONE | TESTIM | GEL | TRANSDERMAL | 50MG/5GM PACKET | 7320968 |
U-843
METHOD FOR ADMINISTRATION OF TESTOSTERONE
|
RX | |
| N022076 | HYDROCORTISONE BUTYRATE | LOCOID | LOTION | TOPICAL | 0.1% | 7378405 |
|
RX | |
| N021254 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | ADVAIR HFA | AEROSOL, METERED | INHALATION | 0.045MG/INH;EQ 0.021MG BASE/INH | 7500444 |
|
RX | |
| N021254 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | ADVAIR HFA | AEROSOL, METERED | INHALATION | 0.23MG/INH;EQ 0.021MG BASE/INH | 7500444 |
|
RX | |
| N021254 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | ADVAIR HFA | AEROSOL, METERED | INHALATION | 0.045MG/INH;EQ 0.021MG BASE/INH | 7500444*PED |
|
RX | |
| N021254 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | ADVAIR HFA | AEROSOL, METERED | INHALATION | 0.23MG/INH;EQ 0.021MG BASE/INH | 7500444*PED |
|
RX | |
| N021318 | TERIPARATIDE | FORTEO | SOLUTION | SUBCUTANEOUS | 0.6MG/2.4ML (0.25MG/ML) | 7517334 |
|
RX | 09/10/2014 |
| N021196 | SODIUM OXYBATE | XYREM | SOLUTION | ORAL | 0.5GM/ML | 7668730 |
U-1110
METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
|
RX | |
| N021196 | SODIUM OXYBATE | XYREM | SOLUTION | ORAL | 0.5GM/ML | 7668730*PED |
|
RX | |
| N215457 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | 10MG/0.4ML (10MG/0.4ML) | 7918823 |
|
DISCN | 03/25/2022 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 7918823 |
|
RX | 02/22/2013 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 7918823 |
|
RX | |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 7918823 |
|
RX | 12/15/2017 |
| N022519 | FAMOTIDINE; IBUPROFEN | DUEXIS | TABLET | ORAL | 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 8067033 |
|
DISCN | 11/30/2011 |
| N201688 | TOBRAMYCIN | TOBI PODHALER | POWDER | INHALATION | 28MG | 8069851 |
|
RX | 04/19/2013 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8113199 |
|
RX | 08/28/2014 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8113199 |
|
RX | 06/13/2018 |
| N203975 | UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | ANORO ELLIPTA | POWDER | INHALATION | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 01/09/2014 |
| N205382 | UMECLIDINIUM BROMIDE | INCRUSE ELLIPTA | POWDER | INHALATION | EQ 0.0625MG BASE/INH | 8113199 |
|
RX | 05/21/2014 |
| N209482 | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | TRELEGY ELLIPTA | POWDER | INHALATION | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 10/06/2017 |
| N209482 | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | TRELEGY ELLIPTA | POWDER | INHALATION | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 10/06/2020 |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.1MG/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 06/04/2013 |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.2MG/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 05/07/2015 |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.05MG/INH;EQ 0.025MG BASE/INH | 8113199 |
|
RX | 06/09/2023 |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.1MG/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N203975 | UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | ANORO ELLIPTA | POWDER | INHALATION | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8113199*PED |
|
RX | |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.2MG/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N209482 | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | TRELEGY ELLIPTA | POWDER | INHALATION | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8113199*PED |
|
RX | |
| N209482 | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | TRELEGY ELLIPTA | POWDER | INHALATION | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N204275 | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | BREO ELLIPTA | POWDER | INHALATION | 0.05MG/INH;EQ 0.025MG BASE/INH | 8113199*PED |
|
RX | |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8161968 |
|
RX | 08/28/2014 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8161968 |
|
RX | 06/13/2018 |
| N205382 | UMECLIDINIUM BROMIDE | INCRUSE ELLIPTA | POWDER | INHALATION | EQ 0.0625MG BASE/INH | 8161968 |
|
RX | 05/21/2014 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8161968*PED |
|
RX | |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8161968*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8168209 |
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8168209*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8173708 |
U-1641
MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8173708*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8283379 |
U-1641
MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8283379*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8329752 |
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8329752 |
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8329752*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8329752*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8362085 |
U-1641
MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8362085 |
U-1641
MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8362085*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8362085*PED |
|
RX | |
| N210496 | ENCORAFENIB | BRAFTOVI | CAPSULE | ORAL | 75MG | 8501758 |
|
RX | 07/25/2018 |
| N210496 | ENCORAFENIB | BRAFTOVI | CAPSULE | ORAL | 50MG | 8501758 |
|
DISCN | 07/25/2018 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8534281 |
|
RX | 08/28/2014 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8534281 |
|
RX | 06/13/2018 |
| N205382 | UMECLIDINIUM BROMIDE | INCRUSE ELLIPTA | POWDER | INHALATION | EQ 0.0625MG BASE/INH | 8534281 |
|
RX | 05/21/2014 |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.2MG/INH | 8534281*PED |
|
RX | |
| N205625 | FLUTICASONE FUROATE | ARNUITY ELLIPTA | POWDER | INHALATION | 0.05MG/INH | 8534281*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8598233 |
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8598233 |
|
RX | 08/16/2016 |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | 8598233*PED |
|
RX | |
| N206439 | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | NAMZARIC | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | 8598233*PED |
|
RX | |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 8734394 |
|
RX | 06/09/2022 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 8734394 |
|
RX | 12/07/2023 |
| N022051 | FLUTICASONE FUROATE | FLONASE SENSIMIST ALLERGY RELIEF | SPRAY, METERED | NASAL | 0.0275MG/SPRAY | 8752543 |
|
OTC | 08/31/2016 |
| N022511 | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | VIMOVO | TABLET, DELAYED RELEASE | ORAL | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 8945621 |
U-1661
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
|
DISCN | 03/02/2015 |
| N022511 | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | VIMOVO | TABLET, DELAYED RELEASE | ORAL | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 8945621 |
U-1661
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
|
DISCN | 03/02/2015 |
| N215457 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | 10MG/0.4ML (10MG/0.4ML) | 9056170 |
|
DISCN | 03/25/2022 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 9056170 |
|
RX | 07/16/2015 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 9056170 |
|
RX | 07/16/2015 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 9056170 |
|
RX | 12/15/2017 |
| N203284 | GLYCEROL PHENYLBUTYRATE | RAVICTI | LIQUID | ORAL | 1.1GM/ML | 9095559 |
U-1383
DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
|
RX | 09/03/2015 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 9149579 |
U-1758
METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
|
RX | 11/06/2015 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 9149579 |
U-1758
METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
|
RX | 11/06/2015 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 9149579 |
U-1758
METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
|
RX | 12/15/2017 |
| N022511 | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | VIMOVO | TABLET, DELAYED RELEASE | ORAL | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9220698 |
U-1781
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
|
DISCN | 01/28/2016 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 9259539 |
|
RX | 03/23/2016 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 9259539 |
|
RX | 03/23/2016 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 9259539 |
|
RX | 12/15/2017 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 9278182 |
|
RX | 04/11/2016 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 9278182 |
|
RX | 04/11/2016 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 9278182 |
|
RX | 12/15/2017 |
| N022511 | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | VIMOVO | TABLET, DELAYED RELEASE | ORAL | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9393208 |
U-1781
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
|
DISCN | 08/17/2016 |
| N022511 | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | VIMOVO | TABLET, DELAYED RELEASE | ORAL | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9393208 |
U-1781
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
|
DISCN | 08/17/2016 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N215866 | TIRZEPATIDE | MOUNJARO (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 9402957 |
|
RX | 06/09/2022 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N217806 | TIRZEPATIDE | ZEPBOUND (AUTOINJECTOR) | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 9402957 |
|
RX | 12/07/2023 |
| N211723 | TAZEMETOSTAT HYDROBROMIDE | TAZVERIK | TABLET | ORAL | EQ 200MG BASE | 9522152 |
U-2738
METHOD OF TREATING A LUNG METASTASIS OF EPITHELIOID SARCOMA
|
RX | 02/19/2020 |
| N209195 | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | VOSEVI | TABLET | ORAL | 400MG;100MG;100MG | 9585906 |
U-2039
TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
|
RX | 07/28/2017 |
| N209195 | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | VOSEVI | TABLET | ORAL | 400MG;100MG;100MG | 9585906 |
U-2040
TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
|
RX | 07/28/2017 |
| N021225 | LEVONORGESTREL | MIRENA | INTRAUTERINE DEVICE | INTRAUTERINE | 52MG | 9615965 |
U-2003
A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
|
RX | 05/09/2017 |
| N203159 | LEVONORGESTREL | SKYLA | INTRAUTERINE DEVICE | INTRAUTERINE | 13.5MG | 9615965 |
U-2003
A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
|
RX | 05/09/2017 |
| N208224 | LEVONORGESTREL | KYLEENA | INTRAUTERINE DEVICE | INTRAUTERINE | 19.5MG | 9615965 |
U-2003
A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
|
RX | 05/09/2017 |
| N021225 | LEVONORGESTREL | MIRENA | INTRAUTERINE DEVICE | INTRAUTERINE | 52MG | 9668912 |
|
RX | 06/28/2017 |
| N203159 | LEVONORGESTREL | SKYLA | INTRAUTERINE DEVICE | INTRAUTERINE | 13.5MG | 9668912 |
|
RX | 06/28/2017 |
| N208224 | LEVONORGESTREL | KYLEENA | INTRAUTERINE DEVICE | INTRAUTERINE | 19.5MG | 9668912 |
|
RX | 06/28/2017 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 9724471 |
U-2092
METHOD FOR CONFIRMING DOSE DELIVERY
|
RX | 08/23/2017 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 9724471 |
U-2092
METHOD FOR CONFIRMING DOSE DELIVERY
|
RX | 08/23/2017 |
| N201739 | EPINEPHRINE | AUVI-Q | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 9724471 |
U-2092
METHOD FOR CONFIRMING DOSE DELIVERY
|
RX | 12/15/2017 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 140MG | 9814721 |
U-1947
TREATMENT OF MARGINAL ZONE LYMPHOMA
|
RX | 11/29/2017 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 70MG | 9814721 |
U-1947
TREATMENT OF MARGINAL ZONE LYMPHOMA
|
RX | 01/19/2018 |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 140MG | 9814721*PED |
|
RX | |
| N205552 | IBRUTINIB | IMBRUVICA | CAPSULE | ORAL | 70MG | 9814721*PED |
|
RX | |
| N211723 | TAZEMETOSTAT HYDROBROMIDE | TAZVERIK | TABLET | ORAL | EQ 200MG BASE | 9872862 |
U-2738
METHOD OF TREATING A LUNG METASTASIS OF EPITHELIOID SARCOMA
|
RX | 02/19/2020 |
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Last Updated April 18, 2024.