Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Newly Added Patents

About This List
  • This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
  • This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
  • Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
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.
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
N214783 BELUMOSUDIL MESYLATE REZUROCK TABLET ORAL EQ 200MG BASE 10183931 10/07/2033
U-3246 FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE
RX 11/17/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 10238668 04/19/2030 DS DP
U-3244 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
RX 11/12/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 10245276 04/19/2030 DS DP
RX 11/12/2021
N214902 BENZOYL PEROXIDE; TRETINOIN TWYNEO CREAM TOPICAL 3%;0.1% 10420743 07/12/2038
U-3194 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
RX 11/24/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 10548909 04/19/2030
U-3244 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
RX 11/12/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 10570139 04/22/2034 DS DP
U-1745 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
RX 06/04/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 10570139 04/22/2034 DS DP
U-3063 RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
RX 06/04/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 10570139 04/22/2034 DS DP
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 06/04/2021
N214902 BENZOYL PEROXIDE; TRETINOIN TWYNEO CREAM TOPICAL 3%;0.1% 10653899 12/30/2030 DP
U-3194 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
RX 11/24/2021
N214783 BELUMOSUDIL MESYLATE REZUROCK TABLET ORAL EQ 200MG BASE 10696660 10/07/2033
U-3246 FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE
RX 11/17/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 11142528 04/22/2034 DS DP
U-1745 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
RX 11/12/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 11142528 04/22/2034 DS DP
U-3063 RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
RX 11/12/2021
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 11142528 04/22/2034 DS DP
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 11/12/2021
N208010 CALCIFEDIOL RAYALDEE CAPSULE, EXTENDED RELEASE ORAL 0.03MG 11154509 04/25/2028
U-3248 TREATING SECONDARY HYPERPARATHYROIDISM IN STAGE 3/4 CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL WHILE AVOIDING PTH OVERSUPPRESSION
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG/VIAL 11154553 09/24/2033
U-3245 MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG/VIAL 11154553 09/24/2033
U-814 TREATMENT OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG/VIAL 11154553 09/24/2033
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG/VIAL 11154553 09/24/2033
U-3245 MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG/VIAL 11154553 09/24/2033
U-814 TREATMENT OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG/VIAL 11154553 09/24/2033
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG 11154553 09/24/2033
U-3245 MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG 11154553 09/24/2033
U-814 TREATMENT OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 300MG 11154553 09/24/2033
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG 11154553 09/24/2033
U-3245 MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG 11154553 09/24/2033
U-814 TREATMENT OF SCHIZOPHRENIA
RX 11/17/2021
N202971 ARIPIPRAZOLE ABILIFY MAINTENA KIT FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 400MG 11154553 09/24/2033
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
RX 11/17/2021
N021945 HYDROXYPROGESTERONE CAPROATE MAKENA (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 275MG/1.1ML (250MG/ML) 11154562 05/02/2036
U-2236 REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH
RX 11/17/2021
N206940 ELUXADOLINE VIBERZI TABLET ORAL 75MG 11160792 03/14/2033 DP
RX 11/24/2021
N206940 ELUXADOLINE VIBERZI TABLET ORAL 100MG 11160792 03/14/2033 DP
RX 11/24/2021
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 5MG/ML (5MG/ML) 11162500 06/27/2034 DP
RX 11/12/2021
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 10MG/2ML (5MG/ML) 11162500 06/27/2034 DP
RX 11/12/2021
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 2.5MG/0.5ML (2.5MG/0.5ML) 11162500 06/27/2034 DP
RX 11/12/2021
N209637 SEMAGLUTIDE OZEMPIC SOLUTION SUBCUTANEOUS 2MG/1.5ML (1.34MG/ML) 8129343 12/05/2031 DS DP
U-2202 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
RX 12/20/2017
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 7MG 8129343 12/05/2031 DS DP
U-2628 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
RX 10/15/2019
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 14MG 8129343 12/05/2031 DS DP
U-2628 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
RX 10/15/2019
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 3MG 8129343 12/05/2031 DS DP
U-2628 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
RX 10/15/2019
N209637 SEMAGLUTIDE OZEMPIC SOLUTION SUBCUTANEOUS 4MG/3ML (1.34MG/ML) 8129343 12/05/2031 DS DP
U-2202 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
RX 09/24/2020
N215256 SEMAGLUTIDE WEGOVY SOLUTION SUBCUTANEOUS 1.7MG/0.75ML (1.7MG/0.75ML) 8129343 12/05/2031 DS DP
RX 06/30/2021
N215256 SEMAGLUTIDE WEGOVY SOLUTION SUBCUTANEOUS 0.5MG/0.5ML (0.5MG/0.5ML) 8129343 12/05/2031 DS DP
RX 06/30/2021
N215256 SEMAGLUTIDE WEGOVY SOLUTION SUBCUTANEOUS 2.4MG/0.75ML (2.4MG/0.75ML) 8129343 12/05/2031 DS DP
RX 06/30/2021
N215256 SEMAGLUTIDE WEGOVY SOLUTION SUBCUTANEOUS 0.25MG/0.5ML (0.25MG/0.5ML) 8129343 12/05/2031 DS DP
RX 06/30/2021
N215256 SEMAGLUTIDE WEGOVY SOLUTION SUBCUTANEOUS 1MG/0.5ML (1MG/0.5ML) 8129343 12/05/2031 DS DP
RX 06/30/2021
N214783 BELUMOSUDIL MESYLATE REZUROCK TABLET ORAL EQ 200MG BASE 8357693 10/30/2029 DS DP
U-3247 FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOLD DISEASE
RX 11/17/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 8598152 04/19/2030 DS DP
RX 11/12/2021
N214902 BENZOYL PEROXIDE; TRETINOIN TWYNEO CREAM TOPICAL 3%;0.1% 8617580 02/03/2028 DP
RX 11/24/2021
N215358 ASCIMINIB HYDROCHLORIDE SCEMBLIX TABLET ORAL EQ 20MG BASE 8829195 05/13/2033 DS
U-3249 U-1374 TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML)
RX 11/19/2021
N215358 ASCIMINIB HYDROCHLORIDE SCEMBLIX TABLET ORAL EQ 40MG BASE 8829195 05/13/2033 DS
U-3249 U-1374 TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML)
RX 11/19/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 8846744 06/03/2031 DP
RX 11/12/2021
N213426 CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS TABLET ORAL 56MG;44MG 9012440 04/19/2030 DS DP
RX 11/12/2021
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9079912 12/12/2026
U-3226 FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9079912 12/12/2026
U-3227 FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9079912 12/12/2026
U-3228 FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9079912 12/12/2026
U-3230 FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9079912 12/12/2026
U-3226 FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9079912 12/12/2026
U-3227 FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9079912 12/12/2026
U-3228 FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9079912 12/12/2026
U-3230 FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9079912 12/12/2026
U-3226 FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9079912 12/12/2026
U-3227 FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9079912 12/12/2026
U-3228 FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9079912 12/12/2026
U-3230 FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9079912 12/12/2026
U-3226 FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9079912 12/12/2026
U-3227 FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9079912 12/12/2026
U-3228 FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9079912 12/12/2026
U-3230 FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9079912 12/12/2026
U-3226 FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9079912 12/12/2026
U-3227 FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9079912 12/12/2026
U-3228 FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
RX 08/04/2015
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9079912 12/12/2026
U-3230 FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
RX 08/04/2015
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 9447106 04/22/2034 DS DP
U-1745 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
RX 11/20/2019
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 9447106 04/22/2034 DS DP
U-3063 RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
RX 11/20/2019
N213217 ZANUBRUTINIB BRUKINSA CAPSULE ORAL 80MG 9447106 04/22/2034 DS DP
U-2145 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 11/20/2019
N214783 BELUMOSUDIL MESYLATE REZUROCK TABLET ORAL EQ 200MG BASE 9815820 10/07/2033
U-3247 FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOLD DISEASE
RX 11/17/2021

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Last Updated November 26, 2021.

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