Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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.

Patent and Exclusivity for: N214787

Product 001
REMDESIVIR (VEKLURY) POWDER 100MG/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8008264 09/06/2029 DS DP
11/12/2020
001 8318682 04/22/2029 DS DP
11/12/2020
001 9724360 10/29/2035 DS DP
11/12/2020
001 9949994 10/29/2035 DS
11/12/2020
001 10065958 09/16/2031 DS
11/12/2020
001 10675296 07/10/2038 DP
11/12/2020
001 10695361 09/16/2036
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
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)
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
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)
11/12/2020
001 11007208 09/16/2036
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
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)
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
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)
06/15/2021
001 11266681 07/10/2038
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
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)
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
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)
04/04/2022
001 RE46762 04/22/2029 DS DP
11/12/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
D-1833-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
COMPETITIVE GENERIC THERAPY
01/21/2025
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
10/22/2025

 

 


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