NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Oct 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Mechanism of Action
2 (SARS-CoV-2) [see ].
Pharmacologic Class:
SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
Indications (1)
Clinical Trials (5)
Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
Started Dec 2025
60 enrolled
Hematopoietic and Lymphatic System NeoplasmAutoimmune DiseaseRespiratory Syncytial Virus Infection
Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
Started Sep 2025
15 enrolled
COVID - 19Renal TransplantSARS CoV 2 Infection
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Started Apr 2021
473 enrolled
Covid19
Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Started Apr 2021
87 enrolled
Covid19
PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US
Started Mar 2021
54 enrolled
COVID-19
Loss of Exclusivity
LOE Date
Nov 28, 2041
191 months away
Patent Expiry
Nov 28, 2041
Exclusivity Expiry
Jan 13, 2027
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| RE46762 | Apr 22, 2029 | SubstanceProduct | — |
| 8318682 | Apr 22, 2029 | SubstanceProduct | — |
| 8008264 | Sep 6, 2029 | SubstanceProduct | — |
| RE46762*PED | Oct 22, 2029 | — | |
| 8318682*PED | Oct 22, 2029 | — |