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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214787


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NDA 214787 describes VEKLURY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the VEKLURY profile page.

The generic ingredient in VEKLURY is remdesivir. One supplier is listed for this compound. Additional details are available on the remdesivir profile page.
Summary for 214787
Tradename:VEKLURY
Applicant:Gilead Sciences Inc
Ingredient:remdesivir
Patents:13
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214787
Generic Entry Date for 214787*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 214787
Suppliers and Packaging for NDA: 214787
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VEKLURY remdesivir POWDER;INTRAVENOUS 214787 NDA Gilead Sciences, Inc. 61958-2901 61958-2901-2 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787 NDA Gilead Sciences, Inc. 61958-2901 61958-2901-2 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MG/VIAL
Approval Date:Oct 22, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 21, 2025
Regulatory Exclusivity Use:3-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
Regulatory Exclusivity Expiration:Jul 13, 2026
Regulatory Exclusivity Use:CLINICAL STUDY INFORMATION ADDED TO LABEL ABOUT THE TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PATIENTS WITH SEVERELY REDUCED RENAL FUNCTION (ESTIMATED GLOMERULAR FILTRATION RATE, EGFR < 30 ML/MIN)
Regulatory Exclusivity Expiration:Oct 22, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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