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 sixteen 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.
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: | 16 |
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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Oct 22, 2020 | TE: | 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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