GenericRadar
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Product profile · United States

VEKLURY

 ·  Patent Litigation & Settlement History ↓

IngredientREMDESIVIR
Application typeNDA
Application214787
Product002
Dosage formSOLUTION
RouteINTRAVENOUS
Strength100MG/20ML (5MG/ML)
Approval date2020-10-22
Marketing statusDISCONTINUED
Status event—
ApplicantGILEAD SCIENCES INC
Product source

Current GenericRadar decision

Year2025
SelectionDISQUALIFIED
ReviewFINAL
Anchor typeFDA_DISCONTINUATION
Anchor date—
Patent anchor2037-03-16
Exclusivity anchor2026-04-22
Protection date2041-11-28
First Final ANDA—
Status event—

FDA DISC action month 2025-06; Final exact ANDA link not identified; not certified generic absence.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
83186822029-04-22DS/DP ————
———
RE467622029-04-22DS/DP ————
———
80082642029-09-06DS/DP ————
———
83186822029-10-22— ————
—2029-10-22—
83186822029-10-22ORANGE_BOOK —YNTRUE_DS
English description not available.
—2029-10-22—
RE467622029-10-22— ————
—2029-10-22—
RE467622029-10-22ORANGE_BOOK —YNTRUE_DS
English description not available.
—2029-10-22—
80082642030-03-06— ————
—2030-03-06—
80082642030-03-06ORANGE_BOOK —YNTRUE_DS
English description not available.
—2030-03-06—
114923532031-12-08DS ————
———
114923532032-06-08— ————
—2032-06-08—
114923532032-06-08ORANGE_BOOK —YNTRUE_DS
English description not available.
—2032-06-08—
100659582032-11-18DS ————
———
100659582033-05-18— ————
—2033-05-18—
100659582033-05-18ORANGE_BOOK —YNTRUE_DS
English description not available.
—2033-05-18—
97243602035-10-29DS/DP ————
———
99499942035-10-29DS ————
———
97243602036-04-29— ————
—2036-04-29—
97243602036-04-29ORANGE_BOOK —YNTRUE_DS
English description not available.
—2036-04-29—
99499942036-04-29— ————
—2036-04-29—
99499942036-04-29ORANGE_BOOK —YNTRUE_DS
English description not available.
—2036-04-29—
106953612036-09-16U U-3829———
———
106953612036-09-16U U-3830———
———
110072082036-09-16U U-3830———
———
110072082036-09-16U U-3829———
———
113829262036-09-16U U-3829———
———
113829262036-09-16U U-3830———
———
106953612037-03-16— ————
—2037-03-16—
106953612037-03-16ORANGE_BOOK U-3829,U-3830NYDS_EQUIVALENT
English description not available.
—2037-03-16—
110072082037-03-16— ————
—2037-03-16—
110072082037-03-16ORANGE_BOOK U-3829,U-3830NYDS_EQUIVALENT
English description not available.
—2037-03-16—
113829262037-03-16— ————
—2037-03-16—
113829262037-03-16ORANGE_BOOK U-3829,U-3830NYDS_EQUIVALENT
English description not available.
—2037-03-16—
114911692041-05-28U U-3833———
———
114911692041-05-28U U-3834———
———
119039532041-05-28U U-3833———
———
119039532041-05-28U U-3834———
———
119750122041-05-28U U-3833———
———
119750122041-05-28U U-3834———
———
114911692041-11-28— ————
—2041-11-28—
114911692041-11-28ORANGE_BOOK U-3833,U-3834NNU
English description not available.
—2041-11-28—
119039532041-11-28— ————
—2041-11-28—
119039532041-11-28ORANGE_BOOK U-3833,U-3834NNU
English description not available.
—2041-11-28—
119750122041-11-28— ————
—2041-11-28—
119750122041-11-28ORANGE_BOOK U-3833,U-3834NNU
English description not available.
—2041-11-28—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
D-1832022-01-212025-01-213-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 DEATHNN—Source
NPP2022-04-252025-04-25English description not available.NN—Source
PED2025-01-212025-07-21English description not available.NN—Source
NCE—2025-10-22————Source
NCE2020-10-222025-10-22English description not available.YY2025-10-22Source
PED2025-04-252025-10-25English description not available.NN—Source
PED—2026-04-22————Source
PED2025-10-222026-04-22English description not available.YY2026-04-22Source
M-301—2026-07-13————Source
M-3012023-07-132026-07-13CLINICAL 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)NN—Source
PED—2027-01-13————Source
PED2026-07-132027-01-13English description not available.NN—Source
NPP—2027-02-28————Source
NPP2024-02-282027-02-28English description not available.NN—Source
PED—2027-08-28————Source
PED2027-02-282027-08-28English description not available.NN—Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / productApplicantEvent / status Certification event date Product mappingSourceLast verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Decision evidence (24)
TypeDateRoleBasisSource
PATENT2029-10-22HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-10-22HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-03-06HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-06-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-05-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2036-04-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2036-04-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-03-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-03-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-03-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-11-28HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-11-28HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-11-28HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXT3-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 DEATHSource
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTCLINICAL 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)Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS—TERMINAL_STATUSFDA DISC action month 2025-06; Final exact ANDA link not identified; not certified generic absence.Source
Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.