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Last Updated: December 5, 2023

Remdesivir - Generic Drug Details


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What are the generic drug sources for remdesivir and what is the scope of freedom to operate?

Remdesivir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Remdesivir has three hundred and fourteen patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for remdesivir
International Patents:314
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 132
Patent Applications: 63
What excipients (inactive ingredients) are in remdesivir?remdesivir excipients list
DailyMed Link:remdesivir at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for remdesivir
Generic Entry Date for remdesivir*:
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.

Recent Clinical Trials for remdesivir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityN/A
Hangzhou Hospital of Traditional Chinese MedicineN/A
The First Affiliated Hospital of Zhejiang Chinese Medical UniversityN/A

See all remdesivir clinical trials

Pharmacology for remdesivir

US Patents and Regulatory Information for remdesivir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for remdesivir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Veklury remdesivir EMEA/H/C/005622
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
Authorised no no no 2020-07-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for remdesivir

Country Patent Number Title Estimated Expiration
China 111093627 用于治疗病毒感染的包含RNA聚合酶抑制剂和环糊精的组合物 (COMPOSITIONS COMPRISING AN RNA POLYMERASE INHIBITOR AND CYCLODEXTRIN FOR TREATING VIRAL INFECTIONS) ⤷  Try a Trial
South Korea 101821680 ⤷  Try a Trial
Taiwan 202039526 Methods for treating Filoviridae virus infections ⤷  Try a Trial
South Africa 201008008 CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT ⤷  Try a Trial
Lithuania 3349758 ⤷  Try a Trial
Cyprus 1120366 ⤷  Try a Trial
Netherlands 301084 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for remdesivir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2595980 C202030068 Spain ⤷  Try a Trial PRODUCT NAME: REMDESIVIR O UNA SAL O UN ESTER FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1459; DATE OF AUTHORISATION: 20200703; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1459; DATE OF FIRST AUTHORISATION IN EEA: 20200703
2937350 CR 2020 00060 Denmark ⤷  Try a Trial PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
2595980 2020C/554 Belgium ⤷  Try a Trial PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2595980 122020000084 Germany ⤷  Try a Trial PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2937350 PA2020539,C2937350 Lithuania ⤷  Try a Trial PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2937350 PA2020539 Lithuania ⤷  Try a Trial PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980 20C1065 France ⤷  Try a Trial PRODUCT NAME: REMDESIVIR OU UN SEL OU UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1459 20200703
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca
McKesson
Moodys

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