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Last Updated: November 26, 2022

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Remdesivir has two hundred and ninety-seven patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for remdesivir
International Patents:297
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 28
Clinical Trials: 127
Patent Applications: 21
What excipients (inactive ingredients) are in remdesivir?remdesivir excipients list
DailyMed Link:remdesivir at DailyMed
Recent Clinical Trials for remdesivir

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

SponsorPhase
ShionogiPhase 3
City of HelsinkiPhase 4
Daewoong Pharmaceutical Co. LTD.Phase 2

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 POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
South Korea 20110005888 CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT See Plans and Pricing
Mexico 2017005250 METODOS PARA TRATAR INFECCIONES POR EL VIRUS DE FILOVIRIDAE. (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS.) See Plans and Pricing
South Korea 20110004883 1'-SUBSTITUTED CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT See Plans and Pricing
Taiwan 202039526 Methods for treating Filoviridae virus infections See Plans and Pricing
Japan 6757294 See Plans and Pricing
Brazil 112017007636 métodos para a preparação de ribosídeos See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for remdesivir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2595980 2020C/554 Belgium See Plans and Pricing PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2937350 PA2020539 Lithuania See Plans and Pricing PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980 132020000000176 Italy See Plans and Pricing PRODUCT NAME: REMDESIVIR O SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO(VEKLURY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1459, 20200703
2595980 C202030068 Spain See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
2937350 CA 2020 00060 Denmark See Plans and Pricing PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca
McKesson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.