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Last Updated: October 4, 2024

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

Remdesivir has three hundred and twenty-five patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for remdesivir
International Patents:325
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 133
Patent Applications: 67
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
Peninsula Clinical Trials UnitPhase 4
University of ExeterPhase 4
University Hospitals of Derby and Burton NHS Foundation TrustPhase 4

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Colombia 6300958 NUCLEOSIDOS DE IMIDAZOL[1,5-F][1,2,4]TRIAZINIL, IMIDAZOL[1,2-F]1,2,4]TRIAZINIL Y [1,2,4]TRIAZOLO[4,3-F][1,2,4]TRIAZINIL PARA TRATAMIENTO ANTIVIRAL. ⤷  Sign Up
African Regional IP Organization (ARIPO) 3237 1'-Substituted carba-nucleoside analogs for antiviral treatment ⤷  Sign Up
New Zealand 588400 1'-SUBSTITUTED CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for remdesivir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2595980 132020000000176 Italy ⤷  Sign Up PRODUCT NAME: REMDESIVIR O SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO(VEKLURY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1459, 20200703
2937350 PA2020539 Lithuania ⤷  Sign Up PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980 C02595980/01 Switzerland ⤷  Sign Up PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.