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-six patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for remdesivir

International Patents:	326
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
University of Exeter	Phase 4
University Hospitals of Derby and Burton NHS Foundation Trust	Phase 4
University of Derby	Phase 4

See all remdesivir clinical trials

Pharmacology for remdesivir

Drug Class	SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for remdesivir

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for remdesivir

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Glossary

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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	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			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			Y	⤷ Sign Up
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1255732	治療沙粒病毒科和冠狀病毒科病毒感染的方法 (METHODS FOR TREATING ARENAVIRIDAE AND CORONAVIRIDAE VIRUS INFECTIONS)	⤷ Sign Up
Mexico	2017005250	METODOS PARA TRATAR INFECCIONES POR EL VIRUS DE FILOVIRIDAE. (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS.)	⤷ Sign Up
Philippines	12020551055	METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS	⤷ Sign Up
China	113620992	治疗丝状病毒科病毒感染的方法 (Method for treating filoviridae virus infection)	⤷ Sign Up
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
New Zealand	745328	Methods for treating filoviridae virus infections	⤷ Sign Up
Ukraine	121485	СПОСОБИ ЛІКУВАННЯ ВІРУСНИХ ІНФЕКЦІЙ FILOVIRIDAE (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for remdesivir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2595980	C202030068	Spain	⤷ Sign Up	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
2595980	C02595980/01	Switzerland	⤷ Sign Up	PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020
2595980	2020C/554	Belgium	⤷ Sign Up	PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2937350	CA 2020 00060	Denmark	⤷ Sign Up	PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: 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	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
2595980	2020/061	Ireland	⤷ Sign Up	PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/20/1459 20200703
>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.