REMDESIVIR - Generic Drug Details

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 twenty-four patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for REMDESIVIR

International Patents:	324
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:	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

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
Suzhou Hospital of Traditional Chinese Medicine	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Hangzhou Hospital of Traditional Chinese Medicine	N/A

See all REMDESIVIR clinical trials

Pharmacology for REMDESIVIR

Drug Class

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

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					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes					Y

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

International Patents for REMDESIVIR

Country	Patent Number	Title	Estimated Expiration
Japan	6220484
Slovenia	3349758
Brazil	122020020745

Supplementary Protection Certificates for REMDESIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2937350	CR 2020 00060	Denmark		PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
2595980	301084	Netherlands		PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	20C1065	France		PRODUCT NAME: REMDESIVIR OU UN SEL OU UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1459 20200703