VEKLURY Drug Patent Profile

Which patents cover Veklury, and what generic alternatives are available?

Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has three hundred and one patent family members in forty-six countries.

The generic ingredient in VEKLURY is remdesivir. One supplier is listed for this compound. Additional details are available on the remdesivir profile page.

DrugPatentWatch^® Generic Entry Outlook for Veklury

Veklury will be eligible for patent challenges on October 22, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 29, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEKLURY

International Patents:	301
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	5
Patent Applications:	39
What excipients (inactive ingredients) are in VEKLURY?	VEKLURY excipients list
DailyMed Link:	VEKLURY at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VEKLURY

NDA:

214787

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 VEKLURY

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

Sponsor	Phase
Mansoura University Hospital	Phase 4
PharmaMar	Phase 3
ASST Fatebenefratelli Sacco	Phase 3

See all VEKLURY clinical trials

Pharmacology for VEKLURY

Drug Class

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for VEKLURY

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 VEKLURY

VEKLURY is protected by twenty-four US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VEKLURY

FDA Regulatory Exclusivity protecting VEKLURY

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
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	Y

EU/EMA Drug Approvals for VEKLURY

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 VEKLURY

When does loss-of-exclusivity occur for VEKLURY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VEKLURY around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2020097635	リボシドの調製のための方法 (METHODS FOR PREPARING RIBOSIDES)
China	114366745	治疗沙粒病毒科和冠状病毒科病毒感染的方法 (Methods of treating arenaviridae and coronaviridae virus infections)
Brazil	112017007636	métodos para a preparação de ribosídeos

Supplementary Protection Certificates for VEKLURY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2595980	C202030068	Spain		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	LUC00193	Luxembourg		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703