VEKLURY Drug Patent Profile

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Which patents cover Veklury, and when can generic versions of Veklury launch?

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

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 was eligible for patent challenges on October 22, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 18, 2033. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VEKLURY

US Patents:	16
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEKLURY

Paragraph IV (Patent) Challenges for VEKLURY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VEKLURY	Powder for Injection	remdesivir	100 mg/vial	214787	1	2025-04-22

US Patents and Regulatory Information for VEKLURY

VEKLURY is protected by sixteen US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,065,958.

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

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		DISCN	Yes	No
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	RE46762*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	8,008,264*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	10,695,361*PED				Y

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:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Israel

Japan

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Ukraine

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
African Regional IP Organization (ARIPO)	3269
Australia	2011280910
Australia	2015238851
Australia	2017201230

Supplementary Protection Certificates for VEKLURY

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	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
2595980	C02595980/01	Switzerland		PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020

Investment Scenario and Fundamentals Analysis for VEKLURY

Last updated: February 20, 2026

What is VEKLURY?

Veklury (remdesivir) is an antiviral medication developed by Gilead Sciences. It is approved by the U.S. Food and Drug Administration (FDA) for treating COVID-19 in hospitalized patients. The drug is administered via intravenous infusion and targets viral RNA polymerase to inhibit viral replication.

Market Overview

Veklury became a cornerstone in COVID-19 treatment protocols during the pandemic, contributing significantly to Gilead’s revenue. As of 2022, Gilead reported approximately $5.4 billion in sales of remdesivir, representing roughly 15% of total revenue. This figure declined from the pandemic’s peak but remains relevant given ongoing pandemic management.

Clinical and Regulatory Status

Approvals

• FDA: Emergency Use Authorization (May 2020), full approval (October 2020).
• EMA: Conditional approval (July 2020).
• Other Regulators: Approved in over 50 countries.

Indications

• COVID-19 treatment in hospitalized patients.
• Authorized for use in adults and pediatric patients aged 12 and above weighing at least 40 kg.

Usage and Efficacy

Multiple clinical trials have yielded mixed results:

• The ACTT-1 trial demonstrated reduced recovery time.
• Subsequent studies reported limited impact on mortality reduction.
• The drug's usage is sometimes supplemented with other therapies, including corticosteroids.

Patent and Competition Landscape

Patent Position

Gilead holds patents covering the composition of remdesivir and its manufacturing methods, extending patent exclusivity until at least 2030.

Competition

Compared to other COVID-19 therapies, Veklury faces competition from oral antivirals such as Pfizer's Paxlovid (nirmatrelvir/ritonavir) and Merck's Lagevrio (molnupiravir). These oral options are gaining prominence due to ease of administration and outpatient use.

Market Dynamics and Future Outlook

Demand Drivers

• Continued COVID-19 hospitalization rates.
• Potential expansion into other viral diseases, pending clinical trials.

Challenges

• Declining pandemic-related demand as vaccination rates increase.
• Competition from emerging oral antiviral therapies.
• Regulatory environments in different countries may restrict or limit use.

Growth Potential

Gilead is investing in clinical trials for remdesivir’s application in:

• Hepatitis C.
• Ebola.
• Other viral infections, expanding market reach.

Product Lifecycle and Patent Expiry

• Original patents valid until 2030 in the U.S.
• Likely to face biosimilar and generic competition post-expiry, affecting pricing and market share.

Financial and Investment Implications

Revenue Outlook

• Gilead’s 2022 revenues from remdesivir: $5.4 billion.
• Projected decline as pandemic demand wanes; stabilization depends on new indications.

Profitability and Cost Structure

• Manufacturing costs are relatively low due to scalable synthesis.
• High R&D costs are amortized; ongoing clinical trials will continue investments.

Stock Impact

• Upward pressure during pandemic peaks, declining with reduced hospitalizations.
• Long-term value depends on diversification and future pipeline progress.

Risks and Opportunities

Risks	Opportunities
Patent expiry post-2030	Expansion into other infectious diseases
Competition from oral antivirals	New combination therapies
Regulatory restrictions in some regions	Development of next-generation antiviral agents

Conclusion

Veklury remains a significant product for Gilead, driven by its initial role in COVID-19 management. However, declining pandemic-related demand, increasing competition, and patent timelines pose challenges. Future growth depends on expanding indications, clinical trial success, and commercialization strategies.

Key Takeaways

• Veklury’s revenues peaked during the pandemic but face decline as demand normalizes.
• Patent protection extends until 2030; biosimilar competition may begin post-expiry.
• Market share will depend on the success of clinical trials for other viral infections.
• Competition from oral antivirals presents a significant threat to market dominance.
• Long-term investment prospects hinge on pipeline innovation and pipeline diversification.

FAQs

Q1: What is the main driver of Veklury’s revenue?
The primary driver is its use in hospitalized COVID-19 patients, especially during pandemic surges.

Q2: When will Gilead’s patent protection for remdesivir expire?
Patents are valid until 2030 in the U.S., with potential extensions or challenges.

Q3: How does Veklury compare to oral COVID-19 treatments?
Veklury requires intravenous infusion and is used in hospitalized settings, whereas oral treatments like Paxlovid are suitable for outpatient use and have easier administration.

Q4: What are the key risks affecting Veklury’s future market share?
Patent expiry, competition from oral antivirals, and changing regulatory policies are key risks.

Q5: Are there ongoing efforts to repurpose remdesivir?
Yes, Gilead conducts trials in hepatitis C, Ebola, and other viral diseases to expand its application.

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References

[1] Gilead Sciences. (2022). Gilead's Remdesivir (Veklury) product information.
[2] U.S. Food and Drug Administration (2020). FDA approves first treatment for COVID-19.
[3] European Medicines Agency. (2020). EMA/CHMP considerations on remdesivir.
[4] World Health Organization. (2021). Therapeutics and COVID-19 Update.
[5] MarketWatch. (2022). Gilead’s COVID-19 antiviral sales data.