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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and forty patent family members in forty-nine 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 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 April 29, 2036. This may change due to patent challenges or generic licensing.

There have been four 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

International Patents:	340
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	4,532
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEKLURY
What excipients (inactive ingredients) are in VEKLURY?	VEKLURY excipients list
DailyMed Link:	VEKLURY at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VEKLURY

Constraining patent/regulatory exclusivity:

9,724,360*PED

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
Hospital Universitario 12 de Octubre	PHASE2
Chiang Mai University	PHASE2
PENTA Foundation	PHASE2

See all VEKLURY clinical trials

Pharmacology for VEKLURY

Drug Class

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

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 eight FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,724,360.

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	9,949,994*PED				Y
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	11,007,208*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	8,318,682*PED				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/005622Veklury 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

Malaysia

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
China	113620992	治疗丝状病毒科病毒感染的方法 (Method for treating filoviridae virus infection)
Mexico	2013000744	METODOS Y COMPUESTOS PARA TRATAR INFECCIONES VIRALES POR PARAMYXOVIRIDAE. (METHODS AND COMPOUNDS FOR TREATING PARAMYXOVIRIDAE VIRUS INFECTIONS.)
Taiwan	201733595	Methods for treating arenaviridae and coronaviridae virus infections
Peru	20171155	METODOS Y COMPUESTOS PARA TRATAR INFECCIONES VIRALES POR PARAMYXOVIRIDAE
New Zealand	606156	Methods and compounds for treating paramyxoviridae virus infections

Supplementary Protection Certificates for VEKLURY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2595980	2020C/554	Belgium		PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2937350	PA2020539	Lithuania		PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	C02595980/01	Switzerland		PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020
2595980	132020000000176	Italy		PRODUCT NAME: REMDESIVIR O SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO(VEKLURY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1459, 20200703
2595980	2090055-1	Sweden		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1459 20200703

Market Dynamics and Financial Trajectory for VEKLURY (Remdesivir)

Last updated: July 27, 2025

Introduction

VEKLURY (remdesivir) has established itself as a critical antiviral treatment in the landscape of infectious diseases, notably during the COVID-19 pandemic. Originally developed by Gilead Sciences, VEKLURY’s market prospects hinge on evolving clinical data, regulatory pathways, competitive landscape, and broader healthcare trends. Understanding its market dynamics and financial trajectory is paramount for stakeholders navigating this high-stakes pharmaceutical domain.

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Overview of VEKLURY

Remdesivir is an antiviral initially developed for Ebola virus disease but gained prominence as a treatment for COVID-19 following emergency use authorizations and subsequent full approvals by global regulatory authorities, including the FDA in May 2020. VEKLURY functions as a nucleotide analog inhibitor of viral RNA polymerase, disrupting the replication of SARS-CoV-2, the virus responsible for COVID-19. Its administration involves intravenous infusion, limiting its outpatient use but making it integral for hospitalized patients.

Current Regulatory Status and Clinical Positioning

In the United States, VEKLURY holds full FDA approval for hospitalized COVID-19 patients, with a dosage regimen approved for specific patient groups. Internationally, regulatory acceptance varies, with countries like the EU and Japan granting conditional or full approvals. The continued clinical evaluation and real-world data collection are fundamental to expanding its indications and maintaining regulatory support.

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Market Dynamics

1. Pandemic-Driven Demand and Its Fluctuation

The initial surge in demand for remdesivir was driven by the urgent need for COVID-19 therapeutics. According to Gilead’s fiscal reports, the drug generated approximately $3.7 billion in 2021, a sharp increase from pre-pandemic levels. However, as multiple oral antiviral agents like Pfizer's Paxlovid and Merck’s molnupiravir emerged with easier administration routes, VEKLURY’s usage shifted predominantly to hospitalized patients.

This transition reflects typical pandemic lifecycle dynamics: rapid initial adoption, plateauing, and eventual stabilization at a more routine level. The global decline in COVID-19 case severity and emergence of new variants further influence demand, potentially reducing the drug's utilization outside specific patient segments or high-risk groups.

2. Competitive Landscape and Therapeutic Alternatives

The pharmaceutical market for COVID-19 therapeutics is highly competitive. Oral antivirals, with their ease of administration, have overtaken intravenous options in outpatient settings. Paxlovid, with its oral route and proven efficacy, has dominated the market, accounting for a substantial share of COVID-19 prescriptions. Molnupiravir similarly offers oral dosing, positioning itself as an alternative for early-stage outpatient treatments.

VEKLURY remains clinically significant for hospitalized patients, especially those unable to tolerate oral therapies. Nevertheless, these competing agents exert pressure on remdesivir’s market share, especially as their efficacy profiles, safety data, and evolving guidelines shape prescriber preferences.

3. Regulatory and Policy Influences

Regulatory bodies continue to influence VEKLURY’s market landscape:

• EUA Extensions and Approvals: The FDA’s extension of remdesivir’s approval to pediatric populations and new indications for certain COVID-19 variants protect its relevance.
• Guideline Recommendations: Agencies like the NIH recommend remdesivir in specific hospitalized patient subsets, cementing its clinical role.
• Global Access and Pricing Policies: Governments and health organizations’ procurement strategies affect availability and uptake, particularly in low- and middle-income countries.

4. Manufacturing and Supply Chain Considerations

Gilead’s capacity to produce rapid, large-scale supplies of remdesivir remains critical. Supply chain disruptions, raw material costs, and manufacturing efficiencies influence both availability and pricing, directly affecting market penetration and revenue streams.

5. Post-Pandemic Outlook

As COVID-19 transitions toward endemicity, the sustained demand for VEKLURY depends on:

• Its incorporation into routine hospital formulary and treatment protocols.
• Ongoing clinical trials exploring its efficacy in other viral diseases, potentially broadening indications.
• Competitive innovations and combination therapies emerging from ongoing research.

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Financial Trajectory

1. Revenue Projections

Gilead’s financial reports demonstrate that remdesivir remains a significant revenue contributor, despite declining pandemic-driven sales from its 2021 peak. Analyst estimates suggest a stabilization at several hundred million dollars annually in the coming years, contingent on ongoing demand from hospitalized COVID-19 patients and potential new indications.

Gilead’s forecast indicates tempered growth among existing markets but emphasizes expanding access and indications as strategic priorities. Net revenues from VEKLURY are expected to plateau or slightly decline as outpatient oral options become more prevalent.

2. Pricing Strategies

Remdesivir’s pricing—approximately $3,120 for a five-day treatment course in the U.S.—reflects its status as a hospital-administered biotech asset. Gilead has employed tiered pricing strategies internationally, adjusting for economic segments and procurement agreements.

Future pricing policies may evolve based on competitive pressures and payer negotiations, especially as efficacy comparisons with new oral agents solidify.

3. Investment and R&D Considerations

Gilead continues to invest in clinical trials for remdesivir’s Expanded Use and combinatorial strategies. Investment in development of next-generation antivirals and formulation improvements could influence long-term financial outlooks. Additionally, patent protections and potential for lifecycle management through new indications are crucial for revenue sustainability.

4. Potential Market Expansion

Possible future avenues include:

• Utility in emerging viral diseases.
• Use as part of combination regimens.
• Pediatric and outpatient applications.

However, these depend on successful trials and regulatory approvals, which influence long-term growth trajectories.

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Market Challenges and Opportunities

Challenges:

• Sharp competition from oral antivirals offering ease of use and rapid deployment.
• Changing treatment paradigms favoring outpatient management.
• Variability in regulatory approval and reimbursement pathways internationally.
• Price sensitivity among public health systems and insurers.

Opportunities:

• Expansion into new viral indications with demonstrated efficacy.
• Positioning as part of combination antiviral therapies.
• Engagement in global health initiatives to expand access, especially in underserved markets.
• Adaptation to emerging COVID-19 variants and potential future pandemics.

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Conclusion

VEKLURY’s market dynamics are shaped by the evolving COVID-19 treatment landscape, competitive innovations, and regulatory frameworks. While its role in hospitalized COVID-19 care remains significant, the decreasing pandemic intensity, emergence of oral alternatives, and shifting clinical preferences suggest a stabilized but constrained financial trajectory. Strategic positioning, ongoing clinical research, and global access initiatives will determine its long-term commercial viability.

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Key Takeaways

• External variables, including competitive oral antivirals and shifting clinical guidelines, significantly influence remdesivir’s market penetration.
• Gilead’s manufacturing capacity and international positioning impact supply stability and revenue streams.
• Expanding indications and combination therapies offer pathways for revenue growth despite a maturing COVID-19 market.
• Pricing strategies must adapt to competitive pressures and reimbursement policies to sustain profitability.
• Long-term success depends on clinical innovations, regulatory support, and sustained global access efforts.

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FAQs

1. Will VEKLURY maintain its market relevance post-pandemic?
Yes, especially within hospitalized patient care protocols, though its role may diminish as outpatient oral options dominate early-stage treatment.

2. How does the emergence of oral antivirals affect remdesivir’s sales?
Oral antivirals like Paxlovid and molnupiravir have reduced inpatient demand for remdesivir, confining its usage primarily to hospitalized cases, thereby limiting growth.

3. Are there ongoing clinical trials to expand remdesivir’s indications?
Yes, Gilead and collaborators are investigating remdesivir's efficacy in other viral infections and in combination therapies, potentially broadening its application.

4. What pricing strategies could influence Gilead's revenue from VEKLURY?
Tiered international pricing, value-based pricing, and negotiated discounts with healthcare systems will shape revenue outcomes.

5. How does supply chain stability impact remdesivir’s market prospects?
Robust manufacturing capabilities and supply chain resilience are vital to meet demand and prevent Revenue loss due to shortages or delays.

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Sources

[1] Gilead Sciences Annual Financial Reports, 2021-2022.
[2] FDA. Full Approval of VEKLURY for COVID-19 Treatment, 2020.
[3] National Institutes of Health (NIH). COVID-19 Treatment Guidelines, 2023.
[4] Market research reports on COVID-19 therapeutics, 2022.
[5] WHO. Global Access Strategies for COVID-19 Drugs, 2021.