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-four 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 June 8, 2032. This may change due to patent challenges or generic licensing.

There have been five 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:	344
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	3,656
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

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
PENTA Foundation	PHASE2
AMS-PHPT Research Collaboration	PHASE2
Hospital Universitario 12 de Octubre	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 four 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.

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					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No					Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes					Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes

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:

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
Peru	20171155	METODOS Y COMPUESTOS PARA TRATAR INFECCIONES VIRALES POR PARAMYXOVIRIDAE
Japan	6671424
Hungary	E039231
Eurasian Patent Organization	201071128
Lithuania	PA2020539
Hungary	E057928

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	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	202040053	Slovenia		PRODUCT NAME: REMDESIVIR OR ITS PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; NATIONAL AUTHORISATION NUMBER: EU/1/20/1459; DATE OF NATIONAL AUTHORISATION: 20200703; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2937350	PA2020539,C2937350	Lithuania		PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2937350	CA 2020 00060	Denmark		PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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

Market Dynamics and Financial Trajectory of VEKLURY (Remdesivir)

Last updated: February 20, 2026

What is VEKLURY's Market Position and Revenue Profile?

VEKLURY (remdesivir) was developed by Gilead Sciences as an antiviral medication approved for COVID-19 treatment. It holds a significant share in hospitalized COVID-19 cases globally, with regulatory approvals in over 50 countries. Gilead reported VEKLURY revenues reaching approximately $3.6 billion in 2022, driven primarily by sales in the U.S. and Europe. The drug's revenue has plateaued since 2021 due to declining COVID-19 hospitalization rates and competition from oral antivirals.

How Has the Market for Remdesivir Evolved?

The initial surge in demand occurred in 2020 and 2021, driven by emergency use authorizations and full approvals amid the pandemic. Since then, multiple factors have influenced market dynamics:

• Declining COVID-19 hospitalizations: Reduced hospital admissions in many regions lessen the need for intravenous antivirals.
• Emergence of oral antivirals: Pfizer's Paxlovid and Merck's Lagevrio (molnupiravir) gained approvals, providing alternatives for early treatment.
• Regulatory Restrictions: The FDA revoked Emergency Use Authorization (EUA) for VEKLURY in certain outpatient settings in 2022, limiting sales potential.

Table 1 summarizes key market shifts:

Year	Key Events	Impact
2020	Emergency use authorization granted	Rapid market penetration
2021	Full approval in the U.S.	Increased prescriptions
2022	FDA restricts outpatient use	Market contraction
2023	Competition from oral antivirals	Reduced market share

What are the Key Competitive and Regulatory Factors?

Gilead faces competition from multiple antiviral drugs that target different aspects of the COVID-19 lifecycle. Paxlovid's oral route provides a distinct advantage for early treatment, affecting remdesivir's inpatient focus. Regulatory approval trajectories diverge globally; for example:

• Expanded indications: Gilead is pursuing broadened approvals for treatment of other viral diseases such as influenza (Phase 2 trials).
• Limitations: Some countries have placed restrictions on remdesivir due to safety concerns, including potential kidney and liver toxicity reports.

Despite these factors, remdesivir remains a standard therapy in hospitalized COVID-19 management in many regions, preserving its market relevance.

What Are the Financial Forecasts for VEKLURY?

Gilead's 2022 revenue of $3.6 billion declined from a peak of $5.2 billion in 2021, reflecting decreased global usage. Projections suggest:

• 2023: Revenues may decline further to approximately $2.8 billion, factoring in waning COVID-19 cases and commercialization challenges.
• Long-term: Gilead is exploring combination therapies and new indications, which could stabilize or eventually increase revenues.

The company's strategic focus on expanding antiviral indications and pipeline development indicates a potential shift from COVID-19 dependence.

How Do Pricing and Reimbursement Impact VEKLURY?

Pricing strategies differ across markets. In the U.S., the wholesale acquisition cost (WAC) has been approximately $520 per 100-mg vial. Payer negotiations and government procurement programs influence net prices, with some countries securing lower prices through bilateral agreements. Reimbursement policies are often aligned with clinical guidelines, which have evolved with emerging evidence.

What is the Future Outlook for VEKLURY?

Market dynamics are primarily driven by:

• Epidemiology: Fluctuations in COVID-19 hospitalizations directly influence demand.
• Regulatory landscape: Approvals, restrictions, and guideline updates shape prescribing behaviors.
• Competitive landscape: Oral antivirals are expected to maintain dominance outside inpatient settings.
• Pipeline progress: Development of alternative uses and combination therapies could alter the revenue structure.

Gilead's ongoing clinical trials for remdesivir in hepatitis and other viral infections suggest potential future indications, but immediate revenues remain tied to COVID-19 hospitalizations.

Key Takeaways

• VEKLURY generated approximately $3.6 billion in 2022, with revenues declining since 2021.
• Market growth is constrained by competition from oral antivirals, evolving guidelines, and decreased hospitalization rates.
• Regulatory restrictions in outpatient contexts limit near-term growth potential.
• Gilead is diversifying its antiviral portfolio with new indications to sustain long-term value.
• Future revenue depends on epidemiological trends, approval outcomes, and pipeline success.

FAQs

1. Will VEKLURY remain Gilead's leading COVID-19 antiviral?
It will sustain a significant role in inpatient management, but oral antivirals are likely to dominate early outpatient treatment, reducing its overall market share.

2. Are there new indications for remdesivir beyond COVID-19?
Gilead is exploring remdesivir for influenza, hepatitis, and other viral diseases, but these are in clinical trial phases with uncertain timelines.

3. How will regulatory restrictions affect VEKLURY's sales?
Restrictions on outpatient use in some regions limit growth but do not eliminate use in hospitalized patients where the drug remains standard.

4. What pricing pressures impact VEKLURY?
Pricing varies globally due to negotiated discounts, procurement contracts, and reimbursement policies, generally reducing net revenues.

5. How might emerging competition affect the long-term outlook?
New oral therapies and evolving treatment guidelines may shift focus away from intravenous remdesivir, especially for early intervention.

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[1] Gilead Sciences. (2022). Financial results. https://gilead.com/investors

[2] FDA. (2022). Remdesivir (VEKLURY) approval and restrictions. https://fda.gov

[3] MarketWatch. (2023). COVID-19 antiviral drug sales analysis. https://marketwatch.com