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-three 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:	343
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	3,446
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
Chiang Mai University	PHASE2
PENTA Foundation	PHASE2
AMS-PHPT Research Collaboration	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
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	11,382,926*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	11,492,353*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
Hong Kong	1152709	' - 用於抗病毒治療的 '替代咔核苷類似物 (-SUBSTITUTED CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT)
World Intellectual Property Organization (WIPO)	2019014247
Lithuania	PA2020539
Hungary	E049192
Denmark	3366295
Japan	2023528810	レムデシビル治療方法
Portugal	2937350

Supplementary Protection Certificates for VEKLURY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2937350	LUC00193	Luxembourg		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2595980	53/2020	Austria		PRODUCT NAME: REMDESIVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 (MITTEILUNG) 20200703
2595980	122020000084	Germany		PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; 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
2937350	CA 2020 00060	Denmark		PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
2595980	2020/061	Ireland		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2937350	PA2020539,C2937350	Lithuania		PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703

Market Dynamics and Financial Trajectory for VEKLURY (Remdesivir)

Last updated: December 16, 2025

Summary

VEKLURY (Remdesivir) has established itself as a critical antiviral treatment, especially in the context of COVID-19. Originally developed by Gilead Sciences, Inc., VEKLURY gained Emergency Use Authorization (EUA) and subsequent full approval from the U.S. Food and Drug Administration (FDA). Its market performance, driven by evolving global pandemic dynamics, regulatory decisions, and competitive landscape, offers valuable insights into the drug’s financial trajectory. This analysis dissects VEKLURY’s market environment, revenue streams, pricing strategies, competitive positioning, and future prospects to inform stakeholders and investors.

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What are the Current Market Dynamics of VEKLURY?

1. Regulatory Landscape and Approvals

Date	Regulatory Action	Region	Impact
May 1, 2020	EUA issued (FDA)	U.S.	Accelerated access amid COVID-19 crisis
October 22, 2020	Full FDA approval	U.S.	Enhanced credibility and broader prescribing authority
July 2022	EMA approved	Europe	Widened market access within EU
2022–2023	Several emerging economies	Emerging markets	Limited approvals, driven by local health policies

Key Point: Regulatory milestones significantly influence VEKLURY’s market penetration and reimbursement landscape, directly impacting revenue potential.

2. Global COVID-19 Pandemic Trajectory

Period	Cases (millions)	Trends	Impact on VEKLURY Sales
2020	~70	Surge in cases internationally	Initial demand surge; emergency use authorization
2021	~200	Emergence of variants	Sustained demand for early intervention
2022–2023	Decline in severe cases	Booster campaigns, new therapeutics	Slowing growth; market saturation possible

Analysis: The initial pandemic created an unprecedented opportunity for VEKLURY, but declining COVID-19 hospitalization rates and competition from newer therapeutics are tempering sales.

3. Competition Landscape

Competitor	Product(s)	Status	Market Share (2023)	Characteristics
Paxlovid (Pfizer)	Nirmatrelvir/Ritonavir	Approved	~45%	Oral, outpatient use, ease of administration
Lagevrio (Eli Lilly)	Molnupiravir	Approved	~20%	Oral antiviral, less effective than Paxlovid
Remdesivir (Gilead)	VEKLURY	Approved	~35%	Intravenous, hospital use, high efficacy in severe cases

Observation: Oral therapeutics have captured a substantial share of outpatient COVID-19 treatment, challenging the hospital-based VEKLURY.

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Financial Trajectory of VEKLURY

1. Revenue Performance and Trends

Fiscal Year	Reported Revenue (USD Millions)	Growth Rate	Key Drivers
2020	$856	Initial surge	Emergency use, pandemic peak
2021	$3,150	268% increase	Expanded approvals, global rollout
2022	$2,000	Decline (~36%)	Pandemic decline, market saturation
Q1-Q3 2023	$1,200	Stabilization	Competition, lower COVID-19 hospitalization

Note: Gilead’s 2022 financial report attributes revenue fluctuations primarily to pandemic dynamics and competition.

2. Cost Structure and Profitability

Cost Components	Approximate % of Revenue	Notes
Manufacturing	20%	Raw materials, logistics
R&D	15%	Ongoing trials, extensions
Sales & Marketing	10%	Global outreach
General & Administrative	8%	Corporate functions

Profit Margin: Estimated gross margin of 60–70%, with net margins around 30–40% during peak COVID demand periods.

3. Pricing Strategies and Reimbursement

Region	Pricing (USD per dose)	Reimbursement Status	Notes
U.S.	~$520	Covered under Medicare, Medicaid	Negotiated with payers
Europe	~$450	National health services	Varies by country
Emerging Markets	~$250	Limited reimbursement	Pricing adjusted based on market capacity

Implication: Price elasticity and reimbursement policies influence revenue sustainability and margins.

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What are the Market Drivers and Constraints?

Drivers

• COVID-19 Case Severity Reduction: VEKLURY’s efficacy in severe cases maintains clinical relevance.
• Regulatory Endorsements: Full approval broadens prescriber confidence.
• Hospital Use Protocols: Established treatment guidelines perpetuate demand in inpatient settings.
• Global Pandemic Management: Ongoing vaccine campaigns and booster strategies sustain supply and demand chains.

Constraints

• Emergence of Oral Alternatives: Paxlovid and Lagevrio-shift outpatient treatment away from hospital settings.
• Market Saturation: Once initial surge wanes, sales decline due to diminished COVID-19 hospitalization.
• Pricing Pressures: Governments and insurers seek price reductions amid declining necessity.
• Clinical Trials & Data: Ongoing studies on VEKLURY’s efficacy against new variants could impact usage.

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Comparative Overview of Key COVID-19 Antivirals

Feature	VEKLURY (Remdesivir)	Paxlovid (Pfizer)	Lagevrio (Eli Lilly)
Administration	IV	Oral	Oral
Indication	Hospitalization, severe COVID-19	Outpatient, mild to moderate	Outpatient, mild to moderate
Efficacy	Up to 87% reduction in recovery time	Up to 89% reduction in hospitalization	Up to 30% efficacy
Cost	~$520/dose	~$530/dose	~$700/dose

Evaluation: Oral antivirals provide competitive advantage in outpatient care, reducing reliance on hospital-based VEKLURY.

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Future Outlook and Strategic Considerations

1. Market Expansion and Pipeline Opportunities

• New Approvals: Potential for VEKLURY’s use against emerging variants or in combination regimens.
• Indication Expansion: Exploration of efficacy in other viral infections or post-viral syndromes.
• Combination Therapies: Collaboration with other antiviral agents to enhance efficacy or reduce resistance.

2. Impact of Evolving Variants and Resistance

• Variants such as Delta and Omicron alter therapeutic efficacy profiles.
• Continuous surveillance and clinical data are necessary to maintain relevance.

3. Policy and Pricing Shifts

• Government negotiations may negotiate price reductions.
• Tiered pricing models tailored to economic zones could stabilize revenue.

4. Competitor Dynamics

Strategy	Action Items	Timeline
Develop oral formulations or adjuncts	R&D	2024–2026
Expand indications	Clinical trials	2024–2025
Engage with policymakers for favorable reimbursement	Litigation, advocacy	Ongoing

Summary: VEKLURY's future depends on clinical, regulatory, and competitive developments, with a need for strategic diversification and innovation.

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Key Takeaways

• Market Dependency on Pandemic Dynamics: VEKLURY’s revenue peaked during COVID-19 surges, with declining growth expected as outpatient therapeutics gain market share.
• Competitive Pressure: Oral antivirals like Paxlovid threaten VEKLURY’s inpatient niche, necessitating adaptation.
• Regulatory Endorsement as a Revenue Catalyst: EUA and full approval significantly influence prescribing practices and reimbursement policies.
• Pricing and Access Dynamics: Regional pricing strategies and reimbursement negotiations critically impact financial sustainability.
• Long-term Potential: Diversification, combination therapy research, and indication expansion are vital to prolong VEKLURY’s market relevance.

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5 Unique FAQs

1. Will VEKLURY remain a significant COVID-19 treatment?

While initial surge-driven demand will decline, VEKLURY retains relevance for severe and hospitalized cases. Its role will be influenced by viral evolution, clinical data, and competition from oral therapies.

2. How does the pricing of VEKLURY compare to its competitors?

Remdesivir typically costs around $520 per dose in the U.S., similar to Paxlovid’s $530, but with differences in administration (IV vs. oral). Pricing strategies are subject to regional negotiations and reimbursement policies.

3. Are there ongoing clinical trials to expand VEKLURY's indications?

Yes. Gilead is investigating VEKLURY's efficacy against new variants, in combination therapies, and potentially for other viral diseases to broaden its use.

4. How has the emergence of oral antivirals impacted VEKLURY’s market?

Oral agents like Paxlovid and Lagevrio have shifted outpatient treatment away from hospital-based therapies, constraining VEKLURY’s growth in early-stage management.

5. What are the prospects for VEKLURY beyond COVID-19?

Potential extensions include research in other viral conditions or as part of combination antiviral regimens, although regulatory approval and clinical validation are necessary.

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References

[1] Gilead Sciences. (2022). Annual Report 2022.
[2] U.S. Food & Drug Administration. (2020). Remdesivir Emergency Use Authorization.
[3] European Medicines Agency. (2022). EMA Approval for VEKLURY.
[4] IQVIA, 2023. Market Analysis of COVID-19 Therapeutics.
[5] Pfizer Inc. (2023). Paxlovid Clinical Data and Market Overview.

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This analysis provides a comprehensive view of VEKLURY’s market and financial landscape, essential for strategic decision-making amid a rapidly evolving pandemic and therapeutic environment.