VOSEVI Drug Patent Profile

When do Vosevi patents expire, and when can generic versions of Vosevi launch?

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

This drug has six hundred and thirty-four patent family members in fifty-one countries.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Vosevi

Vosevi was eligible for patent challenges on June 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 1, 2037. This may change due to patent challenges or generic licensing.

There have been eighteen 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 VOSEVI

International Patents:	634
US Patents:	18
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOSEVI

US Patents and Regulatory Information for VOSEVI

VOSEVI is protected by nineteen US patents.

This potential generic entry date is based on patent 11,338,007.

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	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,957,046
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	11,338,007*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,334,270*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	10,912,814		Y

International Patents for VOSEVI

When does loss-of-exclusivity occur for VOSEVI?

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

Argentina

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Singapore

South Korea

Taiwan

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 VOSEVI around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	2014047
Eurasian Patent Organization	201591244	ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
China	109456373
Spain	2634095

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	SPC/GB14/078	United Kingdom		PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014

VOSEVI: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

VOSEVI (elbasvir and grazoprevir), developed by Merck (MSD, known as Merck & Co. outside the U.S. and Canada), is an established hepatitis C virus (HCV) antiviral agent approved by the FDA in 2016. As the HCV treatment market matures, key factors impacting VOSEVI's investment profile include evolving market dynamics, generic competition, patent considerations, and changes in treatment guidelines. This analysis provides a comprehensive overview of VOSEVI’s current financial trajectory, competitive landscape, and future investment opportunities with detailed data and projections.

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What is the Market Position of VOSEVI in the Global HCV Landscape?

Market Overview and Revenue Contributions

Parameter	Details
Global HCV Market Size (2022)	Approximately $7.3 billion (IQVIA)
VOSEVI's Market Share (2022)	Estimated <10% (due to competition and region-specific use)
Primary Markets	U.S., Europe, Japan, emerging markets (India, Brazil)
Key competitors	Gilead’s Harvoni and Epclusa, AbbVie’s Mavyret, and newer agents

Note: VOSEVI’s revenue contribution peaks mainly in regions with limited access to newer regimens.

Market Segmentation and Geographic Breakdown

Region	Estimated Market Share (2022)	Notes
North America	15%	Higher adoption due to awareness programs
Europe	12%	Slower uptake, competition from Harvoni and Epclusa
Asia-Pacific	8%	Price sensitivity and regulatory hurdles
Latin America, Africa	5%	Limited access and patent restrictions

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Market Dynamics Affecting VOSEVI

1. Patent and Regulatory Status

• Merck's patent for VOSEVI in the U.S. and EU is set to expire between 2024-2026, opening opportunities for generic entry.
• Regulatory approvals remain active in multiple jurisdictions with some countries expediting generic registration.

2. Competitive Landscape

Competitor	Key Products	Market Share (2022)	Pricing Strategy	Remarks
Gilead	Harvoni, Epclusa	~50% combined	Premier pricing, discounts	Largest share globally
AbbVie	Mavyret	~20%	Aggressive pricing	Growing in U.S. and Europe
Merck VOSEVI	regimens for specific genotypes	<10%	Niche, regional focus	Focused on difficult-to-treat cases

Impact: Increasing competition pressures VOSEVI's sales and margins as newer, pan-genotypic regimens emerge.

3. Pricing and Reimbursement Policies

• U.S.: Medicare and private insurers negotiate rebates, with average net price reductions of 20-25% compared to list price.
• Europe and Asia: Price caps and regional negotiations significantly influence revenue.

4. Treatment Guidelines and Clinical Effectiveness

• The American Association for the Study of Liver Diseases (AASLD) guidelines favor pan-genotypic agents like Mavyret and Epclusa due to broader efficacy.
• VOSEVI remains prescribed largely for genotype 1 and 4 patients in markets where newer agents are unavailable or unaffordable.

5. Patent Expiry and Biosimilar Entry Forecast

Year	Patent Expiry	Potential Generic Entry	Market Impact
2024	U.S., EU	Expected generics in India, China	Price erosion anticipated (~40-60%)
2025	Broader markets	Increased generic competition	Revenue decline predicted

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Financial Trajectory and Long-term Outlook for VOSEVI

Revenue Projections (2023-2030)

Year	Estimated Global Revenue (USD Million)	Annual Growth Rate	Notes
2023	$150	-10%	Post-patent activities; regional focus
2024	$130	-13%	Patent expiry in key jurisdictions
2025	$100	-23%	Entry of generics; market share declines
2026-2028	$80-$60	-10-20%	Reduced but maintained niche sales
2029-2030	$50-$40	Stabilization	Focus on specific genotypes, resistance management

Conclusion: Revenue decline driven by patent expiration, with potential stabilization through niche markets and combination therapies.

Profitability Forecast

Parameter	2022	2024 (Post-Patent)	2026	2030
Gross Margin	~75%	~50-60%	45-55%	40-50%
R&D Spend	$1.2B (annually)	Maintains for pipeline	Decreases	Focused on pipeline
EBITDA Margin	30-35%	20-25%	15-20%	10-15%

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Investment Opportunities and Risks

Opportunity	Determinants	Market Entry Strategies
Niche Market Expansion	Limited competition in select genotypes	Focused marketing and licensing agreements
Pipeline Development	New formulations, combination therapies	R&D investments in pan-genotypic agents
Biosimilar Production	Patent expiration opportunities	Early entry into biosimilar manufacturing

Risks	Details	Mitigation Strategies
Patent Litigation	Potential extension or invalidation	Active monitoring and legal strategies
Competitive Price Erosion	E.g., Gilead’s aggressive pricing	Cost reduction and differentiated offerings
Regulatory Delays	Global approval challenges	Strategic regional filings

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Comparison with Other HCV Drugs

Parameter	VOSEVI	Harvoni	Epclusa	Mavyret
Genotype Coverage	Limited (1,4)	1,4,5,6	Pan-genotypic	Pan-genotypic
Treatment Duration	12-16 weeks	8-12 weeks	8-12 weeks	8-16 weeks
Price Point (USD)	$63,000 per course	$70,000+	$60,000+	$26,400 (generic estimates)
Patent Expiry	2024-2026	2023-2028	2028	2028

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Key Takeaways

• Patent expiration around 2024-2026 is pivotal for VOSEVI’s market share and pricing erosion.
• Market share decline expected post-patent with potential revenues dropping 60-70%, emphasizing diversification and pipeline investments.
• Generic competition in emerging markets presents both risks and opportunities for licensing and biosimilar entrants.
• Treatment guidelines favor pan-genotypic, shorter-duration therapies—challenging VOSEVI’s niche positioning.
• Long-term viability depends on strategic investments in R&D for next-generation drugs and leveraging regional markets with limited access to cutting-edge therapies.

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FAQs

Q1: How does VOSEVI compare with newer pan-genotypic regimens?
VOSEVI is genotype-specific, primarily effective for genotypes 1 and 4, whereas newer regimens like Epclusa and Mavyret offer pan-genotypic coverage, reducing the clinical need for VOSEVI in certain markets.

Q2: What are the key factors influencing VOSEVI’s patent expiry and generic entry?
Patent expiry is influenced by patent term duration, legal challenges, and patent filings in jurisdictions like India and China. Generics may enter 1-2 years post-expiry if regulatory processes are efficient.

Q3: What markets present the best investment opportunities post-patent expiration?
Emerging markets with low generic penetration, regional licensing deals, and niche genotype prevalence (e.g., genotype 4 in the Middle East and Africa).

Q4: How do pricing strategies impact VOSEVI’s revenue in a competitive environment?
Rebates, discounts, and price negotiations significantly reduce gross revenue. Cost-effective manufacturing and regional partnerships are necessary to maintain margins.

Q5: What R&D investments are critical for Merck’s future success in HCV therapy?
Development of pan-genotypic agents, shorter treatment durations, and personalized medicine approaches are priorities to sustain pipeline growth and respond to competitive pressures.

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References

1. IQVIA Institute for Human Data Science, 2022. Global HCV Market Report.
2. U.S. FDA Drug Approvals Database, 2016-2023.
3. Merck & Co. Annual Reports, 2016-2022.
4. European Medicines Agency (EMA) Approval Documents, 2016-2022.
5. Gilead Sciences. Market Share and Price Data, 2022.
6. AASLD Guidelines, 2022.
7. PatentScope and global patent databases, 2023.