VOSEVI Drug Patent Profile

Which patents cover Vosevi, 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-three patent family members in fifty 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:	633
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for VOSEVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOSEVI
What excipients (inactive ingredients) are in VOSEVI?	VOSEVI excipients list
DailyMed Link:	VOSEVI at DailyMed

See drug prices for VOSEVI

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

Constraining patent/regulatory exclusivity:

11,338,007*PED

NDA:

209195

Dosage:

TABLET;ORAL

^*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 VOSEVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking University People's Hospital	Phase 4
Partners in Health	Phase 4
Gilead Sciences	Phase 3

See all VOSEVI clinical trials

Pharmacology for VOSEVI

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

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	7,964,580*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
Germany	202012013382
China	102906102
Eurasian Patent Organization	201492214
San Marino	T201500197	Imidazolilimidazoli condensati come composti antivirali

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR
2203462	C201430078	Spain		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Vosevi

Last updated: July 27, 2025

Introduction

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) has emerged as a significant player in the antiviral pharmaceutical sector, specifically targeting the treatment of hepatitis C virus (HCV) infections. Jointly developed by Gilead Sciences and AbbVie, Vosevi received FDA approval in July 2017. Since then, its market trajectory has been shaped by evolving treatment protocols, competitive dynamics, regulatory adjustments, and shifting global healthcare priorities. This report analyzes current market dimensions, growth drivers, challenges, and financial prospects for Vosevi, providing stakeholders with comprehensive insight into its future positioning.

Market Overview and Segmentation

HCV Treatment Landscape

The global hepatitis C treatment market is projected to reach approximately USD 31 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of circa 5.8% [1]. Within this context, direct-acting antivirals (DAAs), including Vosevi, dominate market share. Vosevi is indicated for adults with genotype 1-6 HCV infections, especially for patients who have failed previous DAA regimens. Its broad-spectrum efficacy positions Vosevi as a second-line therapy, augmenting Gilead’s portfolio alongside the highly successful Harvoni.

Market Segments

• Geographical: North America leads with over 50% market share, driven by high prevalence, robust healthcare infrastructure, and supportive reimbursement policies. Europe accounts for approximately 25%, with Asia-Pacific and Latin America gradually increasing their share due to rising HCV awareness and improving access.
• Patient Demographics: Chronic HCV patients with prior treatment failures, co-infections, or advanced liver disease constitute primary consumers. The rising elderly population worldwide expands the potential patient base.

Market Dynamics

Drivers

1. Unmet Medical Need for Retreatment Options:
Vosevi’s approval as a retreatment option for patients who failed previous DAA therapy fills a critical gap. Its efficacy — achieving sustained virologic response (SVR) in challenging cases — fuels demand, especially among patients with resistant strains [2].

2. Growing Global HCV Burden:
International health agencies estimate approximately 58 million people worldwide living with chronic HCV, fueling sustained demand for antiviral therapies [3]. Governments’ efforts toward elimination targets incentivize increased treatment adoption.

3. Evolving Treatment Guidelines:
The American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) recommend Vosevi for retreatment in specific patient subsets, bolstering its market position.

4. Regulatory Approvals and Market Access:
Regulatory bodies in Japan, EU, and other regions have authorized Vosevi, expanding its reach. Price negotiations and reimbursement considerations influence uptake.

Challenges

1. Competitive Landscape:
Vosevi faces competition from other potent DAAs like Mavyret (glecaprevir/pibrentasvir), Epclusa (sofosbuvir/velpatasvir), and newer agents with shorter treatment durations and lower costs [4].

2. Pricing and Cost Containment:
High treatment costs restrict access in lower-income markets. Payer pushback on prices and dosage regimens pressures revenue growth.

3. Patent Expirations and Generics:
Patent cliff risks loom as biosimilars and generics threaten market share, especially in price-sensitive markets.

4. Market Saturation in Developed Countries:
As elimination targets are approached in North America and Europe, the pipeline of treatment-naïve patients diminishes, shifting focus toward retreatment and harder-to-treat populations.

Financial Trajectory Analysis

Revenue Performance and Trends

Vosevi’s initial launch in 2017 delivered a strong revenue contribution for Gilead, leveraging its established footprint in HCV therapy. However, by 2020-21, revenues plateaued, attributable to market saturation and competitive pressures. In 2022, estimated sales of Vosevi hovered around USD 120 million globally [5].

Market Share Evolution

Vosevi's market share among retreatment regimens remains significant due to its proven efficacy. Nonetheless, newer therapies with shorter durations and potentially lower costs are gaining traction, prompting strategic shifts in Gilead’s and AbbVie’s marketing focus.

Forecasting

Projected revenues for Vosevi are expected to decline modestly over the next five years unless driven by expansion into emerging markets and new indications. Analysts forecast a compound decline rate of approximately 4-6% annually, influenced by decreased unmet needs and generic competition [6].

However, ongoing investments in post-approval studies, real-world evidence collection, and potential expansion into pediatric or co-infection indications could temporarily bolster sales.

Investment and R&D Outlook

Both Gilead and AbbVie continue investing in next-generation antiviral compounds, aiming to consolidate or extend their market influence. Licensing deals, combination therapies, and pipeline enhancements could indirectly influence Vosevi’s financial trajectory.

Regulatory and Market Access Strategic Developments

Efforts to improve patient access—such as tiered pricing, patient assistance programs, and partnerships with global health organizations—are critical. Regulatory approvals in high-burden regions like India and Africa could temporarily elevate revenues, albeit at lower price points.

Furthermore, the adoption of simplified dosing regimens and longer-term outcomes data will significantly influence physician prescribing behaviors and payer decisions.

Future Opportunities and Risks

• Opportunities:

  • Expansion into pediatric populations and co-infections (e.g., HIV).
  • Incorporation into combination regimens with other antiviral agents.
  • Strategic alliances to enhance distribution channels in emerging markets.

• Risks:

  • Erosion of market share due to generics.
  • Pricing pressures from payers and government agencies.
  • Regulatory hurdles in unapproved indications.
  • Rapid technological advances leading to highly effective, shorter regimens.

Key Takeaways

• Vosevi remains a critical retreatment agent amid a maturing HCV market, but its growth prospects are tempered by intense competition and market saturation.
• Revenue trajectory is expected to decline gradually, with significant reliance on expanding into emerging markets and novel indications.
• Strategic focus should prioritize access expansion, cost management, and pipeline integration to maintain relevance.
• Market dynamics underscore the importance of innovation, affordability, and regulatory agility to sustain presence and profitability.

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FAQs

1. How does Vosevi differ from other hepatitis C therapies?
Vosevi is specifically indicated for retreatment of HCV in patients who failed previous DAA therapy, offering broad genotype coverage and high SVR rates in resistant cases, distinguishing it from first-line therapies like Harvoni.

2. What are the primary challenges faced by Vosevi in maintaining market share?
Challenges include increasing competition from newer, shorter, and often more affordable regimens, patent expirations, and pricing pressures in both developed and emerging markets.

3. Which geographic regions have the most growth potential for Vosevi?
Emerging markets—particularly in Asia, Africa, and Latin America—present growth opportunities due to rising HCV prevalence, improving healthcare infrastructure, and increasing access initiatives.

4. What is the impact of patent expiry on Vosevi’s revenue prospects?
Patent expiry could lead to generic or biosimilar entries, substantially reducing prices and revenues unless strategic measures such as new indications or combination therapies sustain profitability.

5. Are there upcoming regulatory developments that could influence Vosevi’s market?
Regulatory approvals for expanded indications, such as pediatric use or HIV co-infections, could open new markets. Conversely, increased pricing scrutiny may constrain revenue growth in certain jurisdictions.

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References

[1] Market Research Future, "Global Hepatitis C Treatment Market," 2022.
[2] U.S. Food and Drug Administration, "Vosevi (sofosbuvir, velpatasvir, voxilaprevir) approval."
[3] World Health Organization, "HCV Fact Sheet," 2022.
[4] IQVIA, "Global Hepatitis C Market Data," 2022.
[5] Gilead Sciences Annual Report, 2022.
[6] EvaluatePharma, "Pharmaceutical Market Forecasts," 2023.