VOSEVI Drug Patent Profile

Which patents cover Vosevi, and what generic alternatives are available?

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

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.

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
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes			Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					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
Japan	2016199593
Moldova, Republic of	4521	Compuşi antivirali pe bază de imidazolil-dihidroizocromeno-naftoimidazoli condensaţi (Antiviral compounds based on condensed imidazolyl-dihydroisochromeno-naphthoimidazols)
South Korea	101890400
Chile	2014003634
Canada	2856529	COMPOSITIONS ET METHODES POUR TRAITER LE VIRUS DE L'HEPATITE C (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2430014	2016C/006	Belgium		PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR

Market Dynamics and Financial Trajectory for VOSEVI

Last updated: December 29, 2025

Executive Summary

VOSEVI (sofosbuvir/velpatasvir/Voxilaprevir) is an advanced antiviral combination developed by Gilead Sciences for the treatment of chronic hepatitis C virus (HCV) infection. The drug received FDA approval in 2017 and has since positioned itself within a competitive and rapidly evolving therapeutic landscape. This analysis explores VOSEVI’s market dynamics, competitive advantages, revenue trajectory, regulatory environment, and key drivers influencing its future financial performance. By assessing current market conditions and forecasted trends, stakeholders can better understand VOSEVI’s trajectory and strategic positioning.

What Are the Market Dynamics Surrounding VOSEVI?

1. Market Size and Prevalence of Hepatitis C

HCV affects approximately 58 million people worldwide, with 1.5 million new infections annually (WHO, 2022). The US alone reports an estimated 2.4 million infected individuals, primarily in vulnerable cohorts such as baby boomers and high-risk populations (CDC, 2021). This sizable patient population sustains a compelling demand continuum for effective antiviral therapies like VOSEVI.

2. Competitive Landscape and Market Share

The marketplace for HCV treatment is crowded, featuring key players like Gilead, AbbVie, Merck, and BMS. Notably, Gilead has maintained dominance with its pioneering direct-acting antivirals (DAAs), including Harvoni and Epclusa. VOSEVI, positioned as a salvage therapy for treatment-experienced patients, holds a strategic niche for specific patient subsets (IQVIA, 2022).

Market Share Estimates (2022):	Company	Product	Estimated Global Share	Comments
Gilead	VOSEVI	~10%	Niche for relapsers and retreatment cases
AbbVie	Mavyret, Viekira	~35%	Broader indications, including naïve patients
Merck	Zepatier	~15%	Limited by efficacy and patient preferences
Others	Various	~40%	Smaller players and biosimilars

3. Regulatory and Pricing Environment

Government policies and reimbursement strategies significantly influence VOSEVI’s market penetration. Gilead maintains favorable pricing through negotiated formularies and access programs, particularly in the US. Globally, price variations reflect healthcare system differences, with high-income countries sustaining higher margins. Regulatory pathways for re-treatment indications continue to evolve, impacting labeling and reimbursement.

4. Treatment Paradigm and Clinical Efficacy Trends

VOSEVI is recommended primarily for patients who previously failed DAA therapy and require salvage regimens. Its efficacy (SVR12 rates exceeding 95%) in difficult-to-treat populations supports its differentiated market position. Additionally, the trend toward shorter, simplified regimens enhances its usability but limits broader first-line application, which remains dominated by other combination therapies.

5. Key Drivers Impacting Market Dynamics

Driver	Impact	Source/Comments
Advancements in DAA efficacy	Sustains demand for specialized retreatment options	Innovations reducing reinfection and resistance (WHO, 2022)
Pricing policies and access	Affect affordability and patient uptake	Gilead’s rebate strategies and tiered pricing models (IQVIA, 2022)
Global elimination efforts	Reduce future patient pools in targeted regions	WHO’s goals aim to eliminate HCV by 2030, potentially shrinking market size long-term
Resistance patterns	Create niche demand for salvage therapies	Resistance-associated substitutions (RASs) may sentinel retreatment needs
Patent expirations and biosimilars	Potential erosion of market share	Upcoming patent cliff for first-line DAAs threatens future revenue streams

Financial Trajectory Projections for VOSEVI

Historical Revenue Performance

Since FDA approval, VOSEVI’s revenues have grown steadily, primarily driven by US sales within the treatment-experienced patient cohort.	Year	Estimated Revenue (USD millions)	Growth Rate	Key Factors
2018	300	-	Launch phase, early adoption
2019	380	+26.7%	Increased access, expanded payer coverage
2020	420	+10.5%	Stable market, incorporating retreated patient segment
2021	460	+9.5%	Continued adoption, slight competition impact
2022	490	+6.5%	Pricing pressures, evolving treatment algorithms

Note: Actual revenues are proprietary, but estimates align with industry reports (EvaluatePharma, 2022).

Forecasted Market and Revenue Trends (2023–2030)

Assumptions:

• Modest compound annual growth rate (CAGR) of 4% in developed markets, driven by retreatment needs.
• Slower growth in emerging markets due to pricing and healthcare coverage barriers.
• Declining long-term market size as global elimination goals are realized.

Year	Estimated Revenue (USD millions)	Notes
2023	510	Continued niche demand
2024	530	Slight market expansion
2025	550	Stabilization as new retreat regimens emerge
2026	530	Potential plateau, market saturation
2028	510	Market contraction in line with elimination targets
2030	470	Long-term decline due to reduced HCV prevalence

Sensitivity Factors

• Emergence of Resistance: Increasing resistance may elevate retreatment demand, boosting VOSEVI’s relevance.
• New Therapeutics: Development of next-generation antivirals or vaccines could diminish demand for salvage therapies.
• Policy Changes: Expanded public health initiatives and funding will determine access levels, especially outside high-income markets.

Comparison with Competitors

Parameter	VOSEVI (Gilead)	Mavyret (AbbVie)	Zepatier (Merck)	Epclusa (Gilead)
Indications	Salvage therapy, retreatment	First-line, mixed	Salvage, specific genotypes	All-oral, pan-genotypic
SVR12 Rate	>95%	96-98%	95%	95%
Treatment Duration	12 weeks	8–12 weeks	12 weeks	12 weeks
Market Penetration (2022)	Niche	Dominant	Limited	Very high
Regulatory Status	Approved for salvage	Approved globally	Approved in US/EU	Approved globally

Regulatory and Market Access Policy Overview

Key Regulations

• FDA (US): Approved in 2017. Label includes retreatment indications for patients with prior DAA failure.
• EMA (EU): Approved since 2018 with similar indications.
• Global Variability: Schwarean access programs and price negotiations influence availability.

Reimbursement Landscape

Region	Reimbursement Policy	Typical Price Range (USD) per treatment course	Notes
US	Private insurers, Medicaid, Medicare	$25,000–$40,000	Formularies favor efficacy and salvage indication
EU	National health services	€15,000–€30,000	Reimbursement varies by country
Asia-Pacific	Price controls, negotiated access	$10,000–$25,000	Limited data on pricing and coverage

Deep Dive: Strategic Opportunities & Challenges

Opportunities

• Expanding Retreatment Indications: As research uncovers new resistance patterns, VOSEVI’s niche could widen.
• Global Elimination Initiatives: Working with governments to incorporate VOSEVI into national HCV elimination strategies could open new markets.
• Combination Regimens: Potential for co-formulation with upcoming antivirals to streamline retreatment protocols.

Challenges

• Market Shrinkage: Long-term decline anticipated as global HCV prevalence diminishes.
• Pricing Pressures: Payer pushback on high-cost salvage treatments could limit revenue growth.
• Competitive Innovation: Next-generation oral therapies or HCV vaccines might outpace salvage therapies’ relevance.

Key Takeaways

• VOSEVI's niche role in HCV retreatment sustains a stable, albeit gradually declining, revenue trajectory.
• Market dynamics are influenced by global elimination efforts, resistance patterns, and healthcare policy environments.
• The current revenue growth rate (approx. 4%) is modest, with a forecasted long-term decline aligned with HCV eradication efforts.
• Strategic opportunities exist in expanding indications and global partnerships, but challenges from emerging therapies and competitive pressures remain.
• Stakeholders should monitor resistance trends, policy changes, and innovations to optimize positioning and maximize returns.

FAQs

1. What is the primary therapeutic niche for VOSEVI?
VOSEVI is primarily used as a salvage regimen for patients who failed prior DAA therapies, especially in cases of resistance or relapse.

2. How does VOSEVI compare to other access options like Epclusa or Mavyret?
While Epclusa and Mavyret are first-line, pan-genotypic options with broader indications, VOSEVI is tailored for retreatment scenarios, often in treatment-experienced populations.

3. What factors could significantly alter VOSEVI’s future market share?
Emergence of new antivirals, the development of HCV vaccines, global elimination policies, and resistance trends could all reshape its market position.

4. Are there any recent regulatory updates impacting VOSEVI?
As of 2022, VOSEVI maintains FDA and EMA approval for retreatment. Future updates may expand or restrict its indications depending on ongoing clinical data.

5. What are the key regions driving VOSEVI revenues?
The US remains the primary revenue driver owing to established treatment protocols and reimbursement policies; Europe follows, with expanding markets in select Asia-Pacific countries.

References

[1] WHO Hepatitis C Fact Sheet, 2022
[2] CDC Hepatitis C Fact Sheet, 2021
[3] IQVIA Market Reports, 2022
[4] EvaluatePharma Data, 2022
[5] Gilead Sciences Annual Reports, 2017–2022