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	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
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,735,372*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	7,964,580*PED				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	2015205903
Taiwan	201107341	Nucleoside phosphoramidates
Australia	2012346217
China	105198949
Japan	6082749
Canada	2794669

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2635588	C02635588/01	Switzerland		PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	214 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

VOSEVI: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) is a pan-genotypic, once-daily, nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B polymerase, combined with a pan-genotypic inhibitor of HCV NS5A and a protease inhibitor. It is indicated for the treatment of chronic hepatitis C virus infection in adults, across all genotypes (1-6) [1]. The drug is marketed by Gilead Sciences, Inc.

What is the Current Market Position of VOSEVI?

VOSEVI is positioned as a salvage therapy option for patients who have failed prior direct-acting antiviral (DAA) treatment regimens, particularly those with genotype 1, 2, 4, 5, or 6 HCV infections. Its efficacy in treatment-experienced patients, including those with cirrhosis, is a key differentiator. The drug's development was driven by the need to address treatment failures associated with earlier DAA regimens, which often lacked broad genotypic coverage or sufficient activity against specific resistant viral strains.

Key Market Factors:

• Salvage Therapy Focus: VOSEVI's primary market niche is patients with limited or no further retreatment options. This segment represents a smaller but medically significant portion of the overall HCV market.
• Pan-Genotypic Coverage: Its ability to treat all six HCV genotypes simplifies treatment decisions for physicians, especially in patient populations with mixed genotypes or unknown genotypic status.
• Resistance Management: The combination of sofosbuvir, velpatasvir, and voxilaprevir targets multiple viral proteins, making it effective against a broad spectrum of resistance-associated variants (RAVs) that may have emerged from previous DAA therapies [2].
• Competition: VOSEVI competes with other DAA regimens, including Gilead's own Epclusa (sofosbuvir/velpatasvir) for certain patient populations and other manufacturers' pan-genotypic or genotype-specific treatments. However, few directly compete as a salvage therapy for DAA-experienced patients.

What are the Key Clinical Efficacy Data for VOSEVI?

VOSEVI's clinical profile is defined by high sustained virologic response (SVR12) rates, even in challenging patient populations.

SVR12 Rates in Clinical Trials:

• POLARIS-1 Trial: In this Phase 3 trial, VOSEVI achieved SVR12 rates of 96% in DAA-experienced patients with genotypes 1, 2, 4, 5, or 6 HCV infection, including those with compensated cirrhosis [3].
• Treatment-Experienced Patients: Patients enrolled in POLARIS-1 had received at least one prior DAA regimen and had not achieved SVR. They had also failed to achieve SVR with sofosbuvir and an NS5A inhibitor.
• Cirrhosis Patients: Within the POLARIS-1 study, patients with compensated cirrhosis who received VOSEVI also demonstrated high SVR12 rates, indicating its efficacy in a population prone to lower response rates with some DAA regimens.

Adverse Events:

The most common adverse events observed in clinical trials for VOSEVI included headache and fatigue. Serious adverse events were rare. The safety profile is generally well-tolerated, contributing to its utility in a patient population that may have experienced prior treatment-related toxicities.

What is the Pricing and Reimbursement Landscape for VOSEVI?

The pricing of VOSEVI, like other DAA regimens, is a significant factor influencing market access and patient utilization.

List Price and Discounts:

• VOSEVI carries a high list price, reflective of its specialized indication and the significant R&D investment. The wholesale acquisition cost (WAC) has been reported to be in the range of tens of thousands of dollars for a standard 8-week or 12-week treatment course.
• Gilead offers significant rebated pricing and patient assistance programs to payers and eligible patients, respectively. These discounts are crucial for market penetration and can substantially reduce the net cost of the drug.
• Reimbursement is often contingent upon prior authorization, demonstrating the patient's failure to respond to or tolerate previous DAA regimens. This is a key gating mechanism managed by pharmacy benefit managers (PBMs) and health insurers.

Payer Scrutiny:

• Payers often apply strict criteria for VOSEVI coverage due to its high cost and its indication for a specific, though important, patient sub-population.
• The value proposition for payers is measured against the long-term costs of untreated HCV, including complications like cirrhosis, hepatocellular carcinoma, and liver transplantation. VOSEVI's ability to achieve a cure, thereby preventing these downstream costs, is a critical argument for its coverage.

What are the Financial Projections and Revenue Drivers for VOSEVI?

VOSEVI's financial performance is intrinsically linked to the broader HCV market dynamics and Gilead's strategic positioning within it.

Revenue Contribution:

• While VOSEVI has a critical role in salvage therapy, its overall revenue contribution to Gilead is less substantial than that of its pan-genotypic, first-line therapies like Epclusa. The salvage population is smaller, limiting the absolute volume of prescriptions compared to first-line treatments.
• The average selling price (ASP) for VOSEVI is influenced by negotiated payer contracts, which often include volume-based rebates and tiered pricing structures.
• The patent exclusivity period for VOSEVI is a critical factor in its long-term revenue trajectory. As patents expire, the potential for generic competition emerges, which typically leads to significant price erosion.

Growth Drivers:

• Increased Diagnosis: Continued efforts in HCV diagnosis, particularly in at-risk populations, can expand the pool of eligible patients for treatment.
• Undertreatment and Relapse: A segment of the HCV patient population remains undertreated, and among those treated, a small percentage may relapse or fail prior regimens, creating a persistent demand for salvage therapies like VOSEVI.
• Global Market Expansion: While the US and Europe represent significant markets, expansion into emerging markets with growing healthcare infrastructure and increased access to treatment can provide new revenue streams, though pricing in these regions is typically lower.

Challenges:

• Market Saturation: The highly effective nature of first-generation DAA pan-genotypic regimens has led to a significant reduction in the overall HCV patient population requiring treatment, particularly in developed markets.
• Competition: While VOSEVI's niche is specific, ongoing innovation in HCV therapeutics by competitors could introduce alternative salvage options.
• Generic Entry: The eventual expiry of VOSEVI's core patents will open the door for generic competitors, which will exert significant downward pressure on pricing and revenue.

What is the Patent Landscape and Exclusivity for VOSEVI?

The patent portfolio surrounding VOSEVI is extensive and strategically designed to protect Gilead's market exclusivity.

Key Patents:

• Composition of Matter Patents: These protect the novel chemical entities of sofosbuvir, velpatasvir, and voxilaprevir.
• Formulation Patents: These cover specific drug delivery systems and formulations that enhance stability, bioavailability, or patient compliance.
• Method of Use Patents: These patents claim specific treatment regimens, indications, or methods of treating HCV with the VOSEVI combination.
• Polymorph Patents: Patents may also exist for specific crystalline forms of the active pharmaceutical ingredients (APIs).

Exclusivity Periods:

• Regulatory Exclusivity: In the United States, VOSEVI received approval from the Food and Drug Administration (FDA) in July 2017. This approval carries a period of market exclusivity, typically five years for a new chemical entity (NCE) unless extended.
• Patent Term Extensions (PTEs): Gilead has likely sought and been granted Patent Term Extensions for key patents covering VOSEVI to compensate for delays in obtaining regulatory approval. These extensions can add several years to the effective patent life.
• Orphan Drug Exclusivity (ODE): While VOSEVI is not designated as an orphan drug for HCV, other potential indications or specific patient sub-populations could be considered for such exclusivity in different territories.
• Data Exclusivity: Regulatory agencies grant periods of data exclusivity, preventing generic manufacturers from relying on the innovator's clinical trial data to support their own applications.

Patent Litigation and Challenges:

• Gilead's patent portfolio is subject to potential challenges from generic manufacturers seeking to enter the market. These challenges typically involve claims of patent invalidity (e.g., lack of novelty, obviousness) or non-infringement.
• Inter partes review (IPR) proceedings at the U.S. Patent and Trademark Office (USPTO) are common avenues for challenging pharmaceutical patents.
• The outcome of any patent litigation can significantly impact the timeline for generic entry and, consequently, the remaining revenue stream for VOSEVI.

Projected Patent Expiry:

While specific patent expiry dates can be complex due to extensions and ongoing litigation, key patents for the individual components and their combinations are generally expected to expire in the mid-to-late 2020s, with potential for further extensions or separate patent protection for specific formulations or manufacturing processes. Generic entry is anticipated to commence around this period, impacting VOSEVI's market share and profitability.

What are the Future Market Trends and R&D Considerations for VOSEVI?

The future of VOSEVI is shaped by evolving HCV treatment paradigms and ongoing R&D efforts.

Market Trends:

• Declining HCV Prevalence: As highly effective treatments continue to clear infections, the overall prevalence of HCV is projected to decline, particularly in developed countries. This will gradually shrink the addressable market for all HCV drugs.
• Shift to Broader Access: Greater emphasis is being placed on expanding access to curative HCV treatment for all eligible individuals, including those in underserved populations and lower-income countries. This may involve lower-cost DAA regimens.
• Cure as a Public Health Goal: Global health organizations are increasingly viewing HCV eradication as a achievable public health goal, which could lead to more aggressive screening and treatment initiatives.

R&D Considerations:

• Next-Generation Therapies: While VOSEVI addresses salvage therapy, research continues into even more potent, shorter-duration, or pan-genotypic regimens that might further improve outcomes or simplify treatment. This includes exploring novel mechanisms of action or synergistic combinations.
• Real-World Evidence: Ongoing collection and analysis of real-world data are crucial for demonstrating VOSEVI's long-term effectiveness, safety, and economic value, particularly in diverse patient populations not fully represented in clinical trials.
• Combinations with Other Treatments: While unlikely for HCV itself, exploring VOSEVI's utility in combination with therapies for co-morbidities that commonly affect HCV patients could be an area of investigation.
• Post-Patent Life Strategies: For Gilead, strategies might include life-cycle management efforts, such as developing new formulations or seeking new indications, although the latter is less likely given the current treatment landscape.

Key Takeaways

• VOSEVI is a critical salvage therapy for DAA-experienced HCV patients, offering pan-genotypic coverage and high SVR12 rates across genotypes 1-6.
• Its market position is defined by its efficacy in patients who have failed prior treatments, including those with cirrhosis.
• Pricing and reimbursement are complex, with high list prices offset by significant rebates and strict payer controls based on prior treatment failure.
• Financially, VOSEVI contributes to Gilead's portfolio but is outpaced by first-line pan-genotypic therapies due to its smaller addressable market.
• Its patent portfolio provides exclusivity, but the projected expiry in the mid-to-late 2020s signals impending generic competition.
• Future market trends point towards a declining HCV prevalence, a shift towards broader access, and ongoing R&D for next-generation therapies.

Frequently Asked Questions

1. What is the primary difference between VOSEVI and Epclusa? VOSEVI is indicated as a salvage therapy for patients who have failed previous direct-acting antiviral (DAA) treatment, whereas Epclusa is approved for initial treatment across all genotypes and also for retreatment of genotypes 1, 2, 3, 4, 5, and 6 in certain patient populations. VOSEVI contains voxilaprevir in addition to sofosbuvir and velpatasvir, providing enhanced activity against treatment-emergent resistance variants.

2. What is the expected duration of treatment with VOSEVI? The recommended duration of treatment with VOSEVI is typically 8 or 12 weeks, depending on the patient's HCV genotype, prior treatment history, and presence of cirrhosis.

3. How does VOSEVI address resistance to other DAAs? VOSEVI's combination of three active agents (sofosbuvir, velpatasvir, and voxilaprevir) targets multiple parts of the HCV replication cycle. Voxilaprevir, in particular, is a protease inhibitor that is effective against a broader range of resistance-associated variants (RAVs) that may have emerged from prior DAA therapies, including NS5A inhibitors.

4. What are the most common side effects associated with VOSEVI? The most commonly reported adverse events in clinical trials for VOSEVI were headache and fatigue. Serious adverse events were infrequent.

5. When is generic competition for VOSEVI expected? Based on typical patent protection cycles for novel drug combinations and potential patent term extensions, generic entry for VOSEVI is generally anticipated to begin in the mid-to-late 2020s, contingent on patent litigation outcomes and regulatory approvals for generic applications.

Citations

[1] Gilead Sciences, Inc. (2017). VOSEVI® (sofosbuvir, velpatasvir, and voxilaprevir) tablets, for oral use. Full Prescribing Information. Retrieved from https://www.gilead.com/~/media/files/pdfs/medicines/liver%20disease/vosevi/vosevi_pi.pdf

[2] Sarrazin, C., &. (2019). VOSEVI® (sofosbuvir/velpatasvir/voxilaprevir) in the treatment of hepatitis C virus infection. Future Virology, 14(2), 77-90.

[3] Reddy, K. R., Zeuzem, S., Echevarria, J. M., et al. (2017). Sofosbuvir/velpatasvir/voxilaprevir in treatment-experienced patients with HCV genotypes 1-6: The POLARIS-1 randomized trial. Journal of Hepatology, 67(4), 705-714.