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-eight patent family members in fifty-two 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 June 1, 2037. This may change due to patent challenges or generic licensing.

There have been twenty-five 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:	638
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
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

Jordan

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
Argentina	108616
Australia	2017273851
Brazil	102017011025
Canada	3025380
China	109310678
Eurasian Patent Organization	201892376
European Patent Office	3463346

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	214 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR
2203462	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117

VOSEVI Market Dynamics and Financial Trajectory (Revenue Outlook, Pricing Pressure, and Competition From Generic and Biosimilar-Adjacent Risks)

Last updated: July 20, 2026

VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) is a late-line, interferon-free direct-acting antiviral (DAA) regimen for chronic hepatitis C virus (HCV). Its financial trajectory is dominated by (1) United States and major ex-US sustained virologic response (SVR) demand, (2) payer contracting and price reductions, (3) treatment guideline penetration and cure rates that reduce repeat utilization, and (4) the timing of patent and exclusivity cliffs that enable generic competition in key markets.

How has VOSEVI performed financially since launch, and what drives year-to-year revenue changes?

VOSEVI generated strong initial uptake after launch because it filled the clinical gap for patients with prior DAA exposure (especially prior NS5A inhibitor failure) where earlier regimens had limitations. After early adoption, revenue behavior shifted from rapid cohort capture to contracting-driven volume and mix effects: fewer eligible patients remaining in newly diagnosed populations, payer restrictions tightening, and regimen switching to competing DAAs as formularies refreshed.

What market drivers shaped VOSEVI demand by segment?

• Geography and payer structure
  • US largely drives the headline economic profile due to reimbursement scale.
  • EU and other markets follow with lower per-patient pricing and slower formulary movement.
• Patient history mix
  • VOSEVI’s incremental value is highest in previously treated populations, which are narrower than broad-treatment first-line cohorts.
  • As more patients are cured, incident eligible populations decline, compressing total addressable demand even if penetration stays high.
• Clinical guideline updates
  • Guideline shifts that expand simpler first-line options reduce the proportion of patients routed into salvage regimens.
• Formulary management
  • Payers increasingly steer to lower-cost DAAs once efficacy is equivalent in labeled populations.

What economic levers most affect VOSEVI revenue?

• Net price trajectory
  • DAAs typically experience systematic price reductions through contracting, rebates, and public payer procurement.
• Dose-course pricing vs volume
  • One-time curative courses mean revenue scales with treated patients rather than chronic daily dosing.
• Competition intensity
  • As multiple pan-genotypic regimens reach similar efficacy across treatment-naïve and treatment-experienced populations, differentiation narrows, and pricing becomes the main lever.

What is the competitive landscape for VOSEVI, and how do alternative DAAs change its revenue exposure?

VOSEVI competes in a crowded DAA market that includes other pan-genotypic and retreatment regimens. Competitive dynamics differ by patient subgroup: treatment-naïve versus treatment-experienced, and prior NS5A inhibitor exposure versus protease inhibitor exposure.

Which drug classes compete with VOSEVI?

• Pan-genotypic DAAs
  • Direct-acting regimens with different backbone combinations that can reduce the need for VOSEVI’s salvage positioning.
• Retreatment DAAs
  • Regimens designed for prior DAA failures target overlapping subpopulations, forcing price and access competition.
• Low-cost procurement
  • In public tenders, competitors with earlier generic readiness or lower contracted pricing can displace VOSEVI.

How does competitor availability impact unit economics?

• When multiple regimens are considered clinically interchangeable in a given labeled population, payers choose the lowest net cost.
• In practice, VOSEVI’s revenue exposure becomes highest in:
  • treatment-experienced cohorts where payers can substitute an alternative regimen without sacrificing SVR outcomes,
  • formularies where preferred agents replace VOSEVI after contract renegotiations,
  • tender bidding, where price is decisive.

When does VOSEVI lose exclusivity, and what generic entry risks matter most for revenue?

VOSEVI’s revenue trajectory is sensitive to exclusivity and patent expiry because DAAs are high-cost, one-course therapies with sharp post-entry price compression when generics reach market.

How generic timing affects revenue

• Exclusivity cliffs drive step-change revenue drops
  • DAAs often show inflection points when generic or authorized generic supply scales and payers reprice formularies quickly.
• Paragraph IV and ANDA strategy affects entry pace
  • Where patent litigation accelerates generic approvals or settlements allow earlier entry, revenue decay can start ahead of final expiry.

What commercialization pattern typically follows generic entry?

• Brand retains some share initially via:
  • remaining on formularies where switch is slow,
  • contracting carve-outs,
  • high need cohorts under specific clinical criteria.
• Over quarters, net price falls and unit volume migrates to low-cost options.

What patents and Orange Book status protect VOSEVI, and how do they shape generic launch timing?

The extent to which VOSEVI’s patent estate delays generic competition depends on Orange Book-listed protections covering drug substance, drug product, formulation, and method-of-use. Market impact is often driven by whether remaining patents are:

• composition of matter (high leverage for delay),
• formulation or process (can drive “design-around” efforts or partial generic entry),
• use-related patents (can enable approval but delay substitution in specific populations).

How patent layering affects market protection

• A layered estate can maintain brand viability even if some protections expire, because remaining patents can block full substitution and “all-comers” formulary inclusion.
• Method-of-use or population-specific patents can keep the brand entrenched in salvage niches longer than expected.

What formulation and manufacturing IP barriers influence generic substitution after approval?

VOSEVI is a fixed-dose combination (FDC). For generics, the market risk is not only regulatory approval but also practical substitution:

• bioequivalence,
• stability and manufacturing reproducibility,
• ability to produce at scale under cost targets.

Typical substitution barriers in FDC DAAs

• Fixed-dose manufacturing complexity
  • Combining three actives increases formulation and process constraints.
• Patent-protected manufacturing approaches
  • Process patents can force longer development cycles or restrict alternative manufacturing routes.
• Packaging and tablet specification
  • Product design choices can affect acceptance and switching speed.

What does VOSEVI’s FDA pathway and labeling imply for uptake and payer coverage?

VOSEVI’s FDA labeling and its positioning in clinical guidelines influence payer coverage decisions. In curative DAA markets, uptake is tightly linked to:

• whether the regimen is included in payer policies as preferred,
• whether criteria restrict use to certain prior-treatment histories.

Coverage mechanics that drive realized revenue

• Payers use prior authorization to limit use to labeled and guideline-supported subgroups.
• Coverage policies can tighten when competitors have comparable SVR and are priced lower.
• Label expansions, when present, can increase addressable demand. Without label expansions, revenue mostly tracks existing population growth and formulary inclusion.

How do settlement agreements and litigation outcomes affect VOSEVI exclusivity and generic timelines?

Brand revenue can be materially affected by patent litigation outcomes that determine:

• when the first generic or authorized generic can launch,
• whether launch design avoids infringement allegations,
• whether settlements include no-AG terms or shared market-activity constraints.

What market impacts follow typical DAA settlement structures

• Launch dates shift
  • Settlements often set a specific entry date rather than waiting for the last patent to expire.
• Authorized generic risk
  • Authorized generics can reduce brand revenue even before full generic entry because they undercut net pricing while keeping brand’s distribution structure.
• Formulary repricing
  • Once alternative supply exists, payers tend to re-contract aggressively.

Which geographies produce the biggest revenue upside or downside for VOSEVI?

For DAAs, geography matters because pricing is heavily influenced by:

• public tender systems,
• local reimbursement restrictions,
• generic penetration pace,
• patent enforcement intensity.

Likely geography-based patterns

• United States
  • Highest realized net pricing and fastest contracting cycles.
  • The main driver of near-term quarterly revenue.
• Europe
  • Slower price deterioration but strong public payer procurement influence.
  • Competitive substitution depends on HTA outcomes and tender cycles.
• Emerging markets
  • Often higher generic usage earlier; brand protection varies by patent coverage strength and enforcement.

How does VOSEVI compare with competing DAAs on market-access positioning and likely pricing pressure?

VOSEVI’s market-access position is tied to its clinical niche: prior DAA experience. Competitive regimens that cover similar prior-treatment subgroups create pricing pressure quickly because payers can switch to lower net-cost alternatives.

Market-access comparison framework

• Who is eligible on label/policy?
  • If competitors match the same treated populations, VOSEVI’s pricing power weakens.
• How quickly do payers move?
  • After contract renegotiations, switches can be rapid if outcomes are comparable.
• What is the generic substitution threshold?
  • When generic-ready supply approaches, brand discounts tend to be rebalanced to preserve share.

What is VOSEVI’s revenue sensitivity to pricing, volumes, and mix shifts?

Because VOSEVI is a one-time course curative therapy, revenue sensitivity is:

• high to treated-patient volumes (diagnosis, eligibility, guideline uptake, payer restriction changes),
• moderate to pricing until generic entry changes the baseline market price,
• high to mix (treatment-naïve versus treatment-experienced; cirrhosis and prior failure profiles).

Revenue sensitivity summary

• Before generic competition: net price and formulary share drive revenue.
• At generic entry: revenue typically compresses sharply due to payer repricing.
• After entry: brand may persist in limited niches but with diminished economics.

Key implications for investors and licensors: where is the value most at risk?

• The highest revenue risk is tied to patent/exclusivity cliffs and any litigation-driven early entry.
• The next highest risk is payer contracting deterioration as competing DAAs capture preferred formulary status for overlapping populations.
• The “steady-state” is likely characterized by shrinking addressable salvage demand as more patients are cured over time.

Key Takeaways

• VOSEVI’s financial trajectory is shaped by curative dynamics that shrink eligible populations and by payer contracting that compresses net pricing over time.
• Competition from alternative DAAs intensifies pricing pressure, especially when competitors cover overlapping treatment-experienced subgroups.
• The most material revenue inflection is tied to the timing of exclusivity and Orange Book-protected patent expirations and any litigation settlement that accelerates generic or authorized generic entry.
• For FDC DAAs, generic substitution speed is influenced by both regulatory approval and practical manufacturing and IP barriers.

FAQs

1. How does generic launch timing for VOSEVI typically affect brand net revenue in the US?
2. Do payer prior-authorization criteria protect VOSEVI share in treatment-experienced HCV populations after competing DAAs gain formulary preference?
3. What types of VOSEVI patents (composition, formulation, method-of-use, process) most influence whether generics can be substituted broadly?
4. How do public payer tenders in the EU and other regions accelerate price erosion for VOSEVI compared with private insurance markets?
5. What settlement structures in US Hatch-Waxman litigation most often reduce brand revenue before full patent expiry (authorized generics, partial carve-outs, staggered entry)?

References

1. FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book entries for sofosbuvir/velpatasvir/voxilaprevir). US Food and Drug Administration.
2. FDA Drug Labeling. VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) prescribing information and labeling history. US Food and Drug Administration.

DrugChatter Q&A for VOSEVI

How does vosevi treat hepatitis c?
How does vosevi treat retreatment patients?