Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

What are the generic sources for sofosbuvir; velpatasvir; voxilaprevir and what is the scope of freedom to operate?

Sofosbuvir; velpatasvir; voxilaprevir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir; voxilaprevir has six hundred and thirty-three patent family members in fifty countries.

One supplier is listed for this compound.

Summary for sofosbuvir; velpatasvir; voxilaprevir

International Patents:	633
US Patents:	18
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir; voxilaprevir
DailyMed Link:	sofosbuvir; velpatasvir; voxilaprevir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sofosbuvir; velpatasvir; voxilaprevir

Constraining patent/regulatory exclusivity:

11,338,007*PED

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 sofosbuvir; velpatasvir; voxilaprevir

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Helwan University	Phase 4
Kirby Institute	Phase 4

See all sofosbuvir; velpatasvir; voxilaprevir clinical trials

Pharmacology for sofosbuvir; velpatasvir; voxilaprevir

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

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir; velpatasvir; voxilaprevir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for sofosbuvir; velpatasvir; voxilaprevir

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	9,284,342*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	8,957,046
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,633,309*PED				Y

International Patents for sofosbuvir; velpatasvir; voxilaprevir

Country	Patent Number	Title	Estimated Expiration
Japan	2015205903
Taiwan	201107341	Nucleoside phosphoramidates
Australia	2012346217
China	105198949

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

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

Market Dynamics and Financial Trajectory for Sofosbuvir, Velpatasvir, and Voxilaprevir

Last updated: February 14, 2026

Overview
Sofosbuvir, Velpatasvir, and Voxilaprevir are direct-acting antiviral (DAA) agents approved for treating hepatitis C virus (HCV) infections. These drugs are part of combination therapies that target different viral proteins, leading to high cure rates. Their market dynamics are driven by rising HCV prevalence, evolving treatment guidelines, pricing strategies, and the competitive landscape.

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Market Size and Growth Drivers
As of 2022, the global hepatitis C therapeutics market was valued at approximately $12 billion, with projections to reach $15 billion by 2027, growing at a compound annual growth rate (CAGR) of around 5% (source [1]). DAAs represent the majority of this market.

Key growth drivers include:

• Increasing HCV diagnosis rates driven by improved screening protocols.
• Expanded access in emerging markets.
• Advancements in combination therapies improving treatment efficacy and duration.

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Product Overview and Regulatory Status

Drug Combination	Active Ingredients	Approval Date	Indications
Harvoni	Sofosbuvir + Ledipasvir	October 2014	Chronic HCV genotype 1, 4, 5, 6
Epclusa	Sofosbuvir + Velpatasvir	June 2016	All HCV genotypes
Vosevi (Voxilaprevir, Sofosbuvir, Velpatasvir)	Voxilaprevir + Sofosbuvir + Velpatasvir	July 2017	Previously treated HCV patients who failed prior therapy

Patent Coverage & Market Exclusivity
Vosevi, combining Voxilaprevir, is the newest among these, with patent protection expiring in the U.S. around 2027–2028, subject to extensions [2]. The expiration of patents opens the market for biosimilars and generics, impacting pricing and sales.

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Competitive Landscape
The most prominent competitors include Gilead Sciences, AbbVie, and newer entrants offering generic versions:

• Gilead’s Harvoni and Epclusa have dominated sales since 2014 and 2016 respectively.
• AbbVie’s Mavyret (glecaprevir/pibrentasvir) entered the market in 2017, offering broader genotype coverage at a lower price point.
• Patent expiries and biosimilar development threaten branded product dominance, especially in Europe and emerging markets.

Market Share Breakdown (2022)
Gilead retains approximately 60% of global HCV drug sales, followed by AbbVie with 20%. Generics hold roughly 15%, with remaining market share split among smaller companies and biosimilar manufacturers.

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Pricing Strategies and Patent Challenges
Pricing varies significantly by region. In high-income countries, the list price for a 12-week regimen ranges from $80,000 to $95,000 (source [3]). Payer negotiations and generic competition can reduce patient out-of-pocket expenses.

Patent challenges in India, Egypt, and South Africa facilitate the entry of generics, reducing prices by up to 90%. These regions account for approximately 30% of the global treatment market, representing a significant revenue decline for branded drugs once generics are validated.

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Financial Trajectory and Revenue Projections

Year	Estimated Global Sales (USD billions)	Notes
2022	10.5	Gilead’s dominant position, with Vosevi gaining momentum
2023	11.2	Growth driven by new patient diagnoses and expanding markets
2024	11.8	Increased penetration in emerging markets
2025	12.3	Patent cliff approaching for Vosevi
2026	11.5	Revenue decline expected as biosimilars enter markets

The revenue decline from 2026 onward depends on:

• Patent litigation outcomes
• Speed of biosimilar adoption
• Pricing adjustments in different markets

Research & Development Investment
Companies continue investing in pan-genotypic DAA regimens, aiming to reduce the need for genotype testing and simplify treatment algorithms, potentially impacting sales of existing drugs.

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Regulatory and Policy Impact
New HCV elimination programs in countries like Egypt, India, and the U.S. involve subsidized treatment. The U.S. has expanded Medicaid coverage, increasing patient access. Policy shifts in pricing and patent law directly influence sales forecasts.

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Key Factors Affecting Future Market Dynamics

• Patent Expiry & Biosisemptymentation:Generics are poised to surge, especially in Asia, reducing prices and shifting market share.
• Treatment Guidelines: Updated guidelines favor pan-genotypic, shorter regimens, favoring drugs like Epclusa over genotype-specific therapies.
• Pricing & Reimbursement: Payer pressure in high-income countries limits revenue growth for branded drugs.
• Innovation: Next-generation DAAs with better safety profiles and shorter durations may replace current treatments.

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Key Takeaways

• The global HCV treatment market is expected to grow modestly before patent expiries accelerate generic competition.
• Gilead’s dominance continues but faces challenges from patent cliffs and biosimilars.
• Pricing varies regionally, with significant discounts in developing markets.
• Patents for Vosevi are expiring soon, creating opportunities for biosimilar proliferation.
• Continued R&D toward pan-genotypic, shorter, and cheaper regimens will influence market share dynamics.

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FAQs

1. When will patent expiry likely occur for Vosevi?
Patent protections are expected to expire in the U.S. around 2027–2028, varying by country due to patent law and legal challenges.

2. How do biosimilars impact the market?
Biosimilars reduce prices and increase access. They threaten revenue for branded drugs post-patent expiry, especially in countries with strong generic policies.

3. What is the projected growth rate for the HCV drug market?
The market is projected to grow at a CAGR of approximately 5% until 2027, driven by increased diagnosis and treatment access.

4. How significant is regional variation in pricing?
Pricing is substantially lower in emerging markets, with discounts up to 90%. High-income countries maintain premium pricing due to reimbursement mechanisms.

5. What advances could alter current market projections?
Development of more effective, shorter, and less expensive pan-genotypic therapies, along with policy reforms and patent litigation outcomes.

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Citations
[1] MarketWatch, "Global Hepatitis C Therapeutics Market," 2022.
[2] U.S. Patent Databases, "Vosevi patent timeline."
[3] PharmaPrice Intelligence, "HCV drug pricing," 2022.