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	8,334,270*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,618,076*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	9,868,745		Y	Y
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
Germany	202012013382
China	102906102
Eurasian Patent Organization	201492214
Chile	2014001397	Composicion farmaceutica que comprende a) gs-7977 y b) al menos un excipiente farmaceuticamente estable; forma de dosificacion unitaria; proceso de preparacion de la composicion; uso de la composicion para tratar una infeccion causada por el virus de la hepatitis c.

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

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 Sofosbuvir, Velpatasvir, and Voxilaprevir

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape surrounding antiviral therapies has experienced transformative shifts with the emergence of direct-acting antivirals (DAAs). Among these, sofosbuvir, velpatasvir, and voxilaprevir represent critical innovations targeting hepatitis C virus (HCV) infections, shaping market dynamics and financial trajectories. As a triad often combined into versatile regimens, their strategic positioning influences global health outcomes, market competition, and revenue forecasts.

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Pharmaceutical Overview

• Sofosbuvir: A nucleotide analog polymerase inhibitor developed by Gilead Sciences, introduced in 2013. It revolutionized HCV treatment, offering high cure rates with shorter duration and fewer side effects compared to prior regimens.
• Velpatasvir: An NS5A inhibitor co-developed by Gilead and others, approved in 2016. It complements sofosbuvir by broadening the antiviral spectrum, especially against diverse HCV genotypes.
• Voxilaprevir: A protease inhibitor introduced in 2017/18, primarily used in retreatment of patients with previous DAA failure, enhancing the efficacy of combination therapies.

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Market Dynamics

Global Market Landscape

The hepatitis C therapeutic market reached an estimated USD 19 billion in 2022, with projections to grow as new therapies expand access and resistance issues emerge. The segment's growth is driven by:

• Increasing diagnosis rates: Despite advances, underdiagnosis remains a challenge, especially in low- and middle-income countries (LMICs).
• Expanding treatment access: International health agencies and governments strive to incorporate DAAs into national programs, catalyzing demand.
• Pricing strategies: Gilead's initial high-price models faced resistance but have shifted toward generic licensing in LMICs, influencing market penetration.

Competitive Dynamics

Gilead dominates the market with its proprietary combinations—Sovaldi (sofosbuvir), Harvoni (sofosbuvir + ledipasvir), and Epclusa (sofosbuvir + velpatasvir)—which hold significant market shares due to proven efficacy, simplified dosing, and extensive clinical data. However, competition from newer entrants like AbbVie's Viekira Pak and Merck's late-stage candidates pressures Gilead’s dominance.

Patent Expirations and Generic Competition

Patents covering sofosbuvir and velpatasvir face expiries or licensing agreements in various jurisdictions, facilitating generic entry. This has led to:

• Price erosion, especially in LMICs where generics are prevalent.
• Market segmentation, with branded products maintaining premium positioning in high-income countries (HICs).
• Increased adoption of cost-effective generic regimens.

Regulatory and Policy Influences

WHO's strategic goals aim for HCV elimination by 2030, influencing regulatory environments. Policy shifts towards subsidized treatment programs and generic licensing agreements have expanded access. Simultaneously, patent litigations and exclusivity rights continue to shape R&D investments and market competition.

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Financial Trajectory

Revenue Trends

Gilead’s revenues derived from HCV drugs peaked around 2015-2016, with over USD 12 billion in annual sales, driven principally by sofosbuvir-based therapies. Since then, revenue plateaued due to market saturation and rising generic competition, with annual sales declining to approximately USD 4-6 billion by 2022.

Profitability and R&D Investment

Despite revenue declines, profits remained substantial due to high gross margins. R&D budgets for HCV therapies—though declining—are strategic for developing next-generation regimens, including pan-genotypic drugs and resistance management options.

Emerging Growth Opportunities

• Resistance management: Voxilaprevir’s role in retreatment indicates a trajectory toward addressing DAA resistance, opening niche markets.
• Expanding global access: Strategic licensing, tiered pricing, and inclusion in public health programs are projected to sustain revenues from LMIC sales.
• Combination innovations: Co-formulations improving adherence and simplifying regimens are expected to drive future sales.

Impact of Market Shifts

The transition toward generic competition and the evolution of treatment guidelines towards shorter, pan-genotypic, and affordable regimens influence revenue streams. Gilead and other players are pivoting to newer antiviral strategies for HCV, such as pangenotypic therapies and resistance-associated variant management, impacting the financial Portfolio of existing drugs.

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Strategic Implications

The landscape’s complexity necessitates strategic agility. Pharmaceutical companies investing in developing new DAAs or repositioning existing drugs aim to capitalize on residual unmet needs, particularly in disease management among resistant HCV strains. Alliances, patent litigations, and licensing agreements are critical tools influencing market control, revenue streams, and long-term sustainability.

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Key Challenges and Opportunities

• Price sensitivity in LMICs: While generic licensing expands access, it compresses profit margins. Strategic tiered pricing models balance access and profitability.
• Resistance emergence: Limited treatment options for resistant HCV necessitate ongoing investment in voxilaprevir and similar agents.
• Regulatory hurdles: Complexities around approval of combination treatments across jurisdictions require robust regulatory engagement.
• Market expansion: Untapped populations, including co-infected HIV patients and patients with advanced liver disease, present growth avenues.

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Conclusion

Sofosbuvir, velpatasvir, and voxilaprevir collectively have reshaped the HCV treatment paradigm, with significant market influence over the past decade. However, the trajectory now hinges on balancing patent protections, combating resistance, expanding access through generics, and innovating for unmet needs. While current revenues face pressures from competitive and patent landscapes, ongoing R&D and strategic licensing positioning promise incremental financial returns aligning with the broader goal of hepatitis C elimination.

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Key Takeaways

• The HCV drug market experienced rapid growth post-2013, driven by sofosbuvir’s introduction, but growth has plateaued due to patent expiry and generic competition.
• Gilead remains dominant but faces formidable competition and pressure on profit margins, especially in LMICs.
• Voxilaprevir's role in retreatment signifies an emphasis on resistance and treatment failure management, opening niche markets.
• Market growth depends heavily on global and regional access programs, licensing agreements, and regulatory policies.
• Future profitability will require innovation in pan-genotypic, resistance-resistant, and simplified treatment regimens, alongside strategies for market access expansion.

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FAQs

1. How have patent expirations affected the market for sofosbuvir and velpatasvir?
Patent expirations and licensing agreements have enabled the proliferation of generic versions in many regions, leading to significant price reductions and increased access in LMICs but constraining revenues for brand-name manufacturers in high-income markets.

2. What is the role of voxilaprevir in current hepatitis C treatment strategies?
Voxilaprevir primarily serves as a retreatment option for patients with prior DAA failures, addressing resistance issues, thereby creating a niche but increasingly important market segment.

3. How do emerging resistance patterns impact the financial prospects of these drugs?
Resistance emergence necessitates the development and adoption of newer combinations like voxilaprevir, potentially requiring substantial R&D investments. This could affect the sales of existing drugs but also opens opportunities for targeted therapies.

4. What are the main challenges in expanding hepatitis C treatment access globally?
Key challenges include high drug prices in HICs, patent barriers, limited healthcare infrastructure, and the need for widespread diagnosis. Licensing agreements and tiered pricing are vital strategies to mitigate these barriers.

5. What future innovations are expected to influence the market trajectory of these antivirals?
Development of pan-genotypic regimens with shorter duration, resistance management solutions, and integrated diagnostics are poised to further transform treatment paradigms and sustain market relevance.

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References

1. Gilead Sciences Inc. [Annual Reports and Clinical Data: 2013-2022].
2. World Health Organization. Global hepatitis report 2022.
3. Market Research Future. Hepatitis C therapeutics market analysis 2022.
4. PhRMA. Patent landscapes and licensing strategies for hepatitis C drugs.
5. IQVIA. Global drug market analysis 2022.

(Note: The above references are illustrative, drawn from possible industry sources and reports relevant to this analysis.)