SOFOSBUVIR; VELPATASVIR - Generic Drug Details

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

Sofosbuvir; velpatasvir is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in three NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir has five hundred and twenty-nine patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for SOFOSBUVIR; VELPATASVIR

International Patents:	529
US Patents:	21
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	77
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFOSBUVIR; VELPATASVIR
DailyMed Link:	SOFOSBUVIR; VELPATASVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOFOSBUVIR; VELPATASVIR

Constraining patent/regulatory exclusivity:

9,757,406*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,116,783*PED

Dosage:

PELLETS;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

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

Sponsor	Phase
Lifespan	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4
Atea Pharmaceuticals, Inc.	PHASE3

See all SOFOSBUVIR; VELPATASVIR clinical trials

Pharmacology for SOFOSBUVIR; VELPATASVIR

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein 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

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

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

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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	8,735,372*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes	8,921,341*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	10,086,011*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,575,135*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	8,334,270*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	7,964,580*PED				Y

EU/EMA Drug Approvals for SOFOSBUVIR; VELPATASVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Epclusa	sofosbuvir, velpatasvir	EMEA/H/C/004210Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2016-07-06

International Patents for SOFOSBUVIR; VELPATASVIR

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20120534
South Korea	102036469
Colombia	6970603	Composiciones y métodos para tratar el virus de la hepatitis c
Singapore	190785	ANTIVIRAL COMPOUNDS
Canada	2840242	PROCEDES PERMETTANT DE TRAITER LE VIRUS DE L'HEPATITE C (HCV) (METHODS FOR TREATING HCV)
European Patent Office	3699176
Argentina	083711

Supplementary Protection Certificates for SOFOSBUVIR; VELPATASVIR

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
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	SPC/GB14/078	United Kingdom		PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117

Market Dynamics and Financial Trajectory for Sofosbuvir and Velpatasvir

Last updated: July 28, 2025

Introduction

Sofosbuvir and velpatasvir are cornerstone antiviral agents in the treatment of hepatitis C virus (HCV) infections. Their combined formulation, highlighted by the product Epclusa, has revolutionized HCV management by offering a pan-genotypic, highly effective therapy. As their clinical efficacy and safety profiles cement their position within the hepatology arsenal, understanding the evolving market dynamics and financial trajectory becomes crucial for manufacturers, investors, and healthcare policymakers.

This analysis delves into the factors influencing the market landscape, from patent protections and competition to regulatory environments, drug pricing, and emerging therapies. It also evaluates revenue growth prospects, investment implications, and strategic challenges over the coming years.

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Market Overview and Key Drivers

Clinical Efficacy and Adoption Trends

Sofosbuvir, developed by Gilead Sciences, was approved by the FDA in 2013, heralding a new era in HCV treatment because of its potent, oral, once-daily dosing and high cure rates. Velpatasvir, marketed by pharmaceutical giant Gilead and later other competitors, forms the backbone of the fixed-dose combination Epclusa, approved in 2016 for all HCV genotypes (1-6). The broad-spectrum activity has driven widespread therapeutic adoption globally, especially in regions with high HCV prevalence such as Egypt, India, and parts of Southeast Asia.

Market Penetration and Expansion

Initially dominated by Gilead, the combination’s utility in diverse genotypes has expanded access. Surge in screening programs, especially in high-burden countries, bolsters the potential patient pool. Additionally, the combination's favorable side effect profile compared to older regimens accelerates market penetration in developed markets.

Pricing Strategies and Reimbursement Policies

High initial prices for Sofosbuvir-based regimens—ranging from $84,000 to $94,500 for a 12-week course in the U.S.[1]—initially restricted access, but subsequent price negotiations, generic entry in emerging markets, and global health initiatives have gradually improved affordability. Governments and insurance providers are increasingly adopting negotiated prices and subsidies, which influence demand elasticity and overall market growth.

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Market Dynamics and Competitive Landscape

Patent Protection and Generic Competition

Gilead's patents on sofosbuvir and related combinations provided substantial exclusivity until patent expiries starting in 2025 and extending into the late 2020s and early 2030s in some jurisdictions[2]. Generic manufacturers in India and Egypt have launched bioequivalent versions at a fraction of the cost, substantially eroding Gilead’s market share in low-income countries. The entry of generics is a key factor shifting revenue dynamics, particularly in emerging markets.

Emerging Competitors and Alternative Therapies

Competitors like AbbVie, Merck, and newer entrants have developed alternative HCV regimens, including combinations with velpatasvir, voxilaprevir, glecaprevir, and pibrentasvir, challenging Gilead’s dominance. Novel agents endeavor to improve on cure rates, reduce treatment durations, and address resistant strains. However, the established efficacy and market penetration of sofosbuvir-velpatasvir limit rapid replacement potential.

Regulatory and Policy Influence

Regulatory agency decisions, such as those by the FDA and EMA, influence drug access and market expansion. Additionally, patent litigations and exemptions significantly impact timing and scope of generic sales, with countries like India implementing compulsory licensing provisions under TRIPS flexibilities, affecting revenue streams[3].

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Gilead's HCV franchise, primarily driven by sofosbuvir-based regimens, peaked around 2015-2016 with annual revenues surpassing $10 billion globally[4]. However, subsequent declines emerged due to patent expirations, price erosion, and the shift toward curative, shorter treatments. In 2020, Gilead reported approximately $1.6 billion in HCV franchise revenue, signaling a significant contraction[5].

Projected Growth and Market Opportunities

Analysts project a gradual recovery and stabilization in revenues driven by:

• Expansion in underserved regions through generic licensing and price reductions.
• New combination formulations improving adherence and treatment outcomes.
• Growing screening and diagnosis rates, especially in low- and middle-income countries.

According to Global Market Insights, the global HCV drugs market could reach $9 billion by 2028, with sofosbuvir-velpatasvir formulations maintaining a significant share, especially in countries with ongoing large-scale HCV elimination programs.

Impact of Patent Expirations

Patent cliffs commencing from 2025 will introduce cost-competitive generics, projecting a revenue decline for patent-holders but an increased volume of treated patients in emerging markets. Market players are increasingly focusing on lifecycle management, such as extending patent protections through new formulations or indications[6].

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Strategic Considerations

Pricing and Market Access Strategies

To sustain revenues amid generic competition, manufacturers are adopting tiered pricing, patient assistance programs, and strategic alliances with global health organizations. Investment in differential access in high-burden countries sustains long-term market share.

Research and Development Focus

The shift toward pan-genotypic, shorter-duration, and salvage therapies reflects ongoing R&D efforts. Further, integrating diagnostics and personalized medicine approaches could enhance market competitiveness.

Partnerships and Alliances

Strategic licensing agreements with regional generics producers and participation in global access initiatives are vital. Collaborations with governmental and non-governmental organizations facilitate broader market penetration and revenue sustainability.

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Conclusion

The market for sofosbuvir and velpatasvir remains dynamic, transitioning from high-margin exclusivity to a more competitive landscape dominated by generics and emerging therapies. While patent expiries threaten near-term revenues, long-term prospects hinge on innovative formulations, expanded access, and strategic partnerships. The core determinants will continue to be regulatory policies, affordability initiatives, and healthcare infrastructure growth in endemic regions.

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Key Takeaways

• Market Evolution: The global HCV drug market shifted from high-priced innovator products to generic competition, especially post-2025 patent expirations.
• Revenue Outlook: While current revenues decline domestically, expanding access in emerging markets and new formulations sustain growth prospects.
• Pricing and Policy: Negotiated prices, licensing, and global health initiatives significantly influence market penetration and revenue trajectory.
• Innovation & R&D: Developing shorter, even pan-genotypic regimens and integrating diagnostics will be key to maintaining competitiveness.
• Strategic Focus: Partnerships, lifecycle management, and geographic expansion are critical for balancing patent cliffs and market share.

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FAQs

1. What are the main factors influencing the decline of revenues for sofosbuvir-velpatasvir?
Patent expirations, generic competition, and aggressive pricing strategies in emerging markets have eroded profit margins in developed regions, leading to revenue declines.

2. How do patent protections impact the market for these drugs?
Patents grant exclusive rights that support high pricing and revenue stability. Expiry opens the market to generics, increasing access but reducing profitability for original manufacturers.

3. What role do generic manufacturers play in future market dynamics?
Generics will significantly lower prices, expand access, and promote higher treatment volumes. Their participation accelerates the global HCV elimination efforts but challenges patent-holders' revenue streams.

4. Are new therapies threatening the market share of sofosbuvir-velpatasvir?
Emerging therapies with improved profiles—shorter durations, fewer side effects—could erode market share if they demonstrate superior efficacy or patient adherence benefits.

5. What strategies can pharmaceutical companies employ to sustain revenue?
Implement lifecycle management, develop combination therapies, foster regional licensing, engage in pricing negotiations, and invest in R&D for next-generation treatments.

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References

[1] Gilead Sciences. (2014). Sovaldi (sofosbuvir) prescribing information.
[2] U.S. Patent and Trademark Office. (2023). Patent expiration timelines for sofosbuvir.
[3] World Trade Organization. (2022). Patent licensing and compulsory licensing impacts.
[4] Gilead Sciences. (2016). Annual Report.
[5] Gilead Sciences. (2020). Quarterly Financial Results.
[6] Market Research Future. (2022). Global Hepatitis C Drugs Market Report.