epclusa Drug Patent Profile

Which patents cover Epclusa, and what generic alternatives are available?

Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are sixteen patents protecting this drug.

This drug has five hundred and twenty-nine patent family members in forty-nine countries.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Epclusa

Epclusa 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 July 30, 2034. This may change due to patent challenges or generic licensing.

There have been nineteen 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 epclusa

International Patents:	529
US Patents:	16
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Drug Prices:	Drug price information for epclusa
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epclusa
What excipients (inactive ingredients) are in epclusa?	epclusa excipients list
DailyMed Link:	epclusa at DailyMed

See drug prices for epclusa

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for epclusa

Constraining patent/regulatory exclusivity:

9,757,406*PED

NDA:

208341

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,116,783*PED

NDA:

214187

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 epclusa

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

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	PHASE4
Lifespan	PHASE4
Peking University People's Hospital	Phase 4

See all epclusa clinical trials

Pharmacology for epclusa

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

US Patents and Regulatory Information for epclusa

epclusa is protected by sixteen US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,757,406.

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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	9,085,573*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	9,085,573*PED				Y

EU/EMA Drug Approvals for epclusa

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 epclusa

When does loss-of-exclusivity occur for epclusa?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

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 epclusa around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E039966
Mexico	2016002185
European Patent Office	2432792
China	109970818

Supplementary Protection Certificates for epclusa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2430014	2016C/006	Belgium		PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118

Market Dynamics and Financial Trajectory for Epclusa (Sofosbuvir/Velpatasvir)

Last updated: December 29, 2025

Executive Summary

Epclusa, a broad-spectrum hepatitis C virus (HCV) antiviral therapy developed by Gilead Sciences, represents a pivotal product within the expanding global HCV treatment market. Since its FDA approval in June 2016, Epclusa has become a preferred regimen due to its high efficacy, safety profile, and pan-genotypic activity. This detailed analysis explores the current market dynamics, competitive landscape, regulatory factors, sales and revenue forecasts, and key drivers shaping Epclusa’s financial trajectory through 2030.

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Introduction: Key Facts about Epclusa

Attribute	Details
Active Ingredients	Sofosbuvir (NS5B polymerase inhibitor) + Velpatasvir (NS5A inhibitor)
FDA Approval	June 28, 2016
Indications	Chronic HCV infection (Genotypes 1-6)
Price (Approximate)	$24,000–$26,000 per treatment course in the U.S.
Market Segment	Direct-acting antiviral (DAA), Pan-genotypic
Key Competitors	Mavyret (AbbVie), Zepatier (Merck), Harvoni (Gilead)

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Market Dynamics: Drivers, Challenges, and Trends

What are the primary drivers influencing Epclusa's market performance?

Driver	Impact	Supporting Data/Trends
High Efficacy and Safety Profile	Reinforces physician and patient preference	>95% cure rates across genotypes; minimal adverse events
Pan-Genotypic Spectrum	Simplifies treatment algorithms; broadens eligible patient base	FDA approval for all HCV genotypes in 2018
Global Market Expansion	Increasing treatment access in emerging economies	WHO estimates 58 million chronic HCV infections worldwide (2021)[1]
Pricing Strategies and Reimbursement Policies	Affects market penetration and revenue streams	Tiered pricing in developing nations; insurance coverage growth
Reimbursement and Patent Exclusivity	Patent rights influence sales longevity	Patent expiration forecasted around 2030 in key markets
COVID-19 Pandemic Impact	Disrupted treatment access and diagnosis rates	Decline in new HCV treatments; gradual recovery ongoing

What are the key challenges and risks?

Challenge/Risk	Impact	Mitigation/Notes
Patent Expirations	Increased generic competition reduces prices	Patent life until approximately 2030; biosimilar entry post-expiry
Pricing Pressures and Cost Containment	Lower revenues in price-sensitive markets	Adoption of tiered pricing and negotiation strategies
Market Saturation in High-Income Countries	Growth plateau in mature markets	Focus on expanding treatment in underserved regions
Emergence of New Therapies	Competition from next-generation DAAs	Continuous R&D pipeline and combination therapies
Regulatory Policy Changes	Reimbursement reforms, drug approval processes	Engagement with policymakers; adherence to evolving guidelines

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Market Size and Revenue Trajectory

Global HCV Market Overview

Region	Estimated Market Size (2022)	Growth Rate (CAGR 2022–2030)	Notes
North America	$4.5 billion	4.2%	Dominant market due to high diagnosis and treatment rates
Europe	$2.2 billion	3.8%	Increasing access through public health initiatives
Asia-Pacific	$1.5 billion	7.5%	Rapid growth driven by large population and expanding health programs
Latin America	$700 million	6.9%	Lower treatment rates currently but growth expected
Middle East & Africa	$300 million	7.2%	Emerging market with increasing awareness efforts

Total Global Market (2022): ~$8.2 billion, with projections reaching approximately $12 billion by 2030[2].

Sales and Revenue Projections for Epclusa

Year	Estimated Global Sales (USD billions)	Notes
2022	$1.8 billion	Established market, moderate penetration
2023	$2.2 billion	Expanded access due to price adjustments, new markets
2025	$3.0 billion	Market penetration stabilizes with increased diagnosis and treatment access
2030	$3.9 billion	Post-patent expiration, potential generic competition impacts pricing

Factors Influencing Revenue Trends

• Patent Lifecycle: Patent expiration anticipated around 2030 in European and U.S. markets, opening the landscape for generics.
• Pricing Strategies: Tiered pricing in emerging economies fosters broader access, albeit at reduced margins.
• Commercial Expansion: Entry into new markets and adaptation to local healthcare policies support revenue upticks.
• Therapeutic Competition: Emergence of next-gen DAAs may challenge market share, but Epclusa’s broad spectrum and safety position it favorably.

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Regulatory Environment and Patent Landscape

Region	Key Regulations & Policies	Patent Status	Implications
U.S.	FDA approval pathway; patent protections until ~2030	Pending patent expirations in 2030	Post-expiration generic competition potential
Europe	EMA approvals; centralized regulatory process	Patent expiry forecasted 2030	Alignment with U.S. patent expiry, enabling generic entry
Emerging Markets	Local regulatory pathways; pricing and reimbursement policies	Varying patent protections; some markets patent-free	Increased generic penetration, impacting revenue

Note: Gilead holds multiple patents until 2030 that protect Epclusa, though patent litigation or patent extension efforts could influence timelines.

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Competitive Landscape

Competitor	Key Product(s)	Market Share (Estimate 2022)	Strengths	Weaknesses
AbbVie	Mavyret (Glecaprevir/Pibrentasvir)	25%	Short treatment duration, high efficacy	Slightly lower pan-genotypic spectrum compared to Epclusa
Merck	Zepatier (Grazoprevir/Elbasvir)	8%	Approved for some comorbidities	Less pan-genotypic, lower market penetration
Gilead	Harvoni (Ledipasvir/Sofosbuvir)	40%	Early market leader, extensive data	Higher price point, narrow genotype coverage
Others	Various generic formulations	Varies	Cost-effective options	Lower efficacy and safety profiles

Note: Epclusa’s competitive advantage lies in its pan-genotypic activity, reducing treatment complexity and improving adherence.

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Future Opportunities and Strategic Outlook

Expansion into Special Populations

• Patients with Liver Transplantation: Epclusa’s safety profile supports use in post-transplant patients.
• HIV Co-infected Patients: Demonstrated efficacy in co-infected populations expands market scope.
• Pediatric Use: Ongoing trials for pediatric populations could unlock new revenues.

Combination Therapy Development

• Policymaking: Regulatory acceptance of simplified regimens can streamline prescribing practices.
• Innovation: Potential combination with agents targeting resistant viral strains.

Emerging Markets and Access Programs

• Gilead’s tiered pricing and patient assistance programs can accelerate adoption, especially in resource-limited regions.

Impact of Ongoing Patent Expirations

• Manufacturers are preparing for generic entry post-2030, with Gilead investing in pipeline diversification to mitigate revenue decline.

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Deep Dive: Key Drivers Impacting Epclusa’s Financial Trajectory

Factor	Quantitative Estimate	Implication for Revenues
Market Penetration in Developing Countries	Expected annual growth rate of ~8%	Expanding revenue base beyond developed markets
Patent Expiry Impact	Estimated +25% generic penetration post-2030	Major revenue decline anticipated unless pipeline offsets
Pricing Strategies	Tiered pricing can reduce margins but increase volume	Balancing pricing and volume to maximize profit

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Conclusion: Strategic Outlook & Investment Implications

Epclusa’s trajectory remains resilient through 2025, driven by its broad efficacy and expanding access. However, patent expirations in the next decade necessitate strategic planning around generics and pipeline diversification. Gilead’s ongoing R&D investments and market expansion strategies could mitigate revenue erosion, maintaining Epclusa’s position as a key asset.

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Key Takeaways

• Market Potential: The global HCV market is projected to grow at a CAGR of approximately 4% through 2030, with revenues near $12 billion.
• Revenue Drivers: Efficacy, pan-genotypic coverage, treatment simplification, and expanding access underpin revenue growth.
• Risks: Patent cliff in 2030, generic competition, pricing pressures, and advent of new therapies threaten future sales.
• Strategic Focus: Diversification through pipeline development, special population targeting, and market expansion in emerging economies.
• Investment Outlook: Gilead’s proactive patent management and pipeline investments are crucial for sustaining Epclusa’s valuation.

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FAQs

Q1: When is Epclusa expected to face significant generic competition?
A1: Patent protections extend until approximately 2030 in key markets, after which generic versions are expected to enter, potentially impacting prices and revenues.

Q2: How does Epclusa compare to its competitors in terms of efficacy?
A2: Clinical trials report cure rates exceeding 95% across all genotypes, positioning Epclusa favorably against competitors like Mavyret and Zepatier.

Q3: What role does pricing play in expanding Epclusa’s global market?
A3: Tiered pricing and reimbursement negotiations in emerging markets are pivotal for increasing access, though they reduce margins compared to high-income countries.

Q4: Are there ongoing efforts to expand Epclusa’s indications?
A4: Yes, clinical trials are underway for pediatric populations, and exploring use in special populations such as co-infected or post-transplant patients.

Q5: What strategic measures can Gilead adopt to mitigate patent expiration risks?
A5: Investing in next-generation therapies, expanding indications, acquiring new pipeline assets, and engaging in licensing agreements can help sustain revenues.

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References

[1] World Health Organization. "Global Hepatitis Report," 2021.
[2] Grand View Research. "Hepatitis C Virus Infection Therapeutics Market Size, Share & Trends Analysis," 2022.