epclusa Drug Patent Profile

When do Epclusa patents expire, and when can generic versions of Epclusa launch?

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
Lifespan	PHASE4
National Institute on Drug Abuse (NIDA)	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

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
European Patent Office	2432792
China	104292256
Portugal	3431477

Supplementary Protection Certificates for epclusa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EPCLUSA

Last updated: July 27, 2025

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Introduction

EPCLUSA (sofosbuvir/velpatasvir) has revolutionized the treatment landscape for hepatitis C virus (HCV) infections since its approval by the U.S. Food and Drug Administration (FDA) in 2016. As a fixed-dose combination, EPCLUSA presents a highly efficacious, pangenotypic antiviral therapy that has significantly altered market dynamics in the hepatology sector. This analysis examines the current market landscape and projects the financial trajectory of EPCLUSA by exploring key drivers, competitive forces, regulatory pathways, and emerging trends shaping its long-term commercial prospects.

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Market Overview of Hepatitis C and the Role of EPCLUSA

HCV remains a global health challenge, impacting an estimated 58 million individuals worldwide, with significant morbidity and mortality associated with cirrhosis and hepatocellular carcinoma [1]. The advent of direct-acting antivirals (DAAs) transformed HCV management, offering treatment durations of 8 to 12 weeks with high cure rates, overshadowing previous interferon-based therapies that were less effective and poorly tolerated.

EPCLUSA's pivotal selling point lies in its pangenotypic efficacy, simplifying treatment algorithms and broadening patient eligibility. Its once-daily oral regimen has driven higher adherence, essential for achieving sustained virologic response (SVR)—the clinical marker of cure.

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Market Dynamics

1. Competitive Landscape

EPCLUSA faces competition principally from other DAAs such as Gilead Sciences’ Vosevi, AbbVie’s Mavyret, and emerging generics. Mavyret (glecaprevir/pibrentasvir), for example, gained approval in 2017 as a pan-genotypic regimen with a shorter treatment duration (8 weeks in most cases), challenging EPCLUSA's market share.

Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) serves as a subsequent-line therapy for treatment-experienced patients, further intensifying competition in the space.

Market Share Shifts: According to IQVIA data, EPCLUSA dominated initial markets, capturing over 60% of prescriptions in the U.S. during the first two years post-launch [2]. However, subsequent years saw erosion of market share, primarily due to the entry of Mavyret with its favorable cost profile and shorter regimen.

2. Pricing and Reimbursement Strategies

Pricing has been pivotal. Initially priced at approximately $74,760 for a 12-week course in the U.S., EPCLUSA’s list price exceeded that of some competitors. Payer negotiations and formulary placements Play a decisive role in utilization rates. Price reductions, discounts, and value-based agreements have been increasingly adopted to enhance access, especially in cost-sensitive markets.

3. Patent and Intellectual Property Considerations

EPCLUSA's patent exclusivity is set to expire in 2028 in major markets like the U.S., opening opportunities for generic competition. Patent challenges and potential patent extensions through secondary patents could alter the competitive timeline, impacting revenue projections.

4. Geographic Market Penetration and Access

Development in emerging markets, such as India, Brazil, and parts of Asia, is critical, given high HCV prevalence. However, pricing disparities and regulatory hurdles constrain rapid market penetration. Strategic collaborations with local generics and price reductions are expected to drive future growth in these regions.

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Financial Trajectory Analysis

1. Revenue Projections

In its initial years, EPCLUSA achieved peak sales of over $3 billion globally [3]. However, sales plateaued owing to increased competition and market saturation.

Forecasts suggest a declining trend in mature markets post-2025 due to generic entry. Nonetheless, rising prevalence of HCV and potential expanded indications (e.g., in patients with advanced liver disease) could sustain revenue streams through incremental growth.

Cross-market analysis indicates modest compounded annual growth rates (CAGRs) of 2-3% in newly diagnosed populations, with priority on volume expansion rather than price increases.

2. Cost Structure and Profit Margins

Initial production costs for DAAs, including EPCLUSA, were high but have decreased with manufacturing optimization and patent expirations. Gross margins are projected at approximately 70%, with operating margins influenced by marketing, R&D, and legal expenses related to patent defenses.

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Emerging Trends and Strategic Considerations

• Generic Competition: The expiration of key patents from 2028 will drastically alter the competitive landscape, likely leading to significant price erosion.
• Market Expansion: Focus on underserved geographies and special populations (e.g., prisoners, marginalized groups) can drive incremental sales.
• Combination Therapies: Alliances with other therapeutics, including those targeting liver fibrosis or co-infections, may extend EPCLUSA's lifecycle.
• Policy and Reimbursement: Payer policies favoring cost-effective regimens will influence prescribing patterns. Governments are increasingly favoring shorter, less expensive treatments, pressuring EPCLUSA to demonstrate value.

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Regulatory and Patent Dynamics

While EPCLUSA enjoys broad regulatory approval, patent litigations and challenges are imminent as generic manufacturers prepare for entry. The U.S. Patent Trial and Appeal Board (PTAB) proceedings and international patent disputes can influence the timing and scope of market entry by generics.

Regulatory pathways, including accelerated approvals or indications for broader use, could stimulate or hinder future sales. Additionally, licensing agreements with local manufacturers in emerging markets can facilitate faster market penetration.

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Conclusion

EPCLUSA's market dynamics are characterized by high initial demand, intense competition, and impending patent expiry. Its financial trajectory will depend on strategic positioning, pricing, regulatory developments, and generic entry. While near-term revenues are expected to stabilize or decline, long-term growth prospects lie in geographic expansion, formulations, and remaking the treatment paradigm for complex patient populations.

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Key Takeaways

• EPCLUSA remains a highly effective, convenient treatment for HCV, but its market share faces pressure from competitive regimens and impending patent expiry.
• Strategic pricing, access programs, and collaborations are vital in maintaining profitability amid increasing competition.
• Patent protections lasting until 2028 provide a window for sustained revenues, after which significant generic competition is anticipated.
• Emerging markets offer substantial growth opportunities, provided pricing and regulatory hurdles are navigated successfully.
• Continuous innovation, including combination therapies and expanded indications, is essential for prolonging EPCLUSA’s commercial relevance.

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FAQs

1. When will EPCLUSA face generic competition?
Generic versions of EPCLUSA are anticipated post-2028 following patent expiration in major jurisdictions, with early entrants likely to impact market share significantly.

2. How does EPCLUSA compare cost-wise to other hepatitis C treatments?
Initially priced higher than some competitors like Mavyret, EPCLUSA’s cost-effectiveness is influenced by its high efficacy and shorter treatment durations, but pricing strategies and discounts vary across markets.

3. What factors could extend EPCLUSA’s market life beyond patent expiry?
Possible strategies include developing fixed-dose combination extensions, new indications, or formulations, alongside patent litigation and licensing deals that delay generic entry.

4. What geographic regions hold the most growth potential for EPCLUSA?
Emerging markets such as Asia, Latin America, and Africa are critical due to high HCV prevalence and increasing access initiatives, provided affordability and regulatory access are optimized.

5. How do regulatory changes impact EPCLUSA’s future?
Regulatory policies favoring affordability, accelerated approvals for new uses, and approval of generics shape the competitive landscape and revenue trajectory.

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References

[1] World Health Organization. (2022). Hepatitis C. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
[2] IQVIA. (2018). Hepatitis C market report.
[3] Gilead Sciences. (2019). Annual Report.