HARVONI Drug Patent Profile

When do Harvoni patents expire, and what generic alternatives are available?

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

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

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Harvoni

Harvoni was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14, 2032. This may change due to patent challenges or generic licensing.

There have been four 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 HARVONI

International Patents:	564
US Patents:	17
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	36
Drug Prices:	Drug price information for HARVONI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HARVONI
What excipients (inactive ingredients) are in HARVONI?	HARVONI excipients list
DailyMed Link:	HARVONI at DailyMed

See drug prices for HARVONI

See drug sales revenues for HARVONI

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

Constraining patent/regulatory exclusivity:

10,456,414

NDA:

212477

Dosage:

PELLETS;ORAL

Constraining patent/regulatory exclusivity:

10,039,779*PED

NDA:

205834

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 HARVONI

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

Sponsor	Phase
Mansoura University	Phase 3
Cairo University	Phase 2/Phase 3
University of Maryland, College Park	Early Phase 1

See all HARVONI clinical trials

Pharmacology for HARVONI

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for HARVONI

HARVONI is protected by seventeen US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,456,414.

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	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	9,284,342*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,334,270*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes	9,393,256*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,735,372*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	8,618,076*PED				Y

International Patents for HARVONI

When does loss-of-exclusivity occur for HARVONI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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 HARVONI around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20141056	METODOS PARA EL TRATAMIENTO DE VHC
European Patent Office	3321275
European Patent Office	2430014	COMPOSÉS ANTIVIRAUX (ANTIVIRAL COMPOUNDS)
New Zealand	625532	Compositions and methods for treating hepatitis c virus
Mexico	351816	FORMULACION DE COMBINACION DE DOS COMPUESTOS ANTIVIRALES. (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS.)

Supplementary Protection Certificates for HARVONI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014	16C0005	France		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2430014	2016004	Norway		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2430014	1690002-9	Sweden		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141118

Market Dynamics and Financial Trajectory for HARVONI

Last updated: July 27, 2025

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Introduction

HARVONI (ledipasvir and sofosbuvir) represents a significant milestone in hepatitis C virus (HCV) treatment, offering a once-daily oral regimen with high cure rates. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, HARVONI has transformed clinical management and influenced the pharmaceutical landscape concerning HCV therapies. This article evaluates the evolving market dynamics and financial trajectory of HARVONI, analyzing factors such as competitive landscape, pricing strategies, manufacturing intricacies, and regulatory influences.

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Market Overview and Adoption Trends

HARVONI's introduction revolutionized the HCV treatment market by providing a highly effective, pangenotypic solution. Its efficacy—achieving sustained virologic response (SVR) rates above 95% across multiple genotypes—quickly set new standards (1). Subsequent clinical data and real-world applications reinforced its advantage, leading to accelerated adoption by healthcare providers worldwide.

Market penetration was initially driven by its simplified regimen compared to older interferon-based therapies, which suffered from high adverse effects and lower efficacy. The convenience of a player-friendly, short-treatment course (8–12 weeks) catalyzed rapid uptake among treatment-naive and treatment-experienced populations.

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Competitive Landscape and Market Dynamics

Emergence of Competitors

Post-HARVONI, multiple competitors entered the HCV treatment market, notably Gilead's SOVALDI (sofosbuvir), Vosevi, and newer agents from Merck and AbbVie. The landscape shifted as these therapies offered similar efficacy, with some focusing on specific genotypes or resistance profiles.

In addition, the rise of generic versions, especially in emerging markets like India, intensified price competition, impacting HARVONI's pricing and market share.

Pricing Strategies and Reimbursement Landscape

Initially, branded HARVONI was priced approximately $84,000 for an 8- or 12-week course in the U.S. (2). High pricing initially limited widespread access but was offset by insurance coverage through payers and government programs, including Medicaid and Medicare.

However, increasing competition and pressure from healthcare payers led to significant price negotiations and discounts. Abbott responded by expanding access programs and offering tiered pricing strategies in different markets.

In many regions, especially low- and middle-income countries, generics have drastically reduced treatment costs, affecting HARVONI’s global market share. The company has adapted, forming regional alliances and licensing agreements to maintain revenue streams.

Regulatory and Patent Developments

The expiration of certain patents and the approval of generic equivalents have considerably impacted HARVONI’s exclusivity. Although Abbott's patents were initially robust, patent challenges and legal disputes in various jurisdictions have further eroded exclusivity.

Furthermore, regulatory agencies in target markets have approved biosimilars and generics, further pressuring pricing and market dominance.

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Financial Trajectory and Revenue Impact

Initially, HARVONI contributed significantly to Abbott’s (later AbbVie’s) revenues. In 2015 alone, HARVONI’s sales peaked at approximately $3 billion globally (3). The strong clinical profile and favorable reimbursement landscape drove these revenues, establishing Hepatitis C cures as lucrative pharmaceutical segments.

Over subsequent years, sales plateaued due to market saturation, market entry of generics, and price erosion. AbbVie reported declining sales figures for HARVONI starting around 2019, aligning with increased competition and biosimilar entries (4).

AbbVie's strategic response involved diversifying its antiviral portfolio, emphasizing the development of next-generation agents and combination therapies, but HARVONI’s standalone revenue contribution diminished accordingly.

In emerging markets, where generics dominate and pricing pressure is highest, HARVONI’s revenue generation has been substantially reduced. Nevertheless, in regions with limited generic access, such as certain developed nations and specific patient populations, the drug continues to generate meaningful revenue.

Forecasting Future Revenues

The future financial trajectory hinges on:

• Patent expirations: Expect patent cliffs around 2023-2025, further enabling generic competition.
• Pipeline developments: AbbVie's launch of next-generation fixed-dose combinations may cannibalize HARVONI’s sales.
• Market saturation: Globally, HCV prevalence declines as screening and treatment expand, reducing new patient pools.
• Pricing and access policies: Governments pushing for lower-cost treatments will continue to pressure revenues.

Projected revenues thus are expected to decline cumulatively over the next 3–5 years, with residual sales in underserved markets.

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Global Market and Regional Variations

The global HCV market displays significant heterogeneity. High-income markets, such as North America and Europe, initially dictated HARVONI’s revenues due to favorable reimbursement structures. However, affordability issues and the availability of generics in countries like India, Egypt, and parts of Southeast Asia have limited the drug’s penetration.

In Africa and Latin America, where health systems face resource constraints, lower-priced generics have displaced original branded formulations.

AbbVie's strategic licensing agreements support its presence in specific regions, but the net effect remains a decline in revenue contribution over time.

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Key Drivers and Challenges

Drivers:

• Overall reduction in HCV prevalence via screening and treatment programs.
• Clinical superiority and simplicity of HARVONI.
• Increasing access through licensing and discounts in emerging markets.
• Evolving treatment guidelines endorsing pangenotypic therapies.

Challenges:

• Patent expiries and biosimilar entries.
• Pricing pressures and reimbursement constraints.
• Competition from next-generation therapies.
• Market saturation in high-income countries.
• Limited pipeline differentiation for HARVONI itself.

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Conclusion and Strategic Outlook

HARVONI’s market dynamics illustrate how transformative therapies initially achieve rapid growth and significant revenue, only to face declining trajectories due to patent expirations, competitive pressures, and market saturation. Manufacturers must adapt by diversifying portfolios, engaging in regional licensing, and innovating within the treatment paradigm.

AbbVie's management of HARVONI exemplifies a strategic transition from reliance on a flagship product to broader antiviral innovation. Future revenue streams are likely to be modest relative to peak years but remain financially significant in certain regions.

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Key Takeaways

• HARVONI revolutionized HCV treatment with high efficacy and simple dosing, leading to rapid market penetration.
• Competitive pressures, including generics and biosimilars, have led to substantial price erosion and declining revenues.
• Patent expirations and regulatory changes threaten continued exclusivity, impacting future financial trajectories.
• Market saturation in developed countries and pricing constraints continue to challenge revenue growth.
• Strategic diversification and regional licensing are essential avenues for maintaining profitability post-patent.

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FAQs

1. How has the patent landscape affected HARVONI’s market position?
Patent expirations and legal challenges have enabled generic competition, significantly reducing revenues and market share in key regions.

2. What are the primary factors influencing HARVONI's declining sales?
Increasing generic availability, market saturation in high-income countries, pricing pressures, and the introduction of next-generation therapies have contributed to reduced sales.

3. How does regional variation impact the global revenues of HARVONI?
In developed markets, high prices and reimbursement facilitate sustained revenues; in emerging markets, generics dominate, limiting branded drug sales.

4. What strategies are pharmaceutical companies adopting to maintain profitability in the HCV segment?
Expanding pipelines, forming regional licensing agreements, offering tiered pricing, and developing combination therapies are common strategies.

5. Will HARVONI remain a significant product in the future?
While its standalone sales are declining, it remains part of comprehensive antiviral portfolios, especially in markets lacking affordable generics, and continues to generate revenue in specific contexts.

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References

[1] CDC. (2020). Hepatitis C Statistics and Surveillance. Centers for Disease Control and Prevention.
[2] IMS Health. (2015). Hepatitis C drug pricing and market analysis report.
[3] AbbVie Annual Report. (2015). Revenue from hepatitis C franchise.
[4] AbbVie Q4 2022 Earnings Statement. (2023). Available online.