HARVONI Drug Patent Profile

Which patents cover Harvoni, and when can generic versions of Harvoni launch?

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
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,618,076*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,889,159*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
European Patent Office	2752422
Japan	2014148550	ANTIVIRAL COMPOUND
Malaysia	172166	COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Australia	2012346217
Peru	20141296
Croatia	P20140667
Japan	5872539

Supplementary Protection Certificates for HARVONI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR
2430014	C201630002	Spain		PRODUCT NAME: LEDIPASVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/958; DATE OF AUTHORISATION: 20141117; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/958; DATE OF FIRST AUTHORISATION IN EEA: 20141117
2203462	1491066-5	Sweden		PRODUCT NAME: SOFOSBUVIR; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/894, 2014-01-17
2430014	16C0005	France		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2430014	2016C/006	Belgium		PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2430014	CA 2016 00006	Denmark		PRODUCT NAME: LEDISPAVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116

Market Dynamics and Financial Trajectory for HARVONI

Last updated: December 26, 2025

Executive Summary

HARVONI (ledipasvir and sofosbuvir) represents a pivotal pharmaceutical intervention in the treatment of hepatitis C virus (HCV) infection. Since its U.S. FDA approval in 2014, HARVONI has significantly transformed HCV management, contributing to the broader movement toward direct-acting antiviral (DAA) therapies. Its market performance hinges on factors such as evolving clinical guidelines, patent protections, pricing strategies, competition from new therapies, and global access initiatives. This article dissects HARVONI’s market dynamics and forecasts its financial trajectory, emphasizing key drivers, barriers, and strategic considerations for stakeholders.

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1. What Are the Market Fundamentals of HARVONI?

1.1 Product Profile and Patent Timeline

Characteristic	Details
Active Components	Ledipasvir + Sofosbuvir
FDA Approval Date	October 2014
Patent Expiration	Expected around 2029-2030 (original filings)
Orphan Drug Status	Not applicable

HARVONI offers an all-oral, once-daily regimen that demonstrated high sustained virological response (SVR) rates of over 95% in clinical trials. Patent protections safeguarded exclusivity initially, with patent litigation extending market rights, now scheduled to end in the late 2020s.

1.2 Market Size and Penetration

Indicator	Figure / Estimate
Global HCV Population (2022)	Estimated 71 million chronic cases worldwide (WHO)[1]
U.S. Prevalence	~2.4 million chronic cases (CDC, 2020)
Market Penetration (US)	Estimated 75%-85% of diagnosed patients treated with DAAs; HARVONI’s share estimates vary from 30% to 50% of DAAs[2]
Pricing (US)	Approx. $94,500 for a 12-week course in the U.S. [3]
Year-over-Year Growth	Variable; initial rapid growth, plateaued in subsequent years due to market saturation

1.3 Revenue Trends (2014–2022)

Year	Estimated Global Revenue (USD Billion)	Notes
2014	~$4.5	Launch phase; rapid uptake
2015	~$8.2	Peak market penetration
2016	~$4.5	Market saturation begins
2017	~$2.8	Competitive pricing pressures
2018	~$1.9	Emergence of new therapies
2019–2022	Decline to <$1 billion annually	Market consolidation & generics

(Sources: EvaluatePharma, 2021; IQVIA)

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2. What Are the Drivers Influencing HARVONI’s Market Dynamics?

2.1 Demographic and Epidemiological Factors

The decline in HCV prevalence in developed countries results from screening and treatment programs, reducing the available patient pool for HARVONI. However, in emerging markets, increasing awareness, testing, and limited access sustain demand.

2.2 Clinical Guidelines and Treatment Accessibility

Updated guidelines (American Association for the Study of Liver Diseases – AASLD, 2022) favor pangenotypic, highly effective regimens like HARVONI due to shorter durations and fewer side effects. This boosts acceptance among clinicians.

2.3 Pricing and Reimbursement Policies

Factor	Impact
High Price	Limits access, especially in low-income countries
Patent Protections	Maintain exclusivity, enabling high pricing
Insurance Coverage	Variable; US Medicare/Medicaid negotiations affect volume

2.4 Competition and Emergence of New Therapies

Year	Notable Agents	Market Position
2017	Vosevi, Epclusa	Increased competition, pangenotypic options
2018–2022	Gilead’s Vosevi, Epclusa; AbbVie’s Mavyret	Price competition driving down HARVONI’s share

Emerging agents, notably Mavyret (glecaprevir/pibrentasvir), offer lower costs and comparable efficacy, challenging HARVONI’s dominance.

2.5 Global Access Initiatives and Intellectual Property Challenges

Gilead Sciences’ (manufacturer of HARVONI) engagement with global health organizations (e.g., WHO, GAVI) aims to expand access, especially in low-and middle-income countries through licensing and price reductions.

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3. How Is the Financial Trajectory of HARVONI Evolving?

3.1 Revenue Forecasts (2023–2030)

Year	Expected Revenue (USD Billion)	Key Factors
2023	~$0.6–0.8	Patent expiry risk; global access efforts ongoing
2024	~$0.4–0.6	Market erosion accelerates with generics in emerging markets
2025	<$0.4	Continued decline; innovative therapies emerge
2026–2030	Further decline, possibly <$0.2 annually	Patent expiry; commoditization of HCV treatments

Note: The decline rate depends on patent challenges, off-patent competition, and geographic access expansion.

3.2 Impact of Patent Expiry and Generics

Aspect	Effect
Patent Expiry (Late 2020s)	Entry of generic versions reduces price, eroding revenue
Patent Litigation	Some markets face prolonged patent disputes affecting timing

3.3 Potential for Market Rebound via Line Extensions or New Formulations

Gilead may pursue:

• Fixed-dose combinations with broader indications
• Pediatric formulations
• Shorter-duration regimens in new indications

However, these are unlikely to significantly reverse the overall declining trajectory past 2025.

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4. How Does HARVONI Compare Globally?

Region	Treatment Access	Price Range	Regulatory Status	Key Challenges
North America	High	~$94,500 USD/course	Approved in US, Canada	Reimbursement variability
Europe	Moderate	Negotiated prices, generally lower than US	EMA approved	Reimbursement delays
Latin America	Low to Moderate	Significantly lower	Some markets lack approval	Limited access, patent barriers
Africa/Asia	Limited	Very low (~$300–$500)	Approvals sporadic	Infrastructure, licensing, and affordability hurdles

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5. What Strategic Implications Should Stakeholders Consider?

5.1 For Gilead Sciences

• Diversify portfolio as patent protections wane.
• Engage in tiered pricing to expand access.
• Accelerate pipeline development for next-generation antivirals or curative therapies.

5.2 For Payers and Policymakers

• Negotiate discounts to improve treatment uptake.
• Incorporate generic options post-patent expiry.
• Invest in screening programs to identify new cases before market saturation.

5.3 For Investors

• Recognize growth potential diminishes in developed markets but remains in emerging regions.
• Monitor patent expiry timelines and strategic licensing agreements.

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6. How Is the Competition Shaping Up?

Therapy	Developer	Efficacy	Price	Regulatory Status	Market Share Impact
Vosevi	Gilead	95–100%	High	Approved	Competing with HARVONI
Epclusa	Gilead	95–100%	High	Approved	Dominant global agent
Mavyret	AbbVie	95–100%	Lower	Approved	Displacing HARVONI in some markets
Zepatier	Merck	92–96%	Moderate	Approved	Niche player

Market Share Trends

Year	HARVONI Market Share (Estimated)	Notes
2014	~50%	Sharp initial uptake, dominant initially
2017	~40%	Competition increasing, consolidation
2020	~25%	Generics impact, newer agents gaining traction
2022	<20%	Continued decline, especially outside US

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7. What Are the Future Opportunities and Challenges?

Opportunities

• Expansion into pediatric and special populations.
• Collaboration with global health initiatives.
• Development of combination regimens with broader indications.

Challenges

• Patent expiration leading to generic competition.
• Pricing pressures and reimbursement limitations.
• Emergence of new therapeutic classes (e.g., gene editing technologies).

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Key Takeaways

• HARVONI catalyzed a paradigm shift in hepatitis C treatment, with peak revenues around 2015, followed by a plateau and decline due to market saturation and generic competition.
• The global hepatitis C landscape is increasingly dominated by lower-cost, pangenotypic regimens, impacting HARVONI’s market share.
• Patent expiration slated for late 2020s will significantly accelerate revenue erosion unless offset by pipeline innovations.
• Expansion in emerging markets, though promising for sustained revenues, faces obstacles related to pricing, regulatory approvals, and infrastructure.
• Stakeholders must adapt strategies—lowering prices, innovating formulations, and partnering to preserve revenue streams.

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FAQs

Q1: When will HARVONI lose exclusivity, enabling generic competition?
A1: Patent protection and exclusivity in key markets are expected to expire around 2029–2030, subject to ongoing litigation and licensing agreements.

Q2: How does HARVONI’s pricing compare globally?
A2: It varies significantly—approximately $94,500 in the U.S., with lower negotiated prices in Europe, and minimal costs in some emerging markets due to licensing.

Q3: What are the main competitors to HARVONI?
A3: Vosevi, Epclusa, and Mavyret, among others, offering similar or superior efficacy at lower prices.

Q4: Can HARVONI’s market share increase post-patent expiry?
A4: Unlikely, as generics and biosimilars will replace branded versions, leading to revenue decline unless Gilead innovates with next-generation therapies.

Q5: Are there prospects for new indications or formulations for HARVONI?
A5: While possible, current pipelines focus more on new agents and combination therapies; significant expansion of HARVONI’s use is uncertain.

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References

1. World Health Organization. Hepatitis C Fact Sheet. 2022.
2. IQVIA. Latest Global Pharmaceutical Market Reports. 2022.
3. Gilead Sciences. HARVONI Prescribing Information. 2014–2022.
4. EvaluatePharma. Top Pharmaceutical Revenues. 2021.
5. American Association for the Study of Liver Diseases (AASLD). HCV Guidance. 2022.

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This comprehensive analysis offers critical insights into HARVONI’s market evolution, financial outlook, and strategic considerations, enabling stakeholders to navigate an increasingly complex hepatitis C treatment landscape.