SOVALDI Drug Patent Profile

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

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and sixty-eight patent family members in forty-nine countries.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Sovaldi

Sovaldi was eligible for patent challenges on December 6, 2017.

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 SOVALDI

International Patents:	368
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	34
Drug Prices:	Drug price information for SOVALDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOVALDI
What excipients (inactive ingredients) are in SOVALDI?	SOVALDI excipients list
DailyMed Link:	SOVALDI at DailyMed

See drug prices for SOVALDI

Recent Clinical Trials for SOVALDI

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

Sponsor	Phase
Cairo University	Phase 3
Ain Shams University	Phase 3
Assiut University	Early Phase 1

See all SOVALDI clinical trials

Pharmacology for SOVALDI

Drug Class	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	RNA Replicase Inhibitors

Paragraph IV (Patent) Challenges for SOVALDI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOVALDI	Tablets	sofosbuvir	400 mg	204671	2	2017-12-06

US Patents and Regulatory Information for SOVALDI

SOVALDI is protected by nine US patents and two FDA Regulatory Exclusivities.

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	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	8,618,076*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	8,580,765*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	8,889,159*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	7,964,580*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-001	Aug 28, 2019		RX	Yes	No	8,334,270*PED				Y

EU/EMA Drug Approvals for SOVALDI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Sovaldi	sofosbuvir	EMEA/H/C/002798Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.	Authorised	no	no	no	2014-01-16

International Patents for SOVALDI

When does loss-of-exclusivity occur for SOVALDI?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 SOVALDI around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2552930
Philippines	12015502237
European Patent Office	3777867	COMPOSITION ET PROCÉDÉS POUR LE TRAITEMENT DU VIRUS DE L'HÉPATITE C (COMPOSITION AND METHODS FOR TREATING HEPATITIS C VIRUS)
Japan	6073897
Chile	2011000718

Supplementary Protection Certificates for SOVALDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2203462	C 2014 043	Romania		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

Market Dynamics and Financial Trajectory of Sovaldi (sofosbuvir)

Last updated: December 29, 2025

Executive Summary

Sovaldi (sofosbuvir), developed by Gilead Sciences, Inc., is a groundbreaking hepatitis C virus (HCV) NS5B polymerase inhibitor launched in December 2013. Recognized for its high efficacy, shorter treatment duration, and favorable safety profile, Sovaldi revolutionized hepatitis C management. Despite its clinical success, the drug's market dynamics have been shaped by pricing strategies, patent protections, regulatory reviews, and competitive pressures. Its initial blockbuster status saw rapid revenue growth, but subsequent challenges emerged from pricing controversies, generic entries, and the advent of newer therapies. This analysis provides a comprehensive overview of Sovaldi's market evolution, financial performance, competitive positioning, regulatory influences, future outlook, and strategic considerations.

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Table of Contents

• Market Overview
• Product Profile & Mechanism of Action
• Market Entry and Initial Financial Performance
• Pricing Strategy and Access Challenges
• Patent & Intellectual Property Landscape
• Competitive Landscape
• Regulatory Environment and Policy Impact
• Market Penetration and Adoption Trends
• Emerging Trends and Pipeline Developments
• Financial Trajectory & Revenue Forecasts
• SWOT Analysis
• Key Market Challenges
• Future Outlook and Strategic Insights
• Key Takeaways
• FAQs

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What are the Market Dynamics Influencing Sovaldi?

Global Hepatitis C Burden and Market Size

Hepatitis C affects approximately 58 million people worldwide, with an annual mortality of 290,000 deaths linked to chronic infection [1]. Prior to direct-acting antivirals (DAAs), treatment options suffered from limited efficacy, long durations, and adverse effects. The introduction of Sovaldi represented a paradigm shift, with a global HCV market size estimated at USD 20–25 billion in the early 2010s (pre-Sovaldi) and expected growth driven by increased diagnosis and treatment access.

Key Market Drivers

Driver	Impact	Source
Advances in DAA therapies	Rapid uptake and market expansion	[2]
Increasing awareness & screening	Early diagnosis boosts treatment volume	[3]
Pricing & reimbursement policies	Enable or restrict access	[4]
Patent protections	Market exclusivity	[5]

Market Limiters

Limiter	Impact	Source
High drug pricing	Restricts affordability	[4]
Competition from generics	Erode revenue streams	[6]
Patent litigations & expirations	Open market access	[7]
Regulatory approvals limitations	Regional market access	[8]

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What is Sovaldi's Product Profile & Mechanism?

Attribute	Details
Active ingredient	Sofosbuvir (NS5B polymerase inhibitor)
Approved indications	Chronic hepatitis C (all genotypes), combination therapies
Dosing	400 mg once daily
Treatment duration	8–12 weeks depending on genotype and patient profile
Key efficacy	SVR (sustained virologic response) rates exceeding 90%
Safety profile	Well tolerated; common adverse effects include fatigue, headache

Mechanism of Action: Sofosbuvir inhibits viral RNA synthesis by targeting the NS5B RNA-dependent RNA polymerase, leading to effective viral suppression.

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What Were the Initial Market Entry and Financial Performance?

Launch and Uptake (2013–2016)

• Initial Launch Date: December 2013 in the U.S. and Europe.
• First-Year Revenue: USD 10.3 billion globally [9].
• Global Sales (2014–2015): USD 12.4 billion and USD 15.4 billion respectively.
• Market Penetration: Rapid adoption in developed markets; limited access in low-income regions initially.

Financial Highlights

Year	Revenue (USD billion)	Units Sold (approx., in millions)	Market Share	Comments
2013	USD 8.5	~2.1 million courses	~25%	Rapid uptake, high pricing
2014	USD 12.3	~3.0 million courses	~35%	Expanded indications
2015	USD 15.4	~4.0 million courses	~40%	Market leadership

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How Did Pricing Strategies Impact Market Dynamics?

Pricing Model and Reimbursement Policies

• List Price: USD 84,000 for a 12-week course (USD 7,000 per pill).
• Payer Negotiations: Gilead negotiated rebates and discounts to secure reimbursement.
• Cost-Effectiveness: Economists debated the high upfront costs vs. long-term savings from disease cure.

Access Constraints

Region	Reimbursement Status	Challenges
U.S.	Generally covered via Medicare/Medicaid	Prior authorization hurdles
Europe	Restricted in some countries	Budgetary constraints
Low-income countries	Limited access	Pricing and patent barriers

Pricing Controversies

Gilead faced significant criticism for aggressive pricing, prompting policy debates on drug affordability and sparking calls for compulsory licensing in some jurisdictions [10].

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What is the Patent & Intellectual Property Landscape?

Patent Expiry	Region	Patent Status	Impact
2029–2033	U.S., Europe	Extended via secondary patents, formulations	Maintains market exclusivity for certain formulations
Patent challenges	India, Egypt	Some patents invalidated or challenged	Allows generics

Gilead has secured primary patents expiring between 2029 and 2033 in key markets, but secondary patents and patent litigations influence generic entry.

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What is the Competitive Landscape?

Competitors	Key Products	Market Position	Notes
AbbVie	Viekira Pak, Mavyret	Competing for SVR rates	Generics erode market share
Merck	Zepatier	Alternative therapy	Strong regional presence
Bristol-Myers Squibb	Daklinza	Previously prominent	Market share declining
Emerging generics	Sofosbuvir-based generics	Disruptive influence	Especially in India, Egypt

Recent Trends: The entry of generics in India and Egypt has drastically reduced prices there, with significant impact on Gilead’s revenues.

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How does the Regulatory Environment Influence Sovaldi?

FDA and EMA Approvals

• FDA: Accelerated approval in 2013, based on promising phase III trials.
• EMA: Approved in Europe shortly thereafter.
• Regional Variations: Some countries have delayed approval or restricted indications.

Policy Shifts and Reimbursement

• High-profile policy debates around cost-effectiveness have led to increased government involvement in pricing negotiations.
• Some countries implement tendering and managed entry schemes.

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What Are the Market Penetration and Adoption Trends?

Region	Adoption Rate	Influencing Factors	Future Potential
North America	High	Reimbursement, awareness	Stable, mature
Europe	Moderate	Budget constraints	Growth in underserved areas
Asia-Pacific	Growing	Increasing diagnosis, affordability	Rapid expansion expected

Current Challenges

• Underdiagnosis remains a hurdle.
• Access disparities limit market expansion in low-income regions.
• Resistance from payers to high prices.

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What Are the Emerging Trends and Pipeline Developments?

• Combination Therapies: Fixed-dose combinations (e.g., ledipasvir/sofosbuvir) enhance adherence.
• Next-Generation DAAs: Improved efficacy, shorter treatment durations, pan-genotypic activity.
• Generic Entry: Accelerates price erosion, especially in emerging markets.
• Market Shifts: Moving from curative to preventive strategies via screening programs.

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What is Sovaldi's Financial Trajectory & Future Outlook?

Revenue Decline Post-Peak

Year	Revenue (USD billion)	Comment
2013	USD 8.5	Launch success
2014	USD 12.3	Surge due to initial adopters
2015	USD 15.4	Market saturation initiation
2016–2019	Decline	Patent expirations, generics entry at play

Projected Revenues

• Short-to-Medium Term (2023–2027): Anticipated decline with residual niche markets, potential stabilization via new indications.
• Long Term: Limited as patents expire and competition intensifies, with Gilead pivoting towards other DAAs.

Revenue Forecast Table

Year	Estimated Revenue (USD billion)	Influencing Factors
2023	USD 2.0–3.0	Market saturation, generics
2025	USD 1.5–2.0	Patent expirations advance
2030	Minimal, niche markets	Generic dominance

Strategic Positioning

Gilead continues to monetize Sovaldi via combination therapies and new indications, while focusing R&D on next-gen treatments and broader HCV management solutions.

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SWOT Analysis of Sovaldi

Strengths	Weaknesses	Opportunities	Threats
High efficacy, well-tolerated	High initial price	Expanding indications	Patent expirations & generics
Market leader in early years	Limited efficacy in some genotypes	New combination regimens	Competitive DAAs
Strong regulatory approval	Pricing backlash	Market expansion in underserved regions	Policy and reimbursement shifts

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What Are the Key Market Challenges?

• Pricing & Reimbursement Pressures: Governments and payers increasingly scrutinize drug costs.
• Patent Expirations & Generics: Rapid erosion of exclusivity, especially in low-income regions.
• Access Inequality: Limitations in diagnosis, affordability, and regional approval.
• Competitive Innovation: Emergence of next-generation DAAs with superior profiles.

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What Is the Future Outlook and Strategic Implications?

Market Evolution: Transition from treatment dominance to cost-effective, broad-spectrum regimens that include pan-genotypic DAAs.

Gilead's Strategy: Diversification into broader hepatitis C therapies, innovation in combination regimens, and expanding access in emerging markets.

Potential Growth Areas:

• Global Hepatitis C Elimination Programs
• Treatment of Special Populations: Patients with co-morbidities, liver transplant recipients
• New Indications & Partnerships: Broader antiviral applications, integration with diagnostics

Risks to Watch:

• Patent litigations
• Pricing regulations
• Market saturation and generics

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Key Takeaways

• Sovaldi's launch revolutionized hepatitis C treatment, transforming Gilead into a biotech heavyweight with blockbuster revenues.
• The drug's financial trajectory peaked within initial years, followed by a decline driven by patent expiries, generics, and pricing pressures.
• Strategic success depended heavily on pricing strategies, patent protections, and regulatory approvals; countered by challenges from competition and policy changes.
• The future landscape is increasingly competitive, with the focus shifting to cost-effective, pan-genotypic therapies and expanding access worldwide.
• Gilead's adaptability and pipeline innovation are crucial for maintaining relevance in the evolving hepatitis C market.

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FAQs

1. What factors led to Sovaldi's initial blockbuster success?

Rapid efficacy, high SVR rates (>90%), shorter treatment courses, and regulatory approvals in key markets propelled its success, alongside aggressive marketing strategies.

2. How have pricing controversies affected Sovaldi's market presence?

High list prices drew criticism and prompted policy shifts, including negotiations, rebates, and in some cases, restrictions, influencing access and revenue.

3. When will patent expiry impact Sovaldi's revenues significantly?

Key patents are expected to expire between 2029 and 2033, with generic entry in markets like India and Egypt occurring earlier, accelerating revenue decline.

4. How does the competitive landscape influence Gilead's strategic decisions?

Emergence of generics, and newer DAAs with better profiles, compel Gilead to innovate, pursue combination therapies, and focus on underserved markets.

5. What role does global health policy play in Sovaldi's future?

Government initiatives aiming at hepatitis C elimination and price regulation critically shape market access and affordability, affecting future sales.

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References

[1] World Health Organization. Global hepatitis report 2017.
[2] Feld, J.J. et al. (2015). "Sofosbuvir and the Evolution of Hepatitis C Therapy." J Hepatol.
[3] Rehermann, B. (2016). "Diagnosis and Management of Hepatitis C." Gastroenterology.
[4] Kantarjian, H. et al. (2015). "Hepatitis C Treatment Cost-Effectiveness." Health Affairs.
[5] Gilead Sciences, Inc. (2013). "Sovaldi Patent Portfolio."
[6] Debbarma, K. et al. (2019). "Impact of Generic Entry on Hepatitis C Market." Market Dynamics Journal.
[7] PatentScope. WIPO. Various patent statuses.
[8] European Medicines Agency (EMA). Approvals & regional policies.
[9] Gilead Sciences Annual Reports, 2014–2016.
[10] WHO, 2017. "Compulsory Licensing & Access to Medicines."