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
Ain Shams University	Phase 3
Cairo 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

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
Hungary	E034239
Chile	2014000630	Una composicion que comprende 1) un compuesto derivado de nucleosido denominado como compuesto 10 y 2) un compuesto derivado de acido 5-tiofeno-2-carboxilico denominado como compuesto 5 o un compuesto derivado del ester metilico del acido carbamico denominado como compuesto 6; y su uso para el tratamiento profilactico o terapeutico de una infeccion por vhc.
Brazil	112012024923

Supplementary Protection Certificates for SOVALDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2430014	2016C/006	Belgium		PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117

Market Dynamics and Financial Trajectory for SOVALDI

Last updated: July 27, 2025

Introduction

Sovaldi (sofosbuvir) is a groundbreaking pharmaceutical agent developed by Gilead Sciences, marking a paradigm shift in hepatitis C virus (HCV) treatment. Approved by the U.S. Food and Drug Administration (FDA) in December 2013, Sovaldi was among the first direct-acting antivirals (DAAs) to deliver high cure rates, shorter treatment durations, and favorable safety profiles compared to previous therapies. Its introduction has profoundly influenced the global HCV market, triggering significant shifts in clinical practice, pricing strategies, and competitive dynamics. Analyzing Sovaldi’s market trajectory highlights broader trends in pharmaceutical innovation, pricing pressures, and strategic responses within the infectious disease therapeutics landscape.

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Market Dynamics of Sovaldi

1. Market Entry and Initial Adoption

Unlike prior interferon-based regimens, Sovaldi’s approval heralded a new era in HCV management, boasting cure rates exceeding 90%. Its rapid adoption was driven by clinical efficacy, shorter treatment durations (12 weeks), and a better safety profile. Initially launched at an unprecedented wholesale price of approximately $84,000 per treatment course in the U.S., the drug’s price point was a calculated move by Gilead to recover investments made into research and development (R&D) and to position Sovaldi as a premium product.

2. Pricing Strategies and Market Access

Sovaldi’s premium pricing incited heated debates over affordability, drug pricing ethics, and healthcare sustainability. While its high cost limited immediate accessibility in some regions, payers in the U.S. negotiated favorable reimbursement agreements, leading to widespread use in public and private healthcare systems. Health authorities globally faced pressure to balance access with cost containment, prompting tiered pricing strategies and licensing agreements in emerging markets.

3. Competitive Landscape and Sequencing

Following Sovaldi’s success, several pharmaceutical players accelerated development of combination DAA regimens—such as Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Mavyret (glecaprevir/pibrentasvir)—aiming to improve efficacy, ease of use, and price competition. Gilead responded by combining Sovaldi with other agents, creating fixed-dose combinations that enhanced treatment adherence and clinical outcomes. The subsequent proliferation of competitors gradually introduced downward pressure on prices and expanded treatment options.

4. Regulatory and Policy Influences

Global health agencies and policymakers played crucial roles in shaping Sovaldi’s market trajectory. Initiatives like the World Health Organization’s (WHO) goal for hepatitis elimination and national public health programs increased demand for effective, affordable treatments. Conversely, payers and policymakers debated funding for high-cost treatments, advocating for cost-effectiveness analyses and value-based pricing to optimize resource allocation.

5. Evolving Market and Patent Considerations

While Gilead initially held dominant market share, patent expiry timelines and the introduction of biosimilars foreshadowed potential market erosion. Patent extensions or litigation resistant to biosimilar entry could influence long-term revenue streams. Moreover, the advent of generic formulations in some markets and negotiations for voluntary licensing have gradually impacted Gilead’s exclusivity and revenue potential.

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Financial Trajectory of Sovaldi

1. Revenue Growth and Peak Sales

Sovaldi achieved rapid revenue escalation, with Gilead reporting $10.3 billion in net product sales in 2014—the year following its launch—making it one of the fastest drugs to reach such high sales levels in pharmaceutical history. The initial peak reflected strong uptake in the U.S., Europe, and high-income regions, facilitated by broad reimbursement and high demand for curative HCV regimens.

2. Post-Launch Revenue Trends

Following the initial surge, sales stabilized and declined slightly due to competition from newer combination therapies, pricing pressures, and evolving treatment guidelines. Gilead reported worldwide sales of approximately $3.4 billion for Sovaldi in 2020, illustrating a decline from peak levels but still significant revenue attributable to a broad global market presence.

3. Impact of Market Competition

The introduction of Harvoni and Epclusa, offering simplified dosing and broader genotype coverage, cannibalized Sovaldi’s market share. Additionally, price negotiations and policy shifts in low- and middle-income countries led to reduced per-treatment costs, impacting margins.

4. Long-Term Revenue Outlook

While patent protections initially supported Gilead’s revenue, the upcoming patent expirations in various jurisdictions and the proliferation of generics threaten future income streams. The parent company’s strategic focus has shifted toward combination products and expanding indications, including use in more difficult-to-treat populations.

5. Cost-Effectiveness and Reimbursement Pressures

Cost-containment measures, such as negotiated discounts and healthcare system restrictions, have constrained revenue growth. Payors increasingly demand value-based pricing frameworks, emphasizing treatment cost per cure and population health impact, influencing Gilead’s pricing and marketing strategies.

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Market and Financial Outlook

Looking forward, the hepatitis C market continues to evolve. The global burden of HCV remains high, especially in underserved regions, providing growth opportunities for newer, affordable regimens. However, the likelihood of wind-down in Sovaldi’s direct sales persists due to patent expirations and biosimilar entry in key markets.

Gilead’s investments in next-generation antivirals, combination therapies, and initiatives targeting broader indications signal a strategic pivot away from reliance on Sovaldi’s initial blockbuster status. The company’s focus on high-value, innovative treatments aims to sustain revenue streams amidst competitive and regulatory pressures.

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Key Market Influences and Strategic Considerations

• Global hepatitis C prevalence remains over 70 million people worldwide, with heightened advocacy for universal treatment access.
• Cost-effectiveness thresholds and national healthcare policies continue to influence treatment adoption rates.
• Emergence of biosimilars and generics in developed markets likely accelerate revenue decline from Sovaldi’s original formulations.
• Innovations in combination therapies and personalized medicine may redefine treatment paradigms, affecting the legacy positioning of Sovaldi.
• Patent expirations in key markets over the next five years will significantly impact future sales and market share.

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Key Takeaways

• Sovaldi revolutionized hepatitis C treatment, achieving rapid market penetration driven by high efficacy and safety.
• While initially generating record-breaking revenues, market competition and pricing pressures have tempered growth, with sales plateauing and declining post-peak.
• Global health policies and cost considerations heavily influence access, pricing negotiations, and the future of Sovaldi’s revenue streams.
• Patent expirations and biosimilar entry are critical factors shaping Gilead’s long-term strategic outlook.
• The hepatitis C therapeutics market remains dynamic, with innovation and affordability serving as key drivers for future growth and sustainability.

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FAQs

1. What factors contributed to Sovaldi’s rapid market success?
Sovaldi’s high cure rates, shorter treatment duration, favorable safety profile, and the unmet need for effective HCV therapies drove rapid adoption and strong initial sales.

2. How has pricing affected Sovaldi’s market penetration?
Initial high pricing limited access in some regions but was balanced by payor negotiations and tiered pricing, enabling broad use across diverse healthcare systems.

3. What role did competition play in Sovaldi’s financial trajectory?
The introduction of combination therapies like Harvoni and Epclusa, offering simplified regimens and broader genotype coverage, cannibalized Sovaldi’s market share, impacting revenues.

4. What is the expected impact of patent expirations on Sovaldi’s future sales?
Patent expirations in key markets will pave the way for biosimilar and generic competition, likely leading to significant sales decline unless offset by new indications or formulations.

5. How is Gilead repositioning itself in the HCV market?
Gilead is focusing on combination products, expanding indications, and pursuing innovations in hepatitis B and other antiviral areas to mitigate revenue decline from Sovaldi.

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Sources

[1] Gilead Sciences. (2014). “Sovaldi (sofosbuvir) Drug Label.”
[2] IMS Health. (2015). “Global Pharmaceutical Market Trends.”
[3] World Health Organization. (2021). “Hepatitis C Fact Sheet.”
[4] Gilead Sciences. (2020). “Annual Report.”
[5] Reuters. (2018). “Gilead’s hepatitis C franchise faces challenges as pricing pressure grows.”