SOFOSBUVIR - Generic Drug Details

What are the generic sources for sofosbuvir and what is the scope of patent protection?

Sofosbuvir is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Teva Pharms Usa Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.

Summary for SOFOSBUVIR

International Patents:	368
US Patents:	22
Tradenames:	4
Applicants:	2
NDAs:	6
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	327
Patent Applications:	3,648
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFOSBUVIR
What excipients (inactive ingredients) are in SOFOSBUVIR?	SOFOSBUVIR excipients list
DailyMed Link:	SOFOSBUVIR at DailyMed

Recent Clinical Trials for SOFOSBUVIR

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

Sponsor	Phase
Lifespan	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4
Atea Pharmaceuticals, Inc.	PHASE3

See all SOFOSBUVIR clinical trials

Pharmacology for SOFOSBUVIR

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

Medical Subject Heading (MeSH) Categories for SOFOSBUVIR

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for SOFOSBUVIR

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for SOFOSBUVIR

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

US Patents and Regulatory Information for SOFOSBUVIR

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	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	11,116,783*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	7,964,580*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-001	Aug 28, 2019		RX	Yes	No	9,085,573*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,940,718*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	8,580,765*PED				Y

EU/EMA Drug Approvals for SOFOSBUVIR

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 SOFOSBUVIR

Country	Patent Number	Title	Estimated Expiration
South Korea	20140108645	COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Brazil	112012024923
European Patent Office	2552930
Eurasian Patent Organization	201490588	СПОСОБЫ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Israel	231515	תכשירים לטיפול בוירוס הפטיטיס סי (Compositions for treating hcv)
Brazil	PI1012781

Supplementary Protection Certificates for SOFOSBUVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR
2203462	C201430078	Spain		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
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 Sofosbuvir

Last updated: July 29, 2025

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Introduction

Sofosbuvir, branded primarily as Sovaldi by Gilead Sciences, represents a milestone in the treatment of hepatitis C virus (HCV) infections. Approved in 2013 by the U.S. Food and Drug Administration (FDA), it revolutionized antiviral therapy by offering an effective, all-oral, directly acting antiviral (DAA) regimen that significantly improved cure rates. Its introduction underscored a pivotal shift from interferon-based treatments to targeted antiviral agents with shorter treatment durations and fewer side effects.

This article examines the evolving market dynamics and financial trajectory for Sofosbuvir, emphasizing key factors influencing its commercialization, competitive landscape, pricing strategies, and long-term profitability.

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Market Dynamics

1. Market Adoption and Clinical Impact

Sofosbuvir's high efficacy—achieving sustained virological response (SVR) rates exceeding 90% across various genotypes—rapidly propelled its adoption globally. Its regimen simplifies therapy, replacing interferon and ribavirin, which have substantial side-effect profiles. This clinical superiority catalyzed patient and clinician acceptance, driving high demand.

2. Competitive Landscape

Post-approval, the market saw entrance of multiple DAAs, such as Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir). These combination therapies offered broader genotype coverage and improved side-effect profiles, fueling fierce competition. Gilead's initial monopoly was challenged as other pharmaceutical companies, including AbbVie, Merck, and newer entrants from China, introduced alternative agents.

The entry of generic formulations, particularly in cost-sensitive low- and middle-income countries, further pressured branded sales. Indian generics manufacturers, such as Natco and Hetero, began producing cost-effective versions, affecting Gilead’s pricing power.

3. Pricing and Reimbursement Dynamics

Sofosbuvir faced controversy over high pricing in high-income countries—initially listed at $84,000 for a 12-week course in the U.S., sparking debates over affordability and access. Gilead justified the cost by citing the drug’s transformative clinical outcomes and long-term healthcare savings.

Reimbursement policies significantly influenced market dynamics. In the U.S., Medicaid and private insurers negotiated boycotts or tiered access, impacting initial sales. Conversely, governments in some countries negotiated price caps or adopted generic procurement, affecting overall revenue streams.

4. Regulatory Approvals and Global Penetration

Global adoption varied based on health policies. High-income countries adopted Sofosbuvir swiftly, driven by supportive regulatory environments. Meanwhile, lower-income nations relied on patent flexibilities and generic procurement, enabling broader access but often at reduced prices. This expanding access contributed to the global market size, estimated to reach over $20 billion annually during peak years.

5. Market Saturation and Patent Expiry

Gilead’s patent portfolio protection faced erosion as patent expirations approached, notably in developing markets. Patent cliffs encouraged generic manufacturers to flood markets with lower-priced alternatives, shrinking market share for original formulations.

Financial Trajectory

1. Revenue Generation and Growth

Initial blockbuster sales globally positioned Sofosbuvir as one of the top-selling hepatitis C medications. In 2014, Gilead reported approximately $12.4 billion in sales for Sovaldi, with subsequent growth driven by expanding indications, including increased genotypic coverage and shorter treatment regimens with Harvoni.

Over subsequent years, revenue plateaued, influenced by market saturation and evolving treatment algorithms. Nevertheless, Sofosbuvir contributed significantly to Gilead’s therapeutics revenue, underpinning its position as a dominant player in hepatitis C.

2. Profitability and Investment

High product sales translated to substantial profit margins during the initial years. However, acid to the patent expiry wave, the influx of generics and competitive pricing pressured margins. Gilead responded with strategic price reductions, licensing agreements, and securing new combination products to sustain revenues.

3. Impact of Patent Expirations and Generics

By 2018-2020, key patents faced legal challenges or expired in several markets, notably India and Egypt, leading to a surge in generic versions. These markets witnessed a dramatic decrease in per-unit prices—sometimes by over 80%—which significantly impacted branded sales revenues.

Gilead’s financials reflected these pressures, leading to strategic shifts towards pipeline diversification and partnership arrangements to compensate for declining Sofosbuvir revenues.

4. Long-Term Financial Outlook

While initial blockbuster sales have tapered, residual revenues persist due to ongoing treatment needs and modifications, such as retreatment and second-line therapies. Moreover, the expanded treatment of previously underserved populations sustains a baseline demand. Gilead’s strategic focus now leans toward developing next-generation antiviral agents and expanding indications (e.g., hepatitis B, HIV co-infection), supplementing the revenue trajectory.

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Key Drivers Influencing Future Market and Financial Trends

• Price Negotiations & Access Programs: Governments and insurers continue to negotiate pricing and implement access programs, affecting volume sales.
• Patent Litigation & Generics: Patent challenges remain pivotal in shaping market shares, especially in emerging markets.
• Pipeline & New Indications: Expansion into broader viral indications or combination regimens remains crucial for sustaining revenue.
• Market Penetration in Developing Countries: Cost-effective generics facilitate access but at the expense of branded revenues.
• Regulatory & Political Environment: Policy shifts in healthcare funding and patent protections directly influence sales and profitability.

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Conclusion

The market dynamics and financial trajectory of Sofosbuvir exemplify a paradigm shift in pharmaceutical innovation—marked by rapid uptake, subsequent competitive pressures, and the importance of pricing and access strategies. While initial revenue surges established Sofosbuvir as a blockbuster, evolving patent landscapes and market saturation have prompted companies like Gilead to adapt through pipeline expansion and strategic licensing.

The future of Sofosbuvir’s market remains intricately linked to regulatory environments, patent protections, and global health policies emphasizing affordability and broad access. As the hepatitis C landscape matures, sustained profitability hinges on innovation, strategic collaborations, and diversification beyond initial blockbuster formulations.

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Key Takeaways

• Sofosbuvir’s introduction transformed hepatitis C treatment, leading to significant revenue generation but challenged by high prices and emerging generics.
• Market adoption was driven by superior efficacy and safety, yet competition and pricing negotiations shifted market share over time.
• Patent expiries and generic proliferation considerably impacted original drug revenues, prompting strategic shifts toward pipeline diversification.
• Long-term financial sustainability depends on expanding indications, expanding access globally, and navigating patent and regulatory challenges.
• Continuous innovation and strategic licensing are essential to maintain competitiveness and profitability in a rapidly evolving antiviral landscape.

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FAQs

1. How has patent expiry affected Sofosbuvir’s market revenue?
Patent expiries, particularly in developing markets, enabled generic manufacturers to produce lower-cost versions, significantly reducing branded drug revenues. This decline prompted Gilead to shift focus toward pipeline development and licensing strategies to sustain market presence.

2. What are the key factors driving competition against Sofosbuvir?
The entrance of alternative DAAs with broader genotypic coverage, improved safety profiles, and lower prices—especially from generic producers—has intensified competition, reducing market share for Sofosbuvir-based products.

3. How do pricing strategies impact access to Sofosbuvir globally?
High initial prices limited access in many countries, while negotiations, licensing agreements, and patent flexibilities facilitated broader access through generic formulations, balancing profitability with public health needs.

4. What is the outlook for Sofosbuvir’s long-term profitability?
While initial blockbuster earnings have declined, continued demand for hepatitis C treatment, particularly in low- and middle-income countries, combined with pipeline expansion, suggests the drug will maintain a relevant revenue stream for years.

5. Are there prospects for Sofosbuvir in treating other viral infections?
Although primarily approved for hepatitis C, ongoing research explores its potential against other viruses; however, current market focus remains on its role within hepatitis C antiviral regimens.

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Sources:
[1] Gilead Sciences. "Sovaldi (sofosbuvir) [Product Information]." 2013.
[2] IMS Health. "Hepatitis C market analysis." 2022.
[3] World Health Organization. "Global hepatitis report." 2021.
[4] U.S. FDA. "Sofosbuvir approval documents." 2013.
[5] PriceWaterhouseCoopers. "Pharmaceutical market forecasts." 2022.