Sofosbuvir - Generic Drug Details

What are the generic drug 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
National Institute on Drug Abuse (NIDA)	PHASE4
Lifespan	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	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-001	Aug 28, 2019		RX	Yes	No					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
France	14C0082
European Patent Office	2609923
European Patent Office	2792680
France	14C0082
Mexico	2012011324
Taiwan	201136945	Purine nucleoside phosphoramidate
World Intellectual Property Organization (WIPO)	2013066748

Supplementary Protection Certificates for sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	826	Finland
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR, 20140117
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014

Market Dynamics and Financial Trajectory for Sofosbuvir

Last updated: April 9, 2026

What drives the demand for Sofosbuvir?

Sofosbuvir is an antiviral medication used primarily to treat hepatitis C virus (HCV) infections. Its market growth hinges on several factors:

• HCV prevalence: An estimated 58 million people worldwide harbor chronic hepatitis C (WHO, 2021). The largest markets include the U.S., Europe, and parts of Asia.
• Treatment guidelines: Leading health authorities recommend Sofosbuvir-based regimens as first-line therapy for chronic HCV, promoting widespread adoption.
• Drug efficacy and resistance: Sofosbuvir has high cure rates (above 90%) with a favorable side effect profile, boosting physician and patient acceptance.
• Patents and exclusivity: Patent protections lasted until around 2025-2026, influencing pricing power and market share dynamics.
• Pricing and reimbursement: High development and manufacturing costs drove initial prices upwards; payers’ negotiations and generic availability impact pricing strategies.

What is the current market size and forecast?

The global hepatitis C drug market was valued at approximately USD 7.5 billion in 2021. Sofosbuvir, as a flagship drug, dominated this segment, accounting for an estimated 65-70% of global sales.

Year	Estimated Global Market Size (USD billion)	Sofosbuvir's Market Share	Sofosbuvir Sales (USD billion)
2021	7.5	70%	5.25
2025*	9.8	55%	5.39
2030*	12.4	45%	5.58

*Projections based on market research firms (Grand View Research, 2022). The growth is driven by expanding treatment access and drug innovations.

What competitive and regulatory factors influence the trajectory?

• Generic competition: Patent expirations in key markets—Europe (2024), U.S. (2025)—allow generics to enter, reducing prices and market share.
• New drug formulations: Next-generation agents with improved dosing or broader efficacy could cannibalize Sofosbuvir sales.
• Pricing policies: Negotiated discounts and health system uptake heavily influence revenues.
• Patent challenges: Legal disputes over patent rights could delay generic entry or extend exclusivity.

What are the financial implications for stakeholders?

• Pharmaceutical companies: Innovator firms experienced peak revenues before patent expiry; future earnings depend on pipeline diversification and lifecycle management.
• Investors: Stock prices of companies like Gilead Sciences, which marketed Sofosbuvir, correlate with patent positions and sales trends.
• Healthcare payers: Balance between high drug costs and long-term savings from curing HCV in policy decisions influences reimbursement rates.

How might future market developments unfold?

• Emergence of combination regimens: Fixed-dose combinations with other antivirals could extend clinical use and revenue streams.
• Global treatment expansion: Increasing access in low- and middle-income countries (LMICs) through negotiated prices and generics will grow total market volume.
• Innovation pipeline: New drugs targeting resistant HCV strains or co-infections will shape long-term market share.
• Pricing pressures: As generic versions hit markets, revenue decline is expected unless new indications or formulations are introduced.

What are the key takeaways?

Sofosbuvir remains a high-revenue drug driven by HCV prevalence, treatment guidelines, and patent protections. Market growth is slowing due to patent expirations and generic competition but could be sustained through new formulations, expanded access, and future pipeline drugs. Stakeholders should monitor patent timelines, regulatory shifts, and competitive developments to adjust strategies accordingly.

FAQs

1. When will Sofosbuvir lose patent exclusivity?
   Patents are expected to expire around 2024–2026 in major territories, opening markets for generics.

2. How does generic competition affect Sofosbuvir sales?
   Generics typically enter after patents expire, reducing prices and market share, especially in cost-sensitive regions.

3. Is Sofosbuvir still the leading hepatitis C treatment?
   It remains a leading option, but newer direct-acting antivirals (DAAs) with improved profiles have gained market share.

4. What are prospects for Sofosbuvir in low-income countries?
   Price reductions and licensing agreements facilitate increased access, expanding the market volume.

5. What future innovations could impact Sofosbuvir's market?
   Combination therapies with broader efficacy, resistance management, and formulations for co-infections may alter its market position.

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References

1. WHO. (2021). Hepatitis C. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
2. Grand View Research. (2022). Hepatitis C Virus Infection Treatment Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/hepatitis-c-virus-infection-treatment-market