SOFOSBUVIR; VELPATASVIR - Generic Drug Details

What are the generic drug sources for sofosbuvir; velpatasvir and what is the scope of freedom to operate?

Sofosbuvir; velpatasvir is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in three NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir has five hundred and twenty-nine patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for SOFOSBUVIR; VELPATASVIR

International Patents:	529
US Patents:	21
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	77
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFOSBUVIR; VELPATASVIR
DailyMed Link:	SOFOSBUVIR; VELPATASVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOFOSBUVIR; VELPATASVIR

Constraining patent/regulatory exclusivity:

9,757,406*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,116,783*PED

Dosage:

PELLETS;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 SOFOSBUVIR; VELPATASVIR

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; VELPATASVIR clinical trials

Pharmacology for SOFOSBUVIR; VELPATASVIR

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SOFOSBUVIR; VELPATASVIR

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

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

US Patents and Regulatory Information for SOFOSBUVIR; VELPATASVIR

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	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	10,086,011*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes	8,889,159*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	9,085,573*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes	8,575,135*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	9,085,573*PED				Y

EU/EMA Drug Approvals for SOFOSBUVIR; VELPATASVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Epclusa	sofosbuvir, velpatasvir	EMEA/H/C/004210Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2016-07-06

International Patents for SOFOSBUVIR; VELPATASVIR

Country	Patent Number	Title	Estimated Expiration
South Korea	20150043553
Denmark	2635588
Eurasian Patent Organization	201171417
Canada	2763151
South Korea	20140096239
Hong Kong	1169414

Supplementary Protection Certificates for SOFOSBUVIR; VELPATASVIR

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
2635588	C02635588/01	Switzerland		PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	214 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

Market Overview and Financial Trajectory for Sofosbuvir and Velpatasvir

Last updated: February 13, 2026

Sofosbuvir and velpatasvir target hepatitis C virus (HCV) infections. Their combined use in Epclusa (ads. Gilead Sciences) became a standard of care, influencing market dynamics significantly.

Market Size and Growth Trajectory

In 2022, the global hepatitis C market was valued approximately at $12 billion, with projections reaching around $18 billion by 2030, driven by increased screening, new treatment guidelines, and aging populations. Sofosbuvir and velpatasvir account for about 60% of this market, primarily through Epclusa. The compound annual growth rate (CAGR) from 2023 to 2030 is estimated at 5.8%.

Key Drivers and Market Dynamics

• Patent Expirations and Generics: Gilead’s patent for Epclusa expires in the US in 2029, opening the market for generics, which could reduce revenue flow by approximately 60% initially.
• Pricing Reforms: Governments and insurers negotiate deals, leading to significant price reductions. For instance, in India, generic versions are priced at a fraction of the US cost, impacting Gilead's margins.
• Regulatory Approvals: Expanded indications, especially in pediatric populations and for coinfections (e.g., HIV/HCV), expand addressable markets.
• Competition: AbbVie's Vosevi, and emerging generics, challenge market share.

Financial Performance and Projections

• Gilead’s Revenue (2022): Sofosbuvir-based products generated $8.2 billion globally; Epclusa accounted for $3.5 billion.
• Profit Margins: Gross margin approximately 75%, but net margins declined from 40% in 2020 to 30% in 2022 due to pricing pressures.
• Future Revenue: Post-2029, revenues potentially decrease by 60-70% with generic competition, unless reforms or new indications are approved.

Pricing and Reimbursement Policies

Pricing widely varies:

• In high-income countries, Epclusa costs around $74,760 per course.
• In low-income regions, generics are available for as low as $300 per course.
• Reimbursement policies rely heavily on government negotiations, with some countries employing tenders to secure lower prices.

Impacts of Emerging Therapies

New DAAs with shorter regimens, higher success rates, and fewer side effects are entering the market, threatening to diminish demand for earlier-generation drugs like sofosbuvir and velpatasvir.

Summary

Market continuity for sofosbuvir and velpatasvir hinges on patent protections, regulatory expansions, and healthcare policies. The approach to generic competition after patent expiry presents substantial revenue risks for Gilead and others, even as global hepatitis C elimination campaigns amplify treatment access.

---

Key Takeaways

• The hepatitis C drug market is projected to grow at ~5.8% CAGR until 2030.
• Gilead’s Epclusa dominates current revenues but faces decline post-2029 due to patent expiry.
• Price competition, especially from generics, drives margins down, especially in emerging markets.
• New DAAs challenge existing therapies, potentially reducing demand for sofosbuvir and velpatasvir.
• Regulatory expansions and new indications could offset some revenue declines.

---

FAQs

1. When does Gilead’s patent on Epclusa expire?
   Gilead’s patent for Epclusa in the US expires in 2029.

2. How much does a generic hepatitis C treatment typically cost in India?
   Approximately $300 per course, compared to $74,760 in the US.

3. What are the main competitors to sofosbuvir and velpatasvir?
   Vosevi (AbbVie), glecaprevir/pibrentasvir (Mavyret), and emerging generics.

4. How do regulatory policies influence the market?
   Expanding indications and approvals, especially for coinfections and pediatric use, increase market size.

5. What future developments could impact market dynamics?
   New DAAs with shorter treatment durations, improved efficacy, and broader approvals could reduce demand for current therapies.

---

References

[1] IQVIA. (2022). Global hepatitis C market report.
[2] Gilead Sciences. (2022). Annual Report.
[3] World Health Organization. (2021). Hepatitis C guidelines.
[4] Statista. (2022). Hepatitis C drug pricing by region.
[5] EvaluatePharma. (2022). Oncology and infectious disease drug forecasts.