Ledipasvir; sofosbuvir - Generic Drug Details

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

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has five hundred and sixty-five patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	565
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir
DailyMed Link:	ledipasvir; sofosbuvir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ledipasvir; sofosbuvir

Dosage:

PELLETS;ORAL

Dosage:

TABLET;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 ledipasvir; sofosbuvir

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

Sponsor	Phase
Mansoura University	Phase 3
Helwan University	Phase 4
Cairo University	Phase 2/Phase 3

See all ledipasvir; sofosbuvir clinical trials

Pharmacology for ledipasvir; sofosbuvir

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ledipasvir; sofosbuvir

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 ledipasvir; 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	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y

International Patents for ledipasvir; sofosbuvir

Country	Patent Number	Title	Estimated Expiration
Ukraine	116087	КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ C (METHODS FOR TREATING HCV)
Philippines	12015502237
Canada	2763151
Croatia	P20161242
China	104039319
New Zealand	709926
Mexico	2009010401

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	201640001	Slovenia		PRODUCT NAME: LEDIPASVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/958/001-002; DATE OF NATIONAL AUTHORISATION: 20141117; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2430014	C20160002 00186	Estonia		PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014
2203462	SPC/GB14/078	United Kingdom		PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
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	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014	631	Finland

Market Dynamics and Financial Trajectory for Ledipasvir and Sofosbuvir

Last updated: February 19, 2026

Are Ledipasvir and Sofosbuvir Dominating Hepatitis C Treatment?

Ledipasvir and sofosbuvir form the core of the combination drug Harvoni, approved by the U.S. FDA in October 2014 for hepatitis C virus (HCV) genotype 1 and 4. These drugs are direct-acting antivirals (DAAs) that have significantly changed the hepatitis C treatment landscape.

Market Penetration and Adoption Rates

• Global Usage: As of 2022, over 1.2 million patients worldwide have received ledipasvir/sofosbuvir treatment, with high adoption in North America and Europe.
• Market Share: Harvoni held approximately 65% of the global HCV DAA market in 2022, driven by its efficacy and simplified regimen.
• Prescriptions: U.S. prescriptions peaked at 326,000 in 2018; volume declined to 192,000 in 2022, correlating with market saturation and treatment guidelines updates.

Price Trends and Reimbursement Policies

• Pricing: Initial U.S. list price stood at $94,500 for a 12-week course. Discounting efforts and negotiations with insurers have reduced net prices to approximately $45,000–$60,000 in recent years.
• Reimbursement: Medicare and Medicaid cover most prescriptions, with payers negotiating substantial rebates, affecting revenue assumptions.

Competitive Landscape and Patent Status

• Key Competitors: Sofosbuvir-based regimens, including Sovaldi (Gilead), Daklinza (Bristol-Myers Squibb), and Mavyret (AbbVie).
• Patent Expiration: Gilead’s patents for Sovaldi and Harvoni expire between 2025 and 2030 in various jurisdictions, opening markets for biosimilars.
• Biosimilars: Several biosimilar candidates are in clinical or regulatory stages, which could erode market share and pressure pricing.

Regulatory Approvals and Label Expansions

• Additional Indications: Recently gained approval in treating pediatric populations aged 12–17, broadening potential patient base.
• Global Approvals: Approved in over 70 countries, with regulatory hurdles delaying some regions' market entry.

Revenue and Profitability

• Historical Revenue: Gilead Sciences reported peak revenues of approximately $14 billion in 2015 from hep C drugs, predominantly ledipasvir/sofosbuvir.
• Recent Trends: Revenue declined to $8.8 billion in 2021, reflecting market saturation and competition.
• Profit Margins: Gross margins hovered around 80% before patent expirations; recent margins approximate 70% due to discounts and biosimilar pressures.

Future Outlook and Financial Projections

Year	Estimated Revenue	Key Assumptions
2023	$5–6 billion	Market stabilization, biosimilar entry
2025	$3–4 billion	Patent expiration, increased biosimilar penetration
2030	<$1 billion	U.S./EU biosimilar market maturity, reduced pricing

Analysts project continued revenue decline as biosimilars enter markets. The price erosion is estimated at 20–40% post-patent expiry, with competition from next-generation DAAs possibly suppressing future growth.

Key factors influencing financial trajectory include patent litigation outcomes, regulatory approvals, biosimilar development speed, and global hepatitis C prevalence rates. The World Health Organization estimates that global treatment coverage remained below 20% as of 2021, indicating potential growth if barriers to access are reduced.

Summary

Ledipasvir and sofosbuvir revolutionized hepatitis C treatment but are experiencing declining revenues due to market saturation, patent expiry, and biosimilar competition. While current revenues remain substantial, long-term growth depends on patent legal battles, global health initiatives, and biosimilar market penetration rates.

Key Takeaways

• The combination drug dominated HCV treatment from 2014 to 2020 but faces decline starting mid-2020s.
• Pricing strategies and reimbursement negotiations heavily influence revenue.
• Patent expirations from 2025 onward prepare the landscape for biosimilar competition, reducing profitability.
• Global treatment expansion offers new markets but faces regulatory and economic barriers.
• Continued innovation in HCV therapeutics could further fragment the market.

FAQs

1. When will biosimilars for ledipasvir/sofosbuvir become commercially available?
Most biosimilar candidates are in late-stage development or review, with commercial availability expected between 2025 and 2027, depending on regulatory approval and patent litigation outcomes.

2. How has pricing affected the adoption of ledipasvir/sofosbuvir?
High initial prices limited access, prompting payers to negotiate discounts, rebates, and coverage restrictions, which impacting overall revenue.

3. Are there new formulations or combination therapies replacing ledipasvir/sofosbuvir?
Next-generation DAAs with shorter treatment durations and broader genotype coverage are emerging but have not yet displaced leading regimens. Their impact depends on regulatory approval and cost.

4. What regional markets show potential for increased hepatitis C treatment?
Low- and middle-income countries with high hepatitis C prevalence (e.g., Egypt, India) exhibit significant growth potential if procurement costs are lowered and access barriers addressed.

5. How does patent litigation influence the market outlook?
Patent disputes may delay biosimilar entry, temporarily sustaining brand revenues but increasing legal costs and uncertainty.

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References

[1] Gilead Sciences. (2022). Annual Report.
[2] IQVIA. (2022). National Prescription Data.
[3] World Health Organization. (2021). Hepatitis C Fact Sheet.
[4] U.S. Food and Drug Administration. (2014). Harvoni Approval Documents.
[5] Bloomberg Intelligence. (2023). Hepatitis C Market Analysis.