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-four patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	564
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	205834-001	Oct 10, 2014		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	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No

International Patents for ledipasvir; sofosbuvir

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP14005678	COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Costa Rica	20140273	COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Russian Federation	2478104	НУКЛЕОЗИДФОСФОРАМИДАТЫ В КАЧЕСТВЕ ПРОТИВОВИРУСНЫХ АГЕНТОВ (NUCLEOSIDE PHOSPHORAMIDATES AS ANTIVIRAL AGENTS)
Colombia	6970603	Composiciones y métodos para tratar el virus de la hepatitis c

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014	16C0005	France		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2430014	2016004	Norway		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

Market Dynamics and Financial Trajectory for Ledipasvir; Sofosbuvir

Last updated: July 29, 2025

Introduction

The combination of ledipasvir and sofosbuvir revolutionized hepatitis C virus (HCV) therapy, drastically altering the landscape of antiviral treatment since its approval in 2014. This direct-acting antiviral (DAA) duo promises high sustained virologic response (SVR) rates, shorter therapy duration, and fewer side effects compared to previous regimens. Understanding the evolving market dynamics and financial trajectory of ledipasvir-sofosbuvir offers insights into its commercial sustainability, competitive positioning, and future investment opportunities.

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Pharmacological Profile and Clinical Impact

Ledipasvir, an NS5A inhibitor, combined with sofosbuvir, a nucleotide NS5B polymerase inhibitor, offers an effective oral regimen with cure rates exceeding 95% for genotype 1 HCV—one of the most prevalent strains globally. The combination's efficacy, safety profile, and convenience have led to widespread adoption, transforming HCV from a chronic, life-threatening disease into a curable condition.

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Market Dynamics

1. Market Penetration and Global Reach

Initially launched in high-income markets like the United States and Europe, ledipasvir-sofosbuvir rapidly gained market share within the HCV therapeutic space. The drug's groundbreaking efficacy positioned it as the preferred option over interferon-based therapies, which were associated with severe side effects and lower success rates.

Emerging markets represent a significant growth frontier, driven by increasing HCV prevalence and expanded access programs. However, pricing and patent protections influence market penetration speed in these regions.

2. Competitive Landscape and Patent Strategies

The rapid commercialization spurred numerous competitors developing similar DAA combinations, including glecaprevir/pibrentasvir, velpatasvir/sofosbuvir, and others. The market's competitive intensity relies heavily on patent life, exclusivity periods, and ongoing litigation. Patent extensions and the filing of new formulations aim to prolong exclusivity, delay generic entry, and preserve higher margins.

3. Price Sensitivity and Cost-Effectiveness

Pricing strategies have significantly influenced market dynamics. Initially, high prices limited access, prompting payers and governments to negotiate discounts and formulary restrictions. In response, generic versions of sofosbuvir emerged in some markets, creating downward pressure on prices and affecting brand sales.

Cost-effectiveness assessments, especially for mass screening and treatment programs, further impact prescribing behaviors and reimbursement policies.

4. Regulatory and Policy Factors

Government initiatives targeting hepatitis C eradication, such as the U.S. CDC’s screening recommendations and NHS treatment programs, have fueled demand. Regulatory approvals expanding indications — including treatment in pediatric populations and those with advanced liver disease — broaden the target market, influencing sales trajectories.

5. Patent Expiration and Biosimilar Entry

Patent expiry timelines are crucial. For ledipasvir-sofosbuvir, patent protection is expected to last into the late 2020s or early 2030s, depending on jurisdiction-specific extensions and legal challenges. The entry of biosimilars or generics can disrupt market share and pricing, challenging incumbent revenues.

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Financial Trajectory

1. Revenue Trends

Following its launch, leadpasvir-sofosbuvir saw exponential revenue growth, peaking around 2015-2016. The drug’s high efficacy prompted broad adoption, leading to annual sales estimates surpassing $10 billion globally during these years (e.g., Gilead Sciences’ revenue from Harvoni peaked at over $13 billion in 2015 [1]).

Subsequently, revenue growth plateaued due to factors like market saturation, patent challenges, and pricing pressures. The U.S. market alone experienced a decline in new prescriptions as initial wave treatments concluded and new regimens gained approval.

2. Market Saturation and Declining Sales

As the most treatable and accessible patient populations were addressed, the remaining undiagnosed or marginalized groups presented a smaller market. Additionally, payer restrictions limited access to patients with advanced disease, further constraining sales growth.

3. Impact of Generic Competition

Emergence of generics in some jurisdictions has led to price reductions, impacting brand revenue. Studies estimate that generic uptake has reduced Gilead's profits significantly in markets where biosimilars are accessible (e.g., India, Egypt).

4. Future Revenue Potential

The pipeline for hepatitis C treatments has diversified. Novel regimens are entering the market, often with comparable efficacy at reduced costs, adding downward pressure. Nonetheless, large-scale treatment programs in developing countries and ongoing screening may sustain demand, especially for older formulations.

5. Research and Development (R&D) Investment and Pipeline

Gilead and other companies continue to explore next-generation antivirals, aiming for shorter durations, pan-genotypic efficacy, and improved safety. These innovations could revive sales or open new indications, impacting the long-term financial outlook positively.

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Market Outlook and Strategic Considerations

1. Swings in Market Share

The shift from high-cost branded drugs to more affordable generics will continue, especially in low- and middle-income countries. Patents and licensing agreements will drive the landscape, with incumbent companies needing strategic patent defenses or diversification into broad-spectrum antivirals.

2. Pricing and Value-Based Models

Cost containment measures and value-based pricing agreements are crucial. Payers demand evidence of long-term benefits and cost savings from curing HCV, influencing how manufacturers price and market these drugs.

3. Population Management

Expanding screening initiatives and treatment access in underserved areas will be vital for maintaining sales. However, challenges like healthcare infrastructure limitations and sociocultural barriers must be addressed.

4. Regulatory and Policy Impact

Legislative actions aiming at treatment access equity, patent reforms, and global health policies are key drivers. Positive policy developments can significantly boost market stability.

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Key Takeaways

• Market evolution is characterized by initial rapid growth fueled by high efficacy and pressing unmet needs, now transitioning into a phase of consolidation with declining sales due to market saturation and generics.
• Patent protections and legal strategies remain critical to maintaining exclusivity and profitability, but these are increasingly challenged by biosimilar entry in key markets.
• Cost dynamics, including high drug prices and the advent of low-cost alternatives, are central to access and market share. Payer negotiations and value assessments continue to influence prescribing patterns.
• Expanding indications, ongoing R&D, and global health initiatives can renew growth prospects, especially in underserved markets with high HCV prevalence.
• Sustained investment in screening and linkage-to-care programs will be essential for maximizing treatment impact and securing future revenue streams.

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FAQs

1. How will patent expirations impact the financial trajectory of ledipasvir-sofosbuvir?
Patent expirations will facilitate generic entry, leading to reduced drug prices and potential revenue decline for originators. Strategic patent filings and licensing agreements aim to extend market exclusivity, but generics’ proliferation will remain a dominant factor shaping revenues.

2. What role do global health initiatives play in sustaining demand for ledipasvir-sofosbuvir?
Large-scale screening, awareness campaigns, and treatment programs, especially in underserved regions, create new patient populations, supporting demand despite patent challenges and market saturation.

3. Are there promising alternatives to ledipasvir-sofosbuvir that threaten its market share?
Yes. Pan-genotypic regimens, shorter treatment courses, and potentially more affordable formulations from competitors can reduce reliance on ledipasvir-sofosbuvir, especially as they gain approval and market acceptance.

4. How does pricing affect the accessibility of ledipasvir-sofosbuvir in emerging markets?
High prices initially limited access; however, the availability of generics and negotiated discounts have improved affordability in some regions. Pricing strategies remain central to balancing profitability and access.

5. What future developments could influence the financial outlook of HCV therapies?
Advances in antiviral research, integration of HCV treatment into comprehensive healthcare programs, and policy reforms will influence future sales. A potential shift toward universal treatment models can sustain or even grow market size.

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References

[1] Gilead Sciences, Inc. Fiscal Year 2015 Annual Report.