HARVONI Drug Patent Profile

Which patents cover Harvoni, and what generic alternatives are available?

Harvoni is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this drug.

This drug has five hundred and sixty-one patent family members in forty-nine countries.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Harvoni

Harvoni was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14, 2032. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for HARVONI

International Patents:	561
US Patents:	17
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	36
Drug Prices:	Drug price information for HARVONI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HARVONI
What excipients (inactive ingredients) are in HARVONI?	HARVONI excipients list
DailyMed Link:	HARVONI at DailyMed

See drug prices for HARVONI

See drug sales revenues for HARVONI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HARVONI

NDA:

212477

Dosage:

PELLETS;ORAL

NDA:

205834

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 HARVONI

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

Sponsor	Phase
Mansoura University	Phase 3
Cairo University	Phase 2/Phase 3
University of Maryland, College Park	Early Phase 1

See all HARVONI clinical trials

Pharmacology for HARVONI

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

US Patents and Regulatory Information for HARVONI

HARVONI is protected by seventeen US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	205834-002	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	205834-002	Aug 28, 2019		RX	Yes	No					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

International Patents for HARVONI

When does loss-of-exclusivity occur for HARVONI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering HARVONI around the world.

Country	Patent Number	Title	Estimated Expiration
Moldova, Republic of	20140058	Compoziţii şi metode de tratament al hepatitei virale C (Compositions and methods for treating hepatitis C virus)
South Korea	101991298
Eurasian Patent Organization	027493	ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ ДЛЯ ПОЛУЧЕНИЯ ПРОТИВОВИРУСНОГО СОЕДИНЕНИЯ (INTERMEDIATES FOR PREPARING AN ANTIVIRAL COMPOUND)
Eurasian Patent Organization	037281	СПОСОБЫ ПОЛУЧЕНИЯ ПРОТИВОВИРУСНОГО СОЕДИНЕНИЯ (METHODS OF PREPARING AN ANTIVIRAL COMPOUND)
Croatia	P20200138
Taiwan	201107341	Nucleoside phosphoramidates

Supplementary Protection Certificates for HARVONI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	2016C/006	Belgium		PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2430014	122016000009	Germany		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014	232 5001-2016	Slovakia		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014	CR 2016 00006	Denmark		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2430014	4/2016	Austria		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Harvoni

Last updated: July 3, 2025

Introduction

Harvoni, a groundbreaking treatment for hepatitis C virus (HCV), has reshaped the pharmaceutical landscape since its launch. Developed by Gilead Sciences, this fixed-dose combination of ledipasvir and sofosbuvir delivers cure rates exceeding 90% for certain genotypes, transforming chronic liver disease management. As global demand for effective antiviral therapies rises, understanding Harvoni's market dynamics and financial path equips business professionals with critical insights for investment and strategic decisions in the biotech sector.

Overview of Harvoni

Harvoni stands as a pivotal innovation in antiviral medicine, targeting HCV genotypes 1, 4, 5, and 6 in adults. Gilead Sciences received U.S. Food and Drug Administration (FDA) approval for Harvoni in October 2014, marking a leap from interferon-based treatments to direct-acting antivirals. The drug inhibits viral replication by blocking the NS5A protein and the HCV NS5B polymerase, enabling shorter treatment durations—often just 8 to 12 weeks—with minimal side effects.

This efficacy has driven widespread adoption, particularly in high-burden regions like the U.S. and Europe. However, Harvoni's high initial pricing, around $84,000 for a 12-week course in the U.S., sparked debates on accessibility and value-based pricing. Despite these challenges, the drug's success underscores the potential for rapid market penetration in unmet medical needs, with global sales peaking at over $13 billion in 2015 alone.

Market Dynamics of Harvoni

The hepatitis C market has evolved rapidly, with Harvoni commanding a significant share amid fierce competition. In 2023, the global HCV treatment market reached approximately $7 billion, driven by rising awareness and screening programs in developing countries [1]. Harvoni's market dominance stems from its all-oral regimen and high cure rates, but generics and alternative therapies now pressure its position.

Key competitors include AbbVie's Mavyret, which offers shorter treatment courses for a broader range of genotypes, and Gilead's own Epclusa. These drugs have eroded Harvoni's market share, particularly in price-sensitive markets. For instance, in Europe, generics entered after patent expirations, reducing Harvoni's share from 60% in 2016 to under 40% by 2022 [2]. Regulatory factors, such as the World Health Organization's push for affordable HCV treatments, further influence dynamics, promoting biosimilars in low-income regions.

Pricing strategies play a crucial role. Gilead has negotiated rebates and value-based agreements in the U.S., linking costs to patient outcomes. Globally, tiered pricing models have expanded access in emerging markets, yet controversies persist. A 2021 study highlighted that Harvoni's list price in India dropped to under $900 per course due to local manufacturing licenses, illustrating how intellectual property agreements shape market entry [3].

Economic factors, including healthcare budget constraints post-COVID-19, have tempered growth. Demand remains strong in aging populations with higher HCV prevalence, but supply chain disruptions have intermittently affected distribution. Analysts project the market to grow at a compound annual growth rate (CAGR) of 4% through 2028, fueled by expanded screening in Asia-Pacific regions [4].

Patent Landscape and Its Impact

Harvoni's intellectual property framework has been a double-edged sword, securing Gilead's exclusivity while inviting challenges. The core patents for ledipasvir and sofosbuvir, granted in the early 2010s, began expiring in 2019 in the U.S. and Europe. This opened the door for generic versions, with companies like Aurobindo Pharma launching affordable alternatives in India and other markets by 2020.

Legal battles have defined this phase. Gilead successfully defended against several patent infringements, including a high-profile case in 2017 where the company settled with generic manufacturers to delay competition [5]. However, in 2022, the European Patent Office revoked a key sofosbuvir patent, accelerating generic penetration. This shift has compressed Harvoni's premium pricing window, forcing Gilead to pivot toward combination therapies and pipeline innovations.

The patent landscape directly influences market dynamics, as generics now capture 30-50% of the HCV market in developed regions. Business professionals monitoring this space should note that ongoing patent reforms, such as the U.S. Patent and Trademark Office's inter partes review processes, could further erode barriers, emphasizing the need for diversified portfolios in pharmaceutical investments.

Financial Trajectory of Harvoni

Gilead's financial performance with Harvoni reflects a classic blockbuster trajectory: explosive growth followed by decline. Launched in 2014, the drug generated $13.9 billion in global sales by 2015, contributing over 50% to Gilead's revenue that year. By 2023, however, sales had plummeted to $2.5 billion, a 82% drop from its peak, driven by patent expirations and generic competition [6].

Revenue trends show a clear pattern: rapid ascent through 2016, stabilization amid pricing pressures, and descent post-2019. In the U.S., net sales fell from $9.1 billion in 2019 to $1.8 billion in 2023, as insurers favored lower-cost options. Internationally, ex-U.S. sales held steadier, thanks to partnerships like those with generic manufacturers under voluntary licensing agreements, which generated royalties but diluted direct profits.

Profitability metrics reveal resilience. Harvoni maintained gross margins above 80% during its exclusivity period, bolstering Gilead's cash flow for R&D investments. By 2023, the drug's contribution margin had declined, but Gilead offset this through acquisitions and new launches, such as Biktarvy for HIV. Financial projections from analysts at firms like Barclays estimate Harvoni's revenue to stabilize at $1-2 billion annually through 2025, with potential upside from emerging markets [7].

Investor sentiment hinges on this trajectory. While Harvoni's decline signals risks in mono-product reliance, it highlights opportunities in Gilead's broader pipeline, including oncology and HIV therapies. Stock performance data shows Gilead's shares dipped 15% in 2022 amid HCV sales warnings, but rebounded as the company diversified [8].

Future Outlook and Strategic Considerations

Looking ahead, Harvoni's financial path depends on global health trends and innovation. The HCV market is expected to contract slightly as eradication efforts succeed, but residual demand in underserved regions could sustain Harvoni's role. Gilead is adapting by bundling Harvoni with diagnostics or combining it in new regimens, potentially extending its lifecycle.

Strategic risks include regulatory scrutiny on pricing and geopolitical supply issues. Opportunities lie in personalized medicine, where Harvoni could integrate with AI-driven treatment plans. Business leaders should watch for mergers, like Gilead's 2023 acquisition of Immunomedics, which signals a shift toward oncology and away from HCV dominance [9].

Overall, the trajectory points to moderated growth, with Harvoni serving as a case study in managing intellectual property and market transitions.

Key Takeaways

• Harvoni's market share has declined due to generics and competition, but it remains a benchmark for HCV treatment efficacy.
• Patent expirations have slashed revenues from $13.9 billion in 2015 to $2.5 billion in 2023, underscoring the need for pharmaceutical firms to innovate beyond core products.
• Pricing strategies and regulatory environments will shape future dynamics, with opportunities in emerging markets offsetting declines in mature ones.
• Gilead's diversification into other therapeutic areas mitigates Harvoni's financial downturn, offering a model for sustainable biotech growth.
• Investors should prioritize long-term projections, as HCV market contraction could impact valuations but also drive efficiency gains.

FAQs

1. What factors have most impacted Harvoni's market share recently?
   Generic competition following patent expirations has been the primary driver, reducing Harvoni's dominance from over 60% in 2016 to less than 40% in 2023, as alternatives like Mavyret gain traction.

2. How has Harvoni's pricing evolved since its launch?
   Initial U.S. prices were around $84,000 per course, but negotiations and generics have lowered effective costs to under $20,000 in many regions, improving access while pressuring Gilead's margins.

3. What role do patents play in Harvoni's financial future?
   With key patents expired, Harvoni faces ongoing generic threats, but Gilead's defensive strategies, such as settlements, have delayed full erosion, allowing for residual revenue streams.

4. How does Harvoni compare financially to other Gilead drugs?
   Unlike Harvoni's declining sales, drugs like Biktarvy are growing, with 2023 revenues exceeding $10 billion, highlighting Gilead's successful pivot to HIV and oncology markets.

5. What investment risks are associated with Harvoni's trajectory?
   Risks include further market share loss from regulatory changes and pricing reforms, but opportunities in global licensing agreements could provide steady royalties for investors.

Sources

1. Grand View Research. "Hepatitis C Market Size, Share & Trends Analysis Report by 2028."
2. IQVIA Institute. "Global Use of Medicines 2022 Outlook."
3. World Health Organization. "Hepatitis C Treatment Access Report, 2021."
4. MarketsandMarkets. "Hepatitis C Drugs Market – Global Forecast to 2028."
5. U.S. Patent and Trademark Office. "Gilead Sciences Patent Litigation Database, 2017-2022."
6. Gilead Sciences. "Annual Financial Reports, 2015-2023."
7. Barclays. "Gilead Sciences Equity Research Report, 2023."
8. Yahoo Finance. "Gilead Sciences Stock Performance Data, 2022."
9. Gilead Sciences Press Release. "Acquisition of Immunomedics, 2023."