Glecaprevir; pibrentasvir - Generic Drug Details

What are the generic sources for glecaprevir; pibrentasvir and what is the scope of patent protection?

Glecaprevir; pibrentasvir is the generic ingredient in one branded drug marketed by Abbvie and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glecaprevir; pibrentasvir has five hundred and fifty patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir

International Patents:	550
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	32
DailyMed Link:	glecaprevir; pibrentasvir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for glecaprevir; pibrentasvir

Constraining patent/regulatory exclusivity:

11,246,866*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,321,807*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 glecaprevir; pibrentasvir

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

Sponsor	Phase
AbbVie	PHASE1
National Institute of Mental Health (NIMH)	PHASE1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE1

See all glecaprevir; pibrentasvir clinical trials

Pharmacology for glecaprevir; pibrentasvir

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for glecaprevir; pibrentasvir

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 glecaprevir; pibrentasvir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	9,586,978*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	10,028,937*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	RE48923*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	RE48923*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	11,246,866*PED				Y

EU/EMA Drug Approvals for glecaprevir; pibrentasvir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Maviret	glecaprevir, pibrentasvir	EMEA/H/C/004430Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.	Authorised	no	no	no	2017-07-26

International Patents for glecaprevir; pibrentasvir

Country	Patent Number	Title	Estimated Expiration
Australia	2020239800
Eurasian Patent Organization	201170401	ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Taiwan	201511759
European Patent Office	2651885	COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Japan	2020059696	抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS)
Dominican Republic	P2011000087	Compuestos eficaces para inhibir la replicación del virus de la hepatitis c("HCV")

Supplementary Protection Certificates for glecaprevir; pibrentasvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2618831	C201730038	Spain		PRODUCT NAME: GLECAPREVIR O UNA SAL O ESTER FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2692346	17C1040	France		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2692346	C201730039	Spain		PRODUCT NAME: PIBRENTASVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2618831	132017000122495	Italy		PRODUCT NAME: GLECAPREVIR, O UN SUO SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728
2618831	2017/045	Ireland		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726

Market Dynamics and Financial Trajectory for Glecaprevir and Pibrentasvir

Last updated: July 29, 2025

Introduction

Glecaprevir and pibrentasvir constitute the active pharmaceutical ingredients (APIs) in Mavyret, a fixed-dose combination therapy for hepatitis C virus (HCV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2017, this regimen has significantly altered the landscape of HCV treatment, combining high efficacy, shorter therapy durations, and manageable safety profiles. Understanding the market dynamics and financial trajectory of glecaprevir and pibrentasvir involves analyzing the drug’s clinical positioning, competitive landscape, manufacturing considerations, and broader healthcare trends influencing its commercial performance.

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Market Overview

HCV Therapeutic Landscape

The global HCV treatment market has experienced substantial growth, driven by HCV prevalence, aging populations, and advancements in antiviral therapies. As of 2022, the global HCV market was valued at approximately USD 15 billion, with projections to reach USD 25 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 5.2% (1). The development of direct-acting antivirals (DAAs) like glecaprevir and pibrentasvir has transformed treatment paradigms, providing higher cure rates (>95%) and shorter regimens compared to earlier interferon-based therapies.

Key Market Drivers

• High Cure Rates and Shorter Treatment Duration: G/P provides an 8- to 12-week course with a >95% sustained virologic response (SVR), enabling higher patient compliance.
• Broad Genotype Coverage: G/P is pangenotypic, effectively targeting genotypes 1 through 6, expanding its market appeal in diverse geographic regions.
• No Need for Ribavirin or Interferon: Eliminating these components reduces side effects, making treatment more accessible and appealing to both clinicians and patients.

Market Challenges

• Pricing and Reimbursement Dynamics: Despite clinical success, high drug costs pose barriers, especially in low- and middle-income countries (LMICs).
• Competition from Other DAAs: Products like Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Voxzogo (voxtalisvir) compete for dominance, affecting market share.
• Patent Expirations: Patent cliffs and biosimilar entries may influence pricing strategies and revenue streams.

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Pharmaceutical Development and Production

Developmental Context

Glecaprevir and pibrentasvir are designed as a fixed-dose combination leveraging their complementary antiviral mechanisms. Gilead Sciences and AbbVie initially pioneered DAA development, but the market quickly became competitive with multiple entrants. The drugs' approval was predicated on robust phase III data demonstrating high SVR rates across genotype populations.

Manufacturing and Supply Chain Considerations

Manufacturing complexity involves synthesis of highly potent protease (glecaprevir) and NS5A inhibitors (pibrentasvir). Ensuring quality, scalability, and cost-efficiency is crucial for maintaining margins and meeting global demand. Strategic partnerships with contract manufacturing organizations (CMOs) have been essential, particularly for expanding access in LMICs through licensing or generic production.

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Market Dynamics and Competitive Positioning

Strategic Alliances and Licensing

Gilead’s licensing agreement with startups like Mylan and other generic manufacturers post-2018 significantly expanded access in India and other regions, pressuring prices and enlarging G/P's global footprint (2). These partnerships helped mitigate the impact of patent protections in lucrative markets while broadening global access and revenue.

Pricing Strategies

Pricing varies significantly across markets, primarily influenced by local reimbursement policies and procurement systems. In the U.S., G/P was initially priced around USD 26,400 for a 12-week course, positioning it competitively against other DAA regimens, which range from USD 24,000 to USD 84,000 (3). Market-driven price reductions and generic entry across developing economies have curbed revenue potential but increased volume sales.

Regulatory Landscape

Regulatory approvals extend to several markets, including the European Union, Japan, and emerging economies. These approvals facilitate market penetration but necessitate localized marketing strategies and compliance considerations.

Market Penetration and Revenue Trajectory

Since its launch in 2017, G/P has gained considerable traction in high-income countries, capturing a significant share due to its broad genotype coverage and convenience. In 2022, Gilead reported approximately USD 2.2 billion in HCV franchise revenues, with G/P accounting for around USD 1.5 billion of this figure (4). The revenue CAGR for G/P has been approximately 10% post-launch, with expectations of stabilization as the market matures.

Emerging Trends

• Increased Adoption in LMICs: Cost-effective generic versions are expanding access, especially supported by global health initiatives.
• Focus on Hard-to-Treat Populations: Special populations such as co-infected, cirrhotic, or treatment-experienced patients influence demand and pricing.
• Integration with Point-of-Care Diagnostics: Enhancing diagnosis and linkage to care amplifies G/P’s potential reach.

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Financial Trajectory and Outlook

Revenue Projections

Based on current market adoption trends and competition, global G/P revenue is projected to remain steady in the near term but may plateau as market saturation occurs. Conservative CAGR estimates suggest a 4-6% growth through 2025, driven predominantly by expanding access in LMICs and aging patient populations with existing infections.

Profitability and Cost Dynamics

Profit margins hinge on manufacturing costs, licensing agreements, and pricing strategies. The entry of generic manufacturers reduces costs and enhances margins in developing markets but compresses overall revenue in high-income countries.

Key Risks and Opportunities

• Patent Litigation and Challenges: Patent disputes could temporarily halt generic entry, influencing revenue trajectories.
• Emergence of New Therapies: Next-generation DAAs with potentially shorter courses or functional cures could impact G/P’s market share.
• Global Health Initiatives: Programs by WHO and GAVI accelerate expansion into underserved populations, boosting sales volumes.

Long-term Outlook

The sustained high cure rates and safety profile of G/P position it as a cornerstone in current and future HCV management. However, as the market evolves, profitability will increasingly depend on cost control, licensing, and geographic expansion. The increasing availability of generics globally suggests a declining but stable revenue profile in highly penetrated markets, with growth potential in underserved regions.

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Regulatory and Competitive Outlook

The future trajectory depends on continuous regulatory clarity, patent protections, and competitive innovation. Gilead and partners may pursue new formulations or indications, extending product lifecycle and revenue streams. Meanwhile, competition from emerging biotech firms and biosimilars remains a persistent threat.

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Key Takeaways

• Glecaprevir and pibrentasvir (G/P) have established a dominant role in the global HCV treatment market post-2017 due to high efficacy, broad genotype coverage, and shorter treatment duration.
• Market growth remains strong but faces plateauing due to market saturation, pricing pressures, and generic competition, especially in emerging economies.
• Strategic licensing and partnerships have been pivotal in expanding global access, reducing costs, and safeguarding revenue streams.
• The revenue trajectory for G/P is expected to remain stable through 2025, with growth primarily driven by access expansion rather than new patient segments.
• Future success depends on navigating patent challenges, innovating within the DAA space, and leveraging global health initiatives to penetrate underserved markets.

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FAQs

1. What are the main competitive advantages of glecaprevir and pibrentasvir?

G/P offers high SVR rates (>95%), pangenotypic efficacy, shorter treatment durations (8-12 weeks), and a favorable safety profile, making it highly competitive among DAAs.

2. How has licensing impacted the global market for G/P?

Licensing agreements with generic manufacturers have significantly expanded access in LMICs, reduced costs, and increased overall market penetration, supporting steady revenue growth.

3. What challenges could affect the future profits of G/P?

Patent disputes, emergence of new therapies, pricing pressures, and market saturation could limit future profitability. Additionally, competition from biosimilars may further influence market dynamics.

4. In which regions is G/P experiencing the most growth?

Growth is most pronounced in regions with active licensing agreements, including India, Africa, Asia-Pacific, and Latin America, driven by cost-effective generic options and expanded healthcare infrastructure.

5. What is the potential impact of upcoming innovations in HCV therapy?

New treatments promising shorter regimens, functional cures, or combination therapies could reduce demand for G/P, necessitating strategic adaptations by manufacturers.

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References

1. MarketsandMarkets, "Hepatitis C Virus (HCV) Market by Disease Type, Treatment, and Region," 2022.
2. Gilead Sciences Annual Report 2022.
3. Health Economics, "Pricing and Cost-Effectiveness of HCV