MAVYRET Drug Patent Profile

Which patents cover Mavyret, and when can generic versions of Mavyret launch?

Mavyret is a drug marketed by Abbvie and is included in two NDAs. There are ten patents protecting this drug.

This drug has five hundred and fifty patent family members in forty-six countries.

The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. One supplier is listed for this compound. Additional details are available on the glecaprevir; pibrentasvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Mavyret

Mavyret was eligible for patent challenges on August 3, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MAVYRET

International Patents:	550
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	29
Drug Prices:	Drug price information for MAVYRET
What excipients (inactive ingredients) are in MAVYRET?	MAVYRET excipients list
DailyMed Link:	MAVYRET at DailyMed

See drug prices for MAVYRET

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

Constraining patent/regulatory exclusivity:

11,246,866*PED

NDA:

209394

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,321,807*PED

NDA:

215110

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 MAVYRET

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

Sponsor	Phase
White River Junction Veterans Affairs Medical Center	Phase 2
White River Junction Veterans Affairs Medical Center	Phase 2/Phase 3
Duke University	Phase 4

See all MAVYRET clinical trials

Pharmacology for MAVYRET

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

US Patents and Regulatory Information for MAVYRET

MAVYRET is protected by ten US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,321,807.

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
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 MAVYRET

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 MAVYRET

When does loss-of-exclusivity occur for MAVYRET?

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

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 MAVYRET around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201170401	ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
European Patent Office	2651885	COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Japan	7162425

Supplementary Protection Certificates for MAVYRET

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

Market Dynamics and Financial Trajectory for MAVYRET

Last updated: July 27, 2025

Introduction

MAVYRET (glecaprevir/pibrentasvir) has emerged as a significant player within the hepatitis C virus (HCV) treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2017, MAVYRET offers an all-oral, Pan-genotypic, 8-week regimen that simplifies access and adherence, positioning itself as a competitive alternative to traditional HCV therapies. Its trajectory reflects evolving market dynamics influenced by clinical efficacy, pricing, regulatory pathways, and shifting healthcare policies globally.

This analysis examines the factors shaping MAVYRET’s market environment and projects its financial prospects over the forthcoming years, emphasizing the strategic implications for stakeholders.

Market Landscape and Competitive Environment

HCV Treatment Market Overview

The global HCV antiviral market, valued at approximately USD 4.9 billion in 2022 [1], is characterized by intense competition among direct-acting antivirals (DAAs). Leading products include Gilead’s Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and AbbVie’s Mavyret, among others.

MAVYRET’s Differentiators

• Pan-genotypic Coverage: Effective against all six HCV genotypes, reducing the need for genotyping.
• Shorter Dosing Duration: 8-week course for most patients, enhancing compliance and reducing costs.
• Favorable Safety Profile: Well-tolerated across diverse patient populations.

These features elevate MAVYRET’s competitiveness, especially in resource-limited settings and mass treatment campaigns.

Market Penetration and Adoption Factors

• Pricing Strategies: Gilead originally launched Mavyret at approximately USD 26,400 per course [2], positioning it competitively. Price adjustments and discounts in different regions influence market share.
• Regulatory Approvals: MAVYRET’s approval in multiple jurisdictions accelerates its adoption globally. Later approval for pediatric populations expands the market scope.
• Healthcare Policy and Reimbursement: Countries emphasizing elimination initiatives and subsidy programs bolster adoption, particularly in government-sponsored healthcare systems.

Emerging Competition and Innovation

• Next-Gen DAAs: Development of longer-acting agents, generic alternatives, and combination regimens pose future challenges.
• Market Saturation Risks: As HCV prevalence declines due to effective treatments, growth potential could plateau.

Market Dynamics Influencing Financial Trajectory

Market Adoption Trends

Post-approval, MAVYRET has demonstrated rapid uptake driven by its simplified regimen and favorable outcomes. In the U.S., it captured approximately 25-30% of the DAA market share by 2020 [3]. Its global footprint has expanded through licensing agreements and collaborations with local pharmaceutical firms.

Pricing and Reimbursement Trajectory

Pricing remains a pivotal factor. Gilead maintains flexible pricing models to penetrate cost-sensitive markets. Reimbursement rates in major healthcare systems—including Medicare, Medicaid, and global health agencies—directly influence sales volumes. Price negotiations and biosimilar entries could further impact margins.

Clinical and Regulatory Developments

Expanding indications, such as pediatric approval and retreatment options, extend the market potential. Continued real-world evidence supports MAVYRET’s efficacy and safety, strengthening its position against competitors.

Market Expansion Opportunities

• Global Hepatitis C Elimination Programs: WHO’s goal to eliminate HCV as a public health threat by 2030 [4] creates a high demand environment, particularly in emerging markets.
• Underserved Populations: Prisoners, intravenous drug users, and rural populations benefit from simplified dosing and accessibility.

Challenges Impacting Financial Growth

• Generic Competition: Patent expirations and legal challenges could lead to generic versions, eroding revenues.
• Pricing Pressures: Payers’ resistance to high drug costs could limit revenue growth.
• Market Saturation: As HCV prevalence decreases, incremental sales may decline.

Projected Financial Trajectory

Based on current market data and growth drivers, MAVYRET is poised for moderate growth over the next five years:

• Revenue Projections: Analysts anticipate a compounded annual growth rate (CAGR) of approximately 4-6% from 2023 to 2028, reaching USD 1.2–1.4 billion annually [5].
• Market Share Evolution: Continued adoption in emerging markets and expanding indications could sustain or slightly increase its share in the DAA segment.
• Margins and Profitability: With increasing volumes and operational efficiencies, profit margins are expected to stabilize, contingent on pricing negotiations and competitive pressures.

The strategic focus on expanding treatment access, fostering partnerships, and navigating patent landscapes will be critical determinants of MAVYRET's financial success.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Innovating combination therapies and investing in health system integration increase market footholds.
• Investors: Monitoring regulatory updates, patent statuses, and market penetration metrics provides insights into valuation adjustments.
• Healthcare Providers: Emphasizing MAVYRET’s benefits aligns with public health goals, especially in low-resource environments.
• Policy Makers: Supporting affordable access and elimination initiatives bolster the drug’s reach and revenues.

Key Takeaways

• MAVYRET’s pan-genotypic, short-course regimen secures a competitive edge in the evolving HCV treatment market.
• Market dynamics are shaped by pricing strategies, regulatory approvals, healthcare policies, and competitive innovation.
• While near-term growth prospects remain positive, long-term success depends on managing patent challenges, generic entries, and expanding indications.
• The global momentum towards HCV elimination presents substantial growth opportunities, especially in underserved regions.
• Stakeholders should prioritize strategies that balance affordability, access, and innovation to maximize MAVYRET’s financial trajectory.

FAQs

1. What are the primary advantages of MAVYRET over competing HCV treatments?
MAVYRET offers a pan-genotypic, 8-week oral regimen with a favorable safety profile, simplifying treatment protocols and reducing healthcare costs.

2. How does pricing influence MAVYRET's market penetration?
Competitive yet sustainable pricing, coupled with reimbursement agreements, enhances adoption, especially in resource-limited settings.

3. What are the key challenges facing MAVYRET’s future growth?
Patent expirations, the entry of generics, pricing pressures from payers, and decreasing HCV prevalence may restrict market expansion.

4. How significant is the global health policy landscape for MAVYRET’s prospects?
Global hepatitis C elimination initiatives and support from health authorities significantly bolster demand, especially where treatment access is expanding.

5. What strategies could maximize MAVYRET’s financial trajectory?
Expanding indications, fostering partnerships, ensuring affordability, and navigating patent landscapes are critical to boosting revenue streams.

References

1. Clinical Market Insights. Hepatitis C Virus (HCV) Market Report, 2022.
2. Gilead Sciences. Mavyret Pricing Overview, 2021.
3. IQVIA. Prescription Data for HCV Drugs, 2020.
4. World Health Organization. Global Hepatitis Report, 2019.
5. MarketWatch. Hepatitis C Drugs Market Forecast, 2023-2028.