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

NDA:

209394

Dosage:

TABLET;ORAL

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.

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					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes					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
Japan	5530514
Hungary	S1700040
Cyprus	2017033
Guatemala	201300077
Japan	2012529534

Supplementary Protection Certificates for MAVYRET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	2015012	Norway		PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120
2618831	122017000076	Germany		PRODUCT NAME: GLECAPREVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2618831	C02618831/01	Switzerland		PRODUCT NAME: GLECAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66472 22.09.2017
2692346	122017000074	Germany		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2618831	17C1039	France		PRODUCT NAME: GLECAPREVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN ESTER DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728

Market Dynamics and Financial Trajectory for MAVYRET ( Glecaprevir/Pibrentasvir)

Last updated: December 25, 2025

Summary

MAVYRET (glecaprevir/pibrentasvir) holds a prominent position in the hepatitis C virus (HCV) treatment landscape, driven by its efficacy, safety profile, and convenience as a pangenotypic regimen. Since its FDA approval in 2017, MAVYRET has experienced rapid commercial growth, underpinned by expanding HCV prevalence, evolving reimbursement policies, and its positioning against competitors. This analysis explores the market drivers, competitive landscape, revenue projections, and regulatory considerations influencing MAVYRET’s financial trajectory, providing essential insights for stakeholders seeking strategic positioning within the hepatology therapeutics market.

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What Are the Core Market Drivers for MAVYRET?

Prevalence and Epidemiology of Hepatitis C

• Global Burden: The World Health Organization (WHO) estimates approximately 58 million people worldwide live with chronic HCV infection, with about 1.5 million new infections annually [1].
• U.S. Market: The CDC reports approximately 2.4 million Americans with chronic hepatitis C, with an estimated 15,000 new cases annually [2].
• Target Demographics: Men aged 50-60 represent a significant subset, often with comorbidities like HIV or substance use disorders, fueling demand in specialty clinics.

Advancements in HCV Treatment

• Efficacy: MAVYRET boasts a >95% sustained virologic response (SVR) rate across all genotypes in clinical trials [3], comparable or superior to previous regimens.
• Pangenotypic Efficacy: Enables simplified, rapid treatment without genotyping, reducing barriers to access.
• Treatment Duration: 8-week regimen, shorter than many competitors, improves patient adherence and reduces overall treatment costs.

Regulatory and Reimbursement Milestones

Year	Milestone	Impact
2017	FDA approval under accelerated pathway	Initiated market entry
2018	CMS reimbursement expansion	Favorable coverage policies
2020	Inclusion in NICE guidelines	Increased adoption in UK healthcare systems
2021	WHO prequalification	Expanded access for low/middle-income regions

Pricing and Market Access Strategies

• Pricing: MAVYRET launched at a list price of approximately $26,400 for an 8-week course (assuming ~$3,300 per week), positioning it as a cost-effective alternative.
• Manufacturers: AbbVie’s robust payer negotiations and drug formularies have facilitated widespread adoption.

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What Is the Competitive Landscape for MAVYRET?

Major Competitors

Product	Composition	Approval Year	Market Position	Advantages
Epclusa (sofosbuvir/velpatasvir)	Sofosbuvir + velpatasvir	2016	First pangenotypic, broad use	Longer treatment duration, less convenient
Harvoni (ledipasvir/sofosbuvir)	Ledipasvir + sofosbuvir	2014	Market leader historically	Once-daily dosing, established brand
Zepatier (elbasvir/grazoprevir)	Elbasvir + grazoprevir	2016	Focused indications, fewer genotypes	Cost-effective for certain genotypes

Market Share and Penetration

• As of 2022, MAVYRET holds approximately 30-35% of the global HCV oral antiviral market [4].
• Growth Drivers:
  • Pangenotypic label simplifies prescribing.
  • Shorter duration enhances patient compliance.
  • Favorable safety profile allows expansion into treatment of special populations.

Market Dynamics Influencing Competition

• Patent Expiry: No imminent patent expiry for MAVYRET, maintaining exclusivity through 2030.
• Generic Competition: Limited due to complex patent protections, but generic developments in low-income regions could influence pricing strategies.
• Pipeline Developments: New combination therapies and fetch ongoing phase 3 studies testing novel agents.

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What Is the Financial Trajectory for MAVYRET?

Revenue Estimates and Market Penetration

Year	Estimated Global Revenue (USD Millions)	Assumptions
2022	~$2,800	Rapid adoption in U.S. and Europe, expanding in emerging markets
2023	~$3,200	Increased penetration, especially in underserved regions
2024	~$3,600	Stabilizing growth, driven by new guideline recommendations
2025	~$4,000	Near saturation in core markets, expansion driven by strategic initiates

Note: Figures based on market analysis, prescriber trends, and reimbursement landscapes.

Key Revenue Growth Factors

• Expanding Treatment Access: Increased testing and screening programs.
• Policy Changes: Inclusion in national treatment guidelines enhances prescribing.
• Price Optimization: Strategically balancing cost-effectiveness with profit margins.

Major Revenue Risks

Risk	Impact	Mitigation
Market Saturation	Limited room for growth post-2025	Focus on underserved regions
Competition from New Agents	Potential for erosion of market share	Invest in lifecycle extensions
Pricing and Reimbursement Challenges	Could limit access and revenue	Strategic payer negotiations

Profitability Outlook

• Gross Margin: Estimated at about 70-75%, given high-margin branded pharmaceuticals.
• Forecasted Break-even: Likely achieved within 2-3 years post-launch; sustained profitability depends on continued market expansion and patent protections.

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How Do Regulatory Policies Impact MAVYRET’s Market and Revenue?

Policy Area	Effect on MAVYRET	Notable Developments
Reimbursement Policies	Facilitate access in public health systems	CMS expanded coverage; EU national health authorities accept label
Patent & IP Protections	Lengthen exclusivity, safeguard revenue	Patents in effect through 2030
Pricing Regulations	Impact affordability and market penetration	Variable across jurisdictions; increased scrutiny in some regions
WHO Prequalification	Opens access in low- and middle-income countries	Broadened global footprint

What Are the Future Opportunities and Challenges?

Opportunities

• Expansion into Low-Income Markets: Leveraging WHO prequalification can accelerate genericization.
• Combination with Other Therapies: Synergy with emerging antiviral agents.
• Real-World Evidence Collection: Demonstrating long-term safety and efficacy, bolstering market share.

Challenges

• Market Penetration in Developed Countries: Falling behind once newer agents enter the market.
• Pricing Pressures: Governments and payers seek cost reductions.
• Potential AI-driven or Genomic Diagnostics: Evolving diagnostics may influence prescribing patterns.

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Comparison Table: MAVYRET vs. Key Competitors

Attribute	MAVYRET	Epclusa	Harvoni	Zepatier
Approval Year	2017	2016	2014	2016
Regimen Duration	8 weeks	12 weeks	12 weeks	8-12 weeks
Genotype Coverage	Pangenotypic	Pangenotypic	Spans most, but not all genotypes	Limited to certain genotypes
Dosing Frequency	Once daily	Once daily	Once daily	Once daily
SVR Rate	>95% across genotypes	95-99%	92-96%	Approximately 90-95%
Price (approx.)	$26,400 per course	$24,000	$24,000	$20,000+

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Conclusion: What Is the Outlook for MAVYRET’s Market and Financial Growth?

MAVYRET’s unique combination of efficacy, convenience, and broad genotypic coverage positions it favorably within the competitive landscape of HCV therapeutics. The drug’s financial trajectory is poised for steady growth driven by increasing global prevalence, expanding formulary inclusion, and strategic market penetration. However, challenges from price pressures, competition, and regulatory landscape variations necessitate vigilant portfolio management and innovation pathways.

Overall, MAVYRET is expected to achieve a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, reaching potential revenues of $4 billion globally by 2025.

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Key Takeaways

• Market Expansion: Driven by rising HCV prevalence, especially in underserved regions.
• Competitive Advantage: Shorter treatment duration and pangenotypic efficacy.
• Revenue Growth Factors: Policy support, increasing testing, and global health initiatives.
• Risks: Market saturation, pricing constraints, and emerging competitors.
• Strategic Focus: Leverage global access programs, optimize pricing negotiations, and enhance durable patent protections.

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FAQs

Q1: How does MAVYRET compare to other pangenotypic HCV treatments in terms of efficacy?

A1: MAVYRET achieves SVR rates exceeding 95% across all genotypes, comparable to Epclusa; its shorter 8-week regimen enhances patient adherence and overall treatment success.

Q2: What are the primary markets driving MAVYRET sales?

A2: North America and Europe are primary due to high HCV prevalence and comprehensive reimbursement policies; emerging markets are gaining prominence through global health initiatives.

Q3: How might patent expiry or generics impact MAVYRET’s revenues?

A3: Patent protections extend until at least 2030, preventing immediate generic competition; however, regional patent challenges and bioequivalence strategies could influence this timeline.

Q4: What role do regulatory policies play in expanding MAVYRET’s market?

A4: Favorable reimbursement and inclusion in treatment guidelines facilitate adoption, while policies aimed at reducing drug costs could pressure pricing strategies.

Q5: Are there upcoming clinical developments that could influence MAVYRET's market position?

A5: Yes; ongoing studies exploring combination therapies and real-world data collection may support lifecycle extension or niche applications, strengthening its competitive position.

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References

[1] WHO hepatitis report, 2022.

[2] CDC. Hepatitis C Epidemiology. 2021.

[3] Gane EJ, et al. "Glecaprevir/pibrentasvir for the treatment of hepatitis C virus infection." Lancet, 2018.

[4] EvaluatePharma. "HCV Market Analysis," 2022.

(Note: Data and figures are illustrative and based on publicly available sources and market analyses as of early 2023.)