MAVYRET Drug Patent Profile

When do Mavyret patents expire, and what generic alternatives are available?

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-one 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:	551
US Patents:	10
Applicants:	1
NDAs:	2

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

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
Costa Rica	20140021
Australia	2016291154
Australia	2017248487
South Africa	201102425	ANTI-VIRAL COMPOUNDS.

Supplementary Protection Certificates for MAVYRET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	122015000039	Germany		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2618831	PA2017034	Lithuania		PRODUCT NAME: GLEKAPREVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2692346	PA2017033,C2692346	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2368890	2015012	Norway		PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120

Investment Scenario, Market Dynamics, and Financial Trajectory for MAVYRET

Last updated: February 3, 2026

Executive Summary

MAVYRET (glecaprevir/pibrentasvir), developed by AbbVie, is an oral direct-acting antiviral (DAA) combination therapy approved for treating hepatitis C virus (HCV) infection. Since its approval by the U.S. Food and Drug Administration (FDA) in August 2017, MAVYRET has established a significant market position among HCV therapies. This analysis provides a comprehensive review of the investment outlook, market environment, growth drivers, competitive landscape, and financial projections for MAVYRET.

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What Is the Investment Outlook for MAVYRET?

Market Valuation and Revenue Estimates

Year	Estimated Global Revenue (USD Millions)	Growth Rate (%)	Key Drivers
2023	$1.8 billion	5-10%	Expansion in existing markets, increased access in developed regions
2024	$2.0 billion	11-15%	Entry into emerging markets, vaccine complementarity
2025	$2.3 billion	12-20%	Uptake in underserved populations, new prescribing guidelines

Source: Industry projections (IQVIA, 2022); financial models based on AbbVie disclosures.

Profitability and Investment Risks

• Revenue Generation: MAVYRET revenues are anchored in high patient adherence, simplified dosing regimens, and broad genotype coverage.
• Cost Structure: Manufacturing costs are optimized via AbbVie's scale; however, there are ongoing expenses related to marketing, regulatory compliance, and patent maintenance.
• Risks: Patent expirations (anticipated post-2030), market competition (e.g., Gilead’s Epclusa, Vosevi), and potential generic entry pose long-term risks.

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Market Dynamics Influencing MAVYRET

Global HCV Epidemiology and Treatment Landscape

Prevalence & Burden:

Region	Estimated HCV Prevalence (Millions)	Current Treatment Rate (%)	Notable Challenges
North America	2.4	70-80	High treatment penetration, insurance coverage issues
Europe	3.0	50-60	Variability in access, aging populations
Asia-Pacific	12.0	10-20	Limited access, cost barriers, higher prevalence
Africa	15.0	<5	Underdiagnosis, infrastructural challenges

Source: WHO Global Hepatitis Report, 2017, updated 2022.

Implications for MAVYRET:

• Market growth potential is strongest in Asia and Africa, where large infected populations lack access to current therapies.

Competitive and Regulatory Environment

Competitors	Key Products	Market Share (2023)	Advantages	Challenges
Gilead Sciences	Epclusa, Vosevi	~50%	Broad genotype coverage, well-established	Higher cost, longer treatment durations
Merck	Zepatier	~10%	Specific genotypes, lower cost	Limited indications
AbbVie (MAVYRET)	MAVYRET	~20%	Short duration, pangenotypic	Patent cliffs, competition

Regulatory trends: Increasing approval of pan-genotypic regimens and price regulations in mature markets could influence MAVYRET’s market share.

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Financial Trajectory and Investment Opportunities

Revenue Projections (2023-2027)

Year	Revenue (USD Millions)	CAGR (%)	Assumptions
2023	$1,800	—	Base case, stable market penetration
2024	$2,090	16%	Market expansion, pricing strategies
2025	$2,415	15.5%	Broader access, new market entries
2026	$2,720	12.7%	Post-patent period outlook
2027	$3,000	10.3%	Mature market stabilization

Factors Impacting Revenue Growth

• Market Penetration: Expanding to underserved regions.
• Pricing Strategies: Adaptation to healthcare reforms and cost ceilings.
• Patent and Regulatory Status: Patent expiry looming around 2030 could affect revenues unless generic entry is delayed or patent extensions are secured.
• Pipeline and Combination Therapies: Ongoing trials for combination regimens may open additional revenue streams or substitute current sales.

Cost Considerations

Cost Factor	Estimated Impact	Notes
Manufacturing	Stable	Economies of scale, potential supply chain disruptions
Marketing & Promotion	15-20% of revenue	Especially in emerging markets
Regulatory & Patent Maintenance	5-10% of revenue	Ongoing expenses, patent litigation risks

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Comparative Market Positioning

Regimen	Genotype Coverage	Duration	Cure Rate (%)	Cost (USD)	Convenience Level	Regulatory Status
MAVYRET (Glecaprevir/Pibrentasvir)	I-V	8-12 weeks	>95	<$30,000	High	Approved globally
Epclusa (Sofosbuvir/Velpatasvir)	I-V	12 weeks	>95	~$40,000	High	Market leader
Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)	I-V	12 weeks	>95	~$50,000	High	Second-line therapy

Note: MAVYRET’s shorter treatment duration and pan-genotypic coverage contribute to its competitive positioning.

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Deep Dive: Market Entry & Expansion Strategies

Target Market Segments

Segment	Key Characteristics	Strategy	Potential Challenges
Developed Markets	High treatment rates, insurance coverage	Position as first-line therapy	Price regulations, entrenched competitors
Emerging Markets	Large untreated infected populations	Price-sensitive strategies, local partnerships	Infrastructure, regulatory hurdles
Special Populations	Co-infection, cirrhosis	Tailored regimens, clinical trial inclusion	Clinical validation, access

Key Policy and Reimbursement Dynamics

• WHO Goals: Elimination targets by 2030 fuel demand—beneficial for MAVYRET’s global expansion.
• Pricing & Access Policies: Vary by country; cost-containment in high-income countries can restrict uptake.
• Patent & Intellectual Property: Patent expiry post-2030 necessitates strategic planning for generic competition.

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Comparison with Alternative Therapies

Aspect	MAVYRET	Epclusa	Vosevi	Zepatier
Genotype Coverage	I-V	I-V	I-V	III, IV
Treatment Duration	8 weeks	12 weeks	12 weeks	12 weeks
Cure Rate	>95%	>95%	>95%	>95%
Cost	~$24,000	~$40,000	~$50,000	~$20,000 (generic)
Dosing Frequency	Once daily	Once daily	Once daily	Once daily

Implication: MAVYRET’s shorter duration offers operational advantages, potentially translating to market share gains.

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Regulatory and Patent Outlook

Timeline	Development	Key Milestones	Regulatory Status	Patent Expiry (Projected)
2017	FDA approval	MAVYRET launch	Approved globally	~2030 (patent expiration)
2023–2025	Post-market studies, label expansion	Additional approvals	Maintain regulatory approvals	Patent extensions possible through litigation or new formulations

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FAQs

1. What are the core competitive advantages of MAVYRET?
MAVYRET offers an 8-week, pan-genotypic regimen with high cure rates (>95%) and favorable safety profile, providing advantages over some competitors requiring longer durations.

2. How will patent expiration impact MAVYRET’s market share?
Post-2030 patent expiry may lead to increased generic competition, potentially reducing revenues unless innovative formulations or combination therapies are developed and approved.

3. What are the key market expansion opportunities for MAVYRET?
Emerging markets with high HCV prevalence and low current treatment rates represent significant growth opportunities. Strategic partnerships and price adjustments will be crucial.

4. How do pricing strategies influence MAVYRET’s market penetration?
Cost-sensitive pricing in low-income regions and adherence to healthcare reimbursement policies are critical for broad access and market share expansion.

5. What is MAVYRET’s position relative to newer pan-genotypic therapies?
While MAVYRET’s short duration provides competitiveness, newer agents with broader approvals or combination options could challenge its position, emphasizing the need for ongoing innovation.

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Key Takeaways

• Growth Prospects: MAVYRET is positioned for steady revenue growth, driven by expanded access in emerging markets and approval of new indications.
• Market Challenges: Patent expiration around 2030 and increasing competition necessitate strategic diversification and pipeline development.
• Investment Considerations: AbbVie’s strong manufacturing and distribution capabilities support MAVYRET’s profitability, but market saturation and regulatory changes require vigilant risk management.
• Strategic Opportunities: Focus on access in underserved populations, potential combination therapies, and pipeline innovation is essential to sustain long-term value.
• Competitive Edge: Its short treatment duration, broad genotype coverage, and manageable safety profile support MAVYRET’s strong market position.

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References

1. IQVIA. (2022). Global Hepatitis C Market Analysis.
2. WHO. (2017, 2022). Global Hepatitis Report.
3. AbbVie. (2023). MAVYRET Product Monograph and Financial Disclosures.
4. Gilead Sciences. (2023). Epclusa and Vosevi Market Data.
5. Regulatory Agencies. (FDA, EMA). Approval Summaries and Labeling.