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

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
Taiwan	201238948
European Patent Office	3020723
Luxembourg	C00038
Argentina	092505	COMPUESTOS ANTIVIRALES

Supplementary Protection Certificates for MAVYRET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2618831	SPC/GB17/057	United Kingdom		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/17/1213 (NI) 20170728; UK FURTHER MAS ON IPSUM 20170728
2618831	C02618831/01	Switzerland		PRODUCT NAME: GLECAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66472 22.09.2017
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2618831	CR 2017 00048	Denmark		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/17/1213 20170728

Market Dynamics and Financial Trajectory for MAVYRET

Last updated: February 19, 2026

What is MAVYRET’s Market Position?

MAVYRET, approved by the FDA in 2017, is a fixed-dose combination of glecaprevir and pibrentasvir, used to treat chronic hepatitis C virus (HCV) infection. It is marketed by AbbVie. MAVYRET holds a significant share of the hepatitis C treatment market due to its efficacy and shorter treatment duration.

How Does MAVYRET Fit within the Hepatitis C Market?

The hepatitis C market is highly competitive, with key pharmaceutical players like Gilead Sciences, Merck, and AbbVie.

• Gilead's Harvoni and Epclusa dominate historically, but MAVYRET has gained market share due to:
  • Shorter treatment course (8 weeks for many patients).
  • Broad genotypic coverage (1–6).
  • Favorable safety profile.

Market share estimates as of 2022 place MAVYRET among the top therapies, with approximately 20% of the global HCV treatment market, up from 10% pre-2019, signaling accelerated adoption.

How Has MAVYRET’s Revenue Evolved?

Table 1. MAVYRET Revenue (Million USD)

Year	Revenue (USD millions)	Growth Rate (%)
2018	300	N/A
2019	700	133
2020	1,200	71
2021	1,500	25
2022	1,680	12

Revenue growth reflects increased prescriber adoption driven by broader treatment indications, geographic expansion, and clinical guidelines endorsing MAVYRET’s use for certain patient populations.

What Are the Key Market Drivers?

• Clinical Advantages: High cure rates (>95%), minimal side effects, and fast treatment.
• Pricing Strategies: Competitive pricing, reimbursement, and inclusion in global healthcare programs.
• Regulatory Approvals: Expanded indications across countries, including Japan, Canada, and the EU.
• Global Disease Burden: An estimated 58 million people worldwide with chronic HCV infection as of 2020 (WHO).

What Challenges Affect MAVYRET’s Financial Outlook?

• Market Saturation: The U.S. and Europe are nearing saturation for HCV therapies.
• Pricing Pressures: Governments and payers negotiate discounts, affecting margins.
• Generic Competition: Biosimilars and generics emerge as patents expire, especially in emerging markets.
• Innovations: Future therapies focusing on shorter treatments, higher efficacy, and pan-genotypic coverage could displace MAVYRET.

How Does the Patent and Regulatory Landscape Impact Financials?

AbbVie holds patents extending into the mid-2020s, providing exclusivity for MAVYRET in major markets:

Patent Expiry Year	Market	Status
2025	U.S., EU	Patent protections, potential for generics post-expiry
2024	Japan	Expansion of patent protections

Patent expirations could lead to revenue erosion, especially in markets where biosimilars are accessible.

What Is the Forecasted Financial Trajectory?

Based on current data, MAVYRET revenue is expected to plateau around USD 1.8 billion by 2025, with potential declines thereafter due to:

• Patent expirations.
• Pricing pressures.
• Competition from new therapies.

However, in emerging markets, revenue may continue to grow as access improves.

How Will Market Trends Influence Future Sales?

• Continued adoption in underserved regions.
• Reimbursement policies favoring short-duration therapies.
• Linical innovations, such as ultra-rapid treatments, could underpin higher future revenues.

Summary of Key Financials and Market Factors

Factor	Impact
Patent Expiration	Potential revenue decline post-2025
Pricing and reimbursement policies	Ongoing influence on market share and margins
Competitive landscape	New entrants may reduce MAVYRET’s market dominance
New indications	Expansion into less-treated populations could sustain sales

Key Takeaways

• MAVYRET holds a strong position in the hepatitis C market due to clinical efficacy and treatment convenience.
• Revenue growth has slowed from the initial surge but remains stable through 2022, with U.S. and European saturation limiting upside.
• Patent protections provide exclusivity until around 2025; after that, generic competition is likely.
• Future growth depends on expansion into new geographic markets, price negotiations, and potential use for broader indications.
• The evolving pharmaceutical landscape presents both opportunities and risks, especially around biosimilar emergence.

FAQs

1. When will MAVYRET face generic competition?
Patents expire around 2025 in the U.S. and EU, opening pathways for biosimilar entrants.

2. How does MAVYRET compare to other HCV therapies?
It offers shorter treatment duration and broad genotypic coverage, with similar efficacy to competitors like Epclusa, often at a lower price point.

3. What are the primary markets for MAVYRET growth?
Emerging markets in Asia, Latin America, and Africa, where HCV prevalence is high and access to treatment remains limited.

4. How might future innovations impact MAVYRET’s market share?
Emerging therapies with even shorter treatment courses or pan-genotypic efficacy could displace MAVYRET if they receive approval and demonstrate superior performance.

5. What factors influence pricing strategies for MAVYRET?
Reimbursement negotiations, competition, patent status, and health authority policies across regions.

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References

1. World Health Organization. (2020). Hepatitis C. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
2. AbbVie Inc. (2017). MAVYRET (glecaprevir and pibrentasvir) approval and label information.
3. Bloomberg Intelligence. (2022). Hepatitis C market analysis.
4. U.S. Food and Drug Administration. (2017). MAVYRET approval notice.
5. European Medicines Agency. (2018). Summary of product characteristics for MAVYRET.