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-one patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir

International Patents:	551
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

Dosage:

TABLET;ORAL

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE1
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
AbbVie	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	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	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					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
San Marino	T201600100
Japan	2018529671	抗ウィルス性テトラヒドロフラン誘導体
New Zealand	738746
Colombia	2017013305

Supplementary Protection Certificates for glecaprevir; pibrentasvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2618831	300900	Netherlands		PRODUCT NAME: GLECAPREVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2368890	C20150016 00154	Estonia		PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
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	2017/045	Ireland		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Glecaprevir and Pibrentasvir

Product Overview

Glecaprevir and pibrentasvir form a fixed-dose combination marketed under the brand name Mavyret (known as Mavyret or Maviret outside the U.S.). Approved by the FDA in August 2017, the combination targets hepatitis C virus (HCV) genotypes 1-6. It offers an 8- or 12-week treatment course with high cure rates (>95%), minimal side effects, and no requirement for interferon or ribavirin.

Market Demand Drivers

Global HCV prevalence continues to decline due to increased screening, improved diagnostics, and the expanding availability of direct-acting antivirals (DAAs). The World Health Organization (WHO) estimates around 58 million people infected with HCV worldwide as of 2020, with annual new infections at approximately 1.5 million. Despite decline, the demand persists primarily in underserved regions lacking access to diagnosis and treatment.

Key drivers include:

• Regulatory approvals in emerging markets: Regulatory acceptance in countries like China, India, and Russia expands access.
• Pricing and reimbursement policies: Negotiated discounts and inclusion in national health programs influence adoption.
• Treatment guidelines: Recommendations from WHO, American Association for the Study of Liver Diseases (AASLD), and European Association for the Study of the Liver (EASL) favor pan-genotypic regimens like glecaprevir/pibrentasvir.

Competitive Landscape

Glecaprevir/pibrentasvir competes primarily with other pan-genotypic DAA options such as sofosbuvir/velpatasvir (Epclusa) and ledipasvir/sofosbuvir (Harvoni). It matches or exceeds efficacy benchmarks, with shorter treatment durations and fewer side effects.

Major competitors:

• Epclusa (sofosbuvir/velpatasvir): Approved in 2016; globally marketed.
• Vosevi (sofosbuvir/velpatasvir/voxilaprevir): Approved in 2017; used for retreatment.
• Harvoni (ledipasvir/sofosbuvir): First wave DAA, approved in 2014.

Patent and Licensing Status

Glecaprevir/pibrentasvir is protected by patents filed pre-2017, with exclusivity extending through 2030-2035 in major markets. Gilead Sciences holds the original patent rights, with licensing agreements in some jurisdictions allowing generic manufacturing. The absence of biosimilar competition in high-income markets sustains premium pricing.

Revenue and Market Penetration

Since launch, Gilead reports steady growth in sales, with revenues reaching approximately $2.3 billion in 2020 (Q2 report). The drug's market share in the DAA segment rose to nearly 15% globally in 2022, driven by expanding indications and commercial adoption.

In the U.S., reimbursement is through CMS and private insurers, with negotiated prices around $26,400 for a 12-week course. In emerging markets, prices can drop below $300 per treatment course through licensing agreements and generic sales.

Financial Trajectory

Projected revenues are influenced by:

• Market expansion: Inclusion in broad treatment guidelines and access programs.
• Patent expiry and generics: Entry of generic versions post-2030 could significantly impact revenue.
• Treatment demand: About 20-30 million patients remain untreated globally.

Gilead anticipates peak revenues of $3-4 billion annually for glecaprevir/pibrentasvir contingent on market penetration and global access expansion.

Regulatory and Policy Influences

Future growth depends on:

• Regulatory approvals for pediatric and re-treatment indications.
• Pricing negotiations in low-income countries.
• Integration into national hepatitis elimination strategies.

Key Challenges

• Price competition: Generics entering markets post-patent expiration could erode margins.
• Market saturation: In high-income countries, most eligible patients are treated or diagnosed.
• Disease eradication efforts: Slowing new infections reduces the treatment pool.

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Key Takeaways

• Glecaprevir/pibrentasvir is a cornerstone in HCV treatment, with strong efficacy and safety profiles.
• The drug faces competitive pressures but maintains advantage through pan-genotypic coverage and shorter regimens.
• Revenue depends on expanding access in emerging markets and managing patent protections.
• Patent expiration post-2030 offers potential for market share decline due to generics.
• Continued policy support and treatment guideline inclusion sustain its market presence.

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Frequently Asked Questions

1. What is the primary therapeutic advantage of glecaprevir/pibrentasvir?
Its shorter treatment course (8-12 weeks) and pan-genotypic activity improve patient adherence and expand use across diverse patient populations.

2. How does patent expiry impact future revenues?
Post-2030, generic manufacturers may produce lower-cost alternatives, potentially reducing Gilead’s market share and revenue.

3. What are the main barriers to global adoption?
High prices in some markets, limited healthcare infrastructure, and lack of widespread screening hinder adoption.

4. Are there ongoing clinical trials for new indications?
Yes, trials are investigating pediatric use, retreatment options, and patients with complex comorbidities.

5. How does competition affect the drug’s pricing strategy?
In high-income countries, negotiated prices and rebates help maintain margins, while in emerging markets, licensing facilitates affordable access.

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References

[1] Gilead Sciences Q2 Financial Report 2022.
[2] WHO Hepatitis C Fact Sheet 2021.
[3] U.S. FDA Drug Approvals: Glecaprevir/Pibrentasvir.
[4] European Medicines Agency (EMA) Approval Notes 2017.
[5] MarketResearch.com, Global HCV Treatment Market Analysis 2022.