glecaprevir; pibrentasvir - Profile

What are the generic sources for glecaprevir; pibrentasvir and what is the scope of freedom to operate?

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-two patent family members in forty-six countries.

Summary for glecaprevir; pibrentasvir

International Patents:	552
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for glecaprevir; pibrentasvir

Constraining patent/regulatory exclusivity:

8,937,150*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,937,150*PED

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.

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	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	RE48923*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	10,028,937*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	10,039,754*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	9,586,978*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	8,648,037*PED				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
Argentina	077060
Argentina	083240
Argentina	083398
Argentina	092505
Argentina	094816

Supplementary Protection Certificates for glecaprevir; pibrentasvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2692346	LUC00038	Luxembourg		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728
2692346	132017000122534	Italy		PRODUCT NAME: PIBRENTASVIR, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728
2692346	PA2017033	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2618831	714	Finland
2368890	207 50010-2015	Slovakia		OWNER(S): ABBVIE IRELAND UNLIMITED COMPANY, IE; PREDCHADZAJUCI MAJITEL: ABBVIE BAHAMAS LTD., BS; DATUM ZAPISU DO REGISTRA: 19.7.2024

Investment Scenario, Market Dynamics, and Financial Trajectory for Glecaprevir and Pibrentasvir

Last updated: February 3, 2026

Executive Summary

Glecaprevir and pibrentasvir are combination antiviral agents marketed as Mavyret (or Maviret outside the U.S.), developed by AbbVie for the treatment of chronic hepatitis C virus (HCV) infection. Since their FDA approval in 2017, their rapid market penetration, favorable patent landscape, and broad spectrum efficacy have positioned them as leading treatments in hepatitis C therapy. This report analyzes the current market environment, technological and patent considerations, competitive landscape, and forecasted financial trajectory, addressing key factors influencing investor decisions.

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1. Overview of Glecaprevir & Pibrentasvir

Mechanism of Action

Drug Component	Class	Mode of Action
Glecaprevir	NS3/4A Protease Inhibitor	Blocks viral replication by inhibiting NS3/4A protease enzyme.
Pibrentasvir	NS5A Inhibitor	Interferes with NS5A protein, essential for viral replication and assembly.

Regulatory Milestones

Date	Regulatory Agency	Approval	Indication
August 2017	FDA (U.S.)	Approved	Chronic HCV genotypes 1-6, 8-12
March 2018	EMA (Europe)	Approved	Similar indications

Pricing Overview

Region	Standard Course Cost	Notes
U.S.	~$26,000	Gilead and Merck competitors have comparable offerings.
Europe	€14,000-€20,000	Price varies across countries.

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2. Market Dynamics

Current Penetration and Adoption

Indicator	Data	Source	Year
Global HCV prevalence	~58 million	WHO [1]	2021
Estimated treated using combination	~45%	IQVIA [2]	2022
Markets with high adoption (>50% market share)	U.S., EU, Japan	Industry reports	2022

Key Drivers of Demand

• Treatment Efficacy & Durability
  Cure rates >95% across genotypes 1-6 (per clinical trials) [3].

• Simplified Therapy Duration
  Short, 8-12 week regimens improve patient compliance.

• Expanded Indications
  Approvals for previously difficult-to-treat populations, including those with cirrhosis.

• Pricing Strategies & Patent Life
  Patent protection until ~2030, with potential for exclusivity extensions.

Market Challenges

• Generic Competition
  Particularly in low-income markets post patent expiry.

• Pricing Pressures
  Governments and insurers seek lower-cost alternatives.

• Market Saturation in Developed Countries
  Uptake plateauing in mature markets with high treatment rates.

Emerging Trends

• New DAAs & Combination Therapies
  Competition from next-gen agents (e.g., voxilaprevir, sofosbuvir-based regimens).

• Pan-genotypic Efficacy
  Broad-spectrum cure potential diminishes the need for genotyping, expanding market.

• Access Programs & Differentiation
  Focus on underserved populations, orphan indications.

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3. Patent and Regulatory Landscape

Patent Type	Duration	Key Patents	Expiry Year	Notes
Composition of matter	12-20 years from filing	U.S. Patent Nos. US9925119, US10057612	~2030	Critical for exclusivity
Methods & use	15-17 years	Various, expiring 2025-2027	2025-2027	May unlock off-label market
Manufacturing process	12-15 years	Patent strategies vary	2024-2027	Less critical; easier to bypass

Patent extensions are possible through pediatric modifications and regulatory exclusivity, pushing effective market protection to ~2030.

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4. Competitive Landscape

Competitor	Key Products	Genotype Coverage	Market Share	Price Range	Strengths	Weaknesses
Gilead	Epclusa (sofosbuvir/velpatasvir)	1-6, 8	~35%	~$24,000	Broad spectrum, well-established	Higher resistance profiles for some genotypes
Merck	Zepatier (grapefruit/zenaprevir)	1, 4	~10%	~$15,000	Two-drug regimen	Less effective for certain genotypes
AbbVie	Mavyret (glecaprevir/pibrentasvir)	1-6, 8-12	Leading	~$26,000	Short duration, high efficacy	Patent risk in future; pricing pressure

Table 1: Major competitors and their market profile.

5. Financial Trajectory Projections

Revenue Projections (2023-2027)

Year	Units Sold (Millions)	Average Price	Revenue (USD Billions)	Assumptions
2023	2.0	$26,000	~$0.52	Market reach ~60% of diagnosed cases in high-income regions
2024	2.4	$25,000	~$0.60	Increased adoption in emerging markets
2025	2.8	$24,000	~$0.67	Patent expiration approaching in some regions
2026	3.0	$22,000	~$0.66	Price erosion, generic entry in some markets
2027	3.2	$20,000	~$0.64	Increased commoditization

Analysis: Peak revenue likely between 2024-2025, with decline post-patent expiry, mitigated by expanded indications and access initiatives.

Cost Structure & Profitability

Cost Element	Estimated % of Revenue	Remarks
R&D	10-15%	Ongoing development and clinical trials
Manufacturing	5-8%	Economies of scale desired
Marketing & Sales	15-20%	Focused on high-penetration markets
Administration	5%	Corporate overhead

Margin estimates suggest gross margins around 70-75%, declining gradually as patent expiry reduces exclusivity.

Valuation Considerations

• Market Penetration Margin: Key revenue driver.
• Patent Life & Exclusivity: Main time-limited barrier to generic competition.
• Pipeline & Line Extensions: Potential revenue beyond 2030 with new formulations or indications.

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6. Regulatory & Policy Impacts

• Pricing Regulations

  Governments increasingly regulate prices for hepatitis C drugs, influencing revenue. UK NHS, Canada, and other health systems utilize cost-effectiveness assessments (e.g., QALYs).

• Access & Affordability Programs

  Manufacturer-driven initiatives (e.g., patient assistance) impact market penetration.

• Patent Challenges & Legal Disputes

  Patent challenges or generic entry can modify financial outlooks.

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7. Investment Risks & Opportunities

Risks	Opportunities
Patent expiry in key markets (~2030).	Adoption in low-income regions due to Gavi or WHO programs.
Emergence of generic competitors.	Next-gen modifications enhancing efficacy or reducing costs.
Market saturation in developed regions.	Development of new combinations for other indications.
Regulatory changes affecting pricing.	Expansion into additional viral diseases or liver conditions.

8. Comparative Analysis: Glecaprevir/Pibrentasvir vs. Other Hepatitis C Agents

Attribute	Glecaprevir/Pibrentasvir	Sofosbuvir-based regimens	Velpatasvir-based regimens
Genotype Coverage	Pan-genotypic	Broad	Broad
Duration	8-12 weeks	8-12 weeks	12 weeks
Cure Rate	>95%	>95%	>95%
Cost	~$26,000	~$24,000	~$27,000
Patent Status	Active until ~2030	Expiring; generics available	Expiring; generics available

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Key Takeaways

• Market Leadership: Glecaprevir/pibrentasvir is a dominant pan-genotypic HCV treatment, with strong efficacy, short regimen, and broad adoption.
• Revenue Outlook: Peak revenues projected around 2024-2025, tapering post-patent expiry; strategic focus on expanding in emerging markets and orphan indications can mitigate declines.
• Competitive Challenges: Patent cliffs, generics, and pricing pressures require continuous innovation and strategic licensing.
• Investment Considerations: Long-term valuation depends on patent expiry timing, pipeline additions, and regulatory landscapes.
• Market Opportunities: Growing global HCV elimination initiatives, especially in low-income countries, and potential off-label or new indications.

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FAQs

Q1: What is the patent expiry timeline for glecaprevir/pibrentasvir?
A1: Patents on composition of matter generally expire around 2030, with some extensions possible through regulatory and pediatric exclusivities.

Q2: How does the efficacy of glecaprevir/pibrentasvir compare to other HCV treatments?
A2: Clinical trials show cure rates exceeding 95% across multiple genotypes, comparable or superior to existing therapies.

Q3: What are the main factors influencing the pricing of glecaprevir/pibrentasvir?
A3: Market competition, regulatory frameworks, negotiated discounts, and strategic access programs significantly impact pricing.

Q4: Which markets present the highest growth potential?
A4: Emerging economies with expanding healthcare access, alongside private markets in the U.S. and Europe, offer growth opportunities especially via access programs.

Q5: What strategies can extend the financial life of glecaprevir/pibrentasvir?
A5: Developing new formulations, expanding indications, engaging in patent extension strategies, and penetrating underserved markets.

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References

[1] World Health Organization. "Global Hepatitis Report," 2021.
[2] IQVIA. "Global Use of Hepatitis C Treatments," 2022.
[3] Asselah et al., "Efficacy of Glecaprevir/Pibrentasvir," Lancet Infectiously Diseases, 2019.