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-two 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 November 18, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MAVYRET

International Patents:	552
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

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:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Uruguay

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
Argentina	077060
Argentina	083240
Argentina	083398

Supplementary Protection Certificates for MAVYRET

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

Mavyret (glecaprevir/pibrentasvir) Investment Scenario and Patent/Exclusivity Fundamentals (2026)

Last updated: July 9, 2026

Mavyret is a fixed-dose, direct-acting antiviral (DAA) regimen for chronic hepatitis C virus (HCV) and is already in the post-launch competitive phase. The core investment driver is not “near-term exclusivity discovery,” but whether incremental demand still translates into defensible margin after generic and authorized generic pressure, and whether patent estates and litigation materially delay follow-on competition in the highest-value jurisdictions.

High-level investment call

• Demand: HCV treatment remains a large, churn-driven market tied to remaining untreated patients and payer optimization. In practice, “market size” is less determinative than who controls formularies and access.
• Competition: The regimen faces generic and authorized generic competition in many markets, reducing price leverage.
• Key protection: Mavyret’s differentiation and pricing power have been supported by combination composition and method-of-use IP plus regulatory exclusivity windows early in lifecycle; the remaining economic question is whether any secondary formulation/process or label-adjacent patents still matter for launch timing.
• Investment risk: Exposure is mainly to (1) price erosion, (2) payer substitution, (3) residual country-by-country patent effects, and (4) execution in next-line cohorts (cirrhosis, prior treatment, genotype breadth, real-world adherence).

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What is Mavyret (glecaprevir/pibrentasvir) and what are the fundamental market drivers?

Answer (fundamentals): Mavyret is an 8-week pan-genotypic oral DAA regimen (NS3/4A protease inhibitor + NS5A inhibitor) used to cure chronic HCV across broad patient populations, including treatment-experienced cohorts depending on the specific label. The investment fundamentals rest on HCV prevalence in treated markets, national elimination targets, payer formulary dynamics, and gross-to-net erosion from competition.

Core product profile that shapes demand

• Mechanism: NS3/4A protease inhibition plus NS5A inhibition.
• Regimen length: 8 weeks is central to value-based procurement.
• Patient breadth: Pan-genotypic label reduces payer complexity.
• Accessibility: Fixed-dose co-pack and simplified dosing support rapid uptake versus regimens requiring longer treatment durations or genotype-based decision trees.

Where investment returns typically come from

• Formulary placement: Winning preferred status with national payers and large PBMs drives volume.
• Real-world outcomes: Cure rate in practice supports renewal of preferred status.
• Contracting: Price and rebates determine profitability more than headline list price once competition enters.

What to model in an investment case

• Gross-to-net compression after generic/authorized-generic introductions.
• Market share stability: Track share vs other DAAs (sofosbuvir-based and other Pangenotypic combinations).
• Segment mix: Proportion of cirrhosis, prior treatment, renal impairment, and drug-drug interaction-sensitive populations.
• Country mix: Patent and regulatory timelines vary by jurisdiction.

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What patents protect Mavyret (glecaprevir/pibrentasvir) in the US, and how does the estate affect competition?

Answer (IP reality): Mavyret’s protection historically combined composition/combination claims (glecaprevir + pibrentasvir), key salt/polymorph or solid-state variations, manufacturing/process claims, and method-of-use claims tied to treatment of HCV. For investment, the key is whether any non-core patents still provide enforceable barriers as the regimen moves through generics and authorized generics.

US patent landscape: what typically matters for DAA competition

1. Combination product claims
   • Claims covering the therapeutic combination at defined ratios and formulations.
2. Solid-state and formulation claims
   • Salt form, amorphous/crystalline forms, dispersion or tablet properties that can drive infringement arguments.
3. Method-of-use claims
   • Treatment regimens defined by dose, duration, patient stratification, genotype breadth, or prior treatment status.
4. Manufacturing/process claims
   • Steps in producing APIs and final tablets, which can be harder for generics to design around.

Investment implication

Even when the “primary” composition is near or past expiration, secondary patents can still delay generic entry. Conversely, if remaining patents are narrow, the economic effect may be limited.

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When does Mavyret lose exclusivity in key markets (US, EU/UK), and what timelines drive generic entry risk?

Answer (exclusivity timing): For HCV DAAs, the market typically transitions in stages:

• Patent expiration determines legal ability to launch.
• Regulatory exclusivity (where applicable) can restrict certain filings, but the principal constraint for generics is patent status.
• Practical exclusivity often ends earlier because of authorized generics and payer substitution before full legal freedom.

How to structure the exclusivity calendar

Model three time anchors for investment:

• Earliest patent expiry (composition or combination)
• Latest meaningful patent expiry (secondary formulation/method claims still enforced or relevant)
• Launch/settlement timetable (Paragraph IV or equivalent disputes resolved by settlement)

Why this matters

Generic entry affects:

• Net price
• Gross margin
• Rebates and market-share maintenance
• Channel allocation

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What is the Orange Book status of Mavyret, and how many patents cover each formulation strength?

Answer (regulatory/IP cross-check): Orange Book listings for combination DAAs usually include product patents and method-of-use patents, often with multiple patent numbers per strength and dosage form. Orange Book status is the fastest filter for identifying which specific claims are likely to anchor Paragraph IV challenges and enforcement.

How Orange Book entries map to launch obstacles

• If Orange Book lists a high number of patents tied to the tablet formulation and method-of-use, generics face multiple infringement theories.
• If Orange Book patents are mostly expiration-dated late but are weak/narrow, settlement pressure increases and launch risk shifts from “hard injunction” to “timing and settlement cost.”

Investment use

For an investor, Orange Book is less about academic completeness and more about:

• identifying which patents are still “live” on the valuation horizon, and
• quantifying the risk of “at-risk launch” versus delayed entry.

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Which companies are challenging Mavyret with Paragraph IV ANDAs, and what does litigation history imply for settlement probability?

Answer (litigation posture): In HCV DAAs, Paragraph IV challenges often trigger a pattern: multiple filers, staged disputes, and settlements that permit a generic launch at a defined date or with design-around strategies.

What matters for your investment model

• Number of ANDA filers (signals commercialization interest).
• Whether disputes settled with delayed launch dates.
• Whether generic entrants gain broad label coverage at launch or face narrower indications.
• Injunction outcomes (rare in this category once settlements are reached).

Settlement probability framework (business view)

• High settlement probability when the branded firm has a large asserted estate and the generic’s design-around is complex.
• Lower settlement probability when patents are narrow, the generic has strong non-infringement positions, or multiple filers create competitive pressure.

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What generic entry risks exist for Mavyret, and what launch scenarios should investors underwrite?

Answer (risk map): For DAAs, “generic entry risk” often splits into two tracks:

1. At-risk launch if a filer challenges and believes the patents are invalid or not infringed.
2. Settlement launch where the branded firm allows entry earlier than last-patent expiration, usually after a negotiated delay.

Launch scenarios to underwrite

• Scenario A: delayed generic entry due to enforceable method-of-use/formulation patents
  • Slower price compression, longer margin runway.
• Scenario B: settlement-based launch
  • Predictable date but revenue impacts begin before the last patent expires.
• Scenario C: rapid substitution once authorized generics appear
  • Faster price compression independent of full patent expiry.

What investors should treat as leading indicators

• Contracting language with PBMs.
• Formularies switching even before launch.
• Pharmacy channel stocking patterns.
• Wholesale acquisition cost trends vs list price.

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How does Mavyret compare with competing hepatitis C DAAs on efficacy, regimen length, and payer preference?

Answer (competitive benchmark): Mavyret competes in the pan-genotypic DAA class where regimen duration, pill burden, drug-drug interaction profile, and simplifying genotype workflows are key. In mature markets, the competitive axis shifts from “clinical differentiation” to procurement and access.

Comparison dimensions that drive real-world share

• Regimen length (8-week advantage in many segments)
• Label breadth (treatment-naïve vs experienced, cirrhosis status)
• Renal impairment usability
• Concomitant medication interaction burden
• Safety/tolerability
• Total cost of care via fewer follow-up visits and shorter therapy duration

Investment relevance

When multiple DAAs show high cure rates, the winner is usually the one that:

• secures preferred pricing contracts, and
• maintains formulary status across payer segments.

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What formulations are protected by Mavyret patents, and do they constrain generic “design-around” routes?

Answer (design-around): For combination DAA tablets, formulation patents can constrain generic design-around if they cover:

• specific solid-state forms of APIs,
• tablet excipient systems or manufacturing conditions tied to dissolution and stability,
• or process steps that are hard to replicate without risk.

Where design-around tends to fail

• If the branded formulation uses claims on specific crystalline/solid-state features.
• If method-of-use claims remain tied to the clinically effective regimen duration.

Where design-around tends to succeed

• If formulation patents are narrow and generics can choose alternate salts/solid forms.
• If method-of-use claims can be avoided via labeling differences at launch (subject to carve-outs and infringement risk).

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What method-of-use patents could affect Mavyret’s label scope for generics?

Answer (label scope barrier): Method-of-use patents can prevent generics from using the same dosing regimen and patient stratification if infringement is established for label-indicated use. If patents are still in force for specific cohorts (for example, prior treatment or cirrhosis subgroups), the generic launch can be restricted to narrower claims.

How investors should interpret method-of-use claims

• Strongest for limiting label adoption until expiry or settlement.
• Most relevant for payer decisions if the generic product’s approved label is narrower or if substitution requires extra clinical steps.

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What manufacturing and API process IP barriers exist for Mavyret generics?

Answer (manufacturing/IP barrier): Process patents can create risk for generic manufacturers if they include:

• specific API synthesis steps,
• intermediate compounds,
• purification parameters,
• or final tablet manufacturing conditions that are hard to replicate without infringement.

Investment implication

Even with legal freedom on paper, process barriers can delay commercialization, increase cost to qualify, and slow uptake, which supports branded margin longer.

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What is the biosimilar risk profile for Mavyret?

Answer: Mavyret is a small-molecule DAA, not a biologic. Biosimilar risk is not applicable. The competitive framework is instead generic and authorized generic entry plus next-generation DAAs with differentiated access or pricing.

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What FDA regulatory status milestones matter for Mavyret’s commercialization and competition?

Answer: For mature DAAs, FDA milestones matter mostly for:

• label expansion (if any),
• safety updates,
• and any regulatory changes that shift coverage or interchangeability decisions.

How to connect FDA status to market outcomes

• A label expansion that preserves exclusivity can protect share.
• Safety or drug interaction updates can increase prior authorization burden, benefiting incumbent contracting strategies.

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Commercial performance and margin exposure: what should investors model for Mavyret?

Answer (commercial model): Mavyret’s economics depend on:

• net price trajectory,
• share vs competing DAAs,
• payer contracting,
• and gross-to-net compression from competition and channel behavior.

Key KPI set

• Net sales growth/decline vs prior quarters
• ASP/WAC spread changes with competition
• Share in treated HCV segments
• Formulary position changes
• Expected generic entry dates (from patent and litigation timelines)
• Authorized generic activity in major markets

Revenue exposure sensitivity

A practical approach:

• treat price compression as the dominant driver post-generic entry,
• treat volume as secondary unless label restrictions or clinical switching issues exist.

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What patent litigation affects Mavyret, and how do outcomes influence timing of generic launch?

Answer: Litigation outcomes typically translate into:

• delayed generic launch dates via settlements,
• at-risk launch outcomes followed by enforcement actions,
• or claim narrowing through design-around.

What to prioritize in litigation review

• Case count and parties
• Whether the asserted patents are product, formulation/process, or method-of-use
• Whether courts upheld injunctions or narrowed scope
• Whether settlement agreements specify launch dates and labeling restrictions

Investment use

Litigation is a forecasting tool for launch timing. Even a partially enforceable estate can preserve margin longer than a purely “expiration date” view.

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Key Takeaways

• Investment driver shifts from exclusivity discovery to price and access: In mature HCV DAAs, patent status matters through its effect on generic/authorized generic timing and formulary substitution.
• Patent estate composition is critical: Combination, formulation/process, and method-of-use patents can each delay or shape generic entry routes differently.
• Model two timelines: legal patent expiry and practical market substitution (authorized generics, payer switching).
• Competitive benchmark is procurement-led: When cure rates are uniformly high across DAAs, contracting, rebate structures, and preferred coverage dominate outcomes.
• Litigation and settlements are the “real exclusivity calendar”: They determine when new supply is absorbed into formularies and pharmacy channels.

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FAQs

1) What factors determine whether Mavyret faces faster price erosion than other pan-genotypic DAAs?
Formulary substitutability, authorized generic availability, and the breadth of remaining enforceable method-of-use/formulation patents.

2) How do settlement agreements in HCV DAA patent cases typically affect launch dates?
They commonly specify permitted launch timing, labeling carve-outs, and sometimes conditions affecting exclusivity triggers or distribution.

3) Which Mavyret patent types most often delay generic tablets in the US?
Combination product claims, formulation/solid-state patents, and method-of-use dosing regimen claims are typically the most influential.

4) What generic entry scenario is most harmful to branded margin for DAA products like Mavyret?
Rapid authorized generic substitution combined with early payer switching that compresses net price before a full legal “freedom to operate” event.

5) Does manufacturing process IP matter for investment timing in generic DAA launches?
Yes, process patents can delay launch readiness, increase costs for process validation, and slow practical adoption even when legal barriers are limited.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Labeling and approval information for glecaprevir/pibrentasvir (Mavyret). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/