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.

The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. There is one drug master file entry for this compound. 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

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

Constraining patent/regulatory exclusivity:

8,937,150*PED

NDA:

209394

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,937,150*PED

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.

This potential generic entry date is based on patent 8,937,150.

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	RE48923*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	11,246,866*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	8,937,150*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	9,586,978*PED				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:

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
Argentina	092505
Argentina	094816

Supplementary Protection Certificates for MAVYRET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	PA2015012	Lithuania		PRODUCT NAME: OMBITASVIRUM; REGISTRATION NO/DATE: EU/1/14/982 20150115
2368890	CA 2015 00015	Denmark		PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150115
2368890	C02368890/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2368890	C20150016 00154	Estonia		PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015

MAVYRET Market Dynamics and Financial Trajectory

Last updated: August 2, 2026

MAVYRET, AbbVie’s glecaprevir/pibrentasvir regimen, remains a major direct-acting antiviral product despite the contraction of the hepatitis C market. Its commercial profile is defined by broad genotype coverage, short treatment duration, strong performance in patients with renal impairment, and declining disease prevalence. Global sales have stabilized near the $1.8 billion annual range, but long-term growth is constrained by treatment-market saturation, public-health pricing pressure, generic competition in hepatitis C, and the limited pool of newly diagnosed patients.

What is MAVYRET and how does it compete in hepatitis C?

MAVYRET combines the NS3/4A protease inhibitor glecaprevir with the NS5A inhibitor pibrentasvir. The fixed-dose combination is administered once daily with food.

The FDA approved MAVYRET in August 2017 for adults with chronic hepatitis C virus infection across genotypes 1 through 6. The label later expanded to include children aged 3 years and older weighing at least 12 kilograms. For many treatment-naive patients without cirrhosis, the recommended course is eight weeks, shorter than several earlier hepatitis C regimens (FDA, 2024).

MAVYRET’s principal commercial advantages are:

• Pan-genotypic coverage across HCV genotypes 1 through 6.
• An eight-week treatment option for many patients.
• Use in patients with severe renal impairment, including dialysis patients.
• High sustained virologic response rates in clinical studies.
• A single-tablet daily regimen containing two antiviral mechanisms.

The primary branded competitor is Gilead Sciences’ EPCLUSA, which combines sofosbuvir and velpatasvir. Generic sofosbuvir-based regimens also affect net pricing and payer negotiations, particularly outside the United States.

How large is the MAVYRET market?

MAVYRET is one of AbbVie’s largest non-immunology products. AbbVie reported approximately $1.8 billion in annual MAVYRET revenue in recent years, following rapid growth after launch and subsequent stabilization as the HCV treatment pool matured.

Period	Commercial position
2017	U.S. launch
2018-2020	Rapid adoption and geographic expansion
2021-2022	Mature-market stabilization
2023-2024	Revenue broadly near the $1.8 billion annual level
Longer term	Gradual erosion risk from market contraction and pricing

AbbVie does not report MAVYRET as a standalone operating segment. It reports the product within its overall pharmaceutical portfolio and provides product-level net revenue disclosures in its annual reports. Recent filings show that MAVYRET revenue is materially smaller than the company’s leading immunology products, including SKYRIZI and RINVOQ, but remains strategically relevant because of its scale and cash generation (AbbVie, 2024a; AbbVie, 2025).

What drove MAVYRET’s initial revenue growth?

MAVYRET gained share through three commercial factors.

First, it offered a relatively short course for many patients. Treatment duration has a direct effect on payer cost, patient adherence, and physician prescribing behavior.

Second, MAVYRET addressed a broader clinical population than some earlier regimens. Its use in severe renal impairment helped differentiate it from sofosbuvir-containing products, which historically faced renal-use restrictions before label changes and subsequent clinical developments.

Third, AbbVie used aggressive contracting and pricing to compete with Gilead. The list price for a standard eight-week course was materially below the gross cost of several competing branded regimens, although actual net prices vary by payer, government program, rebate structure, and geography.

What is the financial trajectory for MAVYRET?

MAVYRET’s financial trajectory has three phases: launch expansion, market maturity, and gradual erosion risk.

Launch expansion

The product rapidly gained share after its 2017 U.S. approval. AbbVie positioned MAVYRET as a pan-genotypic, short-course regimen and used pricing to challenge Gilead’s dominance in HCV.

Revenue maturity

By the early 2020s, the product had reached a large installed treatment base. Revenue growth slowed as many diagnosed patients had already received therapy, while screening and linkage-to-care remained below the level required to expand the market materially.

Long-term erosion

The principal threat is not immediate clinical obsolescence. It is a shrinking addressable population. HCV prevalence remains significant, but treatment demand depends on diagnosis, patient engagement, insurance coverage, public-health funding, and reinfection prevention.

A reasonable base-case commercial view is:

Driver	Direction	Financial effect
New patient volume	Declining or flat in mature markets	Negative
Treatment duration	Stable	Supports adherence and payer economics
Net price	Under pressure	Negative
International access programs	Mixed	Supports volume but limits price
Generic competition	Increasing	Negative
HCV elimination programs	Potentially positive	Can create episodic volume growth
AbbVie commercial infrastructure	Strong	Supports retention

MAVYRET is therefore a cash-generating mature product rather than a principal growth asset. Its revenue profile contrasts with AbbVie’s immunology portfolio, where SKYRIZI and RINVOQ are expected to carry a larger share of future growth following HUMIRA biosimilar erosion (AbbVie, 2024b).

How does MAVYRET compare with EPCLUSA?

MAVYRET and EPCLUSA are both pan-genotypic HCV regimens, but their commercial positioning differs.

Attribute	MAVYRET	EPCLUSA
Active ingredients	Glecaprevir/pibrentasvir	Sofosbuvir/velpatasvir
Manufacturer	AbbVie	Gilead Sciences
FDA approval	2017	2016
Genotype coverage	1-6	1-6
Typical duration	Often eight weeks in eligible patients	Commonly 12 weeks
Severe renal impairment	Important product advantage	Historical limitation for sofosbuvir
Main commercial strength	Short course and broad use	Strong clinical familiarity and market history
Generic pressure	Combination-product patent and ANDA risk	Generic sofosbuvir-based competition
Market outlook	Mature, with erosion risk	Mature, with erosion and pricing pressure

EPCLUSA has a strong clinical and prescriber base, while MAVYRET’s shorter treatment duration and renal positioning give AbbVie durable commercial differentiation. Neither product has the growth characteristics of a newly launched specialty medicine.

What patents protect MAVYRET?

MAVYRET is protected through patents covering the active ingredients, chemical intermediates, combination compositions, pharmaceutical formulations, and methods of treating HCV.

The relevant U.S. patent estate has included patents assigned to AbbVie and related entities covering glecaprevir, pibrentasvir, and their use in combination. Patent terms for key composition and combination claims extend into the 2030s, subject to patent-term adjustment, patent-term extension, terminal disclaimers, claim scope, and litigation outcomes.

The commercial protection is more complex than a single expiry date. A generic applicant must address:

• Glecaprevir compound patents.
• Pibrentasvir compound patents.
• Combination-treatment patents.
• Dosage and formulation patents.
• Method-of-use patents.
• Any pediatric or revised-label patent listings.
• Regulatory exclusivity and pediatric extensions.

The FDA Orange Book remains the controlling source for listed patents and use codes. Orange Book listings can change when patents are added, delisted, expired, or affected by litigation (FDA, 2025).

When does MAVYRET lose exclusivity?

MAVYRET’s five-year new chemical entity exclusivity expired in the early 2020s because the FDA approved the product in 2017. That regulatory exclusivity did not determine the full commercial protection period. Patent protection is the more important barrier to an ANDA launch.

The practical loss-of-exclusivity window depends on the earliest enforceable patent expiry, any 30-month litigation stay, settlement terms, and whether a generic applicant obtains a judgment of non-infringement or invalidity. Key patent protection extends materially beyond the initial FDA exclusivity period.

What Paragraph IV challenges and generic entry risks affect MAVYRET?

HCV products face a high probability of generic pressure because the market has established clinical guidelines, measurable treatment endpoints, and substantial payer incentives to reduce cost.

A Paragraph IV challenge could arise through an ANDA alleging that listed MAVYRET patents are invalid, unenforceable, or not infringed. If AbbVie receives notice of a Paragraph IV certification and files suit within 45 days, FDA approval may be subject to a statutory 30-month stay, subject to court action and regulatory exceptions.

The most likely generic launch scenarios are:

1. An authorized or licensed generic arrangement that preserves part of AbbVie’s economics.
2. A negotiated launch date before the latest patent expiration.
3. A court decision allowing an earlier launch after invalidity or non-infringement findings.
4. A settlement that permits entry at a confidential or staged date.
5. A later launch after the core patent estate expires.

Publicly visible ANDA litigation, settlement, and launch timing should be monitored through federal court dockets, FDA approval records, and AbbVie’s securities filings. No generic entry date should be treated as definitive unless it is supported by a court order, settlement disclosure, FDA approval, or company filing.

What is the FDA regulatory status of MAVYRET?

MAVYRET is FDA-approved for chronic HCV genotypes 1 through 6 in adults and certain pediatric patients. The product is a small-molecule combination, not a biologic, so biosimilar rules do not apply.

The primary regulatory risks are therefore:

• Label expansion or restriction.
• Manufacturing compliance.
• Postmarketing safety obligations.
• Pediatric requirements.
• Generic ANDA approvals.
• Patent certification litigation.

MAVYRET does not face biosimilar substitution risk. Its competitive threat comes from conventional generic drugs and other direct-acting antiviral regimens.

What licensing deals support MAVYRET?

MAVYRET originated from AbbVie’s collaboration with Enanta Pharmaceuticals. Enanta discovered and developed compounds in the HCV protease inhibitor program, while AbbVie held commercial development and global commercialization responsibilities under the collaboration.

The agreement provides Enanta with milestone payments and royalties tied to products covered by the collaboration. Enanta has identified royalties from glecaprevir-containing products as a material source of revenue in its public filings (Enanta Pharmaceuticals, 2024).

The arrangement reduces AbbVie’s ownership of the full economic value of MAVYRET but also gave AbbVie access to a validated antiviral discovery platform and global commercialization rights.

Which companies are challenging MAVYRET commercially?

The competitive field includes:

• Gilead Sciences, through EPCLUSA and other HCV products.
• Generic manufacturers of sofosbuvir-based regimens.
• Potential ANDA filers targeting glecaprevir/pibrentasvir.
• Government and nonprofit treatment programs that negotiate lower prices.
• Regional manufacturers supplying lower-cost HCV regimens outside the United States.

The strongest commercial pressure comes from payers and generic pricing rather than from a single next-generation branded product. HCV treatment is increasingly a procurement market in which efficacy is broadly comparable, making price, access, supply reliability, and treatment duration central competitive variables.

What generic entry risks exist for AbbVie’s revenue?

MAVYRET’s revenue exposure is high because the product has a concentrated indication and limited lifecycle expansion potential. A generic launch would likely cause:

• Rapid U.S. price compression.
• Formulary exclusion or preferred generic placement.
• Reduced gross-to-net economics.
• Lower international tender pricing.
• Inventory destocking before launch.
• Greater pressure on treatment-course pricing.

The impact would probably be uneven. Medicaid, public-health programs, and large commercial payers could move quickly to generic substitution. Markets with centralized procurement may experience sharper price reductions than fragmented private markets.

The main offset is the remaining volume of untreated or undiagnosed HCV patients. Successful screening programs could preserve unit demand even as price declines.

How strong is the MAVYRET patent estate?

MAVYRET has a stronger protection profile than a product relying only on one formulation patent because its estate spans active ingredients, combination use, and related chemistry. The estate’s strength is reduced by the age of the product, the commercial incentive for ANDA challenges, and the possibility that individual claims may be narrowed or invalidated.

Patent-estate factor	Assessment
Composition-of-matter protection	Historically strong
Combination claims	Important to commercial protection
Formulation protection	Supplemental rather than sole barrier
Method-of-use claims	Relevant to labeled HCV populations
Generic challenge incentive	High
Biosimilar risk	None
Manufacturing barriers	Meaningful but unlikely to block a capable generic indefinitely
Geographic durability	Uneven by country and patent family
Revenue sensitivity to early entry	High

MAVYRET’s manufacturing process and active pharmaceutical ingredient know-how can create technical barriers, but manufacturing complexity is not equivalent to regulatory exclusivity. A well-capitalized generic manufacturer can often overcome process barriers through independent development or licensing.

What is the outlook for MAVYRET revenue?

MAVYRET should remain commercially significant while core patents and market access remain intact. Its medium-term trajectory is more likely to be stable-to-declining than growth-oriented.

The base case is:

• Flat or modestly declining revenue before meaningful generic entry.
• Continued price pressure in government and international channels.
• Selective volume support from HCV elimination programs.
• Accelerating erosion after an approved generic or negotiated launch.
• Limited strategic reinvestment compared with AbbVie’s immunology franchises.

MAVYRET’s value to AbbVie lies in its current cash flow, global scale, and mature commercial infrastructure. Its strategic risk is concentrated in patent timing and payer pricing rather than clinical differentiation.

Key Takeaways

• MAVYRET is AbbVie’s glecaprevir/pibrentasvir treatment for chronic HCV genotypes 1 through 6.
• Annual revenue has stabilized near $1.8 billion in recent years.
• The product’s main advantages are eight-week treatment for many patients, pan-genotypic coverage, and use in severe renal impairment.
• EPCLUSA and generic sofosbuvir-based regimens are the principal commercial competitors.
• FDA five-year exclusivity has expired; patents extending into the 2030s remain the key protection mechanism.
• MAVYRET is exposed to Paragraph IV litigation and conventional generic entry, not biosimilar competition.
• AbbVie’s HCV revenue is mature and likely to decline over time as diagnosis, treatment, and pricing dynamics compress the market.
• The Enanta collaboration creates ongoing royalty economics for the originator of the HCV compounds.

FAQs About MAVYRET Market Exclusivity and Financial Performance

Is MAVYRET still a high-revenue drug for AbbVie?

Yes. MAVYRET generates roughly $1.8 billion in annual revenue, although it is no longer one of AbbVie’s principal growth drivers.

Does MAVYRET have biosimilar competition?

No. MAVYRET is a small-molecule drug, so it is subject to generic-drug regulation rather than the biosimilar pathway.

What is the biggest threat to MAVYRET sales?

The largest threats are generic entry, payer-driven price reductions, and a shrinking pool of diagnosed HCV patients.

Does MAVYRET have a shorter treatment duration than EPCLUSA?

For many eligible patients, MAVYRET can be prescribed for eight weeks, while EPCLUSA is commonly used for 12 weeks. Treatment duration depends on patient history, cirrhosis status, genotype, and applicable labeling.

Who receives royalties from MAVYRET?

Enanta Pharmaceuticals receives royalties under its collaboration with AbbVie covering glecaprevir-containing products.

References

1. AbbVie Inc. (2024a). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.

2. AbbVie Inc. (2024b). Form 10-Q and investor product sales disclosures. U.S. Securities and Exchange Commission.

3. AbbVie Inc. (2025). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2024. U.S. Securities and Exchange Commission.

4. Enanta Pharmaceuticals, Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.

5. U.S. Food and Drug Administration. (2024). MAVYRET prescribing information. FDA.

6. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

7. World Health Organization. (2024). Global hepatitis report 2024. World Health Organization.

DrugChatter Q&A for MAVYRET

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