ZEPATIER Drug Patent Profile

When do Zepatier patents expire, and what generic alternatives are available?

Zepatier is a drug marketed by Msd Sub Merck and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and fourteen patent family members in forty-six countries.

The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Zepatier

Zepatier was eligible for patent challenges on January 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEPATIER

International Patents:	114
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	134
Drug Prices:	Drug price information for ZEPATIER
What excipients (inactive ingredients) are in ZEPATIER?	ZEPATIER excipients list
DailyMed Link:	ZEPATIER at DailyMed

See drug prices for ZEPATIER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZEPATIER

Constraining patent/regulatory exclusivity:

8,871,759

NDA:

208261

Dosage:

TABLET;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 ZEPATIER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	Phase 4
Radboud University	Phase 1
Hepatitis C Trust	Phase 4

See all ZEPATIER clinical trials

Pharmacology for ZEPATIER

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors

US Patents and Regulatory Information for ZEPATIER

ZEPATIER is protected by two US patents.

This potential generic entry date is based on patent 8,871,759.

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
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes	8,871,759		Y	Y
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes	7,973,040		Y	Y

EU/EMA Drug Approvals for ZEPATIER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Zepatier	elbasvir, grazoprevir	EMEA/H/C/004126ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.	Authorised	no	no	no	2016-07-22

International Patents for ZEPATIER

When does loss-of-exclusivity occur for ZEPATIER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Poland

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 ZEPATIER around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201309504
Montenegro	02024
European Patent Office	2410844
World Intellectual Property Organization (WIPO)	2010111483
Israel	215094
Malaysia	169311

Supplementary Protection Certificates for ZEPATIER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2410844	PA2016048	Lithuania		PRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2410844	LUC00003	Luxembourg		PRODUCT NAME: ELBASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI / ZEPATIER - ELBASVIR/GRAZOPREVIR; AUTHORISATION NUMBER AND DATE: EU/1/16/1119
2310095	681	Finland
2310095	CA 2016 00070	Denmark		PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2410844	C02410844/01	Switzerland		FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US
2410844	C20160050	Estonia		(93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016

Market Dynamics and Financial Trajectory for ZEPATIER (Elbasvir and Grazoprevir)

Last updated: September 30, 2025

Introduction

ZEPATIER (elbasvir and grazoprevir) is an antiviral medication approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of chronic hepatitis C virus (HCV) infection. As an oral, once-daily treatment, ZEPATIER has positioned itself within the evolving landscape of HCV therapeutics. This report analyzes key market dynamics and financial trajectories influencing ZEPATIER's performance, examining competitive forces, regulatory factors, demographic trends, and pricing strategies shaping its future.

Market Landscape and Competitive Positioning

The global hepatitis C therapeutics market experienced exponential growth after the advent of direct-acting antivirals (DAAs) in the early 2010s. ZEPATIER entered a competitive space predominantly occupied by brands like Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), as well as AbbVie’s Viekira Pak.

Market Positioning and Differentiation
ZEPATIER distinguishes itself through its efficacy against specific HCV genotypes (notably genotype 1 and 4), favorable safety profile, and its potential for fewer drug interactions. These factors initially fostered a niche customer base among clinicians managing complex cases with polypharmacy or comorbidities. Nevertheless, its market share remains challenged by the repositioning of more broadly effective or simplified regimens, alongside the push for pan-genotypic treatments.

Market Penetration and Adoption Trends
From its launch, ZEPATIER demonstrated moderate adoption primarily within specialist centers. According to IQVIA data, its market share peaked at approximately 2-3% of the HCV drug market in the U.S. during 2017–2019, with a decline thereafter as newer therapies gained FDA approval and reimbursement strategies shifted toward pan-genotypic regimens.

Regulatory and Reimbursement Dynamics

Regulatory Landscape
ZEPATIER received the FDA’s approval based on clinical trials demonstrating high sustained virologic response (SVR) rates—exceeding 95% for genotype 1. However, subsequent approvals of pan-genotypic drugs like Vosevi and Mavyret, offering broader efficacy with simplified regimens, have displaced ZEPATIER’s position in treatment guidelines.

Reimbursement and Pricing Strategies
Pricing remains a decisive factor affecting ZEPATIER's market penetration. In the U.S., list prices ranged around $54,600 for a 12-week course[1], which, despite discounts and insurance negotiations, contrasts unfavorably with more recent pan-genotypic options offering lower total costs and simplified dosing. Payers' propensity to favor drugs with broader coverage and cost-efficiency has curtailed ZEPATIER’s reimbursements, impacting revenue.

Demographic and Epidemiological Drivers

HCV Prevalence Trends
There were approximately 2.4 million Americans infected with HCV in 2016, with the highest prevalence among baby boomers[2]. Although recent efforts by the CDC and public health agencies have targeted screening and linkage to care, treatment uptake remains inconsistent due to barriers like insurance restrictions and medication costs.

Treatment Uptake and Access Barriers
Despite high cure rates, many patients remain untreated. ZEPATIER’s sales have been significantly affected by limited access, especially in resource-constrained settings. Commercial insurance limitations and prior authorization requirements have created barriers that favor drugs with broader applicability.

Financial Trajectory Analysis

Sales Performance and Revenue Trends
Pharmaceutical sales of ZEPATIER peaked at approximately $300 million in 2017 but have declined steadily, aligning with the shrinking patient pool due to increased competition and evolving treatment guidelines[3]. As of 2022, sales estimates have fallen by over 70%, with estimates around $80-$100 million nationally.

Profitability and R&D Impact
Given the decline in sales, the product’s contribution to the parent company's revenue stream (AbbVie, since 2017 after acquiring Merck’s hepatitis franchise) has diminished. The company’s strategic focus has shifted towards pan-genotypic, once-daily regimens with broader markets, deprioritizing ZEPATIER. Ongoing R&D investments are balanced against market saturation and reimbursement challenges.

Market Outlook and Projections
Industry analysts forecast continued decline for ZEPATIER’s revenue. The market is expected to further consolidate around highly effective, pan-genotypic drugs. The transition may be accelerated by patent expirations and generic competition, further reducing ZEPATIER's market share.

Future Considerations

Regulatory and Patent Factors

While ZEPATIER remains patent-protected until the late 2020s, off-patent competitors may enter the market through generic manufacturing. This, combined with evolving treatment protocols, suggests limited future growth prospects.

Strategic Positioning

To sustain profitability, makers might explore niche indications, extended formulations, or combination therapies, though the incentives are diminishing due to market saturation.

Market Expansion & Access Initiatives

Global markets, particularly in low-to-middle-income countries, represent potential growth opportunities. However, high drug prices and limited infrastructure often impede large-scale access.

Conclusion

ZEPATIER’s market dynamics are characterized by an initial period of moderate growth followed by a steady decline driven by competitive pressures, regulatory shifts favoring pan-genotypic regimens, and reimbursement challenges. Its financial trajectory underscores the importance of innovation and adaptability within the hepatitis C market, as new therapies supplant earlier-generation DAAs.

Pharmaceutical companies holding ZEPATIER-related assets must strategize around market consolidation, access expansion, and pipeline development to mitigate declining revenue streams.

---

Key Takeaways

• Market decline: ZEPATIER’s sales peaked shortly after launch but have since declined due to competition from broader-spectrum DAAs and shifting guidelines.
• Competitive pressures: The availability of pan-genotypic, simplified therapies (e.g., Mavyret, Vosevi) has reduced ZEPATIER’s market share.
• Pricing and reimbursement: High costs and insurance restrictions limit access, constraining revenue growth.
• Strategic pivot: Future profitability depends on niche applications, global markets, and potential combination strategies, though prospects are limited.
• Industry impact: The ZEPATIER case exemplifies how rapid innovation and regulatory preferences influence pharmaceutical financial trajectories.

---

FAQs

1. What are the main factors contributing to ZEPATIER’s revenue decline?
The primary factors include competition from pan-genotypic regimens, decreasing treatment initiation, high drug costs leading to reimbursement challenges, and evolving clinical guidelines favoring broader-spectrum therapies.

2. How does ZEPATIER compare to newer hepatitis C treatments?
Compared to drugs like Mavyret and Vosevi, ZEPATIER has a narrower genotype coverage, higher price points, and more complex treatment protocols, making it less attractive from both clinical and economic standpoints.

3. Is there any current or future market expansion potential for ZEPATIER?
While in international markets, especially where access to newer drugs is limited, ZEPATIER could find niche roles, in high-income countries, growth prospects are minimal due to competition and treatment paradigm shifts.

4. What are the patent implications for ZEPATIER?
Patents are due to expire late in the decade, opening the door for generic competition, which will further pressure revenues and market share.

5. How should pharmaceutical companies approach declining drugs like ZEPATIER?
Strategies include diversifying portfolios, initial investment in pipeline development, exploring niche indications, expanding into emerging markets, and implementing cost-effective access programs.

---

Sources
[1] Manufacturer pricing data.
[2] CDC Hepatitis C Surveillance Report 2016.
[3] IQVIA Pharmaceutical Market Data 2022.