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
King's College Hospital NHS 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		DISCN	Yes	No	8,871,759		Y	Y
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		DISCN	Yes	No	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 Korea	20110036627
Dominican Republic	P2011000023
Croatia	P20160476
Luxembourg	C00002

Supplementary Protection Certificates for ZEPATIER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2310095	PA2016049,C2310095	Lithuania		PRODUCT NAME: GRAZOPREVIRAS ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2310095	LUC00002	Luxembourg		PRODUCT NAME: GRAZOPREVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI / ZEPATIER - ELBASVIR/GRAZOPREVIR; AUTHORISATION NUMBER AND DATE: EU/1/16/1119
2310095	SPC/GB17/014	United Kingdom		PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/16/1119 20160726; UK PLGB 53092/0082 20160726
2410844	122017000001	Germany		PRODUCT NAME: ELBASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 20160722

Market Dynamics and Financial Trajectory for ZEPATIER

Last updated: March 14, 2026

What is the current market landscape for ZEPATIER?

ZEPATIER (elbasvir and grazoprevir) is an antiviral medication approved in 2016 by the FDA for the treatment of chronic hepatitis C virus (HCV) infection, specifically genotypes 1 and 4. It is marketed by Merck & Co. as a direct-acting antiviral (DAA).

The global HCV treatment market was valued at approximately $22 billion in 2022. ZEPATIER held a modest share, primarily behind leading competitors like Gilead’s Harvoni and Epclusa, and Bristol-Myers Squibb's Daklinza. Market size is driven by increasing diagnosis rates, evolving treatment guidelines favoring shorter regimens, and the shifting landscape away from interferon-based therapies.

How does ZEPATIER's market performance compare with competitors?

Product	Year of Approval	Indicated Genotypes	Pricing (per course)	Market Share (2022)	Key Competitors
ZEPATIER	2016	1, 4	~$54,000	<5%	Harvoni, Epclusa, Daklinza
Harvoni	2014	1, 4	~$94,500	~55%	-
Epclusa	2016	1-6	~$74,760	~30%	-
Daklinza	2015	3, 4, 5, 6	~$45,000	<5%	-

ZEPATIER's share remains limited due to aggressive pricing, broader genotype coverage by competitors, and prescriber familiarity with established regimens.

What are the key factors influencing ZEPATIER's market trajectory?

• Treatment Guidelines Revisions: The American Association for the Study of Liver Diseases (AASLD) recommends all-oral DAA regimens without interferon, favoring drugs with broader genotype activity like Epclusa.
• Pricing Strategies: High costs limit access, especially in low and middle-income countries. Payers favor cost-effective, pan-genotypic options.
• Patent Expiry and Generics: Patent expiration in several markets could pave the way for generic competition, potentially reducing prices.
• Clinical Approvals: Lack of approval for additional genotypes constrains market growth. Expanding indications could improve commercial prospects.
• Switching Cost: Patients already stabilized on existing regimens are less likely to switch, limiting market penetration.

How have financial metrics evolved for ZEPATIER since launch?

• Sales: Merck reported ZEPATIER sales in the low hundreds of millions annually, with a peak around $300 million in 2018. In subsequent years, sales declined marginally following market trends and competitive pressures.
• R&D Investment: Merck has allocated approximately $150 million to ZEPATIER-related research, mainly for expanding genotype coverage and improving formulations.
• Profitability: Due to high manufacturing and marketing costs, margins have been modest, with profitability heavily influenced by volume growth and pricing negotiations.

What is the outlook for ZEPATIER's financial performance?

• Declining Revenue Trend: Market share erosion points to continued revenue decline in the absence of new indications.
• Potential for Expansion: Submission of supplemental approvals for additional genotypes or combination therapy integration could elevate sales metrics.
• Patent and Market Exclusivity: Patent expiry in key markets is set for between 2024 and 2026, increasing the risk of generic entry.
• Therapeutic Competition: Newer agents with shorter durations, higher efficacy, or better safety profiles threaten ZEPATIER's market position.

Financial forecasts estimate revenue between $100 million and $200 million annually in the next 3-5 years if no significant market expansion occurs. Without regulatory or formulation breakthroughs, ZEPATIER's role is expected to decline further amid generic competition.

Key Takeaways

• ZEPATIER faces declining market share due to competition from pan-genotypic agents and pricing pressures.
• The drug's limited genotype coverage reduces its appeal as newer, broader therapies enter markets.
• Patent expiries forecast potential for generic competition, putting further pressure on revenues.
• Expansion through regulatory approvals could stabilize or grow market presence but requires investment.
• Merck's strategic focus appears to shift toward newer therapies, decreasing emphasis on ZEPATIER.

FAQs

1. Will ZEPATIER regain market share in the future?
Unlikely without new regulatory approvals or indications, especially as generics enter markets.

2. Are there plans for ZEPATIER's combination with other antivirals?
Current information does not indicate active development for new combinations; focus remains on existing approvals.

3. How does pricing affect ZEPATIER's competitiveness?
High prices limit access, especially where payers favor lower-cost alternatives or generics.

4. When does patent expiry occur in major markets?
Patent expiry is expected between 2024 and 2026, varying by jurisdiction.

5. Could ZEPATIER's manufacturing costs decline?
Potentially, through process improvements; however, these are unlikely to offset revenue losses from market share decline.

References

[1] IQVIA. (2022). Global Pharmaceutical Market Report.

[2] U.S. Food & Drug Administration. (2016). FDA approves ZEPATIER for hepatitis C.

[3] Merck & Co. Financial Reports. (2018-2022).