ELBASVIR; GRAZOPREVIR - Generic Drug Details

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

Elbasvir; grazoprevir is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elbasvir; grazoprevir has one hundred and fourteen patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for ELBASVIR; GRAZOPREVIR

International Patents:	114
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	62
Patent Applications:	209
DailyMed Link:	ELBASVIR; GRAZOPREVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELBASVIR; GRAZOPREVIR

Constraining patent/regulatory exclusivity:

8,871,759

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 ELBASVIR; GRAZOPREVIR

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

Sponsor	Phase
Cairo University	Phase 4
University of Pennsylvania	Phase 4
Austin Hospital, Melbourne Australia	Phase 3

See all ELBASVIR; GRAZOPREVIR clinical trials

Pharmacology for ELBASVIR; GRAZOPREVIR

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

Anatomical Therapeutic Chemical (ATC) Classes for ELBASVIR; GRAZOPREVIR

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ELBASVIR; GRAZOPREVIR

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 ELBASVIR; GRAZOPREVIR

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 ELBASVIR; GRAZOPREVIR

Country	Patent Number	Title	Estimated Expiration
South Korea	20110036627
Dominican Republic	P2011000023
Croatia	P20160476

Supplementary Protection Certificates for ELBASVIR; GRAZOPREVIR

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

ELBASVIR; GRAZOPREVIR Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Elbasvir and Grazoprevir?

Elbasvir and grazoprevir are direct-acting antivirals (DAAs) used in combination for hepatitis C virus (HCV) treatment. Approved by FDA in 2016, they are marketed primarily under the name Zepatier. The drugs target HCV genotypes 1 and 4, offering an alternative to earlier interferon-based therapies.

Market size for HCV treatments has contracted from its peak due to increased competition, pricing pressures, and the availability of generic options. Key factors influencing this include:

• Treatment Adoption: High cure rates (>95%) benefit patient adherence and clinician preference. Uptake varies by region, with North America and Europe leading.
• Pricing Strategies: Mirroring the pricing of competitors, Zepatier's list price was approximately $54,600 per 12-week course at launch, but discounts and negotiations have significantly reduced actual transaction prices.
• Generic Penetration: Approval of generic DAAs, notably in India and Egypt, has driven down prices and affected branded drug sales.
• Market Competition: Several new formulations with simplified dosing and shorter treatment durations, such as glecaprevir/pibrentasvir (Mavyret) and voxilaprevir-based regimens, have eroded market share.
• Reimbursement Policies: Health authorities' reimbursement mechanisms influence sales; countries with strict formulary controls and high drug prices see lower utilization.

How Has the Financial Trajectory Evolved for Zepatier?

Sales for Zepatier peaked at approximately $314 million in 2017, shortly after launch, then declined sharply:

Year	Revenue (USD millions)	% Change
2017	314	—
2018	170	-45.9%
2019	70	-58.8%
2020	28	-60.0%
2021	16	-42.9%

This decline reflects market saturation, competition, and the loss of exclusivity as patent challenges or patent expirations in key markets loomed.

Pfizer reported a decrease in Zepatier sales due to reduced demand and competitive pressures. The company has not announced significant investments or pipeline developments centered on Zepatier, signaling limited growth prospects.

What Are the Key Factors Driving Future Market and Financial Trends?

• Patent and Exclusivity Status: Zepatier's patent expiration date in major markets varies; in the U.S., patent expiry is expected around 2027, opening opportunities for generic competitors.
• Regulatory Changes: Payers' shift toward value-based pricing and formulary restrictions could further limit sales.
• Pipeline Developments: The lack of a strong pipeline focus on Zepatier limits potential for renewal or repositioning.
• Regional Market Potential: Countries with high HCV prevalence, such as Egypt and India, increasingly adopt generics, reducing revenue potential for branded Zepatier.
• Pricing Pressures: Global negotiations have driven prices down, making it difficult for Zepatier to sustain high margins.

What Is the Outlook for Elbasvir and Grazoprevir's Market and Financial Trajectory?

The outlook indicates continued decline unless new formulations or indications emerge. The core challenges are:

• Market Saturation: Existing treatments cover most diagnosed patients, diminishing unmet needs.
• Pricing Pressure: Discount-driven sales and payer restrictions restrict profit margins.
• Pipeline Limitations: Lack of significant pipeline updates or new indications limits potential recovery.
• Regional Dynamics: Emerging markets favor generics and biosimilars, constraining growth for branded formulations.
• Regulatory Environment: Slow approval and adoption of new HCV therapies impact future sales.

Key Takeaways

• Zepatier, combining elbasvir and grazoprevir, experienced peak sales shortly after launch, with a rapid decline driven by market saturation and competition.
• Current sales are primarily from mature markets; growth prospects hinge on patent status and pipeline advancements.
• Pricing pressures and regional preferences favor generics, eroding potential profitability.
• The absence of new indications or formulations limits future revenue growth.
• Strategic focus should shift from sales expansion to lifecycle management, including new formulations, indications, or combination therapies.

FAQs

1. Will Zepatier regain market share?
Unlikely without new indications or significantly reduced pricing; market saturation and competition dominate current dynamics.

2. Are generic versions a threat?
Yes. Patent expirations and licensing agreements enable generic manufacturers, especially in emerging markets, to capture market share.

3. Is there a pipeline for new HCV treatments involving elbasvir or grazoprevir?
No substantial pipeline updates focus on these molecules specifically; Pfizer has shifted R&D emphasis elsewhere.

4. How do regional policies affect sales?
Regions with strict formulary control and price negotiation limit sales of branded drugs like Zepatier.

5. What recommendations exist for investors or R&D strategists?
Prioritize pipeline innovation, explore lifecycle extension strategies, and monitor regional market developments for potential opportunities.

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References

1. FDA. (2016). Zepatier (elbasvir and grazoprevir) approval announcement.
2. IQVIA. (2022). Global Hepatitis C Virus Treatment Market Report.
3. Pfizer. (2022). Annual financial reports and sales disclosures.
4. WHO. (2022). Hepatitis C Fact Sheet.
5. MarketWatch. (2023). Drug pricing trends and generics impact analysis.