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		RX	Yes	Yes	7,973,040		Y	Y
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes	8,871,759		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 Africa	201309504
Montenegro	02024
European Patent Office	2410844
World Intellectual Property Organization (WIPO)	2010111483
Israel	215094

Supplementary Protection Certificates for ELBASVIR; GRAZOPREVIR

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

Market Dynamics and Financial Trajectory for Elbasvir and Grazoprevir

Last updated: July 28, 2025

Introduction

Elbasvir and grazoprevir are a combination antiviral therapy developed to combat hepatitis C virus (HCV) infections. Market dynamics for this therapeutic duo are shaped by factors such as evolving medical guidelines, the landscape of existing treatments, and the strategic moves of pharmaceutical firms. Understanding their financial trajectory involves analyzing recent sales trends, patent statuses, regulatory approvals, and competitive positioning within a rapidly changing market.

---

Overview of Elbasvir and Grazoprevir

Elbasvir is an NS5A inhibitor, and grazoprevir is an NS3/4A protease inhibitor. Their combination, marketed as Zepatier by Merck & Co., was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of chronic HCV genotype 1 and 4 infections. The therapy offers a simplified, once-daily oral regimen, with a favorable safety profile and shorter treatment duration compared to previous options.

---

Market Landscape and Key Drivers

1. Competition and Alternative Therapies

The HCV market has experienced profound transformation over the past decade. Pioneering direct-acting antivirals (DAAs), including sofosbuvir (Sovaldi), led the initial wave, followed by a proliferation of fixed-dose combinations such as Harvoni, Epclusa, and Mavyret. These competitors often boast higher efficacy, broader genotype coverage, and shorter durations, creating intense price and market share pressures for elbasvir/grazoprevir.

2. Patent Protection and Market Exclusivity

Merck’s Zepatier faced patent challenges, with regulatory exclusivity expected to broaden until 2026, though some patents began expiring earlier. The expiration of key patents typically precipitates generic entry, dramatically diminishing revenue potential. Continued patent litigations and the safeguarding of orphan or combination patents remain vital to sustaining market share.

3. Pricing and Reimbursement Trends

Pricing strategies significantly influence the drug’s financial trajectory. Zepatier’s initial high price points faced pushback amidst escalated pressure from payers seeking cost-effective alternatives. Simplified treatment regimens and expanding insurance coverage impact reimbursement levels, ultimately affecting sales volume.

4. Diagnostic and Market Penetration Factors

Colorful geographic disparities exist regarding access and diagnosis. Areas with robust screening programs facilitate higher demand, while regions with limited testing and healthcare infrastructure diminish market potential. Ongoing efforts to improve detection of HCV contribute to modest growth prospects.

---

Financial Performance and Trajectory Analysis

1. Sales Trends

Merck’s Zepatier experienced a peak in worldwide sales shortly after launch, with annual revenues estimated at approximately $650 million in 2017. Subsequently, sales declined sharply due to increased competition and patent challenges [1]. In 2019, annual sales had fallen below $200 million, with further reductions projected absent significant market expansion or label diversification.

2. Decline Factors

Key contributors to revenue decline include:

• The entry of superior or more comprehensive therapies
• Patent challenges and impending patent expiries
• Lower treatment initiation in certain populations due to existing regimens
• Pricing pressures in developed markets

3. Current and Future Outlook

Given patent expirations and market saturation, the financial outlook for elbasvir and grazoprevir is cautiously modest. Merck has shifted focus toward innovative therapies and combination regimens. However, niche applications, such as in patients intolerant to other DAAs or in specific genotypes, maintain some revenue streams.

---

Regulatory and Strategic Considerations

1. Regulatory Approvals and Expanded Indications

While originally approved for genotypes 1 and 4, ongoing trials aim to broaden indications. Regulatory marketing extensions and approval for special populations might inject limited upside. Nonetheless, these efforts encounter stiff competition from newer-generation therapies.

2. Pipeline and Lifecycle Management

Merck’s cardiovascular and antiviral pipelines prioritize expanded indications and drug combinations. Lifecycle management strategies, such as fixed-dose combination updates, aim to prolong the profitability window of existing assets.

---

Implications for Stakeholders

Manufacturers: The decline in sales underscores the necessity for innovation, patent protection, and strategic licensing or partnership agreements to sustain revenue.

Investors: The initial high-growth phase for elbasvir/grazoprevir has largely plateaued. Valuation adjustments should factor in patent expiry timelines, market share erosion, and competitive positioning.

Healthcare Systems: Cost pressures motivate shifting preferences toward more effective and cost-efficient therapies, influencing formulary decisions and reimbursement policies.

---

Key Market Challenges and Opportunities

• The advent of pan-genotypic therapies with higher efficacy and shorter durations presents a major threat to elbasvir/grazoprevir.
• Patent expiries underscore the importance of developing next-generation treatments and biosimilars.
• Geographic expansion and targeted marketing for niche indications could slightly enhance financial contributions.
• The integration into combination regimens with other DAAs offers some potential for renewed relevance.

---

Conclusion

The market dynamics for elbasvir and grazoprevir reveal a trajectory characterized by rapid initial growth followed by an accelerated decline driven by competition, patent expirations, and evolving treatment paradigms. While current revenues are subdued, strategic adaptations—such as pipeline diversification and niche targeting—could mitigate some financial erosion. Stakeholders should continuously monitor regulatory developments, competitive innovations, and pricing trends to navigate this complex landscape effectively.

---

Key Takeaways

• Early market dominance: Initial launch of Zepatier generated significant revenues, but subsequent competition rapidly diminished its market share.
• Patent and exclusivity expiration: Patent expirations slated for 2024–2026 threaten further revenue decline; proactive lifecycle management is essential.
• Competitive pressures: The rise of pan-genotypic regimens and superior combination therapies has reduced the drug’s attractiveness.
• Market penetration challenges: Geographic and diagnostic barriers limit growth potential; targeted strategies are necessary.
• Future prospects: Maintaining niche indications and pipeline innovation are critical to sustain financial relevance amid intense competition.

---

FAQs

1. What are the main factors contributing to the decline of elbasvir/grazoprevir sales?
Competition from newer, more effective DAAs, patent expirations, pricing pressures, and market saturation have led to declining sales.

2. How does patent expiration influence the financial trajectory of these drugs?
Patent expiry allows generic competitors to enter the market, often resulting in significant revenue loss due to price erosion and reduced market share.

3. Are there ongoing efforts to expand the indications for elbasvir and grazoprevir?
Yes, clinical trials aim to evaluate their efficacy in broader genotypes and special populations, but regulatory approvals for expanded indications are yet unresolved or limited.

4. How does competition from pan-genotypic therapies affect the future prospects of Zepatier?
Pan-genotypic therapies, offering simplified treatment across multiple genotypes with high efficacy, diminish the demand for genotype-specific regimens like Zepatier.

5. Can strategic licensing or combination therapy development extend the financial lifespan of elbasvir/grazoprevir?
Potentially, if partnered with innovative treatments or incorporated into combination regimens with better efficacy, they can sustain relevance, but such strategies face stiff competition and regulatory hurdles.

---

References

1. [1] Statista. "Global hepatitis C virus (HCV) market share analysis." 2022.