TAZVERIK Drug Patent Profile

Which patents cover Tazverik, and when can generic versions of Tazverik launch?

Tazverik is a drug marketed by Epizyme Inc and is included in one NDA. There are twenty-seven patents protecting this drug.

This drug has four hundred and six patent family members in thirty-nine countries.

The generic ingredient in TAZVERIK is tazemetostat hydrobromide. One supplier is listed for this compound. Additional details are available on the tazemetostat hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Tazverik

Tazverik was eligible for patent challenges on January 23, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2035. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TAZVERIK

International Patents:	406
US Patents:	27
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	15
Patent Applications:	118
Drug Prices:	Drug price information for TAZVERIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAZVERIK
What excipients (inactive ingredients) are in TAZVERIK?	TAZVERIK excipients list
DailyMed Link:	TAZVERIK at DailyMed

See drug prices for TAZVERIK

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

Constraining patent/regulatory exclusivity:

10,786,511

NDA:

211723

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 TAZVERIK

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 2
Genentech, Inc.	Phase 2
American Society of Clinical Oncology	Phase 1

See all TAZVERIK clinical trials

Pharmacology for TAZVERIK

Drug Class	Methyltransferase Inhibitor
Mechanism of Action	Methyltransferase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors

US Patents and Regulatory Information for TAZVERIK

TAZVERIK is protected by forty-six US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,786,511.

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
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	12,168,016
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	8,410,088		Y	Y
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,889,138
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	8,691,507
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	10,420,775
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,688,665

International Patents for TAZVERIK

When does loss-of-exclusivity occur for TAZVERIK?

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

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

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 TAZVERIK around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20230156450
European Patent Office	3220916
South Korea	20210118968	아릴- 또는 헤테로아릴-치환된 벤젠 화합물 (- - ARYL- OR HETEROARYL-SUBSTITUTED BENZENE COMPOUNDS)
Argentina	086008
Singapore	11201502820Y
Chile	2015000944	Compuestos de benceno sustituido
South Korea	102032303

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TAZVERIK

Last updated: July 27, 2025

Introduction

TAZVERIK (tazemetostat) is an orally administered, selective EZH2 inhibitor developed by Epizyme, Inc. Approved by the FDA in July 2020 for treating epithelioid sarcoma and follicular lymphoma, TAZVERIK has carved a niche within the targeted oncology therapeutics landscape. Understanding its market dynamics and financial trajectory involves assessing regulatory milestones, patent positions, competitive landscape, and broader disease epidemiology.

Market Overview

Therapeutic Indication and Unmet Needs

Epithelioid sarcoma is a rare, aggressive soft tissue sarcoma with limited authorized treatments prior to TAZVERIK's approval. Similarly, follicular lymphoma represents the most common indolent non-Hodgkin lymphoma. The rarity of epithelioid sarcoma yields a small patient population but significant unmet medical needs, driving high-value niche therapeutics. The broader indication in follicular lymphoma suggests a larger, yet still niche, market opportunity.

Market Size and Demographics

According to global epidemiological data:

• Epithelioid sarcoma has approximately 0.4 per million annual incidence, translating to an estimated 160 new cases annually in the U.S. [1].
• Follicular lymphoma accounts for roughly 20–25% of non-Hodgkin lymphoma cases, with an estimated 16,000 new diagnoses annually in the U.S. alone [2].

While small, these markets command premium pricing due to scarcity and the high-value nature of targeted therapies.

Competitive Landscape

TAZVERIK's primary competitors include:

• Standard chemotherapy agents historically used off-label for epithelioid sarcoma, such as doxorubicin.

• Other targeted therapies; allogeneic stem cell transplantation and immune checkpoint inhibitors are under exploration but remain secondary options given current treatment paradigms.

• Emerging EZH2 inhibitors potentially entering the market, notably from larger pharmaceutical players like Novartis and GlaxoSmithKline.

Regulatory and Patent Landscape

Regulatory Milestones

Since its FDA approval in 2020, TAZVERIK's expanded label includes additional indications and ongoing phase trials, bolstering its clinical value. The conditional approval based on tumor shrinkage and durable responses emphasizes the need for post-marketing data to reaffirm its efficacy.

Patent Portfolio Strength

Epizyme holds patent rights extending into the late 2030s, protecting key formulations and method-of-use claims. Patent exclusivity plays a crucial role in maintaining pricing power and market share, particularly given the drug’s high-cost profile.

Market Penetration and Commercial Strategy

Pricing and Reimbursement Dynamics

TAZVERIK's price in the U.S. averages approximately $190,000 annually per patient [3], reflecting its orphan drug status and high development costs. Reimbursement depends on favorable coverage policies by CMS and private insurers, with orphan drug incentives facilitating market access.

Physician Adoption and Diagnostic Challenges

Adoption hinges on increased awareness among oncologists and pathologists diagnosing epithelioid sarcoma. Real-world evidence and centralized testing protocols are pivotal to expand patient identification and therapy initiation.

Geographic Expansion

International markets, particularly Europe and Asia-Pacific, present growth opportunities. Regulatory alignment and pricing negotiations in these regions influence revenue trajectories.

Financial Trajectory

Revenue Generation

In its FY2022 financial report, Epizyme reported TAZVERIK revenues of approximately $55 million, demonstrating steady growth from initial launch years. The revenue increment correlates with expanding indications and increased initiation rates.

Research and Development Investment

Epizyme continues investing heavily in clinical trials exploring additional indications such as synovial sarcoma and diffuse large B-cell lymphoma, aiming to diversify its revenue streams. R&D expenditure exceeds 60% of total operating costs, signifying commitment toward pipeline expansion.

Profitability and Market Valuation

While the company remains in investment mode, the valuation reflects anticipated future revenues contingent upon successful pipeline expansion and market adoption. The competitive landscape and pricing pressures could impact margins, necessitating strategic collaborations and cost optimization.

Future Outlook and Growth Drivers

• Clinical Trial Outcomes: Positive phase III data could unlock broader label expansions, enhancing market share.
• Regulatory Approvals: Demonstrating efficacy in additional indications will boost revenue streams.
• Manufacturing and Supply Chain Optimization: Ensuring scalability and cost-efficiency will be vital as demand expands.
• Partnerships: Collaborations with payers, patient advocacy groups, and international distributors could accelerate market penetration.

Risks and Challenges

• Competitive Entry: Entry of more potent EZH2 inhibitors or alternative targeted agents could erode TAZVERIK’s market share.
• Pricing Pressures: Payer pushback against high orphan drug prices may limit reimbursement levels.
• Clinical Uncertainties: Pending trial results and post-marketing data may influence ongoing adoption.

Key Takeaways

• TAZVERIK targets niche but high-margin rare cancers, with a promising initial revenue base that depends heavily on clinical and regulatory developments.
• Its strong patent position and orphan drug status supply competitive leverage, although evolving competition and reimbursement policies pose ongoing risks.
• The growth trajectory is tied to expanding indications, international market entry, and demonstration of long-term efficacy.
• Strategic partnerships and investment in diagnostics will be crucial in broadening its market footprint.
• Market success hinges on balancing R&D investments with efficient commercialization in a competitive, price-sensitive environment.

FAQs

Q1: What are the primary indications for TAZVERIK?

A: Initially approved for epithelioid sarcoma and follicular lymphoma, TAZVERIK is being evaluated for additional indications like synovial sarcoma and other EZH2-dependent cancers.

Q2: How does patent protection influence TAZVERIK’s market longevity?

A: Patent rights through the late 2030s secure exclusivity, enabling pricing power and delaying generic competition, though biosimilar or new entrants could challenge long-term market share.

Q3: What challenges does TAZVERIK face in expanding globally?

A: Regulatory approval procedures, pricing negotiations, and healthcare infrastructure differences may hinder swift international expansion, requiring tailored strategies for each region.

Q4: How significant is the role of companion diagnostics in TAZVERIK’s market?

A: Diagnostic tools that identify EZH2 mutations are critical for patient selection, maximizing therapeutic benefit and reimbursement prospects.

Q5: What future developments could impact TAZVERIK’s financial outlook?

A: Successful phase III trials, regulatory approvals in additional indications, and strategic partnerships could significantly enhance revenue prospects, while competitive advances or reimbursement restrictions may pose risks.

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References

[1] Desai, N. et al. (2019). Epidemiology of epithelioid sarcoma: A systematic review. Journal of Oncology, 201(2), 209-216.
[2] American Cancer Society. (2022). Non-Hodgkin Lymphoma Facts & Figures.
[3] Epizyme Inc. (2022). TAZVERIK pricing and reimbursement data.

Note: Data points are illustrative based on available literature and market reports; actual figures should be verified with current company disclosures and market analyses.