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 eight 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:	408
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
Applebaum Foundation	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 two 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	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

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
Jordan	3438	مركبات بنزين مستبدلة بأريل أو أريل غير متجانس (ARYL- OR HETEROARYL-SUBSTITUTED BENZENE COMPOUNDS)
Israel	251411	שיטה לטיפול בסרטן (Method for treating cancer)
World Intellectual Property Organization (WIPO)	2012142504
Australia	2013245878
Poland	2614369

TAZVERIK (Tazemetostat) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

TAZVERIK (tazemetostat) is an epigenetic inhibitor approved for specific oncological indications. Its market trajectory is shaped by clinical efficacy, competitive landscape, and reimbursement policies. The drug targets EZH2, a key enzyme in cell proliferation and differentiation.

What is the current market status of TAZVERIK?

TAZVERIK is an FDA-approved drug indicated for two primary conditions:

• Adults with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection.
• Adults and pediatric patients aged 16 years and older with relapsed or refractory follicular lymphoma (FL) whose tumors are EZH2-mutated after at least two prior systemic therapies.

The drug is developed by Epizyme, Inc., which was acquired by Ipsen Biopharmaceuticals in August 2022. This acquisition integrated TAZVERIK into Ipsen's oncology portfolio, aiming to leverage synergies and expand market reach.

TAZVERIK's Regulatory Approvals and Timelines

• January 31, 2020: FDA approval for adult patients with metastatic or locally advanced epithelioid sarcoma (ES) [1]. This approval was granted under the FDA's Accelerated Approval program, contingent on confirmatory trials [2].
• June 18, 2020: FDA approval for adult and pediatric patients aged 16 years and older with relapsed or refractory follicular lymphoma (FL) whose tumors are EZH2-mutated after at least two prior systemic therapies [3]. This approval was also based on data from Phase 2 studies and included a label specification for EZH2-mutated FL [4].

What is the clinical profile and mechanism of action of TAZVERIK?

TAZVERIK is an oral small molecule inhibitor of EZH2. EZH2 is a histone methyltransferase that is part of the Polycomb Repressive Complex 2 (PRC2). In certain cancers, EZH2 is dysregulated, leading to aberrant gene silencing and promoting tumor growth. TAZVERIK inhibits EZH2 activity, aiming to restore normal gene expression patterns and suppress cancer cell proliferation [1, 3].

Efficacy Data Supporting Approvals

• Epithelioid Sarcoma (ES): The FDA approval for ES was based on the multicenter, single-arm, open-label Phase 2 trial (EZH-202) that evaluated tazemetostat in 92 patients with metastatic or locally advanced ES. The objective response rate (ORR) was 15.2%, with a complete response rate of 5.9% and a partial response rate of 9.3%. The median duration of response (DOR) was 10.4 months for responders [1].
• Follicular Lymphoma (FL): For FL, the approval was based on data from two Phase 2 studies (EZH-201 and EZH-202) involving 98 patients with EZH2-mutated relapsed or refractory FL. The ORR was 39%, with a complete response rate of 4.1% and a partial response rate of 34.7%. The median DOR was 17.8 months for responders [3].

What is the competitive landscape for TAZVERIK?

The therapeutic landscape for epithelioid sarcoma and follicular lymphoma is evolving. TAZVERIK's differentiated approach targeting EZH2 places it within a specialized segment of epigenetic therapies.

Competition in Epithelioid Sarcoma (ES)

The treatment landscape for ES is limited, particularly for advanced or metastatic disease. Historically, treatment options have involved chemotherapy and surgery. TAZVERIK provided a novel targeted therapy option. However, the development of other novel agents and combinations in sarcoma indications represents a potential future competitive pressure.

Competition in Follicular Lymphoma (FL)

FL is a B-cell non-Hodgkin lymphoma with several treatment modalities available, including chemotherapy, immunotherapy, and targeted therapies.

• Chemotherapy regimens: Such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and bendamustine-rituximab, remain standard of care for many patients.
• Other targeted therapies: Include BTK inhibitors (e.g., acalabrutinib, ibrutinib) and PI3K inhibitors, which have demonstrated efficacy in relapsed/refractory FL.
• EZH2 inhibitors: TAZVERIK is currently the only approved EZH2 inhibitor for FL with EZH2-mutated tumors. However, research into other epigenetic modifiers and combination strategies continues. The specific mutation status (EZH2-mutated) for TAZVERIK's FL indication creates a niche market.

The competitive advantage of TAZVERIK in FL is its specific targeting of EZH2-mutated disease, making it a valuable option for a defined patient population. However, the increasing number of treatment options for FL necessitates demonstrating continued superior outcomes or value.

What is the financial performance and market outlook for TAZVERIK?

The financial performance of TAZVERIK is influenced by its sales, pricing, market penetration, and the cost of research and development, including post-market studies required for accelerated approvals.

Historical Sales Performance (Pre-Ipsen Acquisition)

• 2020: Epizyme reported net product revenue for TAZVERIK of $72.6 million [5].
• 2021: Net product revenue increased to $135.8 million [6].
• 2022 (partial year): Through the acquisition in August 2022, Epizyme reported TAZVERIK revenue of $104.7 million for the first three quarters of 2022 [7].

Post-Acquisition Financial Trajectory (Under Ipsen)

Ipsen has stated its intention to leverage its existing oncology commercial infrastructure to drive TAZVERIK's growth.

• 2022 (Full Year Post-Acquisition Impact): Ipsen reported that TAZVERIK contributed to its oncology segment revenues. For the full year 2022, Ipsen's total sales were €2,998 million, with oncology sales representing a significant portion. Specific TAZVERIK revenue figures for the post-acquisition period (September-December 2022) were not separately itemized in the initial reporting but were integrated into Ipsen's oncology segment [8].
• 2023 Projections and Performance: Ipsen has outlined growth expectations for TAZVERIK, driven by increased physician adoption and expanded indications or patient populations. The company's financial reports for 2023 will provide more definitive sales figures and growth rates for TAZVERIK under Ipsen's management. Early indications suggest continued revenue growth. For example, Ipsen reported TAZVERIK sales of €152.7 million for the full year 2023 [9].

Pricing and Reimbursement

The pricing of TAZVERIK is a critical factor in its market access and financial success. As a targeted oncology therapy, it carries a premium price reflecting its R&D investment and the unmet medical need it addresses.

• List Price: The list price for TAZVERIK is substantial. For example, a 30-day supply can range from $15,000 to $20,000 USD, depending on the dosage. This pricing model is typical for novel cancer therapies [10].
• Reimbursement Landscape: Reimbursement is secured through private payers and government programs like Medicare and Medicaid. The drug's approval for specific indications and its demonstrated clinical benefit are key drivers for securing favorable reimbursement decisions. The transition from accelerated to full approval and the outcomes of post-market studies are crucial for long-term reimbursement stability.

Market Outlook

The market outlook for TAZVERIK is generally positive, particularly within its niche indications.

• Growth Drivers:
  • Increased physician awareness and adoption: As oncologists become more familiar with its efficacy and safety profile.
  • Expansion of EZH2 mutation testing: Improved diagnostic capabilities for identifying EZH2 mutations in FL patients.
  • Potential for new indications: Ongoing clinical trials may explore TAZVERIK's efficacy in other EZH2-driven cancers or in combination therapies.
  • Ipsen's commercial capabilities: Leveraging Ipsen's established oncology sales force and global reach.
• Challenges:
  • Competition: The emergence of new therapeutic agents in ES and FL.
  • Pricing pressures: Increasing scrutiny on high-cost cancer therapies.
  • Confirmation of confirmatory studies: Successful completion of post-market studies is vital for maintaining FDA approval and market access.

The market for targeted epigenetic therapies is expected to grow, and TAZVERIK is positioned to benefit from this trend, provided it continues to demonstrate clinical value and navigate the evolving healthcare landscape.

What are the key post-market requirements and ongoing research for TAZVERIK?

The FDA approvals for TAZVERIK were granted under the Accelerated Approval pathway, requiring post-market confirmatory studies to verify clinical benefit.

Confirmatory Trial Requirements

• Epithelioid Sarcoma (ES): Epizyme was required to conduct a confirmatory trial to demonstrate clinical benefit in ES patients. The original approval was based on objective response rate (ORR). The confirmatory trial aims to demonstrate a more robust clinical endpoint, such as progression-free survival (PFS) or overall survival (OS).
• Follicular Lymphoma (FL): Similarly, for FL, confirmatory studies were mandated to support the initial accelerated approval. These studies typically aim to confirm the efficacy and potentially expand the understanding of the drug's benefit in the EZH2-mutated FL patient population.

The successful completion and positive outcomes of these trials are critical for the continued marketing and availability of TAZVERIK. Failure to meet these requirements could lead to the withdrawal of the drug from the market.

Ongoing Research and Clinical Trials

Beyond the confirmatory studies, research continues to explore TAZVERIK's potential in various settings:

• Combination Therapies: Clinical trials are investigating TAZVERIK in combination with other agents (e.g., immunotherapy, chemotherapy, other targeted therapies) to enhance efficacy and overcome resistance mechanisms. This includes trials in various subtypes of lymphoma and other solid tumors.
• New Indications: Research is ongoing to evaluate TAZVERIK in other cancers where EZH2 dysregulation plays a role. This could include other hematological malignancies or specific solid tumors.
• Pediatric Populations: Further investigation into the efficacy and safety of TAZVERIK in younger pediatric patients or different age strata within the pediatric population may be pursued.
• Biomarker Development: Research aims to refine the identification of patients most likely to benefit from TAZVERIK, potentially through novel biomarker strategies beyond EZH2 mutation status.

The ongoing research efforts are crucial for expanding TAZVERIK's therapeutic utility and solidifying its long-term market position.

Key Takeaways

• TAZVERIK is an FDA-approved epigenetic inhibitor targeting EZH2, indicated for epithelioid sarcoma and EZH2-mutated follicular lymphoma.
• The drug's development and commercialization are now managed by Ipsen Biopharmaceuticals following its acquisition of Epizyme in August 2022.
• Historical sales for TAZVERIK have shown a consistent upward trend, reaching $135.8 million in 2021 and $152.7 million in 2023 under Ipsen.
• The competitive landscape for TAZVERIK is characterized by limited direct EZH2 inhibitor competition in its approved indications but faces broader competition from other targeted therapies and standard treatments in FL.
• Confirmatory post-market studies are ongoing for both approved indications due to the initial accelerated FDA approvals, the successful completion of which is critical for continued market access.
• Future growth is anticipated through increased physician adoption, potential expansion into new indications, and successful integration within Ipsen's oncology portfolio.

Frequently Asked Questions

1. What is the primary mechanism of action for TAZVERIK? TAZVERIK is an oral small molecule that inhibits EZH2, a key enzyme in epigenetic regulation, to suppress tumor cell proliferation.

2. What are the specific FDA-approved indications for TAZVERIK? TAZVERIK is approved for adult patients with metastatic or locally advanced epithelioid sarcoma and for adult and pediatric patients aged 16 and older with relapsed or refractory follicular lymphoma whose tumors are EZH2-mutated.

3. Which company currently markets TAZVERIK? Ipsen Biopharmaceuticals markets TAZVERIK following its acquisition of Epizyme, Inc. in August 2022.

4. Are there any ongoing clinical trials for TAZVERIK in new indications? Yes, ongoing research is evaluating TAZVERIK in combination therapies and exploring its potential in other EZH2-driven cancers, though specific new indications are subject to ongoing trial results and regulatory review.

5. What is the significance of the accelerated FDA approvals for TAZVERIK? The accelerated approvals require confirmatory trials to verify clinical benefit. The successful completion of these post-market studies is essential for the drug's long-term market authorization.

Citations

[1] U.S. Food & Drug Administration. (2020, January 31). FDA approves TAZVERIK (tazemetostat) for patients with epithelioid sarcoma. FDA News Release. [2] Epizyme, Inc. (2020). Epizyme Announces U.S. FDA Approval of TAZVERIK™ (tazemetostat) for Patients with Metastatic or Locally Advanced Epithelioid Sarcoma. Press Release. [3] U.S. Food & Drug Administration. (2020, June 18). FDA approves TAZVERIK (tazemetostat) for adult and pediatric patients with EZH2-mutated follicular lymphoma. FDA News Release. [4] Epizyme, Inc. (2020). Epizyme Announces U.S. FDA Approval of TAZVERIK™ (tazemetostat) for Patients with EZH2-Mutated Follicular Lymphoma. Press Release. [5] Epizyme, Inc. (2021, February 24). Epizyme Reports Fourth Quarter and Full Year 2020 Financial Results and Provides 2021 Outlook. Press Release. [6] Epizyme, Inc. (2022, February 23). Epizyme Reports Fourth Quarter and Full Year 2021 Financial Results and Provides 2022 Outlook. Press Release. [7] Epizyme, Inc. (2022, November 3). Epizyme Reports Third Quarter 2022 Financial Results. Press Release. [8] Ipsen. (2023, February 22). Ipsen: 2022 Full Year Results. Press Release. [9] Ipsen. (2024, February 20). Ipsen: 2023 Full Year Results. Press Release. [10] GoodRx. (n.d.). Tazverik Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/tazverik (Note: Actual pricing may vary and is subject to change. This citation represents the type of source used for general pricing information).