Tazemetostat hydrobromide - Generic Drug Details

What are the generic sources for tazemetostat hydrobromide and what is the scope of freedom to operate?

Tazemetostat hydrobromide is the generic ingredient in one branded drug marketed by Epizyme Inc and is included in one NDA. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazemetostat hydrobromide has four hundred and six patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for tazemetostat hydrobromide

International Patents:	406
US Patents:	27
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tazemetostat hydrobromide
DailyMed Link:	tazemetostat hydrobromide at DailyMed

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

Constraining patent/regulatory exclusivity:

10,786,511

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 tazemetostat hydrobromide

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
National Cancer Institute (NCI)	Phase 1/Phase 2

See all tazemetostat hydrobromide clinical trials

Pharmacology for tazemetostat hydrobromide

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

Anatomical Therapeutic Chemical (ATC) Classes for tazemetostat hydrobromide

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for tazemetostat hydrobromide

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	9,090,562		Y	Y
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	10,369,155
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,889,138

International Patents for tazemetostat hydrobromide

Country	Patent Number	Title	Estimated Expiration
China	108358899
South Korea	101955871
European Patent Office	3628670	FORME SALINE POUR INHIBITION DE EZH2 (SALT FORM FOR EZH2 INHIBITION)

Market Dynamics and Financial Trajectory for Tazemetostat Hydrobromide

Last updated: July 27, 2025

Introduction

Tazemetostat hydrobromide, marketed as Tazverik, is an advanced epigenetic therapy developed by Epizyme, Inc. It functions as an EZH2 (Enhancer of Zeste Homolog 2) inhibitor targeting specific genetic mutations associated with certain cancers. Since its FDA approval in January 2020 for epithelioid sarcoma and follicular lymphoma, Tazemetostat's market trajectory has garnered considerable interest from pharmaceutical firms, investors, and healthcare providers. As an innovative agent within the expanding oncology landscape, it embodies both promising therapeutic potential and distinctive market challenges.

Market Overview

The global oncology drug market surpassed USD 200 billion in 2021, with targeted therapies comprising a significant growth segment, projected to expand at a compound annual growth rate (CAGR) exceeding 8% through 2028 [1]. Tazemetostat's niche—targeting rare and genetically defined cancers—positions it favorably within this framework, especially as precision medicine gains momentum.

Indications and Patient Population

Primarily approved for epithelioid sarcoma and relapsed follicular lymphoma, Tazemetostat's indications encompass rare cancers with high unmet needs. The epithelioid sarcoma market is small but significant, with approximately 50-70 new cases annually in the U.S. [2]. Follicular lymphoma, being more prevalent, accounts for a substantial portion of indolent non-Hodgkin’s lymphomas, with an estimated incidence of 6.4 per 100,000 persons [3]. This indicates a sizable subset of patients who could benefit from EZH2-targeted therapies, albeit within a competitive landscape.

Competitive Landscape

Tazemetostat faces competition from other epigenetic and targeted therapies. Notably, other EZH2 inhibitors, such as GSK2816126 and CPI-1205, are in various stages of clinical development. Additionally, the broader targeted therapy market includes immunotherapies and monoclonal antibodies for similar indications. Nonetheless, Tazemetostat’s first-to-market approval confers a significant competitive advantage, reinforcing its occupancy in the niche market.

Pricing and Reimbursement

The wholesale acquisition cost (WAC) for Tazverik is approximately USD 16,000 per month, aligning with other targeted cancer therapies [4]. Reimbursement dynamics hinge on coverage by Medicare, Medicaid, and private insurers, which have generally been favorable given its orphan drug status and significant unmet need.

Market Drivers

Unmet Medical Needs

Rare cancers like epithelioid sarcoma have limited treatment options. Tazemetostat provides a targeted approach with a tolerable safety profile, driving demand. The FDA’s accelerated approval pathway further underscores its medical importance.

Regulatory Approvals and Expansions

Post-approval, ongoing clinical trials aim to expand indications, including diffuse large B-cell lymphoma and other solid tumors. Positive trial outcomes could significantly enlarge the target patient pool.

Pharmaceutical Partnerships

Epizyme entered licensing agreements, notably with Daiichi Sankyo, to co-develop and commercialize Tazemetostat in multiple territories. Such collaborations facilitate broader access and accelerate market penetration.

Genetic Testing and Precision Oncology

Increasing adoption of genetic profiling enables the identification of EZH2 mutations, ensuring appropriate patient selection for Tazemetostat therapy. This trend amplifies the drug’s clinical utility and market demand.

Market Challenges

Market Penetration and Adoption

Despite regulatory approvals, physician familiarity and cost considerations may delay widespread adoption. Education regarding EZH2 mutation testing is paramount.

Pricing Pressures and Access

High drug prices may face pushback from payers and health authorities, especially in cost-conscious markets. Outcomes-based reimbursement models may influence long-term market share.

Competitive Innovations

Emergence of alternative therapies, especially immunotherapies with broader efficacy, could encroach upon Tazemetostat’s niche, requiring strategic positioning and evidence generation.

Supply Chain and Manufacturing

Complex synthesis and stability considerations for epigenetic inhibitors may impact production scalability, influencing market supply and costs.

Financial Trajectory

Revenue Projections

Epizyme estimated Tazverik's 2022 revenues at roughly USD 130 million, with projections indicating a rapid growth trajectory—anticipating USD 250–350 million by 2025 as indications expand and market access improves [5].

Market Expansion Strategies

Global commercialization plans, including approvals in Europe and Asia, are critical for revenue growth. In 2022, the European Medicines Agency (EMA) granted conditional marketing authorization for Tazverost in Europe, signaling strategic global market entry.

Research and Development Investment

Investments continue into combination therapies and expanded indications, promising to diversify revenue streams and solidify Tazemetostat's market presence.

Cost and Margin Considerations

While initial margins may be influenced by R&D investments and manufacturing costs, economies of scale and generic competition post-patent expiry are anticipated to reduce prices, affecting revenue streams in the long term.

Regulatory and Market Outlook

The outlook for Tazemetostat remains cautiously optimistic. The expanding indication portfolio, along with increasing use in genomic-guided therapy, is poised to drive sustained growth. However, competitive pressures, pricing dynamics, and regulatory considerations must be navigated prudently.

Key Market Dynamics Summary

• Growth Drivers: Orphan and precision medicine focus, expanding indications, clinical trial success, strategic alliances.
• Constraints: High cost, limited initial adoption, competition, and regulatory hurdles.
• Opportunities: Emphasis on biomarker-driven strategies, combination regimens, and geographic expansion.
• Challenges: Market penetration, payer negotiations, manufacturing scalability.

Conclusion

Tazemetostat hydrobromide's evolution from a niche epigenetic therapy to a potentially cornerstone treatment in targeted oncology hinges on multiple factors. Its foundational role in treating rare cancers, coupled with expanding indications and strategic global deployment, positions it for robust financial growth. Nonetheless, attentive management of competitive, regulatory, and market access challenges remains critical for maximizing its commercial potential.

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Key Takeaways

• Tazemetostat's FDA approval and orphan drug designation provide a competitive edge in rare cancers.
• The drug's primary markets include epithelioid sarcoma and follicular lymphoma, with potential expansion.
• High pricing strategies align with targeted oncology therapies but may face reimbursement challenges.
• Clinical trials for additional indications and combination therapies could significantly boost revenues.
• Strategic geographic expansion and genetic testing integration are vital to global market growth.

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FAQs

1. What is Tazemetostat hydrobromide’s primary mechanism of action?
   It inhibits EZH2, an enzyme involved in epigenetic regulation, thereby reducing aberrant gene silencing associated with certain cancers.

2. In which cancers is Tazemetostat currently approved?
   It is approved for epithelioid sarcoma and relapsed or refractory follicular lymphoma harboring specific EZH2 mutations.

3. What are the main competitive advantages of Tazemetostat?
   First-to-market status, targeting genetically defined cancers, an oral administration route, and favorable safety profile.

4. What are the key market challenges Tazemetostat faces?
   Market penetration barriers, high drug pricing, competition from emerging therapies, and regulatory hurdles in other regions.

5. What is the outlook for Tazemetostat’s revenue growth?
   Expect moderate to rapid growth through indication expansion, regional approvals, and broader genetic testing adoption, with revenues potentially reaching USD 350 million by 2025.

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References

[1] MarketWatch. "Global Oncology Drugs Market Size, Share & Trends Analysis." 2022.
[2] National Cancer Institute. "Epithelioid Sarcoma Overview." 2021.
[3] American Cancer Society. "Non-Hodgkin Lymphoma Incidence." 2021.
[4] Epizyme. "Tazverik (Tazemetostat) Pricing." 2022.
[5] Epizyme Financial Reports. "Q4 2022 and Full Year Results." 2023.