TAZEMETOSTAT HYDROBROMIDE - Generic Drug Details

What are the generic sources for tazemetostat hydrobromide and what is the scope of patent protection?

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 eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for TAZEMETOSTAT HYDROBROMIDE

International Patents:	408
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	9,549,931
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	10,821,113		Y	Y
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,333,217
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,394,283		Y	Y

International Patents for TAZEMETOSTAT HYDROBROMIDE

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

Market Dynamics and Financial Trajectory for Tazemetostat Hydrobromide

Last updated: February 13, 2026

Overview

Tazemetostat hydrobromide is an EZH2 inhibitor developed by Epizyme Inc. It received FDA approval in January 2020 for treatment of epithelioid sarcoma (ES) and follicular lymphoma (FL) with specific indications. It targets cancers driven by EZH2 mutations or overexpression, positioning within the oncological treatment landscape.

Regulatory Status and Approvals

• FDA Approval: January 23, 2020 — for relapsed or refractory epithelioid sarcoma, under accelerated approval pathway.
• EMA Approval: September 2021 — for relapsed or refractory follicular lymphoma post two prior therapies.
• Other Markets: Japan and select European countries are evaluating marketing authorization applications.

Market Size and Growth Drivers

• Epidemiology:

  • Epithelioid sarcoma (ES): approximately 1,000 annual cases in the US.
  • Follicular lymphoma (FL): an estimated 14,000 new cases annually in the US.

• Current Treatment Landscape:

  • Limited options for ES; no approved targeted therapies prior to tazemetostat.
  • For FL, multiple approved therapies exist, including chemoimmunotherapy, BTK inhibitors, and PI3K inhibitors.

• Growth Drivers:

  • Rare cancer designation enhances trial opportunities and accelerated approvals.
  • Increasing molecular profiling identifies more patients with EZH2 mutations.
  • Expansion into additional indications, including mucosal melanoma and diffuse large B-cell lymphoma.

Revenue and Financial Trajectory

• Initial Sales Performance:

  • Epizyme reported $24 million in product revenue for 2021, mostly from US sales.
  • Sales in 2022 rose to approximately $38 million, driven by expanded indications.

• Pricing Strategy:

  • List price: around $13,700 per month in the US.
  • Patient access programs and insurance negotiations influence net pricing.

• Market Penetration:

  • Limited to specialized oncology centers initially.
  • Growth depends on physician awareness, dosing guidelines, and treatment reimbursement.

• Forecasts:

  • Analyst estimates project global sales reaching $300 million by 2025.
  • Peak sales could approximate $500 million, contingent on approval in additional indications and broader adoption.

Competitive Landscape

• Competes primarily with other targeted therapies and immunotherapies.
• EZH2 inhibitors:
  • Tazemetostat: First-in-class EZH2 inhibitor approved.
  • Colcetigat: Under clinical development, primarily in Asia.
• Combination therapies in pipeline may impact market share.

Market Challenges

• Limited data on long-term efficacy.
• Competition from emerging therapies and treatment combinations.
• Reimbursement hurdles for high-cost oncology drugs.
• Rare disease designation aids development but limits patient pool size.

Financial Outlook

• Revenue growth hinges on increased indication approvals, payer coverage, and physician adoption.
• Operating expenses remain high due to ongoing clinical trials, regulatory activities, and market expansion efforts.
• Margin improvements hinge on manufacturing efficiencies and higher economies of scale.

Key Takeaways

• Tazemetostat hydrobromide is positioned within niche oncology markets with limited existing therapies.
• Sales growth is projected to accelerate with market expansion, especially if additional indications are approved.
• Financial success depends on regulatory approvals, reimbursement, and market penetration strategies.
• Competitive dynamics favor continued innovation and combination therapy development.

FAQs

1. What are the primary indications for tazemetostat hydrobromide?
It is approved for epithelioid sarcoma and follicular lymphoma with specific genetic markers.

2. How significant is tazemetostat's market opportunity?
While limited by the rarity of indications, cumulative annual sales could reach hundreds of millions as it gains broader approval and adoption.

3. What are key factors influencing its sales growth?
Regulatory approvals, payer coverage, clinician awareness, and expansion into new indications.

4. Who are main competitors?
Other targeted therapies and emerging EZH2 inhibitors, though tazemetostat currently holds first-mover advantage.

5. What are major challenges facing its market expansion?
Long-term efficacy data, high cost, reimbursement issues, and competition from combination treatments.

References

1. Epizyme Inc. Annual Report 2022.
2. FDA Label for Tazemetostat.
3. EMA News Release, September 2021.
4. Market Research Future, Oncology Drug Market Analysis 2022.
5. IQVIA, Oncology Product Sales Data 2022.