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 three hundred and ninety-nine patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for tazemetostat hydrobromide

International Patents:	399
US Patents:	27
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	2
Patent Applications:	22
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	11,052,093		Y	Y
Epizyme Inc	TAZVERIK	tazemetostat hydrobromide	TABLET;ORAL	211723-001	Jan 23, 2020		RX	Yes	Yes	9,688,665
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	11,491,163

International Patents for tazemetostat hydrobromide

Country	Patent Number	Title	Estimated Expiration
San Marino	T201900593
Canada	2870005
World Intellectual Property Organization (WIPO)	2012142504
South Korea	102308488
Japan	2014516931

Market Dynamics and Financial Trajectory for Tazemetostat Hydrobromide

Introduction to Tazemetostat Hydrobromide

Tazemetostat hydrobromide, marketed as TAZVERIK, is an EZH2 inhibitor developed by Epizyme Inc. It has gained significant attention for its potential in treating various types of cancer, including epithelioid sarcoma and follicular lymphoma.

Market Growth and Projections

The global EZH2 inhibitor market, led by tazemetostat hydrobromide, is anticipated to experience rapid growth. Here are some key projections:

• The global EZH2 inhibitors market is projected to grow at a CAGR of approximately 25.85% from 2024 to 2030, driven by increasing R&D investments and the rising demand for effective cancer therapies[1].
• The global Tazemetostat market was valued at around $11.4 million in 2020 and is expected to witness an absolute growth of more than 8000% by 2026, reaching over $1 billion[3].

Regional Market Dynamics

North America

North America is expected to be a significant contributor to the growth of the EZH2 inhibitors market. The region's high adoption rates, increasing research and development activities, and the rising prevalence of cancer are key drivers. For instance, the increasing demand for better healthcare and the presence of numerous hospitals and research centers adopting EZH2 inhibitor drugs are boosting the regional market[1].

Europe and Japan

Tazemetostat has received orphan designation in Europe and has been approved in Japan for specific indications. These approvals are expected to further propel the market growth in these regions. Eisai's collaboration with the National Cancer Center in Japan for clinical research on tazemetostat hydrobromide is a notable example of regional market development[4].

Clinical Trials and Approvals

Tazemetostat hydrobromide has been approved by the US FDA for the treatment of:

• Locally advanced or metastatic epithelioid sarcoma in adults and children aged 16 years and older who are not eligible for complete resection[5].
• Relapsed or refractory follicular lymphoma in adults with specific EZH2 gene mutations and who have received at least two systemic therapies[5].

Ongoing clinical trials, such as the Phase 1b/2 tazemetostat hematological basket study (ARIA) and the Phase 1/1b study of EZM0414, are expected to expand the drug's indications and enhance its market position[2].

Financial Performance

Revenue and Sales

In the first quarter of 2022, TAZVERIK generated net product revenue of $8.7 million, with a 10% increase compared to the fourth quarter of 2021. This represents a 40% increase from the first quarter of 2021, highlighting the drug's growing commercial success[2].

Market Opportunity

The sales opportunity for Tazemetostat is projected to exceed $900 million by 2026, driven by robust sales in the US market and high adoption rates. The integration of EZH2 inhibitors into other therapeutic conditions, such as prostate cancer and ovarian cancers, will further boost the market's growth trajectory[3].

Competitive Landscape

Several pharmaceutical companies are developing potential EZH2 inhibitors, including GSK126, CPI1205 (Lirametostat), SHR2554, and others. These drugs are in various stages of clinical trials and are expected to gain approval during the forecast period, potentially influencing the market dynamics[3].

Government and Reimbursement Policies

The development of favorable reimbursement policies and increasing government initiatives in cancer research are expected to enhance the uptake of EZH2 inhibitors. These policies will play a crucial role in ensuring the high adoption rates of these drugs in the market[3].

Challenges and Opportunities

Challenges

Despite the promising growth, the market faces challenges such as the need for confirmatory trials to demonstrate clinical benefits under the FDA’s Accelerated Approval Program. Additionally, the drug's side effects and interactions with other medications need to be closely monitored[5].

Opportunities

The expanding clinical pipeline and the potential for tazemetostat hydrobromide to be used in treating other types of cancer offer significant opportunities for market growth. The drug's approval in additional regions and its integration into various therapeutic regimens will further drive its financial trajectory[3][5].

Key Takeaways

• Rapid Market Growth: The global EZH2 inhibitors market is expected to grow at a CAGR of 25.85% from 2024 to 2030.
• Regional Dominance: North America is anticipated to be a major contributor to the market growth.
• Clinical Trials: Ongoing and future clinical trials will expand the drug's indications and market reach.
• Financial Performance: TAZVERIK has shown significant revenue growth, with projected sales exceeding $900 million by 2026.
• Competitive Landscape: Multiple EZH2 inhibitors are in development, which could influence market dynamics.

FAQs

1. What is Tazemetostat Hydrobromide used for?

Tazemetostat hydrobromide is used to treat locally advanced or metastatic epithelioid sarcoma and relapsed or refractory follicular lymphoma with specific EZH2 gene mutations[5].

2. What is the projected market size for EZH2 inhibitors by 2030?

The global EZH2 inhibitors market is projected to grow significantly, with a CAGR of approximately 25.85% from 2024 to 2030, though the exact market size by 2030 is not specified in the sources provided[1].

3. Which regions are expected to dominate the EZH2 inhibitors market?

North America, particularly the US, is expected to dominate the market due to high adoption rates and increasing research and development activities[1].

4. What are the key drivers of the EZH2 inhibitors market growth?

Key drivers include increasing R&D investments, rising healthcare spending for cancer treatments, and the development of favorable reimbursement policies[1][3].

5. Are there other EZH2 inhibitors in clinical development?

Yes, several other EZH2 inhibitors, such as GSK126, CPI1205 (Lirametostat), and SHR2554, are in various stages of clinical trials and are expected to gain approval in the coming years[3].

Sources:

1. MarkNtel Advisors, Global EZH2 Inhibitors Market Research Report: Forecast (2024-2030).
2. Business Wire, Epizyme Reports First Quarter 2022 Financial Results and Provides Business Update.
3. PR Newswire, Global EZH2 Inhibitor Market Report 2021: Dosage, Price & Sales Analysis of Tazverik.
4. Eisai, ANTICANCER AGENT “TAZVERIK® TABLETS 200mg”.
5. National Cancer Institute, Tazemetostat Hydrobromide.

Last updated: 2024-12-18