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TAZVERIK Drug Patent Profile

When do Tazverik patents expire, 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-two patents protecting this drug.

This drug has three hundred and eighty-five 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.

Indicators of Generic Entry

Summary for TAZVERIK

International Patents:	385
US Patents:	22
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	15
Patent Applications:	317
Drug Prices:	Drug price information 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 thirty-eight 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
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
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	9,090,562		Y	Y

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
Russian Federation	2013115928	ИНГИБИТОРЫ EZH2 ЧЕЛОВЕКА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
European Patent Office	3628662	COMPOSÉS DE BENZÈNE SUBSTITUÉ (SUBSTITUTED BENZENE COMPOUNDS)
Portugal	3486234
World Intellectual Property Organization (WIPO)	2013138361
Spain	2706951
Brazil	112015008487	compostos de benzeno substituído

TAZVERIK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TAZVERIK

Introduction to TAZVERIK

TAZVERIK, developed by Epizyme Inc., is a groundbreaking EZH2 inhibitor that has gained significant attention in the oncology market. It is approved by the US FDA for the treatment of patients 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) and for adult patients with relapsed or refractory follicular lymphoma (FL)[4].

Approval and Indications

TAZVERIK received accelerated approvals for ES and FL, marking it as the first and only treatment specifically indicated for ES patients and the first FDA-approved EZH2 inhibitor. These approvals were critical milestones for Epizyme, positioning TAZVERIK as a leader in the epigenetics field[3].

Launch and Initial Sales Performance

Despite the high expectations surrounding its launch in February 2020, TAZVERIK's sales were impacted significantly by the COVID-19 pandemic. The drug generated $11.5 million in sales for the full year 2020, with $4.5 million in the fourth quarter, which was a 33% increase over the third quarter but fell short of analysts' predictions[1].

Quarterly Sales Trends

In the first quarter of 2021, TAZVERIK's net product revenue increased by 37% from the fourth quarter of 2020, reaching $6.2 million. This growth was driven by increased adoption in both ES and FL, with March 2021 marking the highest level of commercial demand since the launch. The first quarter of 2022 saw further growth, with TAZVERIK generating $8.7 million in net product revenue, a 10% increase from the fourth quarter of 2021[2][5].

Market Growth and Projections

The global EZH2 inhibitor market, led by TAZVERIK, is expected to experience robust growth. The market is forecasted to grow with a CAGR of more than 110% and is expected to surpass $1 billion by 2026. TAZVERIK itself is projected to achieve sales of over $900 million by 2026, driven by high adoption rates, particularly in the US market[4].

Challenges and Risks

Impact of COVID-19

The COVID-19 pandemic has been a significant hurdle for TAZVERIK's commercial launch. It affected patient visits to physicians, new patient starts, and the ability of Epizyme's field-based teams to access physicians treating ES and FL patients. Despite these challenges, the company has seen gradual recovery and growth in sales[3][5].

Market Acceptance

The success of TAZVERIK is contingent upon its acceptance by physicians, patients, and third-party payors. While the drug has shown promising clinical results, achieving an adequate level of market acceptance is crucial for its commercial success. Any failure to achieve this could impact revenue generation and profitability[3].

Regulatory and Clinical Trials

Continued approval of TAZVERIK for its approved indications is contingent upon verification and description of clinical benefit in confirmatory programs. Delays or failures in these clinical trials could harm Epizyme's business and operations[3].

Financial Performance

Revenue

In the first quarter of 2021, total revenue for Epizyme was $7.6 million, with $6.2 million coming from TAZVERIK sales in the US. By the first quarter of 2022, total revenue had increased to $8.7 million, primarily driven by TAZVERIK sales[2][5].

Operating Expenses

Epizyme's operating expenses have been significant, with total GAAP operating expenses reaching $72.0 million in the first quarter of 2021 and $59.6 million in the first quarter of 2022. These expenses include research and development, selling, general, and administrative costs[2][5].

Cash Position

As of March 31, 2021, Epizyme had $298.9 million in cash, cash equivalents, and marketable securities. This financial cushion is crucial for supporting ongoing operations, clinical trials, and commercial activities[5].

Regional Market Opportunity

The US is expected to dominate the global EZH2 inhibitor market due to high adoption rates and increasing research and development activities. Europe and Japan also present significant market opportunities, with TAZVERIK having received orphan designation in Europe and approval in Japan[4].

Clinical Pipeline and Future Development

Epizyme is expanding its pipeline and evolving its oncology portfolio by bringing novel oncology therapeutics into clinical development. The company aims to leverage commercial, clinical, and research collaborations to increase patient reach and shareholder value. With seven EZH2 inhibitors currently in clinical trials, the future looks promising for this class of drugs[4].

Key Takeaways

• Launch Impact: TAZVERIK's launch was significantly impacted by the COVID-19 pandemic, but it has shown gradual recovery and growth.
• Sales Projections: The drug is projected to achieve sales of over $900 million by 2026, driven by high adoption rates.
• Market Growth: The global EZH2 inhibitor market is expected to grow with a CAGR of more than 110% and surpass $1 billion by 2026.
• Challenges: Market acceptance, regulatory approvals, and clinical trial outcomes are critical for TAZVERIK's long-term success.
• Financial Performance: Epizyme's revenue has been increasing, but operating expenses remain high.

FAQs

What is TAZVERIK and what is it used for?

TAZVERIK is an EZH2 inhibitor developed by Epizyme Inc., approved for the treatment of patients with metastatic or locally advanced epithelioid sarcoma and adult patients with relapsed or refractory follicular lymphoma.

How has the COVID-19 pandemic affected TAZVERIK's sales?

The COVID-19 pandemic significantly impacted TAZVERIK's commercial launch by affecting patient visits to physicians, new patient starts, and the ability of Epizyme's field-based teams to access physicians.

What are the projected sales for TAZVERIK by 2026?

TAZVERIK is projected to achieve sales of over $900 million by 2026, driven by high adoption rates and robust market growth.

What are the key challenges facing TAZVERIK's commercial success?

Key challenges include achieving market acceptance, regulatory approvals, and successful outcomes in clinical trials.

How is the global EZH2 inhibitor market expected to grow?

The global EZH2 inhibitor market is expected to grow with a CAGR of more than 110% and surpass $1 billion by 2026.

Sources

1. FiercePharma: Epizyme shouldn't blame COVID-19 alone for sluggish launch of its cancer med Tazverik, analysts say.
2. Business Wire: Epizyme Reports First Quarter 2022 Financial Results and Provides Business Update.
3. AnnualReports.com: Epizyme Inc. Annual Report 2020.
4. Markets.BusinessInsider: Global EZH2 Inhibitor Market Report 2021: Dosage, Price & Sales Analysis of Tazverik.
5. BioSpace: Epizyme Provides Business Update and Reports First Quarter 2021 Financial Results.