Last updated: March 17, 2026
What is NDC 65862-0237?
NDC 65862-0237 refers to a specific drug, which is recognized by the National Drug Code (NDC) system maintained by the FDA. This code corresponds to Tazemetostat (Tazverik), developed by Epizyme, Inc., for the treatment of epithelioid sarcoma and follicular lymphoma.
Market Overview
Therapeutic Segment
Tazemetostat is classified as an EZH2 inhibitor. Approved by the FDA in January 2020 for epithelioid sarcoma and follicular lymphoma, it operates in the oncology segment targeting rare and underserved cancers. The drug’s market appeal stems from its oral administration, tolerability, and potential use in combination therapies.
Market Size and Growth Drivers
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Prevalence of Indications:
Epithelioid sarcoma cases approximately 1,000 annually in the U.S. (SEER data), with follicular lymphoma accounting for around 100,000 cases nationwide.
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Unmet Medical Need:
Limited approved therapies for epithelioid sarcoma create a niche. For follicular lymphoma, Tazemetostat offers an option for relapsed or refractory cases.
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Market Penetration:
As of 2023, estimates suggest approximately 15-20% market share in its approved indications. The drug is prescribed predominantly in specialized oncology centers.
Competitive Landscape
Major competitors include:
- Farydak (panobinostat)
- Zanubrutinib (Brukanja)
- Other EZH2 inhibitors under development
Despite competition, Tazemetostat's targeted mechanism and oral route advantage confer a sustainable position in its niche.
Current Pricing and Cost Structure
Approved Pricing
- U.S. List Price: Approximately $13,620 per month for a typical dose (Epizyme, 2023).
- Annual Cost: Around $163,440 based on standard dosing cycles.
- Reimbursement: Coverage primarily through Medicare and private insurers, with patient out-of-pocket costs varying depending on insurance.
Cost Components
- Manufacturing: Moderate, owing to small-molecule synthesis.
- Distribution: Standard pharmaceutical logistics.
- Pricing Adjustments: Discounts through managed care, patient assistance programs, and formulary negotiations.
Market Projections (2023–2030)
| Year |
Estimated Sales (USD billion) |
Key Assumptions |
| 2023 |
0.25 |
Launch phase, limited penetration |
| 2025 |
0.50 |
Increased adoption, geographic expansion |
| 2027 |
0.85 |
Broader indication approvals, combination uses |
| 2030 |
1.20 |
Market saturation, new indications |
Growth Factors
- Expansion into additional tumor types driven by ongoing clinical trials.
- Increasing adoption due to heightened physician awareness.
- Competitive pricing strategies and patient assistance programs.
Risks
- Entry of generic EZH2 inhibitors after patent expiration.
- Clinical trial failures or safety concerns.
- Changes in reimbursement policies affecting accessibility.
Patent and Exclusivity Timeline
- Patent Expiration: Expected around 2035, securing market exclusivity through patent protections until then.
- Regulatory Data Exclusivity: Seven years from approval, effectively protecting the market until 2027.
Potential Price Trends
- Price reductions to align with generic competition are projected to start circa 2030.
- Early inventory and supply chain management influence initial pricing strategies.
- Utilization of pricing tiers for different regions may influence global sales.
Market Entry and Strategic Recommendations
- Focus on expanding clinical trial phases for broader indications.
- Engage with payers early to establish favorable reimbursement terms.
- Investigate combination therapies that demonstrate synergy and extend market reach.
Key Takeaways
- NDC 65862-0237 (Tazemetostat) operates in a niche oncology market targeting rare cancers.
- The drug’s current list price is approximately $13,620/month in the U.S.
- Projected revenues reach around $1.2 billion by 2030, driven by expanding indications and adoption.
- Market entry risks include generic competition post-patent expiration and clinical trial outcomes.
- Strategic focus on clinical trials, reimbursement, and combination therapies will influence long-term viability.
FAQs
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When could generic versions of Tazemetostat enter the market?
Patent exclusivity lasts until approximately 2035. Generic competition is expected thereafter.
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How does Tazemetostat compare price-wise with similar therapies?
It has a higher monthly cost compared to standard chemotherapies, reflecting its targeted nature and novel mechanism.
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What are the main therapeutic advantages of Tazemetostat?
Oral administration, manageable side effect profile, and activity in rare, difficult-to-treat cancers.
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What are the key factors influencing its market growth?
Regulatory approval for additional indications and successful clinical trial results.
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Are there plans for expanding Tazemetostat’s approved uses?
Yes, ongoing trials explore efficacy in other tumor types, which could further expand its market.
References
- Epizyme. (2023). Tazverik (Tazemetostat) Prescribing Information.
- SEER Program. (2022). Cancer Stat Facts: Epithelioid sarcoma. National Cancer Institute.
- U.S. Food and Drug Administration. (2020). FDA approves Tazverik for epithelioid sarcoma.
- MarketWatch. (2023). Oncology drug market forecast and analysis.
- IQVIA. (2022). Global Oncology Market Trends.
