Last updated: March 2, 2026
What is the drug associated with NDC 60687-0900?
NDC 60687-0900 corresponds to Tazemetostat, an oral EZH2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of epithelioid sarcoma and certain follicular lymphoma cases. Manufactured by Epizyme, Inc., Tazemetostat targets specific genetic mutations linked to cancer progression (FDA, 2020).
Market Dynamics
Market Size and Patient Population
- Epithelioid Sarcoma: Approximately 1,000 cases annually in the U.S. (SEER, 2021). It mostly affects young adults and lacks approved targeted therapies.
- Follicular Lymphoma: Around 16,000 new cases yearly in the U.S. (NCI, 2021). Tazemetostat is approved for relapsed or refractory cases with specific genetic features.
Competitive Landscape
- Tazemetostat is the first EZH2 inhibitor approved for these indications. Its main competitors include off-label use of other epigenetic drugs or combination therapies.
- Other EZH2 inhibitors are in clinical trials, but none are yet approved (ClinicalTrials.gov, 2023).
Market Trends
- Growing adoption stems from increased biomarker testing to identify EZH2 mutations.
- Expansion of indications could drive revenue growth; current approvals are limited to specific genetic subsets.
Reimbursement and Pricing Influences
- Coverage varies; some insurers require prior authorization.
- Price setting influenced by R&D costs, approval expansion potential, and payer negotiations.
Price Projections
Current Pricing
- The wholesale acquisition cost (WAC) for Tazemetostat is approximately $11,500 per 30-capsule supply (Epizyme, 2022).
- The average sales price (ASP) can be higher, factoring in discounts and rebates.
Short-Term Projections (Next 2 Years)
- Price stability is expected, with possible marginal increases of 3-5% annually, driven by inflation adjustments and expanded indications.
- Any entry of biosimilar or generic EZH2 inhibitors is unlikely within this timeframe, given patent protections and market exclusivity.
Long-Term Projections (3-5 Years)
- Prices may decline by 10-15% if biosimilar competitors enter the market, but this depends on patent status and regulatory decisions.
- Expansion into new indications could sustain or increase pricing through increased demand.
Factors Affecting Price Trends
| Factor |
Impact |
Likelihood |
| Patent expiration |
Potential price decrease |
Moderate (expected after 10 years) |
| Regulatory approvals |
Expansion of indications sustains prices |
High |
| Competitive entrants |
Price erosion possible |
Moderate |
| Manufacturing costs |
Slight influence |
Low |
Regulatory and Patent Outlook
- Patent Status: Filed patents protect Tazemetostat until 2030-2035.
- Regulatory Expansions: Ongoing trials may lead to new labels, influencing price and market size.
Strategic Considerations
- Expansion into additional cancers may improve revenue streams.
- Cost containment efforts by payers may pressure price leverage.
- The potential for biosimilars after patent expiry could reduce prices.
Summary
Tazemetostat's market remains limited but expects growth driven by expanding indications and increased genetic testing. Current pricing is around $11,500 per month, with near-term stability and potential long-term decline contingent on biosimilar competition and market expansion.
Key Takeaways
- NDC 60687-0900 is Tazemetostat, an EZH2 inhibitor approved for epithelioid sarcoma and follicular lymphoma.
- The drug's U.S. market size is small but growing due to targeted therapy adoption.
- Current price: ~$11,500 per 30-capsule supply, with modest increases projected short-term.
- Significant long-term price reduction possible after patent expiration, depending on biosimilar developments.
- Market expansion hinges on additional FDA approvals and increasing biomarker-based diagnoses.
FAQs
1. What are the main factors that could cause the price of Tazemetostat to decrease?
Entry of biosimilars or generics after patent expiry, increased market competition, and tighter payer negotiations.
2. How is the indication expansion affecting the market outlook?
Broader approval for other cancers can increase demand and support higher prices or sustained pricing levels.
3. Are there any upcoming patents or exclusivity periods?
Current patents extend into the early 2030s, delaying biosimilar entry.
4. What is the global market potential?
Limited until approvals in Europe and other regions; approval timelines vary.
5. How does the genetic testing trend impact Tazemetostat sales?
Enhanced testing identifying EZH2 mutations increases eligible patient populations, boosting demand.
References
- FDA (2020). Tazemetostat Summary. U.S. Food and Drug Administration.
- Epizyme (2022). Quarterly Financials and Pricing Data.
- NCI (2021). Cancer Statistics. National Cancer Institute.
- SEER (2021). Incidence Data. Surveillance, Epidemiology, and End Results Program.
- ClinicalTrials.gov (2023). EZH2 inhibitor trials.
