Last updated: March 11, 2026
What is NDC 00121-0576?
NDC 00121-0576 is the National Drug Code for Histone Deacetylase Inhibitor Vorinostat (brand name: Zolinza). Approved by the FDA in October 2006, it is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease after prior therapies.
Current Market Landscape
Market Size and Demand
- Estimated U.S. market size (2022): $150 million.
- Annual prescriptions (2022): approximately 20,000.
- Key competitors:
- Romidepsin (Istodax)
- Belinostat (Beleodaq)
- Patient demographics: Mostly adult patients with advanced-stage CTCL. The prevalence of CTCL in the U.S. is approximately 1,500 new cases annually, with existing patients requiring ongoing treatment.
Revenue Drivers
- Pricing models: Brand-specific wholesale acquisition costs (WAC) for Vorinostat are approximately $6,500 per 100-count, 300 mg capsules.
- Off-label use: Minimal, limited to experimental applications.
- Reimbursement landscape: High insurance coverage, primarily through Medicare Part D, with negotiated discounts affecting net prices.
Competitive Positioning
- Market share (2022): Approximately 40% among HDAC inhibitors for CTCL.
- Innovation status: No recent major reformulations, no biosimilar entry yet.
- Clinical pipeline: No recent approvals for new indications; recent trials have explored combinations with other agents for broader oncological applications.
Price Projection Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 300 mg capsule |
Change from prior year |
| 2018 |
$215 |
— |
| 2019 |
$220 |
+2.3% |
| 2020 |
$220 |
0% |
| 2021 |
$210 |
-4.5% |
| 2022 |
$205 |
-2.4% |
Note: Price reductions reflect payer negotiations, market competition, and discounting strategies.
Projected Pricing (Next 3-5 Years)
- Base case: Prices stabilize around $200 per 300 mg capsule.
- Downward pressures:
- Entry of biosimilars or generics, though none yet approved.
- Payer discounts and pressure for price reductions.
- Potential upward trends:
- New combination therapies might increase demand, supporting slight price premium.
- Expansion into additional indications could marginally increase pricing.
Revenue Projections
| Year |
Prescriptions (000s) |
Average Price per Capsule |
Estimated Revenue (USD millions) |
| 2023 |
21.0 |
$200 |
$1,680 |
| 2024 |
22.0 |
$200 |
$1,760 |
| 2025 |
23.0 |
$200 |
$1,840 |
| 2026 |
23.5 |
$200 |
$1,880 |
| 2027 |
24.0 |
$200 |
$1,920 |
Assumptions: Slow prescription growth driven by ongoing CTCL diagnoses and treatment adherence.
Regulatory and Market Entry Risks
- No imminent patents or exclusivity protections expire before 2030.
- Biosimilar development is ongoing but lacks regulatory approval.
- Emerging therapies targeting CTCL may challenge Vorinostat's market share.
- Price pressures from payers and policymakers could lead to further discounts.
Key Considerations for Stakeholders
- Manufacturers: Focus on market share retention through demonstrating clinical benefits over competitors.
- Investors: Stable demand with modest revenue growth, but potential risk from biosimilar penetration.
- Healthcare providers: Evaluate the cost-effectiveness vis-à-vis newer therapies.
Key Takeaways
- The market for Vorinostat (NDC 00121-0576) remains steady with a valuation around $150 million annually.
- Pricing is expected to hover near current levels ($200–$205 per capsule) over the next five years.
- Growth hinges on prescription volume increases, potential new indications, and competitive dynamics.
- Entry of biosimilars and policy pressure could reduce net prices over time.
- No direct threats from structural patent expiration before 2030, but continued innovation may influence future positioning.
FAQs
1. What are the key factors influencing Vorinostat prices?
Pricing is shaped by market competition, payer negotiations, clinical demand, and emerging biosimilars.
2. Are there generic versions available of Vorinostat?
No, as of 2023, no generics or biosimilars have received FDA approval.
3. How does the competitive landscape affect future pricing?
Entry of biosimilars or new therapies targeting CTCL could lead to price erosion.
4. What is the primary driver for revenue growth?
Increased prescription volume and expanding indications.
5. When might patent protection expire for Vorinostat?
No patent expirations anticipated before 2030, with current exclusivities valid through late 2020s.
References
- U.S. Food and Drug Administration (FDA). (2006). FDA Approval letter for Vorinostat.
- IQVIA. (2022). Pharmaceutical Market Data.
- GoodRx. (2022). Pricing of HDAC inhibitors.
- EvaluatePharma. (2023). Oncology market forecasts.
- Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement and utilization data.
