Last updated: April 17, 2026
What is NDC 46122-0818?
NDC 46122-0818 corresponds to Fletzal (azacitidine for injection), a generic formulation used primarily for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and related hematological conditions. It is a biosimilar or generic alternative to originating branded products, mainly Vidaza.
Market Overview
Product Status and Competition
- Original Brand: Vidaza (Celgene/Bristol-Myers Squibb), launched 2004.
- Generic Entry: Multiple companies received FDA approval for azacitidine generics, including formulations similar to NDC 46122-0818, beginning around 2020.
- Market Dynamics: The market is characterized by limited branded competition and increasing generic penetration, driven by patent expirations and biosimilar development.
Market Size (2022-2026 Forecast)
| Year |
Estimated U.S. Market (USD million) |
Annual Growth Rate |
Notes |
| 2022 |
420 |
— |
Post-patent expiry phase |
| 2023 |
440 |
4.8% |
Growing acceptance of generics |
| 2024 |
460 |
4.5% |
Market stabilization |
| 2025 |
480 |
4.3% |
Continued adoption of biosimilars |
| 2026 |
510 |
6.2% |
Increase in demand due to approval of new indications |
Sources: EvaluatePharma, IQVIA data (estimates based on historical trends).
Key Market Drivers
- Growing prevalence of MDS and AML.
- Increasing adoption of biosimilars to reduce treatment costs.
- Physician and payer acceptance of biosimilars.
- Patent litigation and exclusivity periods affect generic market entry timing.
Distribution Channels
- Hospital formularies account for 60% of sales.
- Oncology specialty pharmacies and outpatient infusion centers make up the balance.
- Reimbursement primarily through Medicare, private insurers, and Medicaid.
Regulatory Status
- FDA approved NDC 46122-0818 in 2020.
- No major safety or efficacy issues reported.
- Patent litigation and exclusivity periods may influence sales trajectory over the next 3-5 years.
Price Analysis and Projections
Current Pricing Landscape (2023)
- List Price per 100 mg vial: approximately USD 1,200.
- Average reimbursement (net of discounts): USD 800–900 per vial.
- Average procurement price: USD 750–800.
Price Trends (2022-2026)
| Year |
Estimated List Price per Vial |
Expected Discount Rate |
Net Price Estimate |
Key Factors Influencing Price Changes |
| 2022 |
USD 1,200 |
25–30% |
USD 840–900 |
Initial generic entry discounts rapidly decline |
| 2023 |
USD 1,150–1,200 |
20–25% |
USD 860–960 |
Market stabilization with increased volume |
| 2024 |
USD 1,100–1,150 |
15–20% |
USD 925–978 |
Competitive pressures intensify |
| 2025 |
USD 1,050–1,100 |
10–15% |
USD 943–1,050 |
Margins reduce as generics dominate |
| 2026 |
USD 1,000–1,050 |
10% or less |
USD 950–1,000 |
Price stabilizes around a lower benchmark |
Pricing Drivers
- Increasing competition among generics reduces prices.
- Hospital contracts and rebate programs influence net prices.
- New bios crop approvals could pressure prices downward.
- Policy changes may introduce price controls affecting overall pricing strategies.
Market Entry Challenges
- Regulatory hurdles for biosimilar approval.
- Patent and exclusivity challenges delaying generics.
- Limited manufacturing capacity for injectable oncology drugs.
- Reimbursement levels impacting profitability.
Strategic Considerations
For companies planning to enter or expand in this segment, focus on:
- Securing competitive prices through supply chain efficiencies.
- Building relationships with hospital formularies.
- Differentiating via patient or provider support programs.
Key Takeaways
- The market for azacitidine generics, including NDC 46122-0818, is growing steadily due to increasing disease prevalence and patent expiration.
- Prices are expected to decline modestly over the next three years, stabilized by generic competition.
- Reimbursement and contracting strategies will heavily influence net pricing.
- Market entry will be challenged by regulatory and patent barriers but favored by a push toward cost containment.
FAQs
1. What is the primary competition for NDC 46122-0818?
Branded Vidaza remains the main competitor, with several generics entering the market since 2020.
2. How does pricing compare between branded and generic azacitidine?
Generics typically sell at a 20–30% discount off the branded list price, with net prices around USD 800–900 per vial.
3. What are the main factors that will affect future prices?
Competitive pressure from biosimilars, hospital procurement policies, reimbursement rates, and regulatory developments.
4. How long will the generic market have pricing power?
Expect gradual price erosion over the next 3–5 years, with stabilization around 2026.
5. What is the impact of policy changes on this market?
Potential price controls and increased emphasis on biosimilar adoption could further reduce prices.
Citations:
[1] EvaluatePharma. (2023). Oncology Market Forecast.
[2] IQVIA. (2023). Market Access Report.
[3] U.S. Food and Drug Administration. (2020). Approval Notice for Azacitidine Generics.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement Data.
