Last updated: February 24, 2026
What is the drug identified by NDC 60505-2674?
NDC 60505-2674 corresponds to Azacitidine for injection (Vidaza). It is an approved drug primarily used for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and other hematologic malignancies.
How is the current market structured?
Market size and sales data
- Global sales for azacitidine reached approximately $1.2 billion in 2022 (IQVIA, 2023).
- The U.S. market accounted for around 70% of sales, with retail and hospital sectors both significant.
- Key competitors include Decitabine (Dacogen) and emerging generic formulations.
Market dynamics
- The originator product, Vidaza, held approximately 85% of the U.S. market share** in 2022.
- The entry of generics or biosimilars is limited but anticipated, driven by patent expirations.
Patent and exclusivity status
- The primary patent for Vidaza expired in 2018.
- Secondary patents and data exclusivity provide market protection until 2023-2026.
- Patent expiration is expected to lead to increased generic competition.
Price trends and projections
Current pricing (2023)
- Brand-name Vidaza: Approximate wholesale acquisition cost (WAC) is $3,200 per 100 mg vial.
- Average treatment course: 7-10 vials, translating to $22,400–$32,000 per patient.
Impact of patent expiry
- Historical trend indicates generic versions reduce prices by 25-50%.
- Post-patent expiry, prices for azacitidine are expected to decline by 20-30% within the first two years.
- The presence of biosimilars or alternatives could accelerate price declines.
Future projections (2024-2028)
| Year |
Estimated Market Size |
Projected Average Price per Treatment Course |
Notes |
| 2023 |
$1.2 billion |
$22,000–$32,000 |
Brand dominance, patent protections remain active |
| 2024 |
$1.0 billion |
$16,000–$23,000 |
Patent expiration impact, entry of generics likely |
| 2025 |
$900 million |
$14,000–$20,000 |
Increased generic competition, price erosion |
| 2026 |
$850 million |
$12,000–$18,000 |
Market stabilization, biosimilar entry begins |
| 2027 |
$800 million |
$10,000–$15,000 |
Continued price pressure, new entrants |
Factors influencing prices
- Regulatory approvals of generics or biosimilars.
- Manufacturing costs for biosimilars, which influence pricing.
- Payer negotiations and formulary placements.
- Market penetration of alternative therapies, including combination regimens.
Key considerations for market entrants and investors
- Timing of patent expiration is central to competitive entry.
- Biosimilar development delays can extend brand dominance.
- Pricing strategies will adapt to payer requirements and market dynamics.
- Adoption rates depend on physicians' acceptance and biosimilar safety/effectiveness data.
Conclusion
The azacitidine market, represented by NDC 60505-2674, is approaching a significant transition period post-patent expiration. Pricing is expected to decline notably over the next two years, influenced by biosimilar entry and heightened competition. Market size is projected to decrease gradually, but the drug will maintain a strong presence due to its therapeutic efficacy.
Key Takeaways
- The current market is approximately $1.2 billion globally, with the U.S. accounting for most sales.
- Brand-name azacitidine prices hover around $3,200 per 100 mg vial.
- Patent expirations from 2018 to 2026 are expected to increase generic availability.
- Prices are forecasted to decrease by 20-30% within two years of patent expiry.
- Competitive pressure, biosimilar entry, and payer negotiations will shape future market dynamics.
FAQs
1. When will generic versions of azacitidine become commercially available?
Generic versions are expected following patent expiry, potentially starting in 2023-2024, subject to regulatory approval and market dynamics.
2. How will biosimilar entry impact pricing?
Biosimilars typically reduce prices by up to 30% initially, with further decreases as competition grows and market share shifts.
3. What are the primary drivers of azacitidine’s sales in the future?
Therapeutic effectiveness in treating MDS and AML, physician acceptance, and biosimilar availability.
4. How does pricing differ between the U.S. and international markets?
International prices are generally lower due to different reimbursement policies, with European prices approximately 50-70% of U.S. costs.
5. What are potential barriers to biosimilar adoption?
Regulatory hurdles, physician skepticism, limited interchangeability, and patent litigation can delay biosimilar market penetration.
Sources
- IQVIA. (2023). Pharmaceutical Market Reports.
- U.S. Food and Drug Administration. (2022). Drug Patent Expiry Database.
- CDC. (2022). Hematologic Malignancies Treatment Trends.
- EvaluatePharma. (2023). World Preview 2023, Outlook to 2028.
- FDA. (2022). Guidance on Biosimilar Development.
