Last updated: February 24, 2026
What is NDC 83324-0221?
NDC 83324-0221 is a pharmaceutical product identified by the National Drug Code (NDC). Based on available data, this NDC corresponds to dasatinib, a tyrosine kinase inhibitor used primarily to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) [1].
Market Size and Demand Dynamics
Indications and Patient Population
- CML incidence: Approximately 1-2 cases per 100,000 people annually in the US [2].
- Ph+ ALL: Less common, about 0.5 per 100,000 annually [3].
- US diagnosed patients: Estimated around 8,000–10,000 for CML; fewer for Ph+ ALL.
Competitive Landscape
- Dasatinib (brand name Sprycel) is the leading drug in this segment.
- Generic versions have entered the market, impacting pricing and accessibility.
- Estimated market share: branded dasatinib retains around 70-80%, with generics capturing remaining share [4].
Market Drivers
- Increased adoption due to improved diagnostic methods.
- Expanding access in emerging markets.
- Off-label uses remain limited but could influence future demand.
Price History and Projections
Current Pricing
- Brand Dasatinib (Sprycel): Wholesale acquisition cost (WAC) approximately $7,500–$8,000 per 30-day supply [5].
- Generic versions: Price range around $4,500–$6,000 per 30-day supply, depending on supplier and region.
Patent and Patent Expiry
- Patent expiration occurred in 2021 in the US.
- Highly likely entry of generics has depressed prices since 2022.
Short-term Price Trends (Next 1-2 Years)
- Generics: Expected to stabilize at $3,500–$5,000 per 30-day supply.
- Branded: Resistance to significant price reductions, remaining in $7,000–$8,000 range unless supply shortages or policy changes occur.
Long-term Price Outlook (3-5 Years)
- Increased competition will result in continued price erosion.
- Potential for new formulations or delivery methods impacting pricing.
- Price increases possible if new indications or combination therapies gain approval.
Regulatory and Policy Factors
- Pricing regulations: U.S. policies targeting drug price transparency may influence list prices.
- Market access: Payers favor generic alternatives, limiting profit margins for branded drugs.
- Pricing caps: Some countries impose caps, affecting international pricing strategies.
Key Considerations for Stakeholders
- Manufacturers may face pressure to lower prices due to patent expiration.
- Investors should monitor generics market penetration.
- R&D efforts for new indications could alter long-term pricing strategies.
Summary Table: Price Estimates Over Time
| Period |
Branded Price (USD/month) |
Generic Price (USD/month) |
| 2023 |
$7,000–$8,000 |
$4,500–$6,000 |
| 2024–2025 |
Stable or slight decrease |
$3,500–$5,000 |
| 2026–2028 |
Potential further decline |
$2,500–$4,000 (if new entrants) |
Final Notes
- The entry of multiple generics post-patent expiry has reduced the drug's market price.
- Market demand aligns with the prevalence of CML and Ph+ ALL, stabilizing around existing levels unless new data influences patient access or indications.
- Price projections depend heavily on regulatory developments, market dynamics, and potential new therapeutic uses.
Key Takeaways
- NDC 83324-0221, likely dasatinib, faces price erosion driven by generic competition.
- Current wholesale prices for generics are approximately $4,500–$6,000 per 30 days.
- Long-term outlook suggests prices could decline further to below $4,000 as market competition intensifies.
- Market size remains limited by disease prevalence but stable due to treatment adherence.
- Policy changes and new indications could alter price trajectories.
FAQs
Q1: Is NDC 83324-0221 still under patent protection?
A1: No, patent expiration in the US occurred in 2021, allowing generic entries.
Q2: How dependent is the market on branded versus generic dasatinib?
A2: Approximately 70-80% of sales are from the branded form, with generics rapidly increasing their market share.
Q3: What factors could significantly impact future pricing?
A3: Patent litigation, new indications, regulatory price controls, or supply chain disruptions.
Q4: Are there premium formulations or delivery methods expected?
A4: No substantial new formulations are announced; pricing will mainly fluctuate based on market competition.
Q5: How does international regulation affect pricing?
A5: Price caps in select countries constrain higher list prices, influencing global market strategies.
References:
[1] FDA. (2022). Drug Approvals and Labeling.
[2] American Cancer Society. (2021). "Chronic Myeloid Leukemia Statistics."
[3] Leukemia & Lymphoma Society. (2022). "Philadelphia Chromosome-Positive Leukemia."
[4] IQVIA. (2022). Pharmaceutical Market Data.
[5] Drugs.com. (2023). Dasatinib Prices and Availability.
