Last updated: February 25, 2026
What is NDC 70677-0083?
NDC 70677-0083 is a drug product listed in the Universal Product Number (UPN) system. It corresponds to a specific formulation, dosage, and manufacturer. Based on available data, this NDC is identified as Azyqeo (azacitidine injection) used in chemotherapy, typically for myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Exact details are confirmed via the FDA’s NDC database.
Market Size and Dynamics
Therapeutic Area and Patient Population
- Indications: MDS, AML.
- Prevalence: MDS affects approximately 10,000 to 20,000 new cases in the U.S. annually, with AML cases exceeding 20,000 annually.
- Treatment landscape: Azacitidine is a standard of care for higher-risk MDS, with growing use in AML. Brand names include Vidaza (marketed by Celgene, now BMS).
Market Players and Competition
| Name |
Product |
Brand/Status |
Market Share (estimated) |
Launch Date |
| Celgene (BMS) |
Vidaza |
Market leader |
70–80% |
2004 |
| BeiGene |
CPX-351 |
Competitor |
10–15% |
2017 |
| Generic providers |
Various |
Increasing presence |
5–15% |
2020s |
Market Trends
- Growth drivers: Aging population, increasing AML and MDS diagnosis, expanding indication scope.
- Regulatory impact: Potential label expansions, combination therapies.
Pricing Background
Historical Pricing
- Brand (Vidaza): Wholesale Acquisition Cost (WAC) averaged around $150 per 100-unit vial in early 2020s.
- Generic versions: Entered in 2020s, with prices dropping 30–50%, averaging $80–$100 per vial.
Pricing Factors
- Formulation: 100 mg vials are standard.
- Reimbursement policies: Include CMS bundled payments; private insurers may reimburse at higher rates.
- Market competition: Generics exert downward pressure on prices.
| Year |
Avg. Price per Vial |
Billed to Medicare (approximate) |
Notes |
| 2020 |
~$150 |
$190 |
Brand dominant with limited generics |
| 2022 |
~$120 |
$150 |
Entry of generics and biosimilars |
| 2023 |
~$100 |
$130 |
Increased generic competition |
Future Price Projections
- Short-term (1-2 years): Assume continued generic proliferation reduces prices. Expected average price per vial: $70–$90.
- Medium-term (3-5 years): Prices stabilize as patents or exclusivity periods expire. With potential biosimilar or alternative therapies, prices may hover around $60–$80.
- Long-term (5+ years): Potential integration into combination regimens could change pricing dynamics, but generic competition remains pivotal.
Market Entrants and Regulatory Developments
- Biosimilar and generic approvals: FDA approved several azacitidine generics (e.g., Mylan, Teva) starting around 2020.
- Patent expirations: BMS’s patent for Vidaza expired in 2019, leading to increased generic competition.
- Orphan drug and exclusivity rules: No new regulatory exclusivities currently protect azacitidine.
Revenue Projections and Market Size
| Year |
Estimated Market Revenue (USD millions) |
Notes |
| 2022 |
$400–$600 |
Based on sales volume and pricing |
| 2023 |
$350–$550 |
Volume declines due to generics |
| 2025 |
$250–$400 |
Market stabilization with price erosion |
Strategic Insights
- Pricing pressure: Generics will continue to exert downward influence.
- Market share: Brand dominance likely to decline below 50% over the next 3 years.
- Innovation potential: Combination therapies and new delivery methods could influence future pricing.
Key Takeaways
- NDC 70677-0083 corresponds to azacitidine injection, primarily used in MDS and AML.
- The drug’s market is mature, with significant generic competition since early 2020s.
- Wholesale prices have declined from approximately $150 per vial in 2020 to about $70–$90 in 2023.
- Future prices will likely stabilize or decline further, aligning with generic market trends.
- Revenue in the U.S. is projected to decrease as competition increases, with total sales potentially dropping by 25–50% over five years.
FAQs
Q1: How does patent expiration affect the drug’s pricing?
Patent expiration allows generics to enter the market, causing significant price reductions and increased competition.
Q2: When did generics start entering the azacitidine market?
Generic azacitidine received FDA approval around 2020.
Q3: What factors influence future prices of this drug?
Competition level, regulatory changes, introduction of biosimilars, and new therapeutic options.
Q4: Which markets are most relevant beyond the U.S.?
Europe and Canada are key markets, with similar patent and regulatory landscapes affecting pricing.
Q5: How can new formulations or combinations impact the market?
They could create premium pricing opportunities, but current competition and patent landscape limit such innovations.
Citations
[1] U.S. Food and Drug Administration. (2023). National Drug Code Directory.
[2] IQVIA. (2022). Prescription Data and Market Estimates.
[3] Bloomberg Industry Reports. (2023). Oncology Drug Market Analysis.
[4] FDA. (2020). Biosimilar Approvals and Policy Updates.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Data.
