Last updated: March 13, 2026
What is the drug associated with NDC 62135-0503?
NDC 62135-0503 is a formulation of azacitidine, marketed under the brand name Vidaza. It is an injectable chemotherapy agent used primarily for the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) in certain cases.
How does the current market landscape for azacitidine look?
Market size and demand
- Global MDS market projected to reach $3.1 billion by 2027, with a compound annual growth rate (CAGR) of approximately 8.2% (source: Fortune Business Insights[1]).
- Azacitidine accounts for roughly 65-70% of the MDS treatment market due to its established efficacy.
- Treatment prevalence: Approximately 100,000 diagnosed MDS patients globally, with annual treatment initiation rates near 15,000-20,000 patients.
Major competitors
- Vidaza (Janssen): The primary branded product.
- Generic azacitidine: Gaining market share following patent expiration of Vidaza in specific regions.
- Other agents: Decitabine (Dacogen) has a comparable market but with differing administration protocols and efficacy profiles.
Patent and regulatory landscape
- Janssen’s patent protections for Vidaza expired in various regions from 2018-2022, opening the market to generics.
- Regulatory approvals extend primarily throughout the US, EU, and other major markets.
- No recent FDA patent extensions for Vidaza; however, Janssen continues to hold orphan drug exclusivity in certain indications until 2025.
Price structure and projections
Current pricing overview
- Brand-name Vidaza: Wholesale acquisition cost (WAC) around $4,700 - $5,300 per 100-unit vial.
- Average treatment cost: For a standard 75 mg/m² dose over 7 days, estimated at $70,000 - $85,000 per treatment cycle.
- Generic azacitidine: Prices vary drastically, typically 20-40% lower than brand, ranging from $3,000 - $4,500 per 100-unit vial.
Future price trends
- Patent expirations have already led to significant price declines in some markets.
- Continued entry of generics is expected to reduce prices further, with some estimates projecting a 15-25% decline in overall costs over the next 3 years.
- Price elasticity depends heavily on regional healthcare policies; US and EU markets tend to sustain higher prices due to market sizes and reimbursement structures.
Market drivers and risks
- Drivers: Increasing demand for effective MDS therapies, approval of combination regimens, and a growing aging population.
- Risks: The advent of biosimilars and generics, regulatory changes affecting pricing, and potential emergence of alternative therapies.
Price projections summary table
| Year |
Brand Price (per vial) |
Generic Price (per vial) |
Estimated Market Share (Generics) |
| 2023 |
$5,000 |
$3,500 |
30% |
| 2024 |
$4,800 |
$3,200 |
45% |
| 2025 |
$4,600 |
$2,900 |
60% |
| 2026 |
$4,400 |
$2,700 |
75% |
Note: These projections assume continued patent expiration momentum and increased generic market penetration.
Key factors influencing future prices
- Patent cliffs: Timing and extent of patent expiry influence price drops.
- Market entry: Number of competitors entering regional markets.
- Reimbursement policies: Medicare, private insurers, and other payers’ willingness to reimburse for branded vs. generic.
- Regulatory changes: Policies promoting biosimilar and generic acceptance.
Key takeaways
- NDC 62135-0503 corresponds to azacitidine, with a dominant position in MDS treatment.
- Patent expiration has prompted a shift toward generics, causing a likely 15-25% price drop within three years.
- The total addressable market is expanding due to rising disease prevalence and treatment adoption.
- Pricing strategies will significantly depend on regional regulatory environments and competition from biosimilars.
FAQs
Q1: When did the patent for Vidaza expire?
A1: Patent expiration occurred variably by region, notably between 2018-2022, depending on jurisdiction.
Q2: How does the efficacy of generics compare to branded azacitidine?
A2: Regulatory agencies require bioequivalence; clinical efficacy is maintained, but manufacturing and excipient differences may influence tolerability.
Q3: What is the primary driver for price reduction?
A3: The entry of generic azacitidine following patent expiry.
Q4: Which markets are most sensitive to price competition?
A4: The US and European markets, due to high reimbursement rates and well-established generic acceptance.
Q5: What are the prospects for combination therapies involving azacitidine?
A5: Growing, with several clinical trials exploring combinations with targeted agents, potentially impacting demand and pricing for monotherapies.
References
[1] Fortune Business Insights. (2021). Myelodysplastic Syndromes (MDS) Market Size, Share & Industry Analysis. https://www.fortunebusinessinsights.com/industry-reports/myelodysplastic-syndromes-market-103157
