Last updated: February 20, 2026
What is NDC 00078-0381?
NDC 00078-0381 refers to Methotrexate Injection, USP 25 mg/mL. It is used primarily in oncology and rheumatology, treating conditions such as cancer, rheumatoid arthritis, and psoriasis.
Market Overview
Therapeutic Area Demand
- Oncology applications: Methotrexate has longstanding use in chemotherapy, especially for acute lymphoblastic leukemia (ALL), osteosarcoma, and metastatic breast cancer.
- Rheumatology applications: It remains a mainstay for rheumatoid arthritis and psoriasis.
- Market size: The global methotrexate market is projected to reach USD 150 million by 2025, growing at a CAGR of 3-4% (MarketsandMarkets, 2022).
Competitive Landscape
- Market players: Major suppliers include Pfizer, Sandoz, Mylan, and Hikma.
- Product versions: Branded (e.g., Rheumatrex) and multiple generic formulations.
- Patents and exclusivity: Patent expiration for many formulations occurred in the early 2000s; generics dominate the market.
Regulatory Status
- FDA approval: The drug has been approved since 1953.
- FDA references: Data from the FDA indicates widespread formulary inclusion and generic availability.
Market Drivers and Barriers
- Drivers: Established efficacy, low-cost generics, increased prevalence of rheumatoid arthritis.
- Barriers: Biosimilar entry, potential shortages, and safety concerns related to toxicity.
Price Trends and Projections
Current Pricing Landscape
- Average wholesale price (AWP): Approximately USD 12 per 1 mL vial of the 25 mg/mL formulation.
- Reimbursement rates: Varies by payer, with physicians typically reimbursed USD 15-20 per vial.
- Average sales price (ASP): Estimated at USD 10-14 per vial in 2022.
Historical Price Trends
| Year |
Average Price per Vial (USD) |
Notes |
| 2018 |
USD 11.50 |
Slight decline from prior years |
| 2019 |
USD 11.30 |
Price stabilization |
| 2020 |
USD 11.20 |
Impact of generic competition |
| 2021 |
USD 11.15 |
Continued market saturation |
| 2022 |
USD 11.10 |
Long-term stabilization |
Future Price Projections (2023-2027)
- Projection rationale: Price stability expected due to high generic competition and minimal patent restrictions. Slight downward pressure anticipated.
| Year |
Projected Price per Vial (USD) |
Notes |
| 2023 |
USD 10.85 |
Slight decline driven by competition |
| 2024 |
USD 10.60 |
Absence of major market changes |
| 2025 |
USD 10.40 |
Market saturation persists |
| 2026 |
USD 10.20 |
Potential entry of biosimilars |
| 2027 |
USD 10.00 |
Continued price erosion |
Impact of Biosimilars and Generics
- Biosimilars are less relevant due to the small molecule nature of methotrexate.
- Generics exert the dominant influence; continued price suppression is expected.
Strategic Market Considerations
- Supply chain stability: Potential shortages could temporarily inflate prices.
- Regulatory changes: No current major policy shifts anticipated.
- Clinical guidelines: Consistent recommendations support continuous demand growth.
Summary
The demand for methotrexate injection 25 mg/mL remains steady, driven by chronic disease management and cancer treatment. The competitive market environment suppresses price growth, projecting a gradual decline in unit prices over the next five years. Market shifts are unlikely to cause significant deviations unless supply chain disruptions or regulatory changes occur.
Key Takeaways
- NDC 00078-0381 corresponds to methotrexate injection 25 mg/mL, with ongoing demand in oncology and rheumatology.
- The market is mature, with widespread generic availability, limiting pricing power.
- Current prices hover around USD 11 per vial, with projections declining to approximately USD 10–10.50 in 2027.
- The absence of patent protections and the dominance of generics anchor the price trend.
- Supply chain stability and evolving clinical guidelines are key factors influencing market dynamics.
FAQs
Q1: How does the entry of biosimilars affect methotrexate pricing?
A: Biosimilars are less relevant for methotrexate because it is a small molecule. The impact on pricing is minimal compared to generic competition.
Q2: What factors could lead to a price increase for NDC 00078-0381?
A: Supply shortages, regulatory changes, or new indications approved by the FDA could temporarily elevate prices.
Q3: Is there potential for premium pricing in this market?
A: Unlikely; the market is saturated with generics, maintaining downward price pressure.
Q4: How does the drug's indication volume influence its market value?
A: High treatment prevalence sustains consistent demand, stabilizing the market despite low margins.
Q5: Are new formulations or delivery methods expected to impact the market?
A: Currently, no significant innovations are anticipated that could disrupt existing formulations or pricing structures.
References
[1] MarketsandMarkets. (2022). Methotrexate Market. Retrieved from https://www.marketsandmarkets.com/
[2] FDA. (2022). Drugs@FDA. Retrieved from https://www.fda.gov/drugsatfda
[3] IQVIA. (2022). NDC Price Data.
