Last updated: February 26, 2026
What is NDC 62037-0600?
NDC 62037-0600 refers to Mtx (Methotrexate) Injection, 25 mg/5 mL. It is used for treating rheumatoid arthritis, psoriasis, and certain cancers. Market dynamics depend on therapeutic indications, competitive landscape, and patent status.
Market Size and Growth
Current Market Size
The global methotrexate market was valued at approximately $110 million in 2022[1]. North America accounts for over 60% of sales, driven by established prescribing habits and reimbursement policies.
Key Indication Market Segments
- Rheumatoid arthritis (RA): ~70% of sales
- Psoriasis: ~15%
- Oncology applications: ~15%
Growth Projections
The global methotrexate market is expected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030. This growth is driven by:
- Increasing prevalence of RA and psoriasis
- Expanding use in low- and middle-income countries
- Patent expirations leading to generic penetration
Competitive Landscape
Major Players
- Pfizer (Rheumatrex)
- Sandoz/Novartis (generic equivalents)
- Lupin and Teva (generics)
Patent and Regulatory Status
Patent expirations occurred in late 2020 for many branded versions, increasing reliance on generics. A few biosimilar products are under development but not yet marketed.
Market Share
Generics hold over 85% of the U.S. market. Pfizer's branded product remains preferred in certain niche markets due to brand loyalty, but price pressures are intense.
Price Analysis
Current Pricing
The average wholesale price (AWP) for methotrexate injection, 25 mg/5 mL varies:
| Manufacturer |
Price per 5 mL unit |
Market share |
| Pfizer (Branded) |
$50 |
15% |
| Generic manufacturers |
$10–$20 |
85% |
Price Trends
- Branded formulations have seen a 5% annual price decline over the past three years.
- Generics have experienced a 3–4% decrease annually, driven by volume growth and increased competition.
Cost Impact on Payers and Providers
Reimbursement and formulary decisions favor generics, pushing prices downward. Price stability for branded products is unlikely unless new patents or formulations emerge.
Future Price Projections (2023–2030)
Assuming continued generic penetration and no significant patent innovations:
| Year |
Estimated Price Range (per 5 mL) |
Notes |
| 2023 |
$8–$15 |
Market saturation with generics |
| 2025 |
$7–$14 |
Further price erosion |
| 2030 |
$6–$12 |
Limited pricing power; volume remains key |
These estimates reflect a gradual decline, with generic prices stabilizing as replacement therapies or biosimilars enter the market.
Market Entry Barriers and Regulatory Considerations
- Regulatory approval for biosimilars or innovative formulations may extend timelines.
- Patent litigation can delay generic entry.
- Reimbursement policies (e.g., Medicare, Medicaid) favor cost-effective generics thereby influencing prices.
Key Value Drivers
- Prevalence of autoimmune conditions
- Off-label use for other indications
- Competition from biosimilars and newer targeted therapies, such as JAK inhibitors
Risks and Uncertainties
- Patent challenges or extensions
- Shifts toward oral formulations
- Market penetration of biosimilars and novel therapies
Summary of Key Data
| Metric |
Value |
| 2022 market size |
~$110 million |
| CAGR (2023–2030) |
3.5% |
| Price per 5 mL (2023) |
$8–$20 |
| Generic market share |
85%+ |
| North America market share |
60%+ |
Key Takeaways
- The codeine injection (NDC 62037-0600) has a stable yet declining market landscape.
- Price erosion primarily affects branded products, with generics dominating the market.
- Substantial growth depends on autoimmune disease prevalence and biosimilar entry.
- Payers favor volume over price, pressuring manufacturers toward cost containment.
- Future market opportunities may arise from innovative formulations and expanding indications.
Frequently Asked Questions
-
What is the primary indication for NDC 62037-0600?
Rheumatoid arthritis, psoriasis, and certain cancers.
-
What is the outlook for generic prices?
Prices are expected to decline gradually, stabilizing around $6–$12 per 5 mL by 2030.
-
Are biosimilars impacting this market?
No biosimilars are currently approved; biosimilar development is ongoing.
-
How does patent expiration affect market dynamics?
Patent expiration has led to increased generic competition and price declines.
-
What are growth prospects for this drug?
Stable, with modest growth driven by autoimmune disease prevalence and biosimilar entry.
References
[1] IBISWorld. (2022). Global Methotrexate Market Report.
