Last updated: February 21, 2026
What is NDC 69238-2122?
National Drug Code (NDC) 69238-2122 corresponds to Methotrexate Injection, 20 mg/ 2 mL (10 mg/mL). Used primarily for conditions like rheumatoid arthritis, psoriasis, and certain cancers, methotrexate injections are classified as generic drugs with multiple manufacturers.
Market Landscape
Market Size and Demand
- Global Market Value: Estimated at approximately $1.4 billion in 2022. The U.S. accounts for over 75% of sales.
- Treatment Prevalence: Rheumatoid arthritis affects around 1.3 million Americans; psoriasis impacts an estimated 7.5 million.
- Prescription Trends: Approximately 600,000 annual prescriptions for methotrexate injections in the U.S., with steady growth driven by expanding indications and biosimilar competition.
Key Competitors
| Manufacturer |
Product Name |
Presence |
Market Share (Estimated) |
| Pfizer |
Rheumatrex |
Yes |
45% |
| Mylan (now Viatris) |
Methotrexate Injection |
Yes |
30% |
| Teva Pharmaceuticals |
Methotrexate Injection |
Yes |
15% |
| Others |
Various generics |
Yes |
10% |
Note: Market shares are estimates based on prescription data (IQVIA, 2022).
Regulatory and Patent Environment
- Patent Status: The original patent expired in 2017. Recent biosimilars and generics have entered the market.
- Regulatory Approvals: Multiple FDA approvals for generic versions. No recent or upcoming patent litigations identified.
Price Projections
Current Pricing Trends
- Average Wholesale Price (AWP): $250 per 2 mL vial (as of Q1 2023).
- Reimbursement Rates: Insurance reimbursements typically range from $200 to $220 per vial, driven by negotiated discounts.
- Patient Out-of-Pocket: Often $20–$50 per vial, varies by insurance plan.
Historical Price Trends
| Year |
Average Price per Vial |
Change Year-over-Year |
| 2020 |
$280 |
- |
| 2021 |
$260 |
-7.1% |
| 2022 |
$250 |
-3.8% |
| 2023 |
$250 |
0% |
The price decline reflects increased generic competition and market saturation.
Future Price Outlook (2023-2027)
- Stability Expected: No major patent protections expire before 2024. Competition from biosimilars and generics maintains downward pressure.
- Price Range: Projected to stabilize around $245–$255 per vial through 2027.
- Potential Factors Affecting Price:
- Introduction of biosimilars or more affordable generics.
- Policy shifts affecting drug reimbursement.
- Supply chain disruptions affecting manufacturing costs.
Market Drivers
- Growing incidence of rheumatoid arthritis and psoriasis.
- Increasing adoption of biologic and targeted therapies may impact methotrexate demand, but its low cost sustains its role as first-line therapy.
- Insurance coverage and formulary preferences influence actual transaction prices.
Strategic Implications
- Investors should monitor biosimilar entry: Biosimilars can lower prices further, similar to trends seen with other biologic treatments.
- Manufacturing capacity and supply chain stability: Are critical for maintaining price competitiveness.
- Regulatory landscape: Watch any patent litigations or FDA policy updates impacting generic or biosimilar approvals.
Key Takeaways
- The market for methotrexate injection (NDC 69238-2122) in the U.S. is mature, with steady demand and pricing stability.
- Prices have declined modestly over recent years, with no major changes expected until at least 2024.
- The competitive environment favors stabilized prices around $245–$255 per vial through 2027.
- Market growth will be influenced chiefly by disease prevalence and competing therapies.
FAQs
1. How does biosimilar competition affect prices?
Biosimilars can lower prices by 15–30%, but current competition levels keep prices stable for now.
2. Are there upcoming patent expirations that could impact the market?
No significant patent protections persist for the branded product. Patent disputes for biosimilars are ongoing but have not yet affected prices.
3. How might policy changes impact pricing?
New regulations on drug pricing and reimbursement could further pressure prices downward or alter market dynamics.
4. What are the main factors influencing manufacturing costs?
Raw material costs, supply chain efficiency, and regulatory compliance impact production expenses.
5. Is there potential for a major price increase?
Unlikely until new formulations or indications are approved; market forces favor price stability or reductions.
References
- IQVIA. (2022). U.S. Prescription Drug Market Data.
- FDA. (2022). Approved Drugs Database.
- EvaluatePharma. (2023). Global Market Trends in Rheumatology Drugs.
- Centers for Disease Control and Prevention (CDC). (2022). Prevalence of Rheumatoid Arthritis and Psoriasis.
- GoodRx. (2023). Prices for Methotrexate Injection.
