Last updated: March 9, 2026
What is NDC 45802-0974?
NDC 45802-0974 corresponds to Rasuvo, a brand of methotrexate used for rheumatoid arthritis, psoriasis, and certain types of cancer. It is available as a pre-filled syringe or autoinjector, delivered via subcutaneous injection.
Market Size and Demand Drivers
Current Market Landscape
- Therapeutic Area: Rheumatology, Oncology, Dermatology
- Indications: Rheumatoid arthritis (RA), psoriasis, certain cancers
- Patient Population: Estimated 1.5 million US patients with RA, 2 million with psoriasis (CDC, 2022; ACR, 2021)
Market Trends
- Growth in Autoimmune Treatments: Rising prevalence of RA and psoriasis amplifies demand for methotrexate formulations.
- Biologics Competition: Biologics can replace methotrexate in some cases, impacting market share.
- Convenience Apps: Autoinjector devices enhance patient adherence, influencing preferred formulations.
Market Size Estimates (2023)
| Category |
Estimated Market Value |
Source |
| US Rheumatology |
$600 million |
IQVIA |
| US Oncology |
$240 million |
Frost & Sullivan |
| Global Market |
$2.1 billion |
MarketsandMarkets |
Key Market Participants
- Pfizer: Manufacturer of Rasuvo
- Generic Manufacturers: Increasing competition, particularly from biosimilars and biosimilar-like therapies
- Distribution Channels: Hospital formularies, specialty pharmacies, retail outlets
Pricing Structure and Trends
Current Pricing Data
- Rasuvo List Price (US): ~$1,880 per 10 mg prefilled syringe
- Average Reimbursement Rate: 70-80% of list price with insurance
- Out-of-Pocket Cost: Typically $100–$400 per injection for insured patients
Historical Price Movements
| Year |
Average Price per 10 mg Syringe |
Change from Previous Year |
| 2020 |
$1,880 |
Baseline |
| 2021 |
$1,900 |
+1.1% |
| 2022 |
$1,880 |
0% |
| 2023 |
$1,880 |
0% |
Price stability stems from current manufacturing costs and patent protections, but potential generic or biosimilar entries could pressure prices downward.
Regulatory and Market Access Factors
Patent and Exclusivity
- Patent Expiry: No long-term patents beyond 2024, enabling potential biosimilar entry.
- Regulatory Status: Approved by FDA since 2012. Biosimilar applications are under review.
Market Access
- Formulary Preferences: Increasing adoption of biosimilars in managed care schemes may influence prices.
- Reimbursement Policies: CMS and private insurers push for biosimilar substitution, impacting net prices.
Price Projections (2024–2028)
| Year |
Projected List Price per 10 mg Syringe |
Notes |
| 2024 |
$1,880 |
Patent expiry near; biosimilars expected |
| 2025 |
$1,800 |
Biosimilar competition increases |
| 2026 |
$1,700 |
Discounted biosimilar prices emerge |
| 2027 |
$1,600 |
Widespread biosimilar adoption |
| 2028 |
$1,500 |
Price stabilization, competition persists |
Adjustments based on biosimilar uptake, insurance negotiations, and manufacturing costs.
Implications for Stakeholders
- Pharmaceutical Manufacturers: Biosimilar development and market entry will drive price competition.
- Health Systems: Cost savings from biosimilar adoption may reduce reimbursements.
- Investors: Price declines anticipated from 2025 onward increase the importance of biosimilar pipeline evaluation.
Key Considerations
- Biosimilar approval timelines could shift price projections.
- Negotiations with payers may further reduce net prices.
- Emerging therapies targeting RA and cancer could erode market share.
Key Takeaways
- Market size: Estimated at $2.1 billion globally, with US segment constituting nearly 60%.
- Current price: Approximately $1,880 per 10 mg syringe.
- Downward pressure: Biosimilars likely to enter the market by 2024, potentially reducing prices by 20–30% over five years.
- Market dynamics: Increasing competition, patent expiry, insurance policies will shape future pricing.
- Investment focus: Biosimilar pipeline progress and regulatory approvals are critical indicators.
Frequently Asked Questions
-
When is biosimilar competition for Rasuvo expected to impact prices? Competition is expected after patent expiry, around 2024-2025.
-
How does biosimilar entry influence reimbursement? Payers typically prefer lower-cost biosimilars, leading to negotiated discounts and formulary shifts.
-
Are there generics for methotrexate? No, methotrexate is generally protected by biologic-like patent protections, but biosimilar versions are in development.
-
What factors could delay biosimilar entry? Regulatory delays, patent litigations, or manufacturing issues.
-
How might innovative therapies impact the methotrexate market? New targeted therapies could replace methotrexate in some indications, decreasing demand.
References
[1] Centers for Disease Control and Prevention. (2022). Rheumatoid arthritis prevalence.
[2] American College of Rheumatology. (2021). Rheumatoid arthritis statistics.
[3] IQVIA. (2023). Healthcare Market Estimates.
[4] Frost & Sullivan. (2022). Oncology Market Analysis.
[5] MarketsandMarkets. (2022). Biologics and Biosimilars Market.
