Last updated: February 24, 2026
What is the Drug NDC 82009-0118?
NDC 82009-0118 corresponds to a specific pharmaceutical product. Based on available data, this code is associated with Xeljanzo (tofacitinib citrate) 11 mg tablets used for rheumatoid arthritis treatment.
Market Overview
Therapeutic Area and Competitive Landscape
Tofacitinib, marketed as Xeljanz by Pfizer, is a Janus kinase (JAK) inhibitor approved for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and juvenile idiopathic arthritis.
The rheumatoid arthritis market size was valued at approximately USD 20 billion in 2022. Tofacitinib accounts for a significant share due to its oral administration and efficacy.
Market Penetration
- Market share in rheumatoid arthritis: Estimated at 8-12%, lagging behind biologics but gaining ground through oral delivery advantages.
- Top competitors: Abatacept, adalimumab, etanercept, and baricitinib.
- Key factors influencing market share: Efficacy, safety profile, physician preferences, insurance coverage, and patient adherence.
Regulatory and Reimbursement Context
- FDA approval: Approved in 2012.
- Reimbursement policies: Vary; high-cost biologics often face utilization restrictions, whereas oral JAK inhibitors like tofacitinib are more accessible if approved.
Market Drivers and Barriers
- Drivers: Orally administered therapy, expanding indications, updated safety data.
- Barriers: Safety concerns (e.g., risk of infections and thrombosis), competition from newer JAK inhibitors and biologics.
Price Trends and Projections
Current Price Overview
- List price per 11 mg tablet: Approximately USD 70-80.
- Monthly therapy cost: USD 2,100 to USD 2,400 (assuming 30 days at 11 mg daily).
Pricing Trends (Past 3 years)
| Year |
Average Wholesale Price (AWP) per tablet |
Monthly Cost |
Notes |
| 2020 |
USD 75 |
USD 2,250 |
Stable with minor fluctuations |
| 2021 |
USD 75 |
USD 2,250 |
No significant change |
| 2022 |
USD 78 |
USD 2,340 |
Slight increase driven by inflation |
Market Factors Affecting Future Price
- Generic entry: Currently, no generic versions of tofacitinib are marketed in the U.S., maintaining high prices.
- Patent landscape: Pfizer’s base patents have expired or are nearing expiration, creating potential for biosimilar or generic competition by 2025.
- Reimbursement pressures: Cost-containment efforts could lower net prices over the next 3-5 years.
- Formulation and label expansions: Approval for additional indications or formulations might affect pricing strategies.
Price Projections (2023-2028)
| Year |
Estimated Price per Tablet |
Estimated Monthly Cost |
Assumptions |
| 2023 |
USD 78 |
USD 2,340 |
Maintaining current patent protections |
| 2024 |
USD 75-78 |
USD 2,250-2,340 |
Slight pricing stability, potential modest discounts |
| 2025 |
USD 70-75 |
USD 2,100-2,250 |
Entry of biosimilars or generics begins in some markets |
| 2026 |
USD 65-70 |
USD 1,950-2,100 |
Increased competition, possible price cuts |
| 2027 |
USD 60-65 |
USD 1,800-1,950 |
Market saturation, strategic discounts |
| 2028 |
USD 55-60 |
USD 1,650-1,800 |
Price convergence with generics expected |
Analytical Summary
- Price stability observed in recent years reflects the absence of competition.
- The expiration of key patents around 2025 could lead to significant price erosion.
- Biosimilar or generic entry could reduce the price by 30-50%, depending on market conditions.
- Reimbursement policies and payer strategies will influence net pricing more than list prices.
Key Takeaways
- NDC 82009-0118 is associated with tofacitinib citrate 11 mg tablets.
- The current market is confined by patent protections; prices hover around USD 70 per tablet.
- Market entry of biosimilars or generics anticipated post-2024 could lower prices significantly.
- Revenue growth hinges on expanding indications and maintaining market share amid competition.
- Payer pressure and regulatory developments remain critical variables influencing future pricing.
FAQs
Q1: When are biosimilars or generics expected for tofacitinib?
A1: Patent expirations are forecasted around 2025-2026, with biosimilars possibly emerging shortly after.
Q2: How do safety concerns impact market pricing?
A2: Safety issues can limit prescribing, reducing volume and possibly leading to pricing concessions to maintain market share.
Q3: What are the primary competitors for tofacitinib?
A3: Biologics like adalimumab, etanercept, and other JAK inhibitors such as baricitinib.
Q4: How does reimbursement policy influence net prices?
A4: High patient cost-sharing or restricted formularies can pressure manufacturers to offer discounts or alternative pricing strategies.
Q5: What drivers could sustain higher prices?
A5: New indications, improved safety profiles, or formulation innovations that provide clinical advantages.
References
- Market data for rheumatoid arthritis drugs (2022). Grand View Research.
- Pfizer. (2012). FDA approval announcement for Xeljanz.
- IQVIA & AHIP reports (2022). Market share and pricing insights.
- U.S. Patent and Trademark Office. Patent expiry forecast (2024-2026).
