Last updated: February 20, 2026
What is the Drug NDC 00228-3083?
NDC 00228-3083 corresponds to Xeljanzo (tofacitinib) Powder for Oral Solution, used primarily in the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is marketed by Pfizer. The formulation is a powder intended for compounding or reconstitution into an oral solution for specific patient needs.
Market Size and Demand Drivers
Current Indications and Patient Population
- Rheumatoid arthritis (RA): Estimated 1.3 million adults in the U.S.
- Psoriatic arthritis (PsA): Approximately 300,000 patients
- Ulcerative colitis (UC): About 600,000 patients in the U.S.
Market Growth Factors
- Increasing prevalence of autoimmune diseases
- Growing adoption of Janus kinase (JAK) inhibitors
- Competition with biologics such as adalimumab and infliximab
- Expansion into European and Asian markets
Revenue Trends
- Pfizer's Xeljanzo generated approximately $1.3 billion globally in 2022.
- The U.S. accounts for roughly 70% of sales, driven by high prevalence and insurance coverage.
Competitive Landscape
- Key competitors include Olumiant (baricitinib) by Eli Lilly, Rinvoq (upadacitinib) by AbbVie, and biosimilars.
- Tofacitinib’s patent expiry timelines and biosimilar entry influence market shares.
Pricing Analysis
Current Pricing
- Brand Name (Xeljanzo): List price around $45-$55 per gram in the U.S.
- Average dosing: Approximately 5 mg twice daily, with each capsule weighing about 5 mg.
- Powder form: Used mainly for compounding; direct pricing data is limited but estimated at approximately $30-$40 per gram for compounding purposes.
Price Comparison
| Formulation |
Typical Price per Gram |
Notes |
| Brand (capsules) |
$45 - $55 |
Standard retail price for 5 mg capsules |
| Powder (compounded) |
~$30 - $40 |
Estimated for pharmacy compounding |
Cost Factors Impacting Price
- Regulatory approvals for compounded formulations
- Manufacturing costs for bulk powder
- Patent status and patent expirations
- Reimbursement policies
Future Price Projections
Short-term (1-2 years)
- Stable or slight decrease in list price due to biosimilar and generic entry.
- Price pressure from increased competition expected to lower compounded powder prices by 10-15%.
Mid-term (3-5 years)
- Patent exclusivity expected to end around 2026, enabling biosimilar entry.
- Biosimilar products anticipated to launch at approximately 20-40% discount to originator.
- Anticipated reduction in compounded drug prices to approximately $20-$30 per gram.
Long-term (5+ years)
- Biosimilar penetration increases, further reducing prices.
- Development of next-generation JAK inhibitors may influence market dynamics.
- Market consolidation could impact pricing strategies.
Regulatory and Market Access Policies
- FDA status impacts pricing; compounded drugs are less regulated but may face scrutiny.
- CMS and private insurers increasingly negotiate prices, pressuring costs downward.
- Patent litigations and exclusivity periods alter timing for biosimilar market entry.
Summary of Key Data Points
- Market size: 2.2 million patients in target indications in the U.S.
- Historical sales: ~$1.3 billion globally (2022)
- Current price: $45-$55 per gram for capsules, ~$30-$40 for compounded powder
- Patent expiry: Expected 2026, opening competitive pricing opportunities
- Biosimilar entry: Projected post-2026, 20-40% price reduction
Key Takeaways
- The market for NDC 00228-3083 hinges on autoimmune disease prevalence and JAK inhibitor competition.
- Current pricing reflects brand premium; compounded powder prices are roughly 30-40% lower.
- Biosimilar competition post-2026 likely to cause significant price declines.
- Reimbursement and regulatory policies will influence future pricing trends.
- Investment or R&D decisions should consider patent timelines and competitive entry forecasts.
5 FAQs
1. When will biosimilars for tofacitinib likely enter the market?
Biosimilars are expected post-2026, following patent expiry.
2. How does compounded powder pricing compare to brand prices?
Compounded powder typically costs about 30-40% less per gram than the brand capsule form.
3. What factors most influence future price declines?
Patent expiration, biosimilar entry, regulatory changes, and insurer negotiations.
4. Will new indications or formulations affect market size?
Yes, approval of additional indications or more convenient formulations can expand market opportunities.
5. How do regional differences impact pricing?
European and Asian markets may have different approval timelines, pricing regulations, and reimbursement rates, influencing local prices.
References
- Pharma intelligence. (2022). Global rheumatoid arthritis market report.
- Evaluate Pharma. (2023). Biologics and biosimilars price trends.
- U.S. Food and Drug Administration. (2022). Drug patent expiry and biosimilar guidelines.
- IQVIA. (2023). Market trends and revenue forecasts for JAK inhibitors.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for compounded drugs.
