Last updated: March 13, 2026
What is NDC 00527-5137?
NDC 00527-5137 refers to Xeljanz (tofacitinib) tablets manufactured by Pfizer. Approved by the FDA for rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis, and other autoimmune conditions, it is a Janus kinase (JAK) inhibitor.
Market Overview
Market Size and Growth
- Global autoimmune drug market was valued at approximately $30 billion in 2022.
- Xeljanz's share in RA treatment approximated $3.8 billion in 2022.
- Compound annual growth rate (CAGR) for JAK inhibitors, including Xeljanz, projected at 8-10% through 2030.
Clinical Indications and Market Penetration
- Approved indications: Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, atopic dermatitis.
- Estimated patient population (US):
- RA: 1.3 million
- Psoriatic arthritis: 300,000
- Ulcerative colitis: 900,000
- Market penetration varies; Xeljanz holds approximately 15-20% of RA market share in the US.
Competitive Landscape
- Main competitors: AbbVie Humira (adalimumab), Eli Lilly Olumiant (baricitinib), AbbVie Rinvoq (upadacitinib).
- Key differentiator: Oral administration versus biologics requiring injections.
Price Projections
Current Pricing Structure
| Pricing Metric |
US Market (2013-2022) |
Notes |
| Wholesale Acquisition Cost (WAC) per 5 mg tablet |
~$46 |
Approximate, varies by pharmacy and insurer |
| Average Monthly Cost (per patient) |
~$2,300 |
Based on 60 mg dose, taken twice daily for RA |
| Patient Pill Burden |
60 mg/day |
Typically requires titration, dosage varies by indication |
Future Price Trends
- Price stabilization expected over the next 3-5 years due to patent protections expiring in 2027.
- Biosimilar Competition: Entry anticipated from biosimilars of biologics like Humira; limited impact on Xeljanz due to differences in administration and indications.
- Pricing pressure: Marginal decrease expected in the US, especially with increased insurer negotiations and value-based pricing models.
Regional Price Differences
| Region |
Average Wholesale Price (AWP) |
Notes |
| US |
~$46 per 5 mg tablet |
Includes discounts, varies per pharmacy |
| EU |
~$35-$45 per 5 mg tablet |
Prices vary by country, explicit government controls |
| Japan |
~$35 per 5 mg tablet |
Price cap reflects negotiation with authorities |
Price Sensitivity and Impact Factors
- Patent Exclusivity: Valuable patent rights protect pricing until patent expiry in 2027.
- Generic/Biosimilar Entry: Expected to reduce prices by 15-25% over 2-3 years post-patent expiry.
- Reimbursement policies: Shift toward value-based and outcome-based contracts could influence list prices.
Regulatory & Patent Landscape
| Year |
Milestone |
Impact |
| 2012 |
FDA approval for RA |
Launch established, initial pricing high |
| 2018 |
Patent litigation subsidized by biosimilar legislation |
Likely to extend patent life or delay biosimme variant entry |
| 2023 |
Patent expiry set for 2027 |
Price decline expected post-expiry |
Key Price Drivers
- Efficacy and safety profile improvements.
- Insurance coverage expansion.
- Biosimilar and generic competition.
- Regulatory and legislative changes impacting drug pricing.
Conclusion
Xeljanz (NDC 00527-5137) remains a high-priced JAK inhibitor with steady demand across multiple autoimmune indications. Its price remains stable through 2027, after which biosimilar competition will likely expedite price reductions. The market is characterized by a combination of brand loyalty, clinical preferences, and regulatory protections that influence current pricing and future projections.
Key Takeaways
- Xeljanz generated approximately $3.8 billion in 2022, representing its significant market position.
- US monthly patient cost averages around $2,300; regional prices range from $35-$46 per 5 mg tablet.
- Current patent protections extend into 2027; biosimilar entry expected thereafter.
- Price pressures will increase post-patent expiry, especially with biosimilar competition.
- The treatment landscape is shifting toward combination therapies and outcome-based reimbursement models.
FAQs
1. How is Xeljanz priced compared to biologics?
Xeljanz is priced higher than many biologics on a per-dose basis but offers the convenience of oral administration, which can influence patient and provider preferences.
2. When will biosimilars for Xeljanz enter the market?
Biosimilars are not applicable to Xeljanz directly but compete with biologic drugs. Biosimilar competition for rheumatoid arthritis biologics will intensify after patent expiry, expected in 2027.
3. Will pricing decrease significantly after patent expiry?
Yes, biosimilar entry is expected to reduce prices by 15-25%. Market dynamics and insurer negotiations may further influence price drops.
4. How does regional pricing differ globally?
Prices are generally lower outside the US, with controlled pricing mechanisms in Europe and Japan, and vary based on local regulations and negotiations.
5. Are there new indications that could affect Xeljanz’s price?
Yes, approvals for ulcerative colitis and other indications increase demand, which can support stable or rising prices until patent expiry.
References
- IQVIA. (2022). Global autoimmune drug market report.
- FDA. (2012). Approval letter for Xeljanz.
- Pfizer. (2022). Xeljanz product information.
- EvaluatePharma. (2022). Pharmaceutical pricing insights.
- Statista. (2023). Biologic and biosimilar market projections.
