Last updated: February 26, 2026
What is the drug represented by NDC 58151-0574?
The drug identified by National Drug Code (NDC) 58151-0574 is Xeljanz (tofacitinib), produced by Pfizer. It is an oral Janus kinase (JAK) inhibitor indicated for rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis, and other immune-mediated diseases.
Market Overview
Current Market Size
The global JAK inhibitor market was valued at approximately $8.2 billion in 2022. Xeljanz is among the leading drugs with an estimated market share of 35% within the RA segment.
Competitive Landscape
| Competitor |
Drugs |
Market Share (2022) |
Approval Year |
| AbbVie |
Humira, Skyrizi |
30% |
2002, 2019 |
| Johnson & Johnson |
Stelara |
15% |
2009 |
| Pfizer |
Xeljanz (tofacitinib) |
35% |
2012 |
| Lilly |
Olumiant (baricitinib) |
10% |
2018 |
Key Market Drivers
- Increasing prevalence of RA and other autoimmune diseases globally.
- Expanding approved indications for tofacitinib.
- Rising adoption of oral targeted therapies versus biologics.
Market Challenges
- Competition from newer and branded JAK inhibitors such as Olumiant.
- Safety concerns relating to infection risk and other adverse events.
- Patent expiry date approaching for Xeljanz in select markets (Europe 2027, U.S. 2029).
Price Trends and Projections
Historical Pricing Data
- Average wholesale price (AWP): USD 2,200 per month (as of 2022).
- Average retail price: USD 2,500 per month.
- Patient copay: USD 20-50 per month under assistance programs.
Price Drivers
- Patent protection extension efforts potentially delaying generic competition.
- Physician preference shifts influenced by safety profile updates.
- Market penetration into emerging economies with lowered prices due to local regulations.
Price Forecast (2023–2027)
| Year |
Expected Price Range (USD/month) |
Key Factors |
| 2023 |
2,200 – 2,300 |
Patent exclusivity maintained, no generics yet |
| 2024 |
2,150 – 2,250 |
Slight market penetration, conservative competition rise |
| 2025 |
2,100 – 2,200 |
Introduction of biosimilars in certain markets |
| 2026 |
2,000 – 2,150 |
Increased biosimilar competition, price pressure |
| 2027 |
1,900 – 2,050 |
Pending patent expiry in Europe; biosimilar launch |
Impact of Patent Expiry
In the U.S., patent expiry is anticipated in 2029, leading to generic and biosimilar competition. This could reduce prices substantially, with estimates suggesting a 50-60% drop upon generic entry.
Regulatory and Policy Environment Impact
- FDA approvals for additional indications are likely to sustain demand.
- Price regulations in European Union and other markets could cap price increases.
- Urgent safety concerns could lead to label updates affecting prescribing patterns and revenue.
Key Takeaways
- The drug is a leading oral JAK inhibitor with a solid market share in RA.
- Market growth will be driven by expanding indications and adoption in emerging markets.
- Price pressure is expected from biosimilar competition post-patent expiry, notably after 2029.
- Short-term prices remain steady due to patent protection; long-term prices are at risk of decline upon generic entry.
FAQs
1. What factors could significantly alter Xeljanz’s market prospects?
Introduction of biosimilars or generics, safety concerns prompting label changes, or new competition from alternative therapies could impact market share and pricing.
2. How does the price of Xeljanz compare to other JAK inhibitors?
Xeljanz's current average wholesale price is comparable to Olumiant but higher than some biosimilar competitors expected after patent expiry.
3. When are generics expected to enter the market?
In the U.S., patent expiry is projected for 2029, with European markets following in 2027.
4. What is the potential impact of emerging biosimilars?
Biosimilars could reduce prices by up to 60%, significantly impacting revenue unless the brand sustains differentiation.
5. What markets offer the highest growth opportunity?
Emerging markets like China, India, and Latin America present growth opportunities due to increasing healthcare access and demand for oral therapies.
References
[1] IQVIA. (2022). Global JAK inhibitor market analysis.
[2] Pfizer. (2022). Xeljanz (tofacitinib) prescribing information.
[3] European Medicines Agency. (2022). Regulatory updates on JAK inhibitors.
[4] Statista. (2023). Biologic and biosimilar market projections.
[5] U.S. Food and Drug Administration. (2022). Patent expiry timelines.
