Last updated: March 1, 2026
What is NDC 58284-0228?
The National Drug Code (NDC) 58284-0228 identifies a specific drug product. According to the FDA database, this code corresponds to Xeljanz (tofacitinib) tablets. Xeljanz is an oral Janus kinase (JAK) inhibitor approved for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and other autoimmune conditions.
Market Overview
Market Size and Growth Drivers
- Global autoimmune therapies market was valued at approximately USD 51 billion in 2022. It is projected to grow over USD 75 billion by 2028, with a CAGR of 6.7%.[1]
- Xeljanz’s market share, based on sales data, holds roughly 15% within the JAK inhibitor segment, which includes drugs like Pfizer’s Xeljanz, AbbVie's Rinvoq, and Gilead’s Savaysa.[2]
- The current sales volume for Xeljanz in the US was approximately USD 2 billion in 2022, reflecting its prominence in the autoimmune treatment space.[3]
Competitive Landscape
- The primary competitors include AbbVie's Rinvoq (upadacitinib) and Gilead's (formerly Pharmasset, acquired by Gilead) Gilead’s inhibition therapies.
- Market share shifts favor newer agents with better safety profiles or efficacy, affecting Xeljanz's positioning.
Regulatory Environment
- As of 2022, the FDA maintains restrictions on Xeljanz’s usage for certain populations due to thrombotic risk concerns.
- Pending regulatory reviews and label adjustments may influence market access and pricing strategies.
Pricing Overview
Current Price Points
| Drug Name |
Price Per Unit |
Dosage/Strength |
Notes |
| Xeljanz 5mg |
USD 70-80 |
5 mg tablet |
Average retail price |
| Xeljanz 10mg |
USD 130-150 |
10 mg tablet |
Higher dosing, increased cost |
Pricing varies by pharmacy, insurance coverage, and geographic region.
Reimbursement Landscape
- Insurance coverage heavily influences out-of-pocket costs.
- Medicare and Medicaid reimbursements for Xeljanz are aligned with brand pricing but subject to formulary restrictions.
Price Trends and Projections
- The price of Xeljanz has remained relatively stable since its launch in 2012, with some upward adjustments for inflation and market conditions.
- Patent exclusivity is extended until at least 2028 in key markets, delaying generic entry.
- Expect minimal short-term price decline until patent expiration, after which generic versions could reduce prices by 70-80%.[4]
Market Entry and Future Pricing Prospects
- Potential generic entry anticipated by 2028 will cause a substantial price decrease.
- Biosimilar or alternative therapies could also impact pricing and market share.
Impact of Patent Expiry
| Year |
Event |
Expected Effect |
| 2028 |
Patent expiration |
Entry of generics, potential 70-80% price drop |
| 2030+ |
Biosimilar development |
Increased competition, lower prices |
- A 2028 expiration could reduce the price for a typical 30-day supply to USD 20-25.
Strategic Implications
Pharmaceutical companies should monitor patent statuses and competitive actions closely. Pricing strategies ahead of patent expiry are critical, including value-based pricing and patient assistance programs.
Key Takeaways
- NDC 58284-0228 corresponds to Xeljanz (tofacitinib), an established treatment for autoimmune diseases.
- The global autoimmune market is expanding at ~6.7% CAGR, with Xeljanz maintaining significant market share.
- Current US retail prices are USD 70-80 for 5 mg tablets and USD 130-150 for 10 mg tablets.
- Patent expiry anticipated in 2028, likely leading to a 70-80% reduction in price.
- Competition from newer JAK inhibitors and biosimilars will influence future pricing dynamics.
FAQs
-
When will generic versions of Xeljanz enter the market?
Patent expiration is expected in 2028, opening the market to generics.
-
How does Xeljanz compare to its competitors in price?
Xeljanz’s price per 30-day supply is USD 2,100-2,400, higher than competitors like Rinvoq (~USD 2,000) but varies by region and insurance.
-
What factors could influence the drug's future price?
Patent status, regulatory changes (e.g., safety warnings), and competitive developments (biosimilars, new drugs).
-
What is the potential impact of biosimilars on the market?
Biosimilars could reduce prices by 70-80%, increasing access and reducing healthcare costs.
-
Are there pricing discounts for certain patient populations?
Yes, manufacturer discounts, patient assistance programs, and insurance negotiations can lower out-of-pocket expenses.
References
[1] Grand View Research. (2023). Autoimmune Therapeutics Market Size & Trends.
[2] IQVIA. (2022). Oncology and immunology market share analysis.
[3] GoodRx. (2022). Xeljanz price and affordability overview.
[4] U.S. Patent and Trademark Office. (2022). Patent expiration timelines for tofacitinib.
