Last updated: March 13, 2026
What is the drug associated with NDC 17478-0716?
NDC 17478-0716 corresponds to Baricitinib, a Janus kinase (JAK) inhibitor approved for rheumatoid arthritis and, more recently, for COVID-19 treatment.
What is the current market size for Baricitinib?
Regulatory approvals
- FDA approval: May 2018 for rheumatoid arthritis.
- EMA approval: June 2018 for rheumatoid arthritis.
- Additional indications: Emergency Use Authorization (EUA) in the US for COVID-19, March 2020.
Sales data
- 2022 global sales exceeded $1.2 billion.
- US market accounts for approximately 60% of sales.
- Other main markets: EU, Japan, and Canada.
Market competitors
- Tofacitinib (Xeljanz)
- Upadacitinib (Rinvoq)
- Filgotinib (Gilead)
- Biosimilars are not yet available; patent expiry expected in late 2020s.
What are the pricing trends for Baricitinib?
US pricing
- Brand name (Olumiant): Approx. $2,200 per month for a typical 2 mg dose.
- Average wholesale price (AWP): Similar range, but payers often negotiate discounts.
European pricing
- EPAR (European Public Assessment Report): Listed prices range from €1,200 to €1,400 per month, depending on country and negotiated discounts.
Insurance impact
- Commercial insurers often secure rebates reducing patient out-of-pocket costs to $10–$50 per month.
- Public payers may pay less based on negotiated prices and formularies.
What are the price projections over the next five years?
| Year |
Price Range (Monthly cost) |
Notes |
| 2023 |
$2,000–$2,500 |
Stable, given patent exclusivity and demand |
| 2024 |
$2,000–$2,500 |
No significant generic competition expected |
| 2025 |
$1,900–$2,400 |
Possible slight reduction if biosimilar entrants emerge |
| 2026 |
$1,800–$2,300 |
Patent expiry considerations, slow biosimilar entry |
| 2027 |
$1,600–$2,000 |
Increasing biosimilar competition expected |
Note: Prices factor in negotiated discounts and rebates.
How will biosimilars or generics influence pricing?
- Patent expiration projected around 2026–2028.
- Biosimilars could reduce prices by 30–50% upon market entry.
- Biosimilar development needs regulatory approval, with potential delays.
What is the supply chain outlook?
- Manufacturers: Lilly and Incyte dominate global supply.
- Production capacity is sufficient to meet current demand.
- Pricing could be influenced by manufacturing costs, supply chain disruptions, and negotiations.
Summary
Baricitinib remains a high-priced biologic with stable sales driven by rheumatoid arthritis and COVID-19 indications. Its price is expected to decline gradually from 2026 onward with biosimilar entry, potentially reducing prices by up to 50%. Current prices in the US hover around $2,200 monthly, whereas European prices are slightly lower, ranging from €1,200 to €1,400.
Key Takeaways
- The drug's market is driven by rheumatoid arthritis, with COVID-19 usage contributing to recent sales.
- Prices are high but declining slowly due to patent protections and upcoming biosimilar competition.
- Purchasers should monitor patent expiry and biosimilar development to anticipate price reductions.
- Market growth remains steady; competition with other JAK inhibitors constrains pricing.
- Supply chain stability supports current pricing levels.
FAQs
1. When will biosimilars for Baricitinib become available?
Biosimilar approval is expected around 2026–2028, depending on patent litigation and regulatory processes.
2. How much could prices drop with biosimilar entry?
Prices could decrease by 30–50%, depending on market dynamics and manufacturer strategies.
3. Are there off-label uses affecting the market?
Currently, no significant off-label uses influence sales; the primary indications are rheumatoid arthritis and COVID-19.
4. How does the COVID-19 indication influence sales and pricing?
It contributed to a temporary surge in demand and sales but is unlikely to significantly alter long-term pricing due to targeted EUA use.
5. What factors could accelerate or delay price declines?
Patent litigation duration, biosimilar development timelines, regulatory approval processes, and market acceptance influence pricing changes.
References
[1] FDA. (2018). Olumiant (Baricitinib) prescribing information. Retrieved from https://www.accessdata.fda.gov
[2] EMA. (2018). Summary of Product Characteristics for Olumiant. Retrieved from https://www.ema.europa.eu
[3] IQVIA. (2022). Global sales data for JAK inhibitors.
[4] EvaluatePharma. (2023). 2023 Industry forecast for rheumatoid arthritis drugs.
