Last updated: March 7, 2026
What is NDC 43393-0024?
NDC 43393-0024 refers to Olumiant (baricitinib), a Janus kinase (JAK) inhibitor approved by the FDA for the treatment of rheumatoid arthritis (RA). It is marketed by Eli Lilly and Company. The drug gained additional approval for COVID-19 treatment in 2022 under emergency use authorization, expanding its market scope.
Market Overview
Indications and Approved Uses
- Rheumatoid arthritis (FDA approved)
Approved since May 2018 for adult RA patients with insufficient response to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
- COVID-19 (EUA since Nov 2021)
Used in combination with remdesivir for hospitalized patients requiring oxygen.
Market Size (2023)
| Segment |
Size (USD billions) |
Growth Rate (2023) |
Notes |
| Rheumatoid Arthritis |
3.2 |
8% |
Global market, key drivers include prevalence and unmet needs |
| COVID-19 treatment |
0.4 |
50% |
Fluctuates with pandemic dynamics, recent approvals expand use |
| Total |
3.6 |
8% overall |
Steady growth driven mainly by RA, pandemic effects add variability |
Competitive Landscape
- Major competitors: tofacitinib (Xeljanz), baricitinib (brand-specific by other companies, e.g., Olumiant), upadacitinib (Rinvoq), and traditional biologic therapies (e.g., adalimumab).
- Market share (2023): Olumiant holds approximately 20-25% of the JAK inhibitor market for RA.
Regulatory Developments
- Full FDA approval for RA was granted in 2018.
- Expanded EUA for COVID-19 in 2022, supporting broader use.
- Ongoing trials for other indications like atopic dermatitis and alopecia areata.
Price Trends and Projections
Current Pricing (2023)
| Market |
List Price (per 28-day supply, USD) |
Notes |
| US |
2,400 |
For RA, based on wholesale acquisition costs |
| Europe |
2,100 |
Varies per country, often lower than US |
| Canada |
2,200 |
Similar to US, with negotiated discounts |
Note: The actual negotiated net prices are often lower due to rebates and insurance discounts.
Price Drivers
- Market exclusivity: Patent protections until 2028, with potential extensions.
- Generic threats: Limited, as biosimilars are biologics, not small molecules, delaying biosimilar entry.
- Pricing strategies: Eli Lilly sets premium pricing due to its pioneering position and clinical efficacy profile.
Price Projections (2024–2028)
| Year |
US Price (USD per 28-day supply) |
Assumptions |
Comments |
| 2024 |
2,500 |
No significant price adjustments; inflationary pressures |
Slight increase due to inflation and increased demand |
| 2025 |
2,550 |
Continued exclusivity, stable demand |
Market penetration stabilizes, no biosimilar competition |
| 2026 |
2,600 |
Potential price increase aligned with inflation |
Possible price negotiations for Medicaid and private insurers |
| 2027 |
2,650 |
Same as above, eventual patent expiry approaches |
Biosimilar competition expected post-2028 |
| 2028 |
2,700 |
Slight increase, anticipation of biosimilar entry |
Patent expiry increases pressure on pricing |
Impact of Biosimilar Entry
- Biosimilars for JAK inhibitors are not expected before 2028.
- Once biosimilars enter the market, average prices could decline by 20–30% within two years.
- Price erosion may be mitigated if Eli Lilly extends patents or develops next-generation formulations.
Key Market Risks
- Regulatory delays/postponements: Potential delays in approval for new indications could slow growth.
- Pricing pressure: Entry of biosimilars after patent expiry is inevitable.
- Market saturation: High adoption rates for RA could plateau, limiting sales growth.
Strategic Considerations
- Maintaining exclusivity through patent extensions and new indications is vital.
- Diversification into additional indications can sustain revenue growth post-patent expiry.
- Pricing strategies should account for evolving biosimilar landscape and payer negotiations.
Key Takeaways
- NDC 43393-0024 (Olumiant) is a key JAK inhibitor with a primary market in RA and a growing COVID-19 use.
- The current US list price is approximately USD 2,400 per month, with slight increases projected up to 2028.
- Market growth is driven by increasing RA prevalence and pandemic-related expansion.
- Biosimilar competition is imminent post-2028, likely leading to significant price reductions.
- Eli Lilly’s ability to extend patent protections or expand indications will influence revenue stability.
Frequently Asked Questions
1. When will biosimilars for Olumiant potentially enter the market?
Biosimilars for biologics like Olumiant are expected post-2028 when patents expire and regulatory pathways are settled.
2. How does Olumiant's pricing compare to similar drugs?
It is priced similarly to other JAK inhibitors like Xeljanz ($2,200–$2,600/month). Biosimilars could lower prices by 20-30%, impacting competitive positioning.
3. What other indications could improve Olumiant’s market share?
Potential approvals in dermatology (e.g., alopecia areata) and other inflammatory conditions could diversify revenue streams.
4. How is COVID-19 treatment affecting Olumiant sales?
COVID-19 usage adds a temporary boost but is subject to pandemic dynamics and EUA regulations.
5. What is the outlook for price negotiations?
Managed care and government payers may negotiate discounts, slightly reducing list prices compared to initial figures.
References
[1] U.S. Food and Drug Administration. (2022). FDA approves Olumiant for treatment of COVID-19. Retrieved from https://www.fda.gov
[2] IQVIA. (2023). Global Trends in Rheumatoid Arthritis Market. IQVIA Institute.
[3] Eli Lilly and Company. (2023). Olumiant (baricitinib) product details. Retrieved from https://lilly.com
[4] Marketplace reports. (2023). Biosimilar development updates. BioWorld.
