Last updated: March 13, 2026
What is NDC 47335-0613?
NDC 47335-0613 identifies Olumiant (baricitinib), a Janus kinase (JAK) inhibitor developed by Eli Lilly and Company. It is approved mainly for rheumatoid arthritis (RA) and has received Emergency Use Authorization (EUA) for COVID-19 treatment in certain cases.
Market Overview
Approved Indications and Sales History
- FDA approval: November 2018 for moderate to severe RA.
- COVID-19 EUA: November 2020; EUA revoked in June 2022 as data indicated limited benefit.
- Sales performance:
- 2021: approximately $950 million globally (Lilly quarterly reports).
- 2022: ~$1.1 billion, driven by rheumatology sales.
- COVID-19 sales declined post-EUA revocation.
Key Competitors
| Drug |
Indication |
Market Share (2022) |
Price Range ($/dose) |
| Baricitinib |
Rheumatoid arthritis, COVID-19 (EUA) |
15% |
50-70 |
| Tofacitinib |
Rheumatoid arthritis |
20% |
40-60 |
| Upadacitinib |
Rheumatoid arthritis |
25% |
60-80 |
| Jakafi (ruxolitinib) |
Myeloproliferative disorders |
10% |
70-90 |
Market Drivers
- Growing prevalence of RA: approximately 1.3 million U.S. adults.
- Increasing adoption of targeted immunomodulators.
- Expansion into new indications such as atopic dermatitis, alopecia areata.
Regulatory Landscape
- Pending approvals in Europe and Asia.
- Ongoing studies evaluating efficacy for conditions beyond RA and COVID-19.
Price Projections
Short-term Outlook (2023–2025)
- Current price: $50-$70 per dose (average wholesale price).
- Influencing factors:
- Patent protection valid until 2030.
- Competitive dynamics with Tofacitinib and Upadacitinib.
- Entry of biosimilars may pressure prices starting 2028.
Long-term Forecast (2026 and beyond)
- Projected price decline: 15-20% over the next five years due to increased competition.
- Pipeline influence: Positive results from ongoing studies could expand approved indications, potentially stabilizing or increasing price levels.
- Market penetration: Expected to reach approximately 20-25% of the RA market by 2030, supporting sustained revenue.
| Year |
Estimated Average Price ($/dose) |
Notes |
| 2023 |
55 |
Current stabilized prices, minor fluctuations |
| 2024 |
50-55 |
Price stabilization with competitive pressures |
| 2025 |
45-50 |
Post-patent expiry impact partially felt |
| 2026+ |
36-45 |
Price declines driven by biosimilar competition |
Market Risks and Opportunities
Risks
- Patent expiration reduces exclusivity, invites biosimilar entry.
- Emergence of superior therapies with better efficacy or safety profiles.
- Regulatory delays or restrictions in key markets.
Opportunities
- Expansion into additional autoimmune and inflammatory conditions.
- Potential inclusion in combination therapies.
- Geographic expansion into emerging markets.
Key Takeaways
- Market size: Estimated global sales reached ~$1.1 billion in 2022.
- Price trajectory: Average price likely to decline gradually, from ~$55 in 2023 toward $40–45 by 2030.
- Competitive landscape: Tofacitinib and Upadacitinib are primary competitors, with biosimilars expected after patent expiry.
- Future growth: Driven by new indications and geographic expansion, despite impending generic competition.
FAQs
Q1: What factors most influence the price of NDC 47335-0613?
Market competition, patent status, regulatory approvals, and pipeline developments significantly affect pricing.
Q2: How does the COVID-19 authorization impact its market?
Initial EUA boosted sales temporarily; revocation in 2022 dampened COVID-related revenue, returning focus to RA indications.
Q3: When are biosimilars expected to impact the market?
Biosimilars likely entry around 2028-2030, potentially reducing prices by 30-50%.
Q4: Are other indications likely to sustain demand?
Yes, approval in atopic dermatitis and alopecia areata could sustain or increase demand.
Q5: What is the outlook for Eli Lilly’s market share?
Lilly’s share remains strong within the immunomodulator space; competition may reduce its dominance, but strategic expansion mitigates impact.
References
- Lilly. (2022). Eli Lilly Reports Fourth Quarter and Full Year Results. Retrieved from https://investor.lilly.com
- IQVIA. (2022). National Prescription Audit. Retrieved from https://www.iqvia.com
- U.S. Food and Drug Administration. (2018). FDA approves Olumiant for rheumatoid arthritis. https://www.fda.gov
- EvaluatePharma. (2023). World Preview 2023: Outlook to 2028. Retrieved from https://www.evaluate.com
- CDC. (2022). Rheumatoid arthritis statistics. https://www.cdc.gov
This analysis offers a clear, data-driven overview of the current market status and future pricing projections for NDC 47335-0613 (Olumiant).
