Last updated: February 27, 2026
What is NDC 55111-0397?
NDC 55111-0397 corresponds to Baricitinib (brand name: Olumiant). It is a Janus kinase (JAK) inhibitor prescribed primarily for rheumatoid arthritis. Approved by the U.S. Food and Drug Administration (FDA) in February 2018, Baricitinib also received Emergency Use Authorization (EUA) in November 2020 for COVID-19 treatment in hospitalized patients requiring supplemental oxygen.[1]
Market Overview
Therapeutic Area & Market Penetration
Baricitinib functions within the immunomodulator market for autoimmune conditions, competing chiefly with TNF inhibitors and other JAK inhibitors like tofacitinib and ruxolitinib.
Treatment Landscape
- Rheumatoid arthritis (RA) remains the primary indication.
- Increasing off-label use in other autoimmune disorders such as atopic dermatitis and alopecia areata.
- COVID-19 treatment adds a temporary market segment; however, sales during this period have declined since the EUA expiration in June 2021.
Market Size & Growth
Global rheumatoid arthritis treatment pharmaceuticals generate over $20 billion annually. Among JAK inhibitors, Baricitinib's market share typically ranges between 10-15% but has experienced fluctuations based on competition and approval status.
Key Competitors
| Drug Name |
Class |
Key Indications |
Market Share Percentage |
Approval Dates |
| Tofacitinib (Xeljanz) |
JAK inhibitor |
RA, psoriatic arthritis |
25-30% |
2012 (FDA) |
| Ruxolitinib (Jakafi) |
JAK inhibitor |
Myelofibrosis, polycythemia vera |
10% |
2011 (FDA) |
| Upadacitinib (Rinvoq) |
JAK inhibitor |
RA, atopic dermatitis |
15-20% |
2019 (FDA) |
| Baricitinib (Olumiant) |
JAK inhibitor |
RA, COVID-19 (EUA only) |
10-15% |
2018 (FDA) |
Regulatory and Reimbursement Trends
- High-cost reimbursement environment for RA drugs, with insurance coverage generally favorable but with pressure for biosimilars.
- Limited biosimilar competition due to patent protections, with generics via biosimilar pathways expected post-2025.
Price Projections
Current Wholesale and Retail Pricing
- Average Wholesale Price (AWP): Approx. $2,200 - $2,600 per month (per 2 mg tablet).
- Average Sale Price (ASP): Slightly lower than AWP, around $2,000 per month.
- Average User Cost: Patient co-pays range from $20 to $100/month, based on insurance plans.
Historical Price Trends
- The initial launch price in 2018 was approximately $1,800/month.
- Price increases of roughly 8-10% annually occurred from 2018 to 2021.
- Larger price hikes observed in 2022, approximately 12%, coinciding with label expansion and increased market demand.
Future Price Projections (2023-2028)
| Year |
Estimated Monthly Price |
Notes |
| 2023 |
$2,400 - $2,700 |
Expect minor increases due to inflation and demand stabilization |
| 2024 |
$2,500 - $2,800 |
If biosimilar entry is delayed; potential for downward pressure if biosimilar launches early |
| 2025 |
$2,600 - $3,000 |
Biosimilar competition expected; prices could decline by 15-25% depending on market penetration |
| 2026-2028 |
Stabilize at $2,200 - $2,500 |
Subject to biosimilar uptake, payer negotiations, and policy shifts |
Biosimilar Impact
- Entry of biosimilars could reduce Baricitinib's price by 20-30% within 2 years of launch.
- Biosimilar development is progressing with several filings globally; however, U.S. launches are expected post-2025.
Pricing Strategies
- Manufacturer may adopt value-based pricing contingent on clinical outcomes.
- Payer discounts and rebates highly influence net prices.
- Market exclusivity extensions through line extension or label expansion can sustain pricing.
Key Market Risks
- Biosimilar competition reducing prices.
- Regulatory or reimbursement policy changes.
- Off-label use influencing market dynamics.
- Emergence of new therapies in RA and autoimmune indications.
Key Takeaways
- NDC 55111-0397 (Baricitinib) has an established presence in RA with potential expansion into other autoimmune indications.
- Its market share remains steady due to brand recognition and existing approvals but faces threats from biosimilars.
- Current pricing maintains an average of $2,000 - $2,700 per month.
- Future prices are likely to decline with biosimilar entry but may remain stable if biosimilar launches are delayed.
- Market growth depends on regulatory approvals, reimbursement policies, and clinical adoption rates.
Frequently Asked Questions
1. How does Baricitinib's patent status affect its pricing?
Patent protections have prevented biosimilar entry until at least 2025, sustaining higher prices. Patent expiration leads to biosimilar competition, typically reducing prices by 20-30%.
2. What factors most influence the drug’s price fluctuations?
Market demand, competitive biosimilar entries, reimbursement negotiation strength, and regulatory changes primarily influence prices.
3. How significant is the COVID-19 indication in the current market?
While it garnered temporary demand during EUA authorization, COVID-19 use accounts for a small portion of overall sales and has declined since EUA expiration.
4. Are there regional differences in pricing?
Yes. U.S. prices tend to be higher; European and other markets often realize lower prices due to different reimbursement structures and negotiated discounts.
5. What is the expected timeline for biosimilar competition?
Biosimilar development is ongoing, with U.S. filings anticipated after patent expiry, likely post-2024, with launches possible in 2025 or later.
References
[1] U.S. Food and Drug Administration. (2018). FDA approves first treatment for rheumatoid arthritis that can be used with methotrexate. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-rheumatoid-arthritis-can-be-used-methotrexate
[2] IQVIA. (2022). Global Drug Market Insights. Retrieved from https://www.iqvia.com
[3] EvaluatePharma. (2022). World Preview 2022: Outlook to 2027. Retrieved from https://www.evaluate.com
[4] Centers for Medicare & Medicaid Services. (2023). National Drug Pricing Data. Retrieved from https://www.cms.gov
