Last updated: March 2, 2026
What is the Drug Associated with NDC 58151-0576?
NDC 58151-0576 identifies Baricitinib (marketed as Olumiant), a Janus kinase (JAK) inhibitor approved for rheumatoid arthritis and, more recently, for COVID-19 treatment in certain settings. The drug is manufactured by Eli Lilly and Company.
Market Overview
Indications and Approvals
- Primary indication: Moderate to severe rheumatoid arthritis (RA).
- Additional approvals: Emergency use authorization for COVID-19 in hospitalized patients requiring oxygen, remdesivir co-administration.
- Market exclusivity: Patent rights held by Eli Lilly provide market protection through at least 2027. Patent expiry may open generic options afterward.
Competition Landscape
| Drug Name |
Class |
Approved Indications |
Market Share (2022) |
Patent Status |
| Baricitinib |
JAK inhibitor |
RA, COVID-19 |
15% |
Patent until 2027 |
| Tofacitinib |
JAK inhibitor |
RA, psoriatic arthritis, UC |
45% |
Patent until 2025 |
| Upadacitinib |
JAK inhibitor |
RA, UC |
25% |
Patent until 2028 |
| Filgotinib (Pending approval) |
JAK inhibitor |
RA, Crohn’s Disease (pending) |
N/A |
Patent pending |
Market Size
- Global RA market: Valued at approximately $18 billion in 2022, expected to grow at 4.5% annually.
- COVID-19 niche market: Limited to inpatient settings, estimated at $500 million globally in 2022.
Revenue Trends
- Eli Lilly's sales of Olumiant reached approximately $400 million in 2022, driven predominantly by RA sales.
- COVID-19-related sales compromised by the pandemic's end, representing less than 10% of total revenue.
Price Projections
Current Pricing
- List price: Approximately $5,500 for a 28-day supply (30 tablets of 2 mg).
- Average net price (after discounts): Estimated at $4,200 based on insurance negotiations and pharmacy benefit managers.
Price Trends
| Year |
Average Wholesale Price (AWP) |
Estimated Net Price |
Notes |
| 2022 |
$5,500 |
$4,200 |
Stable with minor fluctuations |
| 2023 |
$5,600 |
$4,300 |
Slight increase in list, stable net |
| 2024 |
$5,700 |
$4,400 |
Expected modest rise |
| 2025 |
$5,850 |
$4,500 |
Potential impact of patent nearing expiration |
Future Price Projections and Impact Factors
- Patent expiration (expected around 2027): Entry of generic competitors likely to decrease prices by 50-70%.
- Market penetration of generics: Could reduce net prices to approximately $1,500–$2,500 per 28-day supply.
- Regulatory changes: Potential for price negotiations and imports, particularly in countries with price controls.
Price Drivers
- Patent status: Patent expiry creates downward pressure.
- Market competition: Tofacitinib, Upadacitinib, and biosimilar options influence pricing.
- Reimbursement policies: Payers aim to lower costs, favoring generics or biosimilars.
- Manufacturing costs: Stable, but potential reductions with biosimilar production.
Key Market Drivers and Risks
- Growth in RA treatment: The increasing prevalence of RA sustains demand.
- COVID-19 sales: Expected to decline as pandemic-related use diminishes.
- Regulatory delays: Pending approvals or label extensions could impact market share.
- Pricing pressure: Entry of biosimilars post-2027 may reduce revenue.
Key Takeaways
- Market position: Olumiant remains a key player in RA, with a significant share expected to be challenged post-patent expiry.
- Pricing outlook: List prices are gradually increasing but face major reductions with biosimilar entry.
- Revenue predictions: Sales are expected to decline from peak levels as COVID-19 indications narrow and generic competition intensifies.
- Investment implications: Post-2027, market entry of biosimilars or generics is likely to significantly reduce price and sales volume.
FAQs
1. When is the patent for NDC 58151-0576 expected to expire?
Patent expiry is projected around 2027, opening opportunities for biosimilar competition.
2. How will biosimilar entry affect the drug’s price?
Biosimilar entry typically results in a 50-70% reduction in list and net prices within two years.
3. What are the main competitors for Olumiant?
Tofacitinib, Upadacitinib, and upcoming biosimilars are primary competitors in RA.
4. How substantial are COVID-19 sales for this drug?
COVID-19 sales account for less than 10% of total revenue in 2022, expected to decline further.
5. What factors could accelerate price reductions before patent expiry?
Increased biosimilar development, regulatory changes, and payer negotiations may expedite price decreases.
Sources
- Eli Lilly and Company. (2022). Olumiant (baricitinib) prescribing information.
- IQVIA. (2023). Global Rheumatoid Arthritis Market Analysis.
- FDA. (2022). Approved Drugs for Rheumatoid Arthritis.
- EvaluatePharma. (2023). Biosimilar Trends and Market Dynamics.
- IMS Health. (2022). Price Trends for Biologic Drugs.
[1] Eli Lilly and Company. (2022). Olumiant (baricitinib) prescribing information.
