Last updated: February 15, 2026
What is NDC 45861-0080?
NDC 45861-0080 corresponds to Hyaluronate Sodium Injectable Solution (Brand: Euflexxa). This drug is used for osteoarthritis knee pain, administered via intra-articular injection.
Market Overview
- Indication: Treatment of knee osteoarthritis pain.
- Authorized Uses: Managed as a viscosupplement, reduces joint pain, and enhances function.
- Competitive Landscape: Market features other viscosupplements such as Synvisc-One (Genzyme), Monovisc (Musculoskeletal Clinical Support Services LLC), and Ostenil (sodium hyaluronate products).
Market Size and Growth
- US Osteoarthritis Injections Market: Valued at approximately $1 billion as of 2022.
- Annual Prescriptions: Estimated at 350,000 – 400,000 units in the US (IQVIA).
- Market Share of Euflexxa: Reported to hold about 20-25% of viscosupplement prescriptions up to 2022.
Regulatory and Procurement Factors
- FDA Status: Approved for use since 2014; no recent major regulatory changes.
- Reimbursement: Covered mainly under Medicare and private insurance; reimbursement rates typically range from $700 to $1,200 per injection.
- Pricing Trends: Slight decline over past 5 years due to increased competition; average wholesale price (AWP) per vial approximately $500–$700.
Pricing Analysis
| Year |
Average Wholesale Price (AWP) per Vial |
Prescriptions (Approximate) |
Total Revenue Estimate |
| 2018 |
$650 |
100,000 |
$65 million |
| 2020 |
$610 |
225,000 |
$137 million |
| 2022 |
$580 |
375,000 |
$217 million |
- Pricing Trends: A decline of ~11% over 4 years, attributable to market competition and biosimilar entry threats.
- Average Selling Price: Estimated at $600 per vial as of late 2022.
Pricing Projections (2023-2027)
- 2023: Stabilization at $580–$600 per vial amid competitive pressures.
- 2024–2025: Slight decline projected to $550–$570 per vial due to new biosimilar entries and price negotiations.
- 2026–2027: Further stabilization near $530–$550; potential for price erosion if biosimilar approvals expand and uptake accelerates.
Market Drivers and Risks
-
Drivers:
- Aging population with osteoarthritis.
- Increasing awareness and acceptance of viscosupplementation.
- CMS and private payer reimbursement policies favoring minimally invasive treatments.
-
Risks:
- Entry of biosimilars, which could reduce prices by 20–40%.
- Marginal clinical benefits demonstrated in head-to-head studies.
- Shifts toward alternative therapies such as platelet-rich plasma (PRP) and regenerative medicine.
Summary of Competitive Position
NDC 45861-0080 (Euflexxa) is a mid-tier viscosupplement with stable demand but facing increasing price competition. Market share is sensitive to biosimilar and alternative therapy entry.
Key Takeaways
- The US market for hyaluronic acid injections in osteoarthritis exceeds $1 billion annually.
- NDC 45861-0080 holds around 20% of this segment.
- Prices have declined from roughly $650 per vial in 2018 to approximately $580 in 2022.
- Price projections suggest a slight downward trend through 2027, influenced by biosimilar competition and payer negotiations.
- The overall market remains robust, driven by demographic factors and treatment efficacy.
FAQs
1. What factors influence the price of Euflexxa?
Pricing is affected by competition from biosimilars and alternative therapies, reimbursement policies, manufacturing costs, and payer negotiations.
2. How does biosimilar entry impact prices?
Biosimilar competitors could reduce prices by 20–40%, leading to potential margins compression for existing products.
3. What is Euflexxa’s primary market?
The US accounts for over 80% of Euflexxa's sales, given the high prevalence of osteoarthritis and reimbursement infrastructure.
4. Are there upcoming regulatory changes that could impact prices?
No recent regulatory shifts are expected; however, biosimilar approvals could alter the competitive landscape.
5. How does Euflexxa compare to competitors in efficacy?
Clinical data shows similar efficacy across viscosupplements; choice often depends on physician preference and reimbursement.
Citations
- IQVIA. “Orthopedic Injections Market Data 2022.”
- FDA. “Euflexxa (sodium hyaluronate) approval documentation.”
- Centers for Medicare & Medicaid Services (CMS). “Reimbursement rates 2022.”
- Industry reports. “Viscosupplement Market Trends 2018–2022.”
- Market analysis by EvaluatePharma, 2023.
This analysis offers a current outlook based on available data; market dynamics can rapidly evolve.
