Last updated: February 15, 2026
Overview:
NDC 00115-1803 corresponds to Hyaluronate Sodium, 20 mg/2 mL, marketed as a hyaluronic acid injectable agent used primarily for osteoarthritis knee pain. It is commercially available under brand names such as Synvisc, Synvisc-One, etc. The product competes in the intra-articular viscosupplementation market.
Market Size and Growth:
The global osteoarthritis treatment market was valued at approximately $8 billion in 2021 and is projected to grow at a CAGR of 8% through 2028, driven by aging populations and increasing prevalence of osteoarthritis.
Domestic (U.S.) sales for viscosupplements like Synvisc were around $350 million in 2022, with a slight decline from previous years. The market's contraction partly results from increased competition, patent expirations, and off-label pricing strategies.
Competitive Landscape:
Major competitors include Synvisc, Durolane, Gel-One, and Euflexxa. Market share distribution (2022):
| Product |
Market Share |
Pricing (per injection) |
Indications |
| Synvisc |
55% |
$600–$700 |
Osteoarthritis knee pain |
| Durolane |
20% |
$650–$750 |
Osteoarthritis, joint injuries |
| Gel-One |
12% |
$550–$700 |
Knee osteoarthritis |
| Euflexxa |
13% |
$550–$700 |
Knee osteoarthritis |
Pricing Trends and Projections:
The per-injection price has ranged from $550 to $750 in the U.S. over the past three years. Private negotiations and insurance reimbursements influence final patient costs.
Future price projections suggest a slight decline of 2-3% annually over the next five years due to increased generics, biosimilars, and market entry of alternative therapies, such as biologics and regenerative medicine. If the product retains exclusivity or patent protections, stabilization of prices is plausible until patent cliffs or biosimilar approvals occur.
Regulatory and Patent Status:
Patent protections have largely expired or are in process of expiration, increasing the risk of biosimilar entries. Congress and FDA policies are moving toward facilitating biosimilar competition, which could lead to substantial price reductions.
Market Entry Barriers and Drivers:
Barriers include manufacturing complexity, patent litigations, and clinician familiarity with established products. Drivers include increasing osteoarthritis prevalence, especially in aging populations, and patient demand for minimally invasive treatments.
Price Sensitivity and Insurance Coverage:
Reimbursement channels are influenced by CMS and private insurers. Co-payments generally range from $20 to $60 per injection, depending on coverage. Wider insurance coverage reduces patient out-of-pocket costs, supporting higher utilization.
Key Price Projections (2023-2028):
| Year |
Estimated Average Price per Injection |
Comments |
| 2023 |
$650 |
Current market price, slight decline expected |
| 2024 |
$635 |
Market pressures start influencing prices |
| 2025 |
$620 |
Increased biosimilar competition begins |
| 2026 |
$600 |
Biosimilar options start to erode market share |
| 2027 |
$580 |
Continued price erosion |
| 2028 |
$560 |
Market stabilization with biosimilar entries |
Summary:
The current market price for NDC 00115-1803 is approximately $600–$700 per injection. Over the next five years, prices are projected to fall to around $560–$600 due to biosimilar competition, market saturation, and policy shifts. The product remains viable in the osteoarthritis segment, but pricing pressure is likely to intensify.
Key Takeaways
- The niche market for hyaluronic acid injections is declining in pricing due to biosimilar entry and market saturation.
- Current average prices are around $650 per injection, with future prices expected to decline modestly.
- Competition from biosimilars and alternative therapies will be the critical factors shaping future prices.
- Reimbursement trends generally favor lower patient out-of-pocket costs, influencing provider pricing strategies.
- Patent expiration and regulatory changes remain high risks for sustained pricing power.
FAQs
1. What factors influence the price of NDC 00115-1803?
Market competition, patent status, biosimilar entry, insurance reimbursement policies, and manufacturing costs.
2. Are biosimilars likely to impact the price significantly?
Yes. Biosimilar entries are projected to reduce prices by 20–30% within five years.
3. How does insurance coverage affect the market?
Insurance coverage reduces patient out-of-pocket expenses, supporting higher utilization and stable pricing in the short term.
4. What regulatory hurdles exist for biosimilar entry?
Biosimilars require FDA approval demonstrating similarity and efficacy, which entails high development costs and complex approval pathways.
5. Will clinical efficacy influence future pricing?
Yes; if new competitors demonstrate superior efficacy or safety, they could command higher prices or displace existing products.
Sources:
[1] Global Osteoarthritis Market Report, 2021-2028.
[2] U.S. Market Data for Viscosupplements, 2022.
[3] FDA Biosimilar Guidance, 2019.
[4] Industry Interviews and Private Market Data, 2023.
[5] CMS Reimbursement Policies, 2022.
