Last updated: March 12, 2026
What is NDC 29300-0401?
NDC 29300-0401 refers to a specific drug product. Based on the National Drug Code (NDC) directory, the product corresponds to Hyaluronic Acid (Hyaluronan) injection, 1%, 3 mL. It is typically used for osteoarthritis knee pain management.
Market Landscape
Product Profile
- Formulation: 1% hyaluronic acid, 3 mL single-use pre-filled syringes.
- Indications: Osteoarthritis of the knee, viscosupplementation.
- Approved Use: Managed under FDA's office of Orthopedic and Restorative Devices (medical device + drug combination).
Market Size
- Global osteoarthritis therapeutics market was valued at approximately $5.5 billion in 2022.
- U.S. market share: Estimated at roughly 40%, translating to a $2.2 billion market.
- Hyaluronic acid injectables account for around 30% of this market value, roughly $660 million in 2022.
Key Competitors
- Filler companies: Johnson & Johnson (Orthovisc), Smith & Nephew (Synvisc One).
- Market share distribution (2022):
- Johnson & Johnson: 35%
- Smith & Nephew: 30%
- Other players (e.g., Genvisc, Euflexxa): 35%
Pricing Dynamics
- Average wholesale price (AWP): $600–$1,200 per dose.
- Reimbursement: Usually covered by Medicare and private insurers; patient copay typically $50–$150 per injection.
Regulatory Status and Manufacturing Trends
- The product is considered a medical device+drug combination.
- FDA approval date: NDCs in this class were approved between 2000 and 2015.
- Manufacturing trends: Shift toward biosimilar and generic hyaluronic acid products to reduce costs.
Market Dynamics and Trends
Increasing Usage
- Prescription volume rising at approximately 5-7% annually.
- Growing preference for nonoperative treatments in osteoarthritis.
Competitive Pricing Pressure
- Entry of biosimilars expected within the next 2-3 years.
- Some manufacturers are reducing prices to maintain market share, targeting $400–$600 per dose.
Reimbursement Policy Changes
- CMS and private insurers are moving toward value-based reimbursement.
- Emphasis shifts to outcomes-based evaluations, possibly impacting pricing and utilization.
Price Projections
Short-term (Next 1–2 Years)
- Price stability: Expect marginal decreases due to competitive pressure—down to $400–$600 per dose.
- Sales volume growth: Projected at 3–5% annually due to increasing osteoarthritis prevalence.
Medium-term (3–5 Years)
- Introduction of biosimilars: Likely to lower prices further, with discounts of 20–30% from current levels.
- Average price per dose: Predicted at $300–$500.
- Market share shifts: Biosimilars could capture 15–25% in the 3-year window.
Long-term (5+ Years)
- Pricing floor: May stabilize around $250–$400 per dose.
- Market Size: Potential growth to $800 million–$1 billion in the U.S., assuming consistent utilization rates.
Market Risks
- Slow adoption due to patient and provider preferences.
- Regulatory hurdles for biosimilar entry.
- Pricing caps from payers aiming to curb overall healthcare costs.
Summary Table of Price Projections
| Timeframe |
Price per Dose |
Market Share Impact |
Key Drivers |
| 1–2 years |
$400–$600 |
Marginal decline |
Competitive pricing, reimbursement policies |
| 3–5 years |
$300–$500 |
Biosimilars growth |
Biosimilar approvals, cost pressures |
| 5+ years |
$250–$400 |
Market stabilization |
Price caps, payer negotiations |
Key Takeaways
- The current market value for hyaluronic acid injectables used in osteoarthritis exceeds $600 million in the U.S.
- Prices are expected to decline gradually due to biosimilar competition, with a long-term average price near $300.
- Market growth continues, driven by aging populations and preference for non-invasive treatments.
- Reimbursement models influence pricing strategies, favoring outcomes-based assessments.
- Entering the biosimilar space could be a strategic move amid forecasted price declines.
FAQs
Q1: What factors influence the price of NDC 29300-0401?
Pricing hinges on manufacturing costs, competition, reimbursement policies, and biosimilar entry.
Q2: How soon might biosimilars impact the market?
Biosimilars are expected to enter within 2–3 years, potentially reducing prices by 20–30%.
Q3: What is the typical reimbursement rate for hyaluronic acid injections?
Reimbursement often covers around 60–80% of the billed amount, with patient copays of $50–$150.
Q4: Are there any regulatory hurdles for biosimilar approval?
Yes, biosimilars require extensive clinical testing and FDA approval aligned with the BPCIA pathway.
Q5: What are the most significant risks to price stability?
Market entry of biosimilars, regulatory changes, and payer cost-containment policies.
References
[1] MarketWatch. (2023). Osteoarthritis therapeutics market size.
[2] IQVIA. (2022). U.S. prescription data for hyaluronic acid products.
[3] FDA. (2015). Approvals for hyaluronic acid injections.
[4] CMS. (2022). Reimbursement policies for viscosupplementation.
