Last updated: February 25, 2026
What is NDC 16714-0969?
NDC 16714-0969 refers to a specific drug marketed under a National Drug Code (NDC). Based on available data, this NDC corresponds to Sodium Hyaluronate Gel, 1.3%, used for intra-articular injections, primarily for osteoarthritis of the knee.[1]
Market Overview
Market Size and Demand
- The osteoarthritis (OA) treatment market exceeds $10 billion annually in the U.S. alone.[2]
- Intra-articular hyaluronic acid injections account for approximately $800 million annually in the U.S. market.[3]
- The volume of injections is driven by rising OA prevalence, aging population, and preference for minimally invasive therapies.[4]
- Estimated annual demand for sodium hyaluronate gels like NDC 16714-0969 is approximately 2 million doses nationwide.[5]
Key Competitors and Product Landscape
| Product Name |
Manufacturer |
Composition |
Approval Year |
Market Share (estimated) |
| Synvisc One (hylan G-F 20) |
Sanofi |
Hyaluronan |
2013 |
30% |
| Monovisc |
Anika |
Hyaluronan |
2013 |
20% |
| Euflexxa |
Ferring |
Hyaluronan |
2012 |
15% |
| Ostenil |
TRB Chemedica |
Hyaluronate |
2002 |
10% |
| NDC 16714-0969 (Proposed) |
Unknown |
Hyaluronan |
N/A |
Pending entry |
Market Entry and Regulatory Status
- No recent FDA approval records for NDC 16714-0969.
- Entry into the market expected to face regulatory procedures similar to existing hyaluronic acid products.
- EMA and other international regulators have approved several hyaluronic acid formulations since 2002.[6]
Price Trends and Projections
Current Pricing Data
| Product |
Typical Price per Dose |
Range |
Pricing Factors |
| Synvisc One |
$700 |
$650–$750 |
Brand, provider, insurance coverage |
| Monovisc |
$650 |
$600–$700 |
Generic comparator, provider preferences |
| Euflexxa |
$620 |
$580–$660 |
Cost-sharing agreements |
| Ostenil |
$500 |
$450–$550 |
International availability |
Projected Pricing Trends (Next 5 Years)
- Stable Pricing: Prices for established products have shown little fluctuation, averaging around $600–$700 per dose.
- Market Entry Impact: Introduction of NDC 16714-0969 is likely to induce competitive pricing initially, with prices expected to stabilize 6–12 months post-launch.
- Price Competition: Similar hyaluronic acid products are priced within a narrow range, so price erosion will likely be limited to 10–15% over five years.
- Regulatory and Insurance Considerations: Reimbursement models and payer policies influence achievable prices, with some payers pushing for lower-cost alternatives.[7]
Revenue Projections
- Assuming a market share capture of 5–10% of the intra-articular hyaluronic acid segment in year one.
- Total revenues could reach $50–$80 million based on an average price of $650/dose and 100,000–125,000 doses sold initially.
- Growth will depend on market acceptance and clinical positioning, with projections assuming 10–15% annual volume growth.
Development Timeline and Cost
- Development and regulatory approval could take 18–36 months.
- Estimated R&D costs for bringing a similar biosimilar or generic hyaluronic acid product to market fluctuate around $20–$50 million.[8]
Key Strategic Considerations
- Patent Landscape: Proprietary formulations, manufacturing processes, or delivery systems influence market entry barriers.
- Pricing Power: The product's clinical differentiation will affect premium pricing potential.
- Reimbursement: Payer acceptance and coverage policies are critical for revenue realization.
- Market Penetration: Early adoption by orthopedic specialists and partnerships with payers provide competitive advantage.
Key Takeaways
- The hyaluronic acid intra-articular injection market is mature but continues growth driven by aging populations.
- Prices are relatively stable, with limited erosion prospects, especially for established brands.
- Entry of NDC 16714-0969 could capture a modest market share initially with total sales potential reaching up to $80 million in the first year.
- Market barriers include regulatory approvals, patent rights, and reimbursement policies.
- Long-term growth depends on clinical differentiation, formulary acceptance, and pricing strategies.
FAQs
Q1: What is the typical dosing regimen for hyaluronic acid injections like NDC 16714-0969?
A1: Usually, patients receive a series of injections—often one injection weekly for 3–5 weeks—though specific regimens vary by product.
Q2: How do biosimilars or generics influence pricing in this market?
A2: Biosimilars and generics tend to decrease prices by 20–40%, increasing competition without significantly reducing overall market size.
Q3: What factors determine reimbursement levels for intra-articular hyaluronic acid products?
A3: Reimbursement depends on clinical efficacy, formulary inclusion, manufacturer negotiations, and payer policies.
Q4: Are there emerging therapies threatening the intra-articular hyaluronic acid market?
A4: Yes. Platelet-rich plasma (PRP), stem cell therapies, and synthetic joint replacements are gaining traction.
Q5: What risks could delay the market entry of NDC 16714-0969?
A5: Regulatory hurdles, patent disputes, manufacturing issues, and lack of payer acceptance.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[2] IBISWorld. (2022). Osteoarthritis Market Size.
[3] EvaluatePharma. (2022). Hyaluronic Acid Injection Market Data.
[4] McKinsey & Company. (2021). OA Treatment Trends.
[5] MarketWatch. (2022). Demand Estimates for Intra-Articular Injections.
[6] European Medicines Agency. (2022). Hyaluronic Acid Products Approved.
[7] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for OA Treatments.
[8] IQVIA. (2022). R&D Costs for Biologics and Biosimilars.
