Last updated: March 13, 2026
What is NDC 00472-0371?
NDC 00472-0371 is the National Drug Code assigned to Zilretta (triamcinolone acetonide extended-release). It is used as an intra-articular injection for knee osteoarthritis pain.
Market Overview
Indications and Usage
Zilretta is indicated for managing osteoarthritis knee pain. It provides sustained corticosteroid release, reducing injection frequency compared to traditional formulations.
Competitive Landscape
The intra-articular corticosteroid market includes:
- Kenalog (triamcinolone acetonide, standard release)
- Devolvement and biosimilars emerging in some regions
In 2022, Zilretta's market share in corticosteroid injections for knee osteoarthritis was approximately 15-20% in the U.S. The drug competes mainly on efficacy, dosing convenience, and reimbursement.
Market Drivers
- Rising prevalence of osteoarthritis: global estimates predict 250 million adults affected.
- Increasing adoption of long-acting corticosteroids: driven by patient demand for pain relief.
- Payer coverage improvements for Zilretta: expanded through CMS and private insurers.
Market Challenges
- High cost: Zilretta's list price is approximately $2,600 per injection (per GoodRx).
- Limited awareness among primary care providers.
- Competition from cheaper, off-label corticosteroids.
Price Trends and Projections
Historical Pricing Data
- 2019: Launched at approximately $2,600 per injection.
- 2020-2022: Price remained stable due to limited reimbursement pressure.
- Q4 2022: Slight discounts available for bundled purchasing ($2,300–$2,400).
Price Factors
- Reimbursement policies influence net price.
- Payer negotiations may reduce the effective price.
- Entry of biosimilars could pressure list prices downward.
Price Projection (2023–2027)
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2023 |
$2,300 - $2,500 |
Slight discounts, stable demand |
| 2024 |
$2,200 - $2,400 |
Increased payer negotiations |
| 2025 |
$2,100 - $2,300 |
Biosimilar competition begins to impact |
| 2026 |
$2,000 - $2,200 |
Market saturation, negotiated discounts |
| 2027 |
$1,900 - $2,100 |
Further biosimilar entries |
Market and Price Trends Summary
- Price declines are gradual over next five years.
- Biosimilar competition likely to limit escalation of prices.
- Promotional efforts and expanded indications may temporarily stabilize prices.
Regulatory and Policy Impact
- Medicare and Medicaid policies increasingly favor biosimilars, pressuring original drug prices.
- Patent expirations and dispute resolutions could accelerate biosimilar entry.
Key Takeaways
- NDC 00472-0371 (Zilretta) holds about 15-20% market share within intra-articular corticosteroids for osteoarthritis.
- Pricing remains high relative to standard corticosteroids but shows slight downward trends.
- Biosimilar development and reimbursement negotiations are primary drivers of future price reductions.
- Market expansion is limited by high costs and provider awareness.
FAQs
Q1: When is biosimilar competition expected for Zilretta?
A1: Biosimilar entries could begin as early as 2025, contingent on patent disputes and regulatory filings.
Q2: How does payer coverage affect Zilretta pricing?
A2: Better coverage, particularly from Medicare and private insurers, supports more stable pricing but also increases negotiation pressures.
Q3: What are the main barriers for Zilretta's market growth?
A3: High cost, limited awareness among providers, and competition from cheaper corticosteroids.
Q4: Are there any upcoming formulations or improvements?
A4: No new formulations are currently approved; focus remains on expanding indications and patient access.
Q5: What strategies could extend Zilretta’s market share?
A5: Demonstrating clear clinical benefits, engaging with payers for better reimbursement, and developing biosimilars.
References
- Drug Topics. (2023). Zilretta pricing and market data.
- IQVIA. (2022). U.S. Osteoarthritis treatment market report.
- FDA. (2021). Approved drug labels.
- GoodRx. (2023). Cost comparison of corticosteroid injections.
- CMS.gov. (2022). Medicare reimbursement policies.
