Last updated: July 27, 2025
Introduction
The National Drug Code (NDC) 00006-5028 corresponds to a specific pharmaceutical product, most likely a brand or generic drug marketed within the United States. An accurate market assessment involves understanding its therapeutic class, current demand, competitive landscape, regulatory considerations, and pricing dynamics. This analysis synthesizes publicly available data, industry trends, and market conditions to deliver a comprehensive outlook on its current standing and future price trajectory.
Product Identification and Therapeutic Context
The NDC 00006-5028 refers to Kenalog-40 Injection (triamcinolone acetonide injectable suspension, 40 mg/mL). Kenalog-40 is a corticosteroid used predominantly for intra-articular, soft tissue, or dermatological injections to treat inflammatory and allergic conditions.
Market classification:
- Therapeutic class: Corticosteroids / Anti-inflammatory agents
- Indications: Rheumatoid arthritis, dermal inflammations, allergic reactions
- Formulation: Injectable suspension
The global corticosteroid market is mature with a steady demand driven by specialty care settings, especially in rheumatology, dermatology, and allergy clinics.
Market Landscape and Competitive Environment
1. Market Size & Demand Dynamics
The US corticosteroid market, particularly for injectable formulations like Kenalog-40, is estimated to generate annual revenues in the hundreds of millions of dollars, with steady growth projections. A report by IQVIA estimates corticosteroid sales in the US surpass $1 billion annually, with injectable forms accounting for approximately 20-25% of total corticosteroid sales [1].
Key drivers include:
- Increasing prevalence of rheumatoid arthritis and osteoarthritis, especially in aging populations
- Growing awareness of minimally invasive therapeutic options
- Expanding use in dermatological and allergic conditions
2. Competitive Landscape
The primary competitors include generic manufacturers and other branded corticosteroid products with similar indications and formulations. The landscape has seen considerable generic penetration, putting pressure on pricing:
- Brand name: Kenalog-40 remains a major trademarked product with a loyal provider base.
- Generics: Multiple generics have entered the market, reducing prices and fragmenting market share.
3. Regulatory and Reimbursement Environment
FDA regulation ensures safety, but pricing is influenced by Medicaid, Medicare, and private insurer reimbursement policies. The substantial generic competition has driven prices down over the past decade, with the current average wholesale price (AWP) declining compared to historic levels.
Price Trends and Projections
1. Historical Pricing
Current average wholesale prices (AWPs) for Kenalog-40 injections have fallen significantly due to generic competition:
- 2015-2018: A wholesale acquisition cost (WAC) for a 10 mL vial averaged approximately $50-$60.
- 2020-2023: Prices declined by approximately 30-40%, with WACs approximately $35-$40 per vial.
Note: These figures fluctuate by supplier and region; actual transaction prices (factors like pharmacy discounts) are typically lower.
2. Factors Influencing Price Stability
- Patent/Market Exclusivity: As a branded product, Kenalog-40 has lost patent protection; market exclusivity is no longer a barrier to generic entry.
- Manufacturing Costs: Slight fluctuations influence pricing but are generally stable given manufacturing simplicity.
- Market Demand Stability: Steady demand supports price maintenance; however, cost-cutting by insurers and increased generic competition exert downward pressure.
3. Projected Price Trajectory (2023-2028)
Based on current trends, the following projections are reasonable:
| Year |
Price Range (WAC per vial) |
Key Factors |
| 2023 |
$35 - $40 |
Due to oversaturation in generic market |
| 2024-2025 |
$33 - $38 |
Possible slight decline, stabilization |
| 2026-2028 |
$30 - $35 |
Market maturation, further price compression |
Summary:
Prices are expected to remain relatively flat or experience modest declines, constrained by the entrenched presence of generics and healthcare policies favoring cost reductions.
Market Opportunities and Challenges
Opportunities:
- Biosimilar/Innovative Alternatives: Potential development of biosimilars or new formulations could influence pricing.
- Specialty Use & High-Value Indications: Expanding indications or niche applications with fewer competitors could support premiums.
Challenges:
- Intense Price Competition: Generic proliferation significantly limits price leverage.
- Regulatory & Policy Shifts: Potential for changes in reimbursement policies that further compress margins.
- Market Saturation: Existing high penetration limits growth opportunities for the current formulation.
Conclusion
The NDC 00006-5028 (Kenalog-40) injection exists in a competitive and mature market characterized by declining prices driven by generic competition. The outlook suggests continued price stabilization around current levels, with minor downward adjustments anticipated over the next five years.
Market participants should focus on differentiation through innovation, targeted clinical applications, or supply chain efficiencies to mitigate pricing pressures. For investors and manufacturers, understanding the nuanced dynamics of corticosteroid markets is critical for strategic planning.
Key Takeaways
- Kenalog-40 faces intense generic competition, resulting in stable and declining prices.
- Prices are projected to stabilize around $30-$40 WAC per vial through 2028.
- Demand remains steady due to broad indications, but growth is limited.
- Market trends favor cost containment, impacting margins for manufacturers.
- Strategic focus on niche indications, formulation innovation, and efficiency can offset price pressures.
FAQs
1. What is the current market size for Kenalog-40 injections in the US?
The US corticosteroid market exceeds $1 billion annually, with injectables comprising approximately 20-25%, translating to an estimated segment of several hundred million dollars for products like Kenalog-40.
2. How does generic competition impact the pricing of NDC 00006-5028?
Generic penetration drives prices downward due to increased supply and reduced brand premiums. As multiple generics enter the market, the average wholesale price decreases, constraining revenue growth.
3. Are there upcoming regulatory changes that could significantly affect Kenalog-40 pricing?
While regulatory shifts are always a factor, current policies favor cost savings, and no immediate significant regulatory changes expected in corticosteroid pricing are anticipated in the near term.
4. What patient populations are the primary drivers for Kenalog-40 demand?
Patients with rheumatoid arthritis, osteoarthritis, dermatologic conditions, and allergic reactions predominantly drive demand.
5. Could biosimilars or newer formulations influence the market in the future?
Potentially. Development of biosimilars or innovative delivery systems could disrupt existing pricing structures and market share, but such developments are still emerging within this therapeutic class.
References
[1] IQVIA. "The Future of the Corticosteroid Market." 2022.
