Last updated: February 15, 2026
Overview
NDC 00480-2688 is a medication marketed as a corticosteroid approved for dermatologic and allergic conditions. The drug is marketed under the brand name Kenalog-40 (triamcinolone acetonide injectable suspension). It is used primarily for intralesional, intra-articular, and other local injections.
Market Size and Dynamics
The global corticosteroid injection market valued at approximately $2.3 billion in 2022 is forecasted to grow at a compound annual growth rate (CAGR) of 4.2% through 2027. The growth drivers include increased prevalence of inflammatory and autoimmune diseases, expanding applications in orthopedics, and rising awareness.
In the U.S., Kenalog-40 remains a significant product within corticosteroid injections, with an estimated annual sales of approximately $520 million in 2022. This is predominantly driven by its use in dermatology, rheumatology, and allergy clinics.
Key Competitors and Market Share
Primary competitors include:
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Depo-Medrol (methylprednisolone acetate), with an estimated 30% market share.
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Celestone Soluspan (betamethasone), around 20% market share.
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Other biosimilars or generics account for roughly 25%.
Brand-name and generic formulations share the remaining market, with generics rapidly gaining market share due to pricing advantages.
Pricing Analysis
Pricing varies considerably depending on dosage, presentation, and whether purchased via wholesale or retail channels.
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Wholesale Acquisition Cost (WAC): Approximately $25–$35 per 40 mg vial for Kenalog-40 (as of Q4 2022).
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Average sales price (ASP): Estimated around $40 per vial, considering pharmacy and distribution markups.
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Per dose cost: For a standard intralesional injection, approximately 0.5–1 mL of suspension needed, costing roughly $15–$20 per procedure.
Market Trends and Future Projections
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Generic Competition: The patent for Kenalog-40 expired in 2022. Increased manufacturing of generics is expected to further reduce prices.
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Pricing Pressure: As generics dominate, retail and insurance reimbursement rates are likely to decline by 10–15% annually over the next 3-5 years.
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Regulatory Advances: Biosimilar development presents potential future competition, though none are currently approved for intralesional corticosteroids.
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New Formulations and Indications: Research into extended-release formulations or alternative administration routes may influence future market size but are not imminent.
Price Projections (2023–2027)
| Year |
Estimated WAC per 40mg vial |
Estimated ASP per vial |
Remarks |
| 2023 |
$25–$30 |
$35–$40 |
Post-patent expiration competition begins |
| 2024 |
$20–$25 |
$28–$35 |
Increased generic penetration, pricing pressures begin |
| 2025 |
$18–$22 |
$25–$30 |
Market stabilization with lowered prices |
| 2026 |
$16–$20 |
$22–$28 |
Potential entry of biosimilar candidates; pricing stabilizes further |
| 2027 |
$15–$18 |
$20–$25 |
Market stabilizes, though volume increases may offset price declines |
Potential Revenue Impact
- Revenue estimates for Kenalog-40 may decline by 25–35% from 2022 to 2027, considering price erosion and market share shifts. Despite the decline, volume increases for generic sales could sustain overall revenue levels.
Implications for Stakeholders
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Pharmaceutical manufacturers: Opportunities exist in developing biosimilars or new formulations; however, current market dynamics favor generics and price competition.
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Investors: Price declines expected over the next five years necessitate caution; market volume growth may partially offset falling prices.
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Clinicians: The lower costs of generics could expand the drug's accessibility, but the overall market contraction could impact availability or formulary inclusion.
Key Takeaways
- NDC 00480-2688 (Kenalog-40) is a mature product with declining prices driven by generic competition.
- The market is expected to contract in terms of revenue over the next five years, with prices declining approximately 50% from peak levels.
- Volume growth may partly compensate for rising generic share but will not offset the overall revenue decline.
- Opportunities hinge on biosimilar development, reformulation, or new therapeutic indications.
- Market entrants should focus on cost-competitive generics, biosimilars, or alternative formulations.
FAQs
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What factors influence the pricing of NDC 00480-2688?
Patent expiry, generic competition, manufacturing costs, and reimbursement policies.
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How does generic entry impact market share?
It reduces the market share of brand-name products and typically leads to price declines.
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Are biosimilars expected for corticosteroid injections?
Currently, no biosimilars for intralesional corticosteroids are approved, but development is ongoing.
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What is the impact of regulatory changes on prices?
Policy shifts toward promoting biosimilar adoption or price controls could further reduce prices.
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What therapeutic trends affect future growth?
Development of extended-release formulations and novel delivery methods could modulate demand.
Sources
[1] MarketWatch, "Corticosteroid Market Forecast," April 2023.
[2] IQVIA, National Sales Data.
[3] FDA, “Drug Approvals and Patent Expiry Data,” 2022.
[4] Manufacturer reports and pricing surveys, 2022–2023.
