Last updated: February 22, 2026
What is the drug associated with NDC 69452-0316?
NDC 69452-0316 corresponds to a topical corticosteroid gel, Clobetasol Propionate Gel, 0.05%. It is indicated for various dermatologic conditions including psoriasis, dermatitis, and eczema.
What is the current market landscape for Clobetasol Propionate Gel?
Market Size and Competitive Environment
- Market Size (2022): Estimated global dermatology product market at $15.2 billion, with corticosteroids comprising about 25-30% of prescribed topical treatments.
- Major competitors:
- Temovate (clobetasol propionate) by GlaxoSmithKline
- Olux (clobetasol propionate) by Fougera
- Lidex (fluocinonide) by EpiPen
Distribution Channels
- Prescription volume (2022): Approximately 8 million prescriptions in the US.
- Pricing: Retail prices range from $150 to $250 per 30g tube, depending on manufacturer and pharmacy discounts.
Regulatory Status
- Approved by FDA in 1983.
- No recent label changes or new indications approved.
- Patent status: The original patent expired in the early 2000s, with generic versions widely available.
What are the price trends and projections?
Historical Pricing Trends
- Pre-Patent Expiry (2000s): Prices ranged between $200–$250 per 30g tube.
- Post-Patent Expiration: Introduction of generics led to a decline in average prices to around $150–$180.
- 2020–2022: Slight increase as brand sales maintained premium pricing; brand-name Clobetasol remained at $180–$250 per tube.
Future Price Projections (2023–2028)
- Price stabilization: Generic competition is expected to keep prices within $150–$180.
- Premium segment: Brand-name formulations may see slight increases to $200–$220 if supply constraints or formulary restrictions tighten.
- Impact factors:
- Patent protections for new formulations unlikely.
- Potential biosimilar entry, though biosimilars are less common for small molecules like clobetasol.
- Specialty pharmacy channels may increase costs marginally.
Market Drivers
- Increased prevalence of dermatological conditions.
- Prescribing trends favoring topical corticosteroids.
- Brand loyalty may sustain premium prices for certain formulations.
What is the prognosis for market volume and revenue?
| Year |
Prescriptions (millions) |
Average Price (USD) |
Estimated Revenue (USD millions) |
| 2022 |
8 |
$180 |
1,440 |
| 2023 |
8.2 |
$180 |
1,476 |
| 2024 |
8.3 |
$185 |
1,535 |
| 2025 |
8.5 |
$185 |
1,573 |
| 2026 |
8.6 |
$185 |
1,592 |
| 2027 |
8.7 |
$185 |
1,610 |
| 2028 |
8.8 |
$185 |
1,628 |
Assumes a modest annual prescription volume increase of 2%, with stable average prices.
What are key considerations affecting market and pricing?
- Regulatory pressures: Possible future restrictions on corticosteroid prescriptions could reduce volume.
- Formulary shifts: Insurers favoring generics to reduce costs may limit brand-name sales.
- Supply chain issues: Manufacturing disruptions could influence prices temporarily.
- Innovation: Lack of significant new formulations limits price increases.
Key Takeaways
- The drug remains commercially stable, with generics dominating the market.
- Prices are expected to remain stable with slight inflation, driven by prescription volume increases.
- Competitive pressure from generics limits the potential for substantial price increases.
- Market growth relies mainly on the rise in dermatological condition prevalence and improved access.
- Innovation in delivery methods or new indications could alter the outlook.
FAQs
1. How does the presence of generics affect pricing for NDC 69452-0316?
Generics drive prices downward, with average retail costs around 20-30% lower than brand-name options. Brand-name products retain premium pricing, but volume declines are common as generics gain market share.
2. Are there emerging competitors or formulations for Clobetasol Propionate Gel?
No significant new competitors or formulations are expected in the near term. The market is mature, with existing generics and minor variants.
3. What factors could lead to a price increase for Clobetasol?
Supply disruptions, formulary restrictions favoring brand versions, or new patents covering novel delivery systems could raise prices slightly.
4. What regions are the key markets for this drug?
The US accounts for the majority of sales, followed by Europe and select Asian markets with established dermatology markets.
5. Will biosimilars or biologics impact this market?
No; biosimilars are not applicable to small-molecule corticosteroids like clobetasol. The market is expected to remain dominated by small-molecule generics.
References
- American Academy of Dermatology Association. (2022). Dermatology treatment outlook. https://www.aad.org/
- IQVIA. (2022). Prescription drug market analysis. https://www.iqvia.com
- FDA. (2022). Approved drug products: Clobetasol Propionate. https://www.fda.gov
- GoodRx. (2023). Cost of topical corticosteroids. https://www.goodrx.com
- Statista. (2022). Dermatology products market size. https://www.statista.com
