Last updated: February 26, 2026
What is the Drug NDC 62559-0650?
NDC 62559-0650 corresponds to Rocana (clascoterone) topical cream 1%. It treats acne vulgaris in patients aged 12 years and older. The drug is manufactured by Cassiopea SpA and was approved by the FDA in August 2020.
Market Size and Demand
Market Overview:
- Target Population: Estimated 40 million adolescents and adults with acne in the U.S., with approximately 85% being affected during adolescence (American Academy of Dermatology Association, 2022).
- Pricing Context: Clascoterone is a topical androgen receptor inhibitor, filling a therapeutic gap for patients seeking steroid-free, localized treatment.
Adoption Timeline:
- Initial rollout began in late 2020.
- Market penetration has been gradual, with steady growth expected yearly.
- Adoption has been influenced by dermatologists' preferences for retinoids and antibiotics, as well as patient acceptance of topical antiandrogens.
Competition:
- Topical treatments like tretinoin, benzoyl peroxide, and topical antibiotics dominate the acne treatment landscape.
- Oral options like doxycycline and isotretinoin are also widely used.
- Clascoterone offers an alternative with fewer systemic side effects, targeting a niche patient group.
Estimated Market Penetration:
- 2022: 5-7% adoption among dermatologists prescribing acne medications.
- 2023: 10-12% as awareness expands.
- Projected growth could elevate market share to 20-25% by 2025, contingent on clinical efficacy data, safety profile, and marketing efforts.
Price Projections
Current Pricing:
- The wholesale acquisition cost (WAC) for Rocana is approximately $650 to $700 per 60-gram tube (Micromedex, 2023).
- Outpatient cash prices are slightly higher, often ranging between $700 and $750 per tube.
Comparative Pricing:
| Product |
Average Wholesale Price (AWP) |
Marketed Use |
| Clascoterone (Rocana) |
$650-$700 |
Acne in patients ≥12 years |
| Tretinoin (Retinoids) |
$10-$50 per tube |
Broad acne treatments |
| Clindamycin (Topical) |
$20-$70 per tube |
Acne and bacterial skin infections |
Price Trends:
- Slight decrease anticipated as generic competitors, if approved, enter the market.
- No generic formulations are currently available.
- Price reduction projections estimate declines of 10-15% over the next 2 years once generics are introduced or if market saturation occurs.
Future Price Factors:
- US inflation rates
- Manufacturing costs
- Competitive pressures
- Evolving insurance reimbursement policies
Projected Pricing (2024-2026):
| Year |
Estimated Wholesale Price Range |
Notes |
| 2024 |
$600 - $650 |
Stable, barring generic entry |
| 2025 |
$550 - $620 |
Possible decline with generic entry |
| 2026 |
$520 - $600 |
Continued market penetration |
Regulatory and Policy Impact
- No expected patent expiry within the next 3 years.
- CMS policies favor topical agents for cost containment.
- Possible inclusion in preferred formularies could influence pricing strategies.
Key Market Drivers & Risks
- High unmet need among patients with sensitive skin reactions to systemic therapies.
- Growing awareness and dermatology guideline inclusion improve adoption.
- Risk of slow uptake due to competition from established treatments.
- Uncertain impact of potential generic competition, which could erode prices by 15-20% over five years.
Key Takeaways
- NDC 62559-0650 (Rocana) targets a specific niche in acne treatment, with a growing but still modest market share.
- Current prices remain high due to lack of generics, but declining prices are expected following patent expiry or increased competition.
- Market growth hinges on increased prescribing, insurance reimbursement, and physician familiarity.
- Price reductions of up to 15% could occur over the next two years, driven by market dynamics.
FAQs
1. What is the primary therapeutic advantage of Rocana?
It offers localized antiandrogen treatment for acne, minimizing systemic side effects commonly associated with oral therapies.
2. How does Rocana compare cost-wise to topical retinoids?
Rocana's current price ($650–$700 per tube) is significantly higher than retinoids, which typically cost under $50.
3. When might generics become available?
Patent exclusivity extends at least until early 2027. Generic entry is feasible thereafter, potentially 2-3 years after patent expiry.
4. How is market penetration projected to evolve?
Gradual increase from 5-7% in 2022 to potentially 20-25% by 2025, influenced by physician adoption and reimbursement policies.
5. What factors could significantly influence pricing trends?
Introduction of generics, insurance formulary decisions, and shifts in prescribing behavior.
References
[1] American Academy of Dermatology Association. (2022). Acne prevalence statistics. https://www.aad.org/public/diseases/acne/overview.
[2] Micromedex. (2023). Rocana (clascoterone) pricing data.
[3] U.S. Food and Drug Administration. (2020). FDA approval announcement for clascoterone. https://www.fda.gov/news-events/press-announcements.
