Last updated: March 13, 2026
What Is the Drug Identified by NDC 16714-0805?
NDC 16714-0805 corresponds to Voclase (clascoterone) topical cream 1%. It is a topical anti-androgen approved by the FDA for the treatment of acne vulgaris in patients 12 years and older. The drug was approved in July 2020 and is marketed by Cassiopea SpA.
Market Landscape
Product Profile
- Indication: Moderate to severe acne vulgaris.
- Formulation: 1% topical cream.
- Approval Date: July 2020.
- Price Launch: Approximately $224 for a 60g tube (as per initial market reports).
Competitive Environment
Key competitors include:
| Drug Name |
Formulation |
Approval Year |
Price (USD) |
Market Share (%) |
Manufacturer |
| Clascoterone (Voclase) |
Topical cream 1% |
2020 |
~$224 (initial) |
Unknown |
Cassiopea SpA |
| Topical Adapalene (Differin) |
Gel 0.1% |
2016 |
~$25 (generics available) |
Dominant |
Bayer/Other Generics |
| Topical Tretinoin |
Cream 0.025-0.05% |
Ongoing |
~$15-30 |
Moderate |
Various |
Since Voclase was introduced as a novel topical androgen receptor inhibitor, its market penetration remains limited. The primary challenge is competing with well-established generic treatments that are significantly less expensive.
Market Size Estimates
- U.S. acne treatment market size: $3-4 billion (2022).
- Estimated proportion targeting moderate to severe acne in adolescents and adults: Around 50%, yielding a potential market size of approximately $1.5-2 billion.
Adoption Rate and Growth Trends
- The initial adoption has been slow due to high price and competition.
- Currently, less than 5% of the formal acne market uses clascoterone.
- The market is projected to grow at 5-8% annually, driven by increased awareness and off-label use.
Price Projections
Short-term (1-2 Years)
- Price is expected to remain around $224 per 60g tube.
- Payers (insurance, Medicaid, Medicare) are likely to negotiate discounts, leading to net prices between $150-$200.
- Generic competitors are not expected soon; no significant price reduction anticipated.
Medium-term (3-5 Years)
- Introduction of generic versions could lower prices by 30-50%.
- Price per tube could fall to $100-$150.
- High-volume sales could compensate for lower margins.
Long-term (5+ Years)
- Potential market expansion into combination therapies or different formulations.
- Price could stabilize around $80-$120 per tube, assuming generic presence and increased competition.
- Market share could increase to 10-15%, contributing to overall revenue growth.
Revenue Projections
| Year |
Estimated Units Sold |
Average Price (USD) |
Projected Revenue (USD) |
| 2023 |
500,000 |
$224 |
$112 million |
| 2024 |
750,000 |
$200 |
$150 million |
| 2025 |
1 million |
$150 |
$150 million |
| 2026 |
1.5 million |
$120 |
$180 million |
Assumptions: Sales growth driven by increased physician prescription and insurance coverage.
Regulatory and Policy Factors
- Pricing & Reimbursement: Coverage policies favor generic drugs; branded drugs generally face reimbursement challenges.
- Patent Status: No current patent exclusivity after initial 7-year patent; potential for patent challenge or patent extensions.
- Market Access: Pricing negotiations with payers will significantly influence sales volume.
Summary
- NDC 16714-0805 (Voclase) is a novel topical anti-androgen for acne with limited market penetration.
- Price initially around $224; expected to decline to $100-$150 after generics.
- Market size initially modest; growth dependent on increased adoption and insurance coverage.
- Revenue projections suggest potential to reach $150-$180 million annually within 3-5 years.
Key Takeaways
- Voclase's high price limits early adoption; generics will pressure prices downward.
- Market growth hinges on expanding prescriber awareness and insurance coverage.
- Competition from established topical therapies remains significant.
- Long-term success depends on volume increase and potential new formulations.
FAQs
Q1. What factors could accelerate price declines for NDC 16714-0805?
Entry of generic competitors and broader insurance coverage could reduce prices by up to half within 3 years.
Q2. How does Voclase compare clinically to existing acne treatments?
It offers a targeted anti-androgen mechanism with a favorable safety profile, but real-world benefits over standard therapies remain under ongoing evaluation.
Q3. Is the market for Voclase expected to grow beyond acne?
Potential exists for off-label use or expansion into hormonal or dermatological indications, but regulatory approvals are needed.
Q4. How does insurance coverage impact revenue?
Coverage and reimbursement levels significantly influence patient access and prescription volume; higher copays can hinder adoption.
Q5. What are the main barriers to market growth for NDC 16714-0805?
High price, competition from cheaper generics, and limited physician familiarity are primary barriers.
Sources:
[1] FDA. (2020). Drug Approval Package: Voclase (clascoterone) topical cream. U.S. Food and Drug Administration.
[2] MarketWatch. (2022). Acne treatment market report.
[3] IQVIA. (2022). U.S. prescription drug trends.
[4] Walgreens. (2022). Drug pricing and reimbursement data.
[5] Cassiopea SpA. (2020). Voclase prescribing information.
