Last updated: February 16, 2026
Overview
NDC 60505-0055 corresponds to Soriatane (acitretin), a systemic retinoid approved for severe psoriasis treatment. It is marketed primarily by Stada Arzneimittel AG in the United States. Soriatane operates within a niche market of severe psoriasis therapies, sharing space with biologics and other systemic medications, often driven by specific patient needs and regulatory considerations.
Market Size and Trends
The global psoriasis market is valued at approximately $6.7 billion in 2022 and is projected to grow at an annual rate of 8-10% through 2027[1]. The U.S. market accounts for a significant share, influenced by high prevalence (around 2-3%) and advanced healthcare infrastructure.
Within this market, acitretin remains a second-line systemic option for severe psoriasis, mainly due to its side effect profile compared to biologics.
Market Penetration and Competition
Major competitors include:
- Biologics: Humira (adalimumab), Stelara (ustekinumab), Cosentyx (secukinumab)
- Oral systemic agents: Methotrexate, cyclosporine, apremilast
- Other retinoids: Acitretin (brand version), alitretinoin
Soriatane has a niche due to its teratogenicity and side effects, limiting its overall market share. Estimated U.S. prescriptions in 2022 numbered approximately 5,000-7,000 annually, predominantly for patients contraindicated or unresponsive to biologics[2].
Pricing and Cost Dynamics
As of 2023, the average wholesale price (AWP) for Soriatane is approximately $1,200 per 30-count bottle (15 mg tablets). Cost per treatment cycle, typically 15-30 mg daily for 12-24 weeks, ranges from $4,800 to $12,000 depending on dosage and duration.
Prescription reimbursement rates are influenced by insurer formularies, generic availability, and patient copay assistance programs.
Price Projections
Price changes for brand-name Soriatane are expected to remain relatively stable over the next 2-3 years due to limited competition and regulatory constraints. Factors influencing future prices include:
- Manufacturing costs: Stable, with minimal impact from raw material shortages.
- Regulatory environment: No significant patent expirations or biosimilar filings expected shortly.
- Market dynamics: Slight downward pressure could emerge if biosimilars or generics enter the market, but no approvals are imminent for acitretin.
Expected pricing trajectory:
| Year |
Estimated AWP |
% Change (annual) |
| 2023 |
$1,200 |
N/A |
| 2024 |
$1,200 |
0% |
| 2025 |
$1,220 |
+1.7% |
Overall, a modest increase over the next two years is likely, barring new clinical data or regulatory actions.
Key Factors Affecting Market and Price
- Patent and exclusivity status: No current patents extend exclusivity beyond existing expiration timelines.
- Regulatory approvals: No new indications or formulations expected.
- Market adoption: Limited but steady, as physicians prefer biological agents for severe psoriasis, reserving acitretin for specific cases.
- Generic entry: No generics announced or approved, limiting price competition.
Summary
NDC 60505-0055 (Soriatane) operates within a small, niche segment of the severe psoriasis market with relatively stable pricing and modest growth potential. Market share is constrained by safety concerns and competition from biologic agents, but pricing is unlikely to decline significantly without biosimilar entry.
Key Takeaways
- Soriatane’s market size remains modest, with estimated U.S. prescriptions under 7,000 annually.
- Current wholesale price is approximately $1,200 per bottle, with slight increases projected.
- Competition from biologics and generics influences market dynamics, but no biosimilars are currently approved.
- Price stability is expected through 2025 unless significant regulatory or market changes occur.
FAQs
-
What is the primary use of acitretin (NDC 60505-0055)?
Treatment of severe psoriasis, especially in cases resistant to other therapies.
-
How does acitretin compare price-wise to biologics?
Significantly lower per-treatment costs; biologics often cost $20,000-$50,000 annually.
-
Are biosimilars or generics expected for acitretin?
No biosimilars or generics are announced as of 2023; patent expirations are not imminent.
-
What factors could lead to price increases for Soriatane?
Market inflation, increased manufacturing costs, or regulatory changes could drive slight increases.
-
How does safety impact market share?
Adverse effects like teratogenicity limit use, particularly in women of childbearing age, restricting broader adoption.
Citations
[1] Grand View Research, "Psoriasis Market Size & Trends," 2022.
[2] QuintilesIMS, "Prescription Data for Psoriasis Treatments," 2022.
