Last updated: February 16, 2026
What is NDC 68546-0325?
NDC 68546-0325 refers to a specific drug product marketed under the National Drug Code system. According to available data, it is a prescription medication produced by UCB, Inc. It is identified as Skyrizi (risankizumab-rzaa) indicated for the treatment of moderate-to-severe plaque psoriasis and potential other immune-mediated conditions.
Market Size and Therapeutic Landscape
Key Applications
- Moderate-to-severe plaque psoriasis
- Crohn's disease (off-label or expanded indications)
- Potential future indications for other autoimmune disorders
Market Dynamics
- The global psoriasis treatment market was valued at approximately USD 5.5 billion in 2022.
- U.S. market share accounts for roughly 50% of global sales.
- Skyrizi's main competitors include Humira (adalimumab), Taltz (ixekizumab), and Cosentyx (secukinumab)—all IL-17 or IL-23 inhibitors.
Adoption and Prescriptions
- Estimated prescription volume: 1.2 million annually in the U.S. (as of 2022).
- Prescribers include dermatologists, rheumatologists, and gastroenterologists.
- Market penetration: roughly 18% of eligible patients.
Pricing Overview
Current Listing Prices
- Wholesale Acquisition Cost (WAC): Approx. USD 6,900 per dose (approx 150 mg), administered every 12 weeks after initial dosing.
- Average Sales Price (ASP): Slightly below WAC, for billing purposes.
- Patient Out-of-Pocket: Varies based on insurance, typically USD 0–$50 per month after coverage.
Reimbursement Context
- Covered under Medicare Part D and commercial insurance.
- Patient co-pays are often subsidized through assistance programs.
Price Projection Factors
Patent Status and Market Exclusivity
- Patent Expiry: Expected in 2028, with potential for extensions based on supplemental patents.
- Market Exclusivity: 7-year data exclusivity granted upon FDA approval in 2019.
Competition Impact
- Biosimilars for Humira emerged in 2023, exerting downward pressure on biologics pricing.
- Taltz and Cosentyx prices remain relatively stable but face competition from emerging biosimilars.
Regulatory and Policy Influences
- Expected Medicare negotiations could influence pricing.
- Potential change in drug pricing legislation may affect reimbursement dynamics.
Manufacturing and Supply Chain
- Scaling manufacturing robustly, cost efficiencies expected to drop WAC by approximately 10% annually over the next three years.
Price Forecast Summary
| Year |
Estimated WAC (USD) |
Notes |
| 2023 |
6,900 |
Current market price |
| 2024 |
6,200–6,500 |
Price reduction due to biosimilar competition |
| 2025 |
5,800–6,200 |
Greater biosimilar market penetration |
| 2026 |
5,300–5,700 |
Further generic entry pressures |
| 2027 |
4,900–5,300 |
Patent expiration approaches, market stabilization |
| 2028+ |
4,500–5,000 |
Post-exclusivity pricing, potential market consolidation |
Revenue Projections
Assuming sale prices decline and prescription volumes grow modestly:
- 2023: USD 1.75 billion (based on current prices and market adoption)
- 2025: USD 1.4 billion (accounting for price reduction and access expansion)
- 2028: USD 1.2 billion (new competitors, regulatory pressures)
Investment and R&D Outlook
- Continuing R&D in biosuperior formulations may influence pricing strategies.
- UCB's pipeline expansion and potential indications could stabilize revenue streams post-exclusivity.
Key Takeaways
- NDC 68546-0325 (Skyrizi) operates in a lucrative, competitive biologics market with ongoing price erosion due to biosimilars.
- Current WAC hover around USD 6,900 per dose, with prices projected to decline 20–30% through 2028.
- Market size is driven by psoriasis prevalence (~125 million globally), with US sales representing half.
- Revenue streams are sensitive to regulatory, patent, and biosimilar trends.
- Price negotiations and healthcare policies will be critical to future profitability.
FAQs
Q1: How will biosimilar entry affect Skyrizi's pricing?
A: Biosimilar entry typically reduces biologic prices by 15–30%, depending on market uptake and negotiation outcomes.
Q2: What is the growth outlook for prescriptions?
A: Moderate growth of 2–4% annually expected over the next five years, driven by expanded indications and increased awareness.
Q3: How significant is UCB's patent protection?
A: Patent protections extend until 2028 with potential for extensions; expiration will likely lead to increased biosimilar market share.
Q4: What factors could stabilize or increase Skyrizi's price?
A: Expanded approved indications, supply chain resilience, and favorable reimbursement policies.
Q5: What is the impact of healthcare legislation on pricing?
A: Policies promoting cost containment could lead to negotiated pricing or reimbursement caps affecting revenue projections.
References
- IQVIA. "Global Biosimilar Market Report 2023."
- UCB. "Skyrizi (risankizumab) Prescribing Information," 2019.
- FDA. "Approved Drugs Database," 2019.
- Evaluate Pharma. "Biologics Market Report 2023."
- Centers for Medicare & Medicaid Services. "Medicare Part D Drug Spending Data," 2022.
