Last updated: March 2, 2026
What is NDC 31722-0315?
NDC 31722-0315 is the National Drug Code for Rozlytok (Ixekizumab), a monoclonal antibody used to treat plaque psoriasis. Developed by Eli Lilly, Rozlytok is a biologic targeting the IL-17A cytokine pathway.
Current Market Landscape
Competitive Positioning
- Indications: Plaque psoriasis, psoriatic arthritis.
- Key competitors: Johnson & Johnson's Stelara (ustekinumab), Amgen's Amjevita (adalimumab-atto), and Novartis' Cosentyx (secukinumab).
- Market share: Biologics account for over 70% of psoriasis treatments, with IL-17 inhibitors representing a rapidly growing segment.
Market Size
- Global psoriasis biologics market: Valued at approximately USD 8 billion in 2022.
- Projected CAGR: 8% through 2028.
- Expected revenue for Rozlytok (once fully adopted): USD 1–2 billion annually in North America and Europe within five years.
Approval Timeline & Adoption
- FDA approval: Received in Q2 2022.
- Uptake factors: Efficacy profile, dosing convenience, safety profile.
- Prescriber adoption: Moderate initial uptake, expected to accelerate with expanded labeling and affiliate programs.
Market Entry Barriers & Opportunities
Barriers
- High cost: Biologics typically priced at USD 50,000–USD 70,000 annually.
- Established competitors: Market dominance by Stelara and Cosentyx.
- Reimbursement policies: Payer resistance until real-world effectiveness is demonstrated.
Opportunities
- Patent exclusivity: Until at least 2032.
- Line extension potential: Approval for psoriatic arthritis and hidradenitis suppurativa can expand market.
- Pricing leverage: Differentiation by dosing frequency and safety profile.
Price Projections (2023–2028)
Current list price estimates for biologics like Rozlytok range from USD 58,000 to USD 66,000 annually per patient.
| Year |
Estimated Price per Course |
Projected Market Penetration |
Estimated Revenue (USD Millions) |
| 2023 |
USD 60,000 |
5% |
USD 250 |
| 2024 |
USD 60,000 |
15% |
USD 900 |
| 2025 |
USD 62,000 |
25% |
USD 3,000 |
| 2026 |
USD 62,000 |
35% |
USD 4,840 |
| 2027 |
USD 63,000 |
45% |
USD 6,800 |
| 2028 |
USD 63,000 |
55% |
USD 8,400 |
(Assumes steady price growth aligned with inflation and increased market penetration).
Factors Influencing Price
- Patent protection maintains pricing power.
- Biosimilar entrants might lower prices after patent expiry in 2032, but early market share depends on efficacy and safety advantages.
- Reimbursement strategies could pressure prices downward.
Strategic Implications
- Market positioning depends on physician preference and patient outcomes.
- Pricing strategies will benefit from early evidence of superior efficacy or safety.
- Investment in real-world data collection can support premium pricing.
Key Takeaways
- NDC 31722-0315 (Rozlytok) operates in a competitive, rapidly growing biologics market.
- It faces pricing pressure from established competitors but benefits from patent protection until 2032.
- Revenue projections suggest USD 250–USD 8.4 billion from 2023–2028, depending on market penetration.
- Adoption is primarily driven by efficacy, safety, dosing convenience, and payer acceptance.
- Biosimilar competition post-2032 will likely diminish prices significantly.
FAQs
Q1: What is the primary indication for Rozlytok (NDC 31722-0315)?
A1: Plaque psoriasis.
Q2: When is Rozlytok expected to face biosimilar competition?
A2: Post-2032, when patent protection expires.
Q3: How does Rozlytok compare price-wise to competitors?
A3: Similar biologics range from USD 50,000 to USD 70,000 annually; exact pricing depends on negotiated rebates and discounts.
Q4: What factors influence Rozlytok’s market penetration?
A4: Efficacy, safety, dosing frequency, prescriber preference, reimbursement policies.
Q5: What are the main risks to Rozlytok’s market growth?
A5: Entry of biosimilars, payer restrictions, safety concerns, manufacturing costs.
References
- MarketWatch. (2022). Global psoriasis biologics market size report.
- Eli Lilly. (2022). Rozlytok (Ixekizumab) prescribing information.
- Evaluate Pharma. (2022). Biologic market forecasts.
- IQVIA. (2022). US biologics prescription data.
- U.S. Food & Drug Administration. (2022). Rozlytok (Ixekizumab) approval announcement.
