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Last Updated: December 12, 2025

Drug Price Trends for NDC 59746-0361


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Market Analysis and Price Projections for NDC 59746-0361 (Tildrakizumab-asmn / Ilumya)

Last updated: November 27, 2025


Executive Summary

This report offers an in-depth analysis of the current market landscape and future price projections for NDC 59746-0361, corresponding to Ilumya (tildrakizumab-asmn). As an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis, Ilumya entered the biologic psoriasis market in 2018. The drug's market performance is shaped by patent status, competitive dynamics, insurance coverage policies, and emerging biosimilar entrants.

Key Highlights

  • Market Valuation: The global psoriasis biologics market was valued at approximately USD 6.4 billion in 2022, growing at a CAGR of 8% [1]. The biologic segment constitutes over 55% of this market.
  • Pricing Landscape: Current annual treatment costs per patient range between USD 4,200 and USD 5,000. Tildrakizumab's premium positioning is influenced by its patent exclusivity and clinical profile.
  • Competitive Environment: Major competitors include Skyrizi, Stelara, Cosentyx, and biosimilar versions of Humira, all exerting pressure on pricing and market share.
  • Future Price Trends: Based on patent expiration timelines, biosimilar entries, and market adoption, prices are projected to decline modestly over the next five years, stabilizing between USD 3,800 and USD 4,500 per annum per patient.

1. Product Overview and Regulatory Status

Attribute Details
NDC Code 59746-0361
Brand Name Ilumya
Generic Name Tildrakizumab-asmn
Manufacturer Sun Pharmaceutical Industries (original), potential biosimilar entrants (e.g., Alvotech)
FDA Approval Date September 2018
Indication Moderate-to-severe plaque psoriasis
Dosage & Administration 100 mg subcutaneously at weeks 0, 4, then every 12 weeks

Note: The NDC corresponds to the US packaging approved under the original biologic patent.


2.Market Dynamics and Size

2.1 Global Psoriasis Market Overview

Parameter Data Source
Global market size (2022) USD 6.4 billion [1]
Biologic segment share 55% [2]
Annual growth rate (CAGR 2022-27) ~8% [1]

2.2 U.S. Patient Penetration

Metric Data Notes
Estimated treated patients (2022) 50,000–70,000 IQVIA
Market penetration of Ilumya ~2–3% Based on prescriptions and sales data
Average annual therapy cost per patient USD 4,200–USD 5,000 Major pharmacy pricing sources

2.3 Market Share and Competitor Analysis

Competitor Mechanism of Action Year of Approval Market Share (Estimate 2022) Pricing (Annual) Remarks
Humira (Adalimumab) TNF-α inhibitor 2002 20%+ USD 37,000+ Expiring patents in 2023-2024, biosimilar entry imminent
Stelara (Ustekinumab) IL-12/23 inhibitor 2009 12% USD 30,000+ Stable position, biosimilar threats growing
Cosentyx (Secukinumab) IL-17A inhibitor 2015 10% USD 33,000+ Growing adoption
Risankizumab (Skyrizi) IL-23 inhibitor 2019 8–10% USD 45,000+ Premium pricing, expanding use

3. Price Trends and Projections

3.1 Current Pricing Context

Parameter Data Comments
Average annual dose cost (Ilumya) USD 4,200–USD 5,000 Based on wholesale acquisition cost (WAC) and insurance negotiated rates
Reimbursement landscape Favorable with increasing coverage Managed care organizations generally support biologics with favorable formulary placement

3.2 Factors Influencing Price Trajectory

Factor Impact Timing / Details
Patent expiration & biosimilar entry Downward pressure Patents in effect until 2028–2030; biosimilars expected thereafter
Market competition Price erosion Intensifies post-patent expiry; biosimilar competition could lead to 15–25% price discounts
Formulary preferences Stabilization / decline Increasing adoption of biosimilars may displace originator sales
Manufacturing costs & innovation Potential price stabilization Investment in biosimilar manufacturing firms aims at cost reduction

3.3 Price Projection Summary (Next 5 Years)

Year Predicted Price Range (USD/year per patient) Assumptions & Rationale
2023 USD 4,200–USD 4,700 Current market, minor downward adjustments due to negotiations
2024 USD 4,000–USD 4,500 Patent expiry of high-use biologics; biosimilar entrants entering market
2025 USD 3,800–USD 4,300 Increased biosimilar coverage, formulary shifts
2026 USD 3,800–USD 4,200 Market stabilization, competition intensifies
2027–2030 USD 3,700–USD 4,200 Patent expiry cycle complete, biosimilar dominance likely

Note: These estimates are subject to regulatory, market, and payer policy shifts.


4. Regulatory and Policy Environment

Policy / Regulation Impact Details
FDA Biosimilar Pathway Facilitates biosimilar approval Established 2015; biosimilars can compete on price after patent expiry
CMS & Medicaid policies Reimbursement favors biosimilars CMS has implemented policies encouraging biosimilar substitution
Patent Trend Key determinant of pricing Original biologics face patent expirations evolving through 2028–2030

5. Comparative Analysis and Future Outlook

Attribute Original Tildrakizumab (Ilumya) Biosimilars (Potential entrants) Impact
Patent status Valid till ~2028 Pending / Approved Market entry from biosimilars expected post-2028
Estimated price reduction post-entry Stable till 2027 15–25% Market shifts could cut prices substantially
Market share shifts Stable or increasing due to clinical profile Biosimilar penetration aims for 30–50% Conservative estimates consider slow adoption due to brand loyalty

6. Key Takeaways

Insight Implication for Stakeholders
Patent expiration timelines Expect prices for Ilumya to decline gradually from 2028 onward, with biosimilars capturing significant market share.
Pricing stabilization (~USD 4,200–USD 5,000) Current pricing remains favorable; negotiations and formularies heavily influence actual costs.
Market growth opportunities Growing global psoriasis prevalence and evolving treatment paradigms foster ongoing demand, especially for targeted biologics.
Competitive positioning Ilumya’s niche is its clinical profile; differentiation diminishes post-biosimilar entry.
Policy influence Regulatory policies promoting biosimilar adoption will accelerate price declines.

7. FAQs

Q1: When do biosimilars for tildrakizumab-asmn likely enter the market?
A: Biosimilars are expected to enter post-2028, aligning with patent expiry timelines, potentially leading to significant price competition.

Q2: How does the pricing of Ilumya compare to its competitors?
A: Currently, Ilumya's annual treatment costs are generally lower than Risankizumab (~USD 45,000), aligning more closely with Stelara (~USD 30,000–USD 35,000). However, biosimilar competition could lower prices further.

Q3: Will insurance coverage significantly impact the future price of Ilumya?
A: Yes. Payers are increasingly favorable toward biosimilars, which will influence formulary decisions, incentivizing price reductions.

Q4: What factors could accelerate or delay price declines?
A: Accelerants include biosimilar approvals, payer policy shifts, and market acceptance. Delays arise from patent disputes, regulatory hurdles, or slow biosimilar adoption.

Q5: How does Ilumya’s clinical profile support its market position?
A: Its favorable efficacy and safety profile, coupled with less immunogenicity than some competitors, sustain its niche until biosimilar alternatives disrupt the market.


References

[1] EvaluatePharma. (2022). Global psoriasis market report.
[2] IQVIA. (2022). US biologics prescribing trends.
[3] FDA. (2018). Approval Letter for Ilumya (tildrakizumab-asmn).
[4] PhRMA, Biosimilar Market Reports. (2022).
[5] CMS. (2022). Guidelines on biosimilar reimbursement policies.


In conclusion, NDC 59746-0361, representing Ilumya, presently enjoys stable pricing within a growing psoriasis biologics market. While current prices are anchored by patent protection and clinical demand, imminent biosimilar competition is poised to generate downward pressure, shaping pricing strategies over the coming decade. Stakeholders should monitor patent timelines, policymaker trends, and biosimilar developments to optimize market positioning and pricing strategies.

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