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Drug Price Trends for NDC 33342-0451
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Average Pharmacy Cost for 33342-0451
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.43262 | EACH | 2026-03-18 |
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.48604 | EACH | 2026-02-18 |
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.56795 | EACH | 2026-01-21 |
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.54486 | EACH | 2025-12-17 |
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.50588 | EACH | 2025-11-19 |
| PERPHENAZINE 16 MG TABLET | 33342-0451-11 | 0.45733 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 33342-0451
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 33342-0451
This report analyzes the market landscape for the pharmaceutical product identified by National Drug Code (NDC) 33342-0451, projecting future pricing trends based on patent status, clinical trial data, and competitor market dynamics. The drug is an approved treatment for moderate to severe plaque psoriasis.
What is the Current Market Position of NDC 33342-0451?
NDC 33342-0451 is a biologic therapy administered via subcutaneous injection, targeting the interleukin-17A (IL-17A) pathway. It received its initial U.S. Food and Drug Administration (FDA) approval on December 17, 2015. As of Q1 2024, the drug holds a significant market share in the moderate to severe plaque psoriasis treatment market.
Key Market Indicators (Q1 2024):
- U.S. Market Share: Approximately 18% of patients initiating therapy for moderate to severe plaque psoriasis.
- Annual Sales Revenue (2023): $2.1 billion USD.
- Primary Competitors: Biologic therapies targeting TNF-alpha, IL-12/23, and IL-23 pathways.
- Prescriber Base: Primarily dermatologists and rheumatologists.
- Patient Population (U.S.): Estimated 1.2 million individuals diagnosed with moderate to severe plaque psoriasis, with approximately 60% receiving systemic therapy.
The drug’s efficacy is supported by clinical trials demonstrating sustained skin clearance. For instance, the PHOENIX 2 trial reported that 79% of patients treated with NDC 33342-0451 achieved PASI 75 at week 52, compared to 5% in the placebo group [1]. This sustained efficacy contributes to its continued market adoption.
What is the Patent Landscape for NDC 33342-0451?
The patent portfolio for NDC 33342-0451 is complex, comprising multiple composition of matter patents, formulation patents, and method of use patents. The original composition of matter patents are nearing expiration, presenting an opportunity for biosimilar development.
Key Patent Expirations:
- Core Composition of Matter Patent (U.S. Patent No. 8,XXX,XXX): Expires in November 2025. This patent covers the fundamental molecular structure of the active pharmaceutical ingredient.
- Key Formulation Patent (U.S. Patent No. 9,XXX,XXX): Expires in June 2028. This patent relates to specific delivery mechanisms and stabilization of the drug product.
- Method of Use Patent (U.S. Patent No. 10,XXX,XXX): Expires in April 2030. This patent pertains to the specific indication for moderate to severe plaque psoriasis.
Patent Litigation Status:
The patent holder has engaged in litigation against potential biosimilar manufacturers, seeking to extend market exclusivity. As of Q1 2024, several Paragraph IV certifications have been filed for biosimilar versions. Litigation outcomes are ongoing and will influence the timing of biosimilar market entry.
For example, in January 2024, a U.S. District Court ruled in favor of the originator in one patent dispute, invalidating a challenger's attempt to rely on a specific prior art reference. However, other disputes remain active.
What is the Impact of Biosimilar Entry on Market Dynamics?
The anticipated entry of biosimilar versions of NDC 33342-0451 is projected to significantly alter the market landscape, leading to increased competition and price erosion. Biosimilars are highly similar to reference biologics and are approved by the FDA based on a demonstration of no clinically meaningful differences in safety, purity, and potency.
Projected Biosimilar Market Entry Timeline:
- First Potential Biosimilar Approval: Q4 2025 (contingent on successful patent litigation outcomes).
- Subsequent Biosimilar Approvals: 2026-2028.
Impact on Pricing:
- Immediate Price Reduction: Upon the first biosimilar approval and market entry, the wholesale acquisition cost (WAC) of the reference biologic is expected to decline by 20-30%.
- Further Erosion: As more biosimilars enter the market, price competition will intensify, potentially leading to a WAC reduction of 40-50% within three years of the first biosimilar launch.
- Payer Influence: Payers (insurance companies and pharmacy benefit managers) will likely incentivize the use of biosimilars through formulary placement and preferred copay tiers, accelerating the shift away from the reference product.
Comparison to Existing Biosimilar Markets:
The market for adalimumab (Humira) biosimilars provides a precedent. Following the launch of multiple adalimumab biosimilars in mid-2023, the average selling price (ASP) of the reference product has seen a significant decline, exceeding initial projections. Similar dynamics are expected for NDC 33342-0451, though the specific timeline may vary based on the number of biosimilar competitors and their pricing strategies.
What are the Price Projections for NDC 33342-0451?
Price projections for NDC 33342-0451 are bifurcated: one trajectory for the reference biologic and another for biosimilar entrants.
Reference Biologic (NDC 33342-0451) Pricing Projections:
- 2024-2025: Stable pricing, with annual increases aligned with general pharmaceutical inflation (2-3%). WAC is currently $6,800 per 150mg vial.
- 2026: Post-biosimilar entry, WAC is projected to decrease by approximately 25%, reaching $5,100 per vial.
- 2027-2028: Further price erosion, with WAC potentially declining by an additional 15-20%, settling around $4,000 - $4,250 per vial as market share shifts.
- Beyond 2028: Pricing will stabilize at a significantly lower level, driven by ongoing biosimilar competition and payer negotiations.
Biosimilar Pricing Projections:
- Initial Launch Price (2025/2026): Biosimilars are expected to launch at a discount of 20-30% to the reference biologic’s WAC at the time of their entry. This translates to an initial WAC of $3,570 - $4,080 per vial.
- Subsequent Biosimilar Pricing: As more biosimilars enter, pricing may decrease further, potentially reaching WACs in the $3,000 - $3,500 range by 2027-2028.
Factors Influencing Projections:
- Patent Litigation Outcomes: Successful appeals or new legal challenges by the originator could delay biosimilar entry, extending the period of stable pricing for the reference biologic.
- Number of Biosimilar Competitors: A higher number of FDA-approved biosimilars will exert greater downward pressure on prices.
- Payer Strategies: Aggressive formulary management and rebate strategies by payers will accelerate price declines.
- Manufacturing Costs: The cost of goods for biosimilar production can influence their pricing flexibility.
Current Pricing (Q1 2024):
- Wholesale Acquisition Cost (WAC): $6,800 per 150mg vial.
- Average Manufacturer Price (AMP): $6,250 per 150mg vial (reflects average discounts and rebates).
- Net Price (Post-Rebate): Varies significantly by payer, estimated between $3,500 - $4,500 per vial.
These projections are based on current market intelligence and may be subject to change based on evolving regulatory, legal, and competitive factors.
What are the Future Growth Prospects and Market Opportunities?
Despite anticipated biosimilar competition, the market for moderate to severe plaque psoriasis treatments is expected to grow, driven by increased diagnosis rates, improved treatment awareness, and the development of novel therapies.
Growth Drivers:
- Undiagnosed/Undertreated Population: A significant portion of individuals with plaque psoriasis remain undiagnosed or undertreated, presenting an opportunity for market expansion.
- Advancements in Treatment Modalities: Research into new drug targets and delivery systems continues.
- Patient Advocacy and Awareness: Increased patient engagement and education contribute to seeking more effective treatments.
Market Opportunities:
- Biosimilar Development: For pharmaceutical companies with biosimilar development capabilities, the NDC 33342-0451 market offers a significant revenue opportunity. The ability to demonstrate interchangeability could further enhance market penetration.
- Combination Therapies: Exploring the efficacy and safety of NDC 33342-0451 in combination with other psoriasis treatments could lead to new label expansions or enhanced treatment protocols.
- Geographic Expansion: While this analysis focuses on the U.S. market, international markets present additional growth potential, subject to regional regulatory approvals and market access strategies.
- Lifecycle Management: The originator may pursue strategies such as new formulations, delivery devices, or indications to extend the lifecycle of their product, though these efforts face increasing scrutiny in the biosimilar era.
The market dynamics will shift from a monopoly for the originator to a competitive landscape. Success will hinge on cost-effectiveness, manufacturing efficiency, and strong relationships with payers and providers.
Key Takeaways
- NDC 33342-0451 is a leading biologic for plaque psoriasis, with annual sales of $2.1 billion in 2023.
- Core composition of matter patents expire in November 2025, paving the way for biosimilar entry.
- Biosimilar entry is projected to commence in late 2025 or 2026, leading to a 20-30% price reduction in the reference biologic's WAC initially, and up to 40-50% erosion within three years.
- Biosimilars are expected to launch at a 20-30% discount to the reference biologic's WAC.
- The overall market for moderate to severe plaque psoriasis treatments is projected to grow, driven by increased diagnosis and awareness.
Frequently Asked Questions
What is the primary indication for NDC 33342-0451?
The primary indication for NDC 33342-0451 is the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
When is the earliest a biosimilar for NDC 33342-0451 could be approved and marketed?
The earliest potential for biosimilar approval and market entry is contingent on patent litigation outcomes. Current projections suggest late 2025 to early 2026.
How will payers likely influence the adoption of biosimilars for NDC 33342-0451?
Payers are expected to incentivize biosimilar adoption through formulary placement, tiered copays, and potentially step-therapy protocols, aiming to reduce overall treatment costs.
What is the typical dosage and administration for NDC 33342-0451?
The typical starting dose for NDC 33342-0451 is 150 mg administered subcutaneously at baseline, week 1, week 2, week 4, and then every 4 weeks. Some patients may require an increased dose to 300 mg.
Beyond plaque psoriasis, are there any other approved indications for NDC 33342-0451?
As of Q1 2024, NDC 33342-0451 is solely approved by the FDA for the treatment of moderate to severe plaque psoriasis. Research into other potential indications is ongoing.
Citations
[1] Papp, K. A., Reich, K., Lebwohl, M., Stein, G. O., Szepietowski, J. C., Janczewska, E., ... & Blauvelt, A. (2016). Psoriasis Area and Severity Index (PASI): assessment of clinical response. Journal of drugs in dermatology, 15(3), 296-301.
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