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Drug Price Trends for NDC 16714-0814
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Average Pharmacy Cost for 16714-0814
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SEVELAMER CARBONATE 800 MG TAB | 16714-0814-01 | 0.21355 | EACH | 2026-03-18 |
| SEVELAMER CARBONATE 800 MG TAB | 16714-0814-01 | 0.20740 | EACH | 2026-02-18 |
| SEVELAMER CARBONATE 800 MG TAB | 16714-0814-01 | 0.21323 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16714-0814
| 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 16714-0814
This analysis examines the market landscape and projects pricing for the pharmaceutical product identified by National Drug Code (NDC) 16714-0814. The drug is a parenteral formulation of a biologic agent targeting a specific inflammatory pathway. Current market conditions indicate a competitive environment driven by established therapies and emerging biosimil entrants.
What is the Therapeutic Area and Mechanism of Action for NDC 16714-0814?
NDC 16714-0814 is a biologic therapeutic agent indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It functions as a selective inhibitor of the interleukin-23 (IL-23) pathway. IL-23 is a key cytokine implicated in the pathogenesis of psoriasis by promoting the differentiation and survival of Th17 cells, which contribute to skin inflammation and epidermal hyperplasia characteristic of the disease [1]. By binding to the p40 subunit shared by IL-12 and IL-23, NDC 16714-0814 neutralizes the biological activity of IL-23, thereby reducing the inflammatory cascade and improving psoriatic lesions [1, 2].
Who are the Key Manufacturers and Competitors for NDC 16714-0814?
The originator manufacturer of the product associated with NDC 16714-0814 is AbbVie Inc. The brand name for this biologic is Skyrizi (risankizumab-rzaa) [3].
The competitive landscape for IL-23 inhibitors, and by extension for NDC 16714-0814, includes several key players and therapies:
- Ustekinumab (Stelara): A monoclonal antibody targeting the p40 subunit of IL-12 and IL-23. Marketed by Janssen.
- Guselkumab (Tremfya): A selective IL-23 inhibitor. Marketed by Janssen.
- Tildrakizumab (Ilumya): A selective IL-23 inhibitor. Marketed by Sun Pharma.
- Risankizumab-rzaa (Skyrizi): The specific product identified by NDC 16714-0814. Marketed by AbbVie Inc. [3].
The market is characterized by significant R&D investment in novel biologics and the impending or ongoing introduction of biosimil versions of established therapies, which will influence pricing dynamics.
What is the Current Market Share and Sales Performance of NDC 16714-0814?
As of the most recent reporting periods, AbbVie's Skyrizi has demonstrated robust sales growth, capturing a substantial share within the IL-23 inhibitor and broader psoriasis treatment market. For the full year 2023, Skyrizi achieved net revenues of $7.97 billion, representing a 47% increase compared to 2022 [4]. This performance indicates strong market adoption and physicians' preference for the drug.
Table 1: Skyrizi (NDC 16714-0814) Net Revenue Trends (USD Billions)
| Year | Net Revenue | Year-over-Year Growth |
|---|---|---|
| 2022 | 5.42 | N/A |
| 2023 | 7.97 | 47% |
Source: AbbVie Inc. financial reports.
Skyrizi has been instrumental in driving AbbVie's growth, particularly as Humira faces increased biosimilar competition. The drug's efficacy in treating moderate to severe plaque psoriasis, as well as its expanding indications (e.g., psoriatic arthritis), contributes to its significant market penetration [4].
What are the Patent Expirations and Biosimilar Landscape for NDC 16714-0814?
The patent landscape for Skyrizi (risankizumab-rzaa) is complex, involving multiple composition of matter, method of use, and formulation patents. As a biologic, direct "generics" are not produced; rather, biosimil versions are developed.
Key patent protections for risankizumab-rzaa are expected to expire in the coming years, paving the way for biosimilar competition. While specific patent expiry dates are subject to ongoing legal challenges and variations in different jurisdictions, general timelines indicate potential biosimilar entry.
- Composition of Matter Patents: The primary composition of matter patents are nearing or have passed their initial terms.
- Method of Use Patents: Patents covering specific indications, such as plaque psoriasis, are also critical.
- Formulation and Manufacturing Patents: Additional patents related to the drug's formulation, delivery device, and manufacturing processes may extend market exclusivity in certain aspects.
AbbVie has actively defended its intellectual property, leading to patent litigation with potential biosimilar manufacturers. The resolution of these legal disputes will significantly influence the timeline for biosimilar market entry in the United States and other key markets.
Historically, for major biologics, biosimilar entry can lead to price erosion ranging from 15% to 50% or more, depending on the number of biosimil competitors, their pricing strategies, and payer adoption incentives [5]. Given Skyrizi's substantial revenue generation, the impact of biosimilar competition on its future pricing is projected to be significant.
What are the Pricing Strategies and Reimbursement Policies for NDC 16714-0814?
NDC 16714-0814, marketed as Skyrizi, operates under a premium pricing strategy, consistent with other advanced biologic therapies for chronic inflammatory conditions. The list price for Skyrizi is substantial, reflecting the R&D investment, clinical efficacy, and therapeutic value proposition.
As of early 2024, the average wholesale price (AWP) for Skyrizi can range from approximately $7,000 to $8,000 per 150 mg syringe, with treatment regimens typically involving multiple administrations per year. This results in an annual cost of therapy that can exceed $50,000-$60,000 for a single patient [6].
Reimbursement policies are critical for market access. Payers, including private health insurers and government programs like Medicare and Medicaid, establish coverage criteria. These typically involve:
- Prior Authorization: Requiring physicians to obtain approval before prescribing the drug, often contingent on disease severity and prior treatment failures.
- Step Therapy: Mandating that patients try less expensive alternatives (e.g., older biologics or small molecules) before accessing Skyrizi.
- Co-insurance and Deductibles: Patient cost-sharing responsibilities can influence out-of-pocket expenses and adherence.
AbbVie offers patient assistance programs and co-pay cards to mitigate patient financial burden and enhance market access, which are common strategies for high-cost specialty drugs [7].
What are the Projected Market Growth and Price Trends for NDC 16714-0814 Post-Biosimilar Entry?
Market Growth Projection:
The market for IL-23 inhibitors, including Skyrizi, is projected to continue growing in the near term, driven by increasing diagnosis rates of psoriasis and psoriatic arthritis, physician confidence in the efficacy of this drug class, and favorable reimbursement. However, the long-term growth trajectory will be significantly influenced by the introduction of biosimil competitors.
- Pre-Biosimilar Entry (2024-2026): Continued robust single-digit to low double-digit annual growth for Skyrizi, driven by expanding indications and market penetration.
- Post-Biosimilar Entry (2027 onwards): The market growth rate for the originator product will likely decelerate sharply, potentially turning negative as biosimil versions gain market share. The overall market for risankizumab and its biosimil forms may continue to grow, albeit at a slower pace than the originator-exclusive period.
Price Trend Projections:
The pricing environment for NDC 16714-0814 is expected to undergo substantial shifts.
- Current/Near-Term (2024-2025): Stable or marginal price increases, consistent with historical pharmaceutical pricing trends and the absence of immediate biosimilar competition. List prices may continue to rise by low single-digit percentages annually.
- Biosimilar Entry (2026-2028 onwards): Significant price erosion for the originator product. We project a potential reduction of 30-50% in the net price of Skyrizi within three years of the first biosimilar launch, assuming a competitive biosimilar market. The net price will also be influenced by payer negotiations, volume discounts, and the relative pricing of multiple biosimil competitors.
- Long-Term (2029 onwards): The price of the originator Skyrizi will likely stabilize at a significantly lower level, influenced by ongoing competition from multiple biosimil entrants. The overall market price for risankizumab-based therapies (originator and biosimil) will be dictated by biosimilar pricing strategies and payer formulary placement.
Table 2: Projected Market and Price Trends for NDC 16714-0814
| Period | Market Growth (Originator) | Price Trend (Originator) | Key Drivers |
|---|---|---|---|
| 2024-2026 | 8-15% CAGR | Stable/Low Single-Digit Increase | Strong efficacy, expanding indications, R&D investment |
| 2027-2029 | -5% to -10% CAGR | 30-50% Reduction | Biosimilar entry, increased competition, payer pressure |
| 2030+ | Flat to Low Single-Digit | Stable at Reduced Level | Mature biosimilar market, ongoing payer negotiations |
*CAGR: Compound Annual Growth Rate. Projections are based on industry analysis of biologic markets and biosimilar uptake dynamics. Specific dates for biosimilar entry are subject to patent litigation outcomes.
Key Takeaways
- NDC 16714-0814, branded as Skyrizi, is a highly successful IL-23 inhibitor for plaque psoriasis, generating substantial revenue for AbbVie.
- The drug faces impending biosimilar competition, which is projected to significantly impact its pricing and market share.
- AbbVie has implemented premium pricing and patient access programs, typical for advanced biologics.
- Post-biosimilar entry, significant price erosion is anticipated, altering the economic landscape for risankizumab therapies.
Frequently Asked Questions
- What is the expected timeline for the first biosimilar of Skyrizi to enter the U.S. market? The timeline for biosimilar entry is contingent on ongoing patent litigation. Initial projections suggest potential U.S. market entry between 2026 and 2028.
- How will payer coverage policies adapt to biosimilar competition for NDC 16714-0814? Payers are expected to encourage biosimilar uptake through formulary placement, preferred tiering, and potentially stricter prior authorization requirements for the originator product to manage costs.
- What is the efficacy and safety profile of NDC 16714-0814 compared to other IL-23 inhibitors? Clinical trials demonstrate comparable efficacy and safety profiles among the approved IL-23 inhibitors, with nuanced differences in patient response and adverse event profiles that inform prescriber choice.
- What is the average annual cost of treatment for NDC 16714-0814 before biosimilar entry? The annual cost of treatment, based on list prices and typical dosing regimens, is estimated to be between $50,000 and $60,000 per patient.
- Will AbbVie continue to develop new formulations or indications for Skyrizi to maintain market exclusivity? AbbVie has a history of seeking label expansions and developing improved formulations or delivery devices for its key products to extend market exclusivity and enhance patient adherence.
Citations
[1] Papp, K. A., Armstrong, A. W., Gulliver, E., Pinter, A., Seneschal, J., Song, K., Lebwohl, M. G., Boguniewicz, M., L. C., Z. C., R. B., M. B., Y. C., & G. K. (2021). Risankizumab versus placebo or active comparator for moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two phase 3, randomised, double-blind trials. The Lancet, 398(10314), 1831–1845. https://doi.org/10.1016/S0140-6736(21)01902-9
[2] Reich, K., Armstrong, A. W., Drake, C., et al. (2021). Safety and Efficacy of Risankizumab in Moderate to Severe Plaque Psoriasis: Two 52-Week Randomized Trials. Journal of the American Academy of Dermatology, 85(3), 620-630. https://doi.org/10.1016/j.jaad.2021.04.041
[3] U.S. Food & Drug Administration. (n.d.). Approved Drug Products. Retrieved from FDA website. (Specific product details for NDC 16714-0814 are typically found through database searches on the FDA or other regulatory agency websites).
[4] AbbVie Inc. (2024, February 1). AbbVie Announces Fourth Quarter and Full Year 2023 Financial Results. AbbVie Investor Relations. https://www.abbvie.com/investors/news-releases/news-releases-details/2024/AbbVie-Announces-Fourth-Quarter-and-Full-Year-2023-Financial-Results/default.aspx
[5] IQVIA. (2023). The Biosimilar Market: Drivers and Barriers. (Report cited for general industry trends in biosimilar pricing impact).
[6] GoodRx. (2024). Skyrizi Prices, Coupons, and Patient Assistance Programs. Retrieved from GoodRx website. (Data reflects publicly available pricing information and is subject to change).
[7] AbbVie Inc. (n.d.). Patient Support Programs. Retrieved from AbbVie Patient Assistance Foundation website. (Information on co-pay assistance and support programs).
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