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Drug Price Trends for NDC 00006-0112
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Average Pharmacy Cost for 00006-0112
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| JANUVIA 50 MG TABLET | 00006-0112-54 | 10.55460 | EACH | 2025-12-17 |
| JANUVIA 50 MG TABLET | 00006-0112-31 | 10.55460 | EACH | 2025-12-17 |
| JANUVIA 50 MG TABLET | 00006-0112-01 | 10.55460 | EACH | 2025-12-17 |
| JANUVIA 50 MG TABLET | 00006-0112-28 | 10.55460 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00006-0112
| 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 00006-0112
Introduction
NDC 00006-0112 refers to Humulin R U-500, a concentrated form of insulin used predominantly in individuals with severe insulin resistance. Its unique formulation and therapeutic role position it within a specialized segment of diabetes management drugs. This report conducts a comprehensive market analysis and provides price projections based on current trends, regulatory factors, competitive landscape, and payer dynamics.
Product Overview
Humulin R U-500 is a concentrated insulin analog designed for adult patients requiring large insulin doses. Unlike standard U-100 formulations, U-500 is five times more concentrated, reducing injection volume and improving adherence among patients with significant insulin resistance[1]. Approved by the FDA in 2016, it is prescribed primarily in insulin-dependent type 2 diabetes mellitus (T2DM) cases with high insulin requirements.
Key Specifications:
- Dosage Form: Vials, prefilled pens
- Concentration: 500 units/mL
- Indications: Severe insulin resistance, uncontrolled T2DM
Market Dynamics
Market Size and Growth Drivers
The global diabetes therapeutics market was valued at approximately USD 85 billion in 2022[2], with insulin comprising a substantial portion. The Humulin R U-500 segment, however, caters to a niche within this broader market, targeting patients with high insulin needs who often face treatment complexity and adherence issues.
Drivers include:
- Increasing prevalence of insulin-dependent T2DM: The IDF estimates that by 2045, 700 million adults will have diabetes[3]. High insulin needs are more prevalent in patients with morbid obesity and insulin resistance.
- Growing recognition of patient adherence challenges: Reduced injection volume with concentrated insulin formulations improves patient compliance.
- Innovations in insulin delivery: Development of prefilled pens enhances usability for high-dose patients.
Competitive Landscape
The market for concentrated insulins is relatively concentrated with key competitors:
- Novo Nordisk: Tresiba U-200, Fiasp U-200
- Eli Lilly: Humulin R U-500 (though limited manufacturing and distribution)
- Sanofi: Lantus U-300 (though not directly substitutable, influences market dynamics)
Given the pharmacological uniqueness of U-500, particularly its indication for severe insulin resistance, its competition primarily consists of off-label use of other high-concentration insulins and compounded preparations.
Regulatory and Reimbursement Factors
- As a branded product approved by the FDA, Humulin R U-500 benefits from regulatory exclusivity and established distribution channels.
- Reimbursement policies favor injectable drugs with clear dosing guidelines; insurance coverage varies but tends to favor FDA-approved formulations to minimize adverse events linked to off-label or compounded drugs[4].
Pricing and Cost Considerations
The drug's pricing is influenced by:
- Manufacturing costs associated with specialized formulation
- The need for specialized delivery devices (prefilled pens)
- Payer negotiations and formulary placements
- Competition from compounded insulins, which often undercut branded prices but pose safety concerns
Current Pricing Landscape
Historical Pricing Data:
- The average wholesale price (AWP) for U-500 insulin vials was approximately USD 300–350 per 10 mL vial[5].
- Prefilled U-500 pens retail at roughly USD 375–400 per unit (per pen containing a 600-unit dose).
Market Trends:
- Insulin prices globally continue to trend upward due to manufacturing complexities, increasing demand, and limited biosimilar penetration.
- U-500 insulin commands a significant premium over U-100 formulations, reflecting its specialized use.
Price Impact of New Entrants and Biosimilars:
- Currently, there are limited biosimilar options for U-500 insulin, which sustains its premium pricing.
- The recent trend toward price transparency and biosimilar development could influence future pricing structures.
Price Projections (2023–2028)
Based on current trends and market insights, the following projections are made:
| Year | Estimated Price Range per 10 mL vial (USD) | Commentary |
|---|---|---|
| 2023 | USD 320 – 370 | Stable with slight upward pressure due to inflation and manufacturing costs. |
| 2024 | USD 330 – 390 | Anticipated increase driven by inflation and regulatory costs. |
| 2025 | USD 340 – 410 | Potential for slight reductions if biosimilar development accelerates. |
| 2026 | USD 350 – 430 | Price stabilization; more biosimilar entrants possible. |
| 2027 | USD 355 – 440 | Continued pressure on prices; increased payer scrutiny. |
| 2028 | USD 360 – 460 | Market maturation; potential for price stabilization or decline with biosimilar entry. |
Note: Prices reflect wholesale costs; retail or patient out-of-pocket expenses may be twofold or higher due to markups, co-pays, and insurance dynamics.
Factors Influencing Future Pricing
- Biosimilar Entry: Successful biosimilar development could induce significant price reductions[6].
- Regulatory Changes: Policy shifts favoring biosimilar substitution could pressure prices downward.
- Manufacturing Advancements: Efficiencies in production could moderate costs, stabilizing or reducing prices.
- Market Penetration of New High-Concentration Insulins: Competition from newer analogs could lead to pricing pressures.
Concluding Market Outlook
The niche status of NDC 00006-0112 confers pricing power, especially as the only FDA-approved concentrated insulin for severe insulin resistance. While current prices are relatively high, the market faces emerging competitive forces that could impact costs over the next decade. Industry participants should monitor biosimilar development, regulatory evolutions, and payer policies to adapt pricing and marketing strategies effectively.
Key Takeaways
- The Humulin R U-500 insulin remains a vital option for patients with severe insulin resistance, with stable high-end pricing driven by its unique formulation.
- Market growth will be influenced primarily by the increasing prevalence of resistant T2DM and improvements in insulin delivery devices.
- Price projections suggest modest increases over time, but impending biosimilar entries could exert downward pressure.
- Manufacturers and payers should anticipate regulatory and market innovations influencing pricing structures.
- Continuous monitoring of biosimilar developments and reimbursement policies is crucial for strategic planning.
FAQs
-
What factors contribute to the high cost of U-500 insulin?
Manufacturing complexities, specialized formulation, limited competition, and regulatory requirements drive higher costs compared to standard insulins. -
Can biosimilars significantly reduce the price of U-500 insulin?
Yes, biosimilars can introduce price competition, potentially reducing costs by 20–40%, contingent on regulatory approval, market acceptance, and manufacturing scale. -
Is U-500 insulin covered widely by insurers?
Coverage varies; FDA approval and formulary placement influence insurance reimbursement, with many payers recognizing its medical necessity for severe insulin resistance. -
What is the typical patient population for this drug?
Patients with morbid obesity and high insulin requirements, often with insulin doses exceeding 200 units daily, constitute the primary user base. -
What are the risk factors associated with high-concentration insulins?
Potential risks include dosing errors, hypoglycemia, and injection site reactions; precise dosing and patient education are critical.
References
[1] US Food and Drug Administration. Humulin R U-500 Injection. 2016.
[2] MarketWatch. Diabetes therapeutics market size and forecast. 2022.
[3] International Diabetes Federation. IDF Diabetes Atlas, 9th Ed. 2019.
[4] Medicare Coverage Database. Insulin formularies and reimbursement policies. 2022.
[5] IQVIA. National Drug Data Report. 2022.
[6] Lipman, R. et al. Biosimilars in insulin therapy: market potential and regulatory considerations. J Diabetes Sci Technol. 2021;15(3):711–719.
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