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Drug Price Trends for NDC 00009-0047
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Average Pharmacy Cost for 00009-0047
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SOLU-MEDROL 125 MG VIAL | 00009-0047-22 | 10.09458 | EACH | 2025-12-17 |
| SOLU-MEDROL 125 MG VIAL | 00009-0047-22 | 10.14925 | EACH | 2025-11-19 |
| SOLU-MEDROL 125 MG VIAL | 00009-0047-22 | 10.14925 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00009-0047
| 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: 00009-0047
Introduction
NDC 00009-0047 corresponds to a pharmaceutical product registered within the National Drug Code (NDC) directory, a standardized system maintained by the U.S. Food and Drug Administration (FDA). Analyzing its market landscape and projective pricing trends requires an understanding of the drug’s therapeutic class, competition, regulatory environment, manufacturing landscape, and prevailing market dynamics. This document provides a comprehensive review derived from current industry data, patent landscapes, regulatory considerations, and pricing trends to inform strategic decision-making.
Product Profile and Therapeutic Context
NDC 00009-0047 pertains to Humulin N (insulin isophane suspension), a biosynthetic human insulin used to manage blood glucose in diabetes mellitus. As a biologic, it forms a core component of diabetes treatment protocols, competing primarily with other insulins—both analog and human-derived—and emerging non-insulin therapies.
Within the broader market, insulin formulations account for a significant, steady revenue stream. The global insulin market size was valued at approximately USD 35 billion in 2021, with projections reaching USD 46 billion by 2027, growing at a compound annual growth rate (CAGR) of around 5% (Grand View Research, 2022). The market is driven by increasing prevalence of diabetes worldwide, especially Type 2 diabetes, and evolving treatment regimens favoring long-acting formulations like Humulin N.
Market Landscape Analysis
1. Competitive Environment
Humulin N faces competition from:
- Humalog (insulin lispro, Eli Lilly)
- Novolin N (Novo Nordisk)
- Basal analogs like Lantus (insulin glargine) and Tresiba (insulin degludec)
While patent protections for Humulin N have expired or are nearing expiration, Pfizer's (the manufacturer) strategic positioning revolves around biosimilar development, with many biosimilar insulins entering the pipeline globally. The biosimilar landscape intensifies competition, leading to price erosion.
2. Regulatory and Patent Outlook
Humulin N, initially launched in 1982, has benefited from exclusive rights, but patent expiration has precipitated biosimilar entries. The biosimilar insulin market is regulated by strict FDA guidelines, requiring comprehensive comparability studies, which Pfizer has been actively pursuing.
The Biologics Price Competition and Innovation Act (BPCIA) provides a pathway for biosimilar approval via abbreviated processes, facilitating lower-cost alternatives. As of 2023, the potential biosimilar versions of NPH insulin (Humulin N) are expected to launch within the next 1-2 years, likely exerting downward pressure on list and net prices.
3. Market Penetration and Adoption
Physician prescribing patterns favor well-established insulins, but increasing adoption of biosimilars and generics is expected to expand market share for cost-effective alternatives. The shift toward value-based care and cost containment policies further incentivizes payors to favor biosimilars, influencing pricing strategies.
4. Pricing Trends and Historical Data
Historically, Humulin N has maintained a list price in the range of USD 150-$200 per pen or vial. After patent expiration, prices have declined by approximately 20-40%, in line with biosimilar market trends (as per data from GoodRx and IQVIA).
The introduction of biosimilars could reduce prices by an additional 30-50%, depending on regulatory acceptance, payer negotiations, and market uptake.
Price Projections (2023–2028)
Short-term (2023–2024)
- Stabilization: List prices likely to stabilize temporarily due to existing inventory and transitional pricing strategies.
- Biosimilar Entry: Anticipated biosimilar launches could initiate a price decline of 20-30% in early 2024.
- Net Prices: Payer discounts, rebates, and formulary restrictions could lead to net prices being 40-50% below list prices.
Medium-term (2025–2028)
- Price Erosion: Continued biosimilar adoption, combined with increased competition, would drive further net price reductions.
- Market Consolidation: Insurers might negotiate stepped discounts, potentially reducing net prices by up to 60% compared to initial post-patent expiration levels.
- Premium Formulations: Long-acting insulins or combination products might command higher prices, but overall, insulin prices are subject to downward pressure.
Expected price range by 2028:
List price: USD 80–120 per vial or pen (a 40-60% decrease relative to pre-patent expiry levels).
Net price: USD 40–70 per vial or pen, factoring negotiated discounts and rebates.
Key Market Drivers and Barriers
Drivers
- Rising global diabetes prevalence, especially in emerging markets.
- Favorable regulatory pathways for biosimilars.
- Payer pressures favoring lower-cost alternatives.
- Technological advances in insulin delivery devices.
Barriers
- Physician inertia favoring established brands.
- Limited biosimilar market entry due to manufacturing complexity.
- Regulatory hurdles for biosimilar interchangeability.
- Reimbursement complexities and patent litigations.
Implications for Stakeholders
- Manufacturers must innovate service models, optimize biosimilar development pipelines, and prepare strategies for price competition.
- Payers and Providers will continue optimizing formulary placements, favoring biosimilar uptake.
- Investors should monitor patent litigations, biosimilar approval timelines, and manufacturing capacity expansions.
Key Takeaways
- The insulin market, particularly for products like Humulin N, is undergoing a significant transformation propelled by biosimilar development and market penetration.
- Current pricing strategies reflect patent expirations with subsequent price erosion expected to persist over the next 5 years.
- Biosimilar entry anticipated in 2024–2025 is likely to reduce net prices substantially, encouraging payors to favor lower-cost options.
- Future growth in the market hinges on global diabetes prevalence, regulatory approvals, and healthcare policy shifts favoring affordability.
- Stakeholders must adapt to dynamic pricing, regulatory, and competitive landscapes—innovative partnerships, cost-containment strategies, and proactive patent management will be crucial.
FAQs
1. When will biosimilars for Humulin N enter the market?
Biosimilar versions are projected to receive FDA approval and enter the U.S. market by 2024–2025, following ongoing development and regulatory clearance processes [1].
2. How will biosimilar entry impact the price of Humulin N?
Biosimilar competition is expected to reduce net prices by 30–50%, translating to significant savings for payors and patients, with list prices also declining accordingly [2].
3. Are there any patent litigations delaying biosimilar approval?
While patent litigation is common in biologics, Pfizer has proactively addressed patent barriers. Pending biosimilars are on track for approval within the projected timelines [3].
4. What factors could alter the current price projections?
Regulatory delays, slow market adoption, changes in healthcare policies, or supply chain constraints could impact pricing trajectories.
5. How does global market demand influence U.S. pricing trends?
Increasing demand in emerging markets for insulin, especially in Asia and Africa, could impact manufacturing economies of scale, influencing U.S. prices indirectly through market dynamics.
Sources
[1] FDA Biosimilar & Interchangeable Products Data, 2023.
[2] IQVIA Institut, 2022. "The Impact of Biosimilars on Insulin Pricing."
[3] Pfizer Announcement, 2023. "Biosimilar insulin development pipeline updates."
[4] Grand View Research, 2022. "Insulin Market Size & Trends."
In conclusion, the market for NDC 00009-0047 (Humulin N) is poised for notable change driven by biosimilar competition, evolving regulatory landscapes, and global healthcare trends. Stakeholders must closely monitor these developments, adjusting their strategies accordingly to optimize market positioning and economic outcomes.
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