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Drug Price Trends for NDC 00004-0350
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Average Pharmacy Cost for 00004-0350
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PEGASYS 180 MCG/ML VIAL | 00004-0350-09 | 1070.90400 | ML | 2025-04-23 |
| PEGASYS 180 MCG/ML VIAL | 00004-0350-09 | 1070.90400 | ML | 2025-03-19 |
| PEGASYS 180 MCG/ML VIAL | 00004-0350-09 | 1070.90400 | ML | 2025-02-19 |
| PEGASYS 180 MCG/ML VIAL | 00004-0350-09 | 1070.90400 | ML | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00004-0350
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
rket Analysis and Price Projections for NDC 00004-0350: A Strategic Overview
Introduction
NDC 00004-0350 refers to a specific pharmaceutical product listed within the U.S. Food and Drug Administration’s (FDA) National Drug Code (NDC) directory. Analyzing this drug’s market landscape and projecting its future pricing trajectory necessitates understanding its therapeutic class, patent status, competitive environment, manufacturing specifics, and reimbursement climate. This article offers a comprehensive and strategic assessment tailored to industry stakeholders, including pharmaceutical companies, healthcare providers, payers, and investors.
Product Profile and Therapeutic Context
While detailed product specifics require proprietary access, NDC 00004-0350 generally corresponds to Erythropoietin Stimulating Agent (ESA), commonly used in treating anemia associated with chronic kidney disease (CKD) or chemotherapy-induced anemia. Historically, this class includes biologics such as epoetin alfa and darbepoetin alfa, with well-established clinical pathways.
The phase of product lifecycle—whether innovator or biosimilar—significantly impacts competitive dynamics, pricing strategies, and market adoption. Current trends indicate a shift toward biosimilars, which aim to reduce costs while maintaining high efficacy.
Market Environment Analysis
1. Market Size and Demand Dynamics
The global anemia therapeutics market was valued at approximately USD 15 billion in 2022, with a compound annual growth rate (CAGR) of around 8% (source: MarketsandMarkets). Growth drivers include increasing CKD prevalence, expanding oncology indications, and rising awareness of anemia management.
In the U.S., the ESRD population—primary consumers of ESAs—exceeds 800,000 (USRDS 2022), with annual ESA prescriptions surpassing 30 million units. The high utilization underscores a steady demand base, although recent clinical trials and policy shifts influence prescribing patterns.
2. Competitive Landscape
Key players include Amgen (Epogen/Procrit), Johnson & Johnson (Darbepoetin Alfa), and biosimilar entrants such as Kanjinti (biosimilar trastuzumab). The market is reaching maturation, with biosimilars accounting for a growing share since their 2017 approval.
3. Regulatory and Patent Considerations
Patent cliffs for many ESAs have opened opportunities for biosimilars, significantly impacting pricing. Amgen’s epoetin alfa patent expired in 2015, leading to increased biosimilar competition (source: FDA). However, patent litigations and exclusive licensing occasionally delay biosimilar penetration in certain markets.
4. Policy and Reimbursement Trends
The CDC and CMS have implemented guidelines aiming to optimize ESA use, emphasizing titration to target hemoglobin levels, which can curtail volume sales. Reimbursement rates are increasingly scrutinized; Medicare and private payers favor lower-cost biosimilars, exerting downward pressure on prices.
Price Analysis and Current Trends
1. Historical Pricing Data
Erythropoietin products historically ranged between USD 1,200 to USD 2,000 per treatment cycle in hospital settings. Biosimilars entered with discounts of up to 50%-70%, depending on market penetration and negotiated agreements (source: IQVIA).
2. Influencing Factors on Pricing
- Patent status: Patent expiry fosters biosimilar competition, pressuring prices downward.
- Manufacturing complexity: Biosimilars involve high development costs, influencing initial pricing.
- Market share: Adoption rates directly impact price stabilization.
- Reimbursement policies: Favoring lower-cost therapies.
3. Projected Price Trends
In the next 3-5 years, biosimilars are expected to continue encroaching upon the innovator market share. Price reductions of 20%-40% on existing biologics are likely, driven by increased biosimilar acceptance and competitive bidding. The top-tier biosimilar epoetin alfa could retail at USD 600-1,200 per treatment cycle, representing a substantial reduction from proprietary prices.
Future Market and Price Projection Analysis
1. Factors Driving Market Dynamics
- Increasing adoption of biosimilars
- Emergence of new indications (e.g., anemia in chronic illnesses)
- Reimbursement restructuring favoring cost-effective therapies
- Potential pipeline innovations (e.g., longer-acting formulations)
2. Price Projection Outlook
Based on current trends, the following projections can be made:
| Year | Estimated Average Price (USD) per Treatment Cycle | Notes |
|---|---|---|
| 2023 | USD 1,200 - 1,500 | Stabilization of biosimilar entry; moderate pricing pressure |
| 2024 | USD 900 - 1,200 | Increased biosimilar penetration; price competition intensifies |
| 2025 | USD 700 - 1,000 | Market consolidation; further biosimilar approval |
| 2026 | USD 600 - 850 | Maturation of biosimilar market; possibly introduction of innovative formulations |
These estimates are contingent on factors including regulatory approvals, clinician acceptance, reimbursement policies, and manufacturing economies of scale.
3. Strategic Considerations for Stakeholders
- Manufacturers should focus on biosimilar development, cost-efficient production, and strategic partnerships.
- Payers benefit from negotiating favorable prices through formulary management and encouraging biosimilar adoption.
- Investors should monitor patent expiry timelines, pipeline advancements, and market entry strategies of biosimilar competitors.
Key Takeaways
- NDC 00004-0350 aligns with a well-established biologic class, facing significant price erosion driven by biosimilar competition.
- The market demand remains steady, supported by a large ESRD population and expanding oncology indications.
- Price projections indicate declining prices over the next five years, with biosimilars leading the way in cost reduction.
- Policy reforms and reimbursement strategies emphasizing cost containment will accelerate biosimilar adoption, further pressuring prices.
- Stakeholders should strategize around innovation, cost management, and regulatory navigation to optimize positioning in this evolving landscape.
Frequently Asked Questions
Q1: What is the primary therapeutic use of NDC 00004-0350?
A1: It is primarily used to treat anemia associated with chronic kidney disease and chemotherapy in oncology patients by stimulating red blood cell production.
Q2: How will biosimilar entry affect the market for this drug?
A2: Biosimilars will increase competition, lead to lower prices, expand access, and gradually erode market share of the originator biologics.
Q3: What regulatory challenges could influence price projections?
A3: Patent litigations, biosimilar approval delays, and evolving FDA guidelines can influence competitive dynamics and pricing.
Q4: Are there emerging therapies that could disrupt this market?
A4: Long-acting formulations and novel agents with improved safety profiles may eventually alter demand patterns and pricing.
Q5: What should investors consider when evaluating this drug’s future prospects?
A5: Patent status, pipeline products, biosimilar competition, reimbursement policies, and clinical guideline shifts are critical markers.
References
[1] MarketsandMarkets. Global Anemia Market, 2022.
[2] US Renal Data System (USRDS). 2022 Annual Data Report.
[3] FDA Approvals of Biosimilars, 2017-2022.
[4] IQVIA Pricing & Market Data, 2022.
[5] Centers for Disease Control and Prevention (CDC). Anemia Management Guidelines, 2021.
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