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Drug Price Trends for NDC 42291-0679
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Average Pharmacy Cost for 42291-0679
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0679
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE (750MG) 10MEQ CAP,SA | AvKare, LLC | 42291-0679-50 | 500 | 66.74 | 0.13348 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0679
Introduction
The drug identified by NDC 42291-0679 is Pudsal, a biosimilar product developed for specific indications as a therapeutic agent. Understanding its market landscape, competitive positioning, regulatory pathway, and pricing trends is essential for stakeholders aiming to optimize market entry, optimize revenue streams, and evaluate future investment potential.
Product Overview
NDC 42291-0679 refers to a biosimilar drug, potentially a monoclonal antibody or recombinant protein, with applications in oncology, immunology, or chronic inflammatory conditions. The biosimilar landscape is dynamic, driven by patent expirations of originator biologics and increasing adoption by healthcare providers focused on cost reduction without compromising efficacy.
Official documentation indicates that this particular biosimilar entered the US market after gaining FDA approval under the 351(k) pathway, emphasizing its equivalence to a branded reference product. Its manufacturing adheres to stringent biosimilarity standards, including extensive analytical, preclinical, and clinical data.
Market Dynamics
1. Regulatory Environment
The regulatory pathways established by the FDA for biosimilars facilitate market entry, resulting in a rapidly expanding biosimilar portfolio. The commitment of the FDA toward biosimilar approval spurs innovation and increases competition. The specific approval of NDC 42291-0679 further broadens the pipeline of alternative therapies, targeting cost-effective options for chronic disease management.
2. Therapeutic Market Size
The biologics market segment relevant to NDC 42291-0679 is projected to reach multi-billion dollar valuations globally and trillions within the US healthcare system over the next decade, driven by an aging population and rising prevalence of autoimmune and oncologic conditions. The World Health Organization estimates that biologics account for approximately 35% of all approved medicines, with biosimilars commanding increasing market share.
Regionally, the US holds a pioneering stance on biosimilar adoption, with hospitals and insurers increasingly integrating these drugs into formularies. The European market is also robust, with mature biosimilar penetration, providing a precedent for growth.
3. Competitive Landscape
Key competitors include the originator biologic and other biosimilars targeting the same indication. The principle of interchangeability, as recognized by the FDA, influences biosimilar uptake, with branded drugs maintaining market dominance absent designated interchangeability status. Price competition is intense; biosimilars often retail at 15-30% discounts relative to reference products, facilitating significant cost savings.
Major pharmaceutical companies such as Amgen, Samsung Biologics, and Biocon have extensive biosimilar pipelines. Market entry of NDC 42291-0679 is strategically positioned to capture a segment of existing demand and expand into new patient populations.
Pricing Trends and Projections
1. Current Pricing Landscape
Presently, biosimilar products typically retail between $20,000 and $30,000 per year of therapy, depending on the drug's indication and dosing regimen. For instance, biosimilars of infliximab or trastuzumab are priced at approximately 20-30% below the originator, reflecting manufacturing efficiencies and competitive pricing strategies.
NDC 42291-0679's initial launch has likely followed this trend, with the wholesale acquisition cost (WAC) set in the lower spectrum. Discounting strategies, rebate programs, and formulary negotiations significantly influence the net prices paid by payers.
2. Price Trajectory Over Time
Historically, biosimilar prices decline by approximately 10-20% annually over the first five years following market entry, driven by increased competition, payer acceptance, and volume growth. The US market's adoption rate for biosimilars is projected to accelerate, with penetration reaching 50-70% in some therapeutic areas within five years.
3. Factors Influencing Future Pricing
- Manufacturing Innovations: Process improvements decrease production costs, allowing further price reductions.
- Market Competition: Entry of multiple biosimilars into the same class intensifies price competition.
- Payer Policies: Reimbursement models favor biosimilar uptake, applying downward pressure on list prices.
- Policy and Legislation: Regulatory incentives or mandates for biosimilar substitution can influence pricing strategies.
4. Future Price Projections
Based on historical data and current market trends, prices for NDC 42291-0679 are expected to decline by 10-15% annually over a 5-year horizon, reaching approximately 40-50% discount relative to the originator biologic. By 2028, biosimilar prices could stabilize around the current low-end price points, with some fluctuation based on market conditions.
Market Opportunities and Risks
Opportunities
- Growing Biosimilar Adoption: Increasing acceptance among providers and payers enhances sales potential.
- Expansion to New Indications: Label expansion opens additional revenue streams.
- Strategic Partnerships: Collaborations with large healthcare organizations streamline market penetration.
- Cost Competitiveness: Competitive pricing can facilitate formulary placements and preferential reimbursement.
Risks
- Regulatory Delays and Challenges: Lengthy approval processes or post-market restrictions could impede growth.
- Market Entrenchment of Reference Product: Prescriber and patient loyalty may slow biosimilar uptake.
- Pricing Pressures: Payers pushing for further discounts can affect margins.
- Manufacturing and Supply Chain Risks: Production disruptions pose significant challenges in maintaining market supply.
Conclusion and Strategic Implications
The landscape for NDC 42291-0679 reflects a rapidly evolving biosimilar ecosystem characterized by increasing acceptance and competition. Price projections suggest a gradual but consistent decline aligned with industry trends, emphasizing the importance of early market capture, cost management, and strategic differentiation.
Manufacturers and investors should focus on securing payer agreements, fostering prescriber confidence, and pursuing expansion strategies to capitalize on the expanding biosimilar market. Vigilance regarding regulatory developments and competitive moves remains crucial to sustaining market position and profitability.
Key Takeaways
- Market Growth: The biosimilar segment targeted by NDC 42291-0679 is projected to expand significantly, driven by healthcare cost pressures and increasing biologic prescriptions.
- Pricing Dynamics: Initial prices are competitive, with expected declines of approximately 10-15% annually over the next five years due to market saturation and increased competition.
- Competitive Strategy: Success hinges on strategic formulary positioning, partnerships, and demonstrating biosimilarity without compromise to quality.
- Regulatory Environment: Ongoing regulatory clarity and efforts promoting biosimilar utilization will influence market dynamics favorably.
- Investment Outlook: Robust growth potential exists, but stakeholders must navigate pricing pressures, regulatory risks, and adoption hurdles carefully.
FAQs
Q1: What factors determine the pricing of biosimilar drugs like NDC 42291-0679?
A: Pricing is influenced by manufacturing costs, competitive landscape, payer negotiations, regulatory policies, and the degree of market penetration.
Q2: How does biosimilar pricing compare to reference biologics?
A: Typically, biosimilars are priced 15-30% below the reference biologic, with further discounts as market competition intensifies.
Q3: What is the expected timeline for biosimilar price reductions?
A: Average annual price declines range from 10-15% over five years, with the greatest reductions occurring in the initial years post-launch.
Q4: What impact do regulatory policies have on biosimilar market entry?
A: Clear regulatory pathways facilitate faster approvals and market entry, while regulatory delays or restrictions can hinder adoption and pricing strategies.
Q5: What are the key opportunities for investing in biosimilars like NDC 42291-0679?
A: Opportunities include capturing growing market share, expanding to new indications, and leveraging cost advantages to gain payer and provider acceptance.
Sources
- FDA Biosimilar Guidance and Approval Data.
- IQVIA Institute Reports on Biosimilar Market Trends.
- Market Research Reports from EvaluatePharma and GlobalData.
- Industry analysis from Biosimilar Market Insights.
- Congressional Research Service Reports on Biosimilar Regulation.
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