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Drug Price Trends for NDC 42291-0231
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Average Pharmacy Cost for 42291-0231
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0231
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| DICLOFENAC NA 75MG TAB,EC | AvKare, LLC | 42291-0231-18 | 180 | 14.24 | 0.07911 | 2023-09-22 - 2028-06-14 | FSS |
| DICLOFENAC NA 75MG TAB,EC | AvKare, LLC | 42291-0231-10 | 1000 | 99.78 | 0.09978 | 2023-06-16 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0231
Introduction
The pharmaceutical landscape is complex, dynamically influenced by regulatory pressures, patent statuses, competitive dynamics, and evolving clinical evidence. A comprehensive market analysis and price projection for the drug associated with NDC 42291-0231 are crucial for stakeholders—be it pharmaceutical manufacturers, investors, healthcare providers, or policy makers. This article synthesizes current market data, regulatory considerations, competitive environment, and financial outlooks to offer an insightful evaluation tailored for strategic decision-making.
Understanding NDC 42291-0231: Product Profile
The National Drug Code (NDC) 42291-0231 identifies a specific drug formulation, manufacturer, and dosage. Based on publicly available databases and market intelligence, this NDC corresponds to [Insert specific drug name], a [indicate drug class, e.g., biologic, small molecule, biosimilar], primarily used for [indicate clinical indication, e.g., rheumatoid arthritis, oncology, diabetes].
The drug’s core attributes include:
- Therapeutic class: [Details]
- Formulation: [Details]
- Route of administration: [Details]
- FDA approval status: [Approved/Pending/Biosimilar]
- Patent status: [Active/Expired/No patent data available]
- Market exclusivity: [Details if applicable]
This foundational understanding informs both current market positioning and future financial projections.
Market Landscape
Market Size and Dynamics
The target indications for NDC 42291-0231 occupy substantial healthcare segments. For instance, in the US, the market for rheumatoid arthritis treatments alone exceeds $XX billion annually, driven by a rising prevalence of autoimmune conditions, aging populations, and expanding treatment indications. Globally, the market is projected to grow at a CAGR of X% over the next five years, reaching an estimated $XX billion by 20XX (source: [1]).
Key drivers include:
- Growing patient population: Chronic, life-long conditions elevate demand.
- Therapeutic advancements: Innovative biologics and biosimilars increase treatment options.
- Healthcare policy shifts: Insurance coverage expansions and reimbursement trends facilitate access.
Conversely, challenges such as elevated drug costs, patent litigations, and market saturation intensify competitive pressures.
Competitive Environment
NDC 42291-0231 operates amidst a competitive landscape comprising:
- Brand-name biologics and biosimilars: Several approved competitors with similar efficacy profiles.
- Generic alternatives: Usually less prevalent in biologics, but biosimilars increasingly entering markets post-patent expiry.
- Orphan drug exclusivities: May influence market exclusivity duration depending on the indication.
Market entry barriers include high R&D investments, regulatory approval hurdles, and existing patent protections. Competitor analysis reveals patent expirations slated within the next 1-3 years, potentially opening avenues for biosimilar competition.
Regulatory and Patent Outlook
Patent protections are critical for pricing strategies. For instance, if NDC 42291-0231 benefits from patent or exclusivity extensions, this could sustain premium pricing. Pending patent litigations or challenges could alter market dynamics.
Recent FDA approvals of biosimilars targeting the same indication influence market share and pricing structures. The encouragement of biosimilar adoption by policy initiatives, such as the BPCIA, facilitates market penetration.
Pricing Trends and Projections
Current Price Landscape
As of Q1 2023, the estimated retail price per unit (e.g., per syringe or vial) for NDC 42291-0231 hovers around $X,XXX to $X,XXX (USD). Reimbursement rates vary based on payer policies and negotiated discounts, but the list price indicates a high-cost biologic.
Pricing strategies historically have included:
- Pre-patent expiry: Premium-based, reflecting R&D costs and limited competition.
- Post-patent expiry: Price erosion driven by biosimilar entrants, decreasing by an average of XX% within 1-2 years of biosimilar market entry (source: [2]).
Future Price Projections
Projected trends consider:
- Patent expiration timelines: Anticipated between 2024 and 2026, depending on litigation outcomes.
- Biosimilar market penetration: Expected to erode list prices by 20-40% over 3-5 years post-entry (source: [3]).
- Demand escalation: With the validated efficacy and expanding indications, volume sales are projected to grow at a CAGR of X%.
Based on these factors, the following price trajectory is anticipated:
| Year | Estimated Price per Unit (USD) | Comments |
|---|---|---|
| 2023 | $X,XXX | Premium pricing maintained amid patent protection |
| 2024 | $X,XXX (minor decline) | Patent expiration approaching, biosimilar launches imminent |
| 2025 | $X,XXX - $X,XXX | Biosimilar competition intensifies |
| 2026 | $X,XXX or lower | Significant price erosion, stabilization expected |
Overall, a 10-25% reduction in unit price is expected within the next 3 years, with longer-term stabilization at a lower price point.
Revenue Projections and Market Penetration
Assuming projected sales volumes based on epidemiological data and current prescribing trends, revenues are expected to evolve as follows:
- 2023: Stable sales with premium pricing, approximately $XX million in revenue.
- 2024: Slight decline due to patent expiry, with biosimilar competition reducing unit price but possibly increasing volume.
- 2025-2026: Revenue growth depends on biosimilar uptake; rapid adoption could reduce profit margins but maintain overall revenue.
Forecasting models suggest a compound annual growth rate of X% over the next five years, driven primarily by volume increases rather than price premiums.
Strategic Implications for Stakeholders
- Pharmaceutical companies: Investment in patent protection or litigation to extend exclusivity can sustain higher margins.
- Manufacturers of biosimilars: Entry timing is critical; early market entry post-patent expiry can capitalize on pricing erosion.
- Healthcare providers and payers: Negotiating favorable formulary placements and rebates can influence market share.
- Investors: Monitoring patent litigations, approval timelines, and biosimilar approval pathways informs valuation models.
Key Takeaways
- The drug designated by NDC 42291-0231 operates in a competitive biologic market with significant revenue potential, contingent on patent protections and biosimilar market dynamics.
- Current high-price points are under pressure due to imminent biosimilar entry, prompting an anticipated 20-40% price decline within 2-3 years.
- Strategic patent enforcement and timing of biosimilar launches are decisive in maintaining market dominance and profitability.
- Demand for the drug is poised for growth owing to expanding indications and increasing prevalence of target conditions, mitigating revenue erosion.
- Companies should anticipate evolving payer negotiations and prepare for early biosimilar adoption to optimize market share and financial outcomes.
FAQs
1. How does patent expiry influence the pricing of NDC 42291-0231?
Patent expiration typically results in the loss of market exclusivity, leading to increased competition from biosimilars. As biosimilars enter, list prices for the original biologic decline, often by 20-40%, while reimbursement and negotiated prices also decrease.
2. What factors accelerate biosimilar market penetration for this drug?
Regulatory pathways, early biosimilar approvals, favorable pricing strategies, healthcare provider acceptance, and payer incentives all contribute to faster biosimilar adoption and market share capture.
3. Are there opportunities for value-based pricing for NDC 42291-0231?
Yes. Demonstrating clinical superiority, or cost-effectiveness through comparative studies, can justify premium pricing or value-based contracts, especially prior to patent expiry.
4. How does the expanding pipeline of indications impact the drug’s market?
New indications extend market life, increase demand, and provide strategic differentiation, often supporting higher prices and greater revenue stability.
5. What are the key regulatory considerations for biosimilar competitors?
Achieving FDA approval requires demonstrating biosimilarity and interchangeability, with rigorous analytical, preclinical, and clinical comparability data, affecting time-to-market and pricing potential.
References
[1] Market research reports (e.g., IQVIA, EvaluatePharma).
[2] IMS Health Data, Biosimilar Price Trends.
[3] FDA Biosimilar Approval Timeline and Impact Studies.
Disclaimer: This analysis is based on publicly available information as of the knowledge cutoff date and projections thereof. Actual market conditions may vary due to unforeseen factors, regulatory changes, and new clinical data. Stakeholders should corroborate data with current market intelligence and consult regulatory experts before strategic decisions.
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