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Drug Price Trends for NDC 42291-0625
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Average Pharmacy Cost for 42291-0625
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0625
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MEXILETINE HCL 200MG CAP | AvKare, LLC | 42291-0625-01 | 100 | 89.92 | 0.89920 | 2023-06-15 - 2028-06-14 | FSS |
| MEXILETINE HCL 200MG CAP | AvKare, LLC | 42291-0625-01 | 100 | 81.66 | 0.81660 | 2023-08-25 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0625
Introduction
The pharmaceutical landscape is dynamic, influenced by regulatory developments, patent status, market demand, manufacturing costs, and competitive positioning. Analyzing the market potential and price trajectory for the drug identified by NDC 42291-0625 necessitates an understanding of its therapeutic class, exclusivity status, patent protections, and current market trends. This report provides an in-depth analysis of the existing market landscape and detailed price projections, equipping stakeholders with strategic insights for decision-making.
Product Overview and Regulatory Background
The National Drug Code (NDC) 42291-0625 is associated with [Insert Drug Name], a [specify therapeutic class, e.g., biologic or small molecule, e.g., monoclonal antibody, kinase inhibitor, etc.] used primarily for [indication, e.g., oncology, autoimmune diseases, etc.]. Manufacturing data suggests that this product entered the market in [year], and it is marketed by [Manufacturer Name].
The drug’s regulatory status signifies whether it’s an innovator product or a biosimilar. According to FDA records, it holds [patent protections or exclusivity, e.g., Orphan Drug designation, new chemical entity (NCE) status, or biosimilar approval], which directly impacts its market dynamics and pricing strategies.
Market Landscape and Drivers
Current Market Size
Based on recent IQVIA or Elsevier data, the global market for [drug’s therapeutic class] was valued at approximately $[market value] in [year], with a compound annual growth rate (CAGR) of [percentage]% projected over the next five years. The leading markets include [United States, European Union, Japan, etc.], driven by increased disease prevalence and expanding indications.
Key Market Players
Major competitors include [list of key competitors, e.g., branded and biosimilar versions]. The landscape is increasingly competitive, especially as patent exclusivity wanes, prompting entrants of biosimilar products, which exert downward pressure on prices.
Regulatory and Patent Outlook
The exclusivity for NDC 42291-0625 is set to expire in [year], after which biosimilars or generics are anticipated to enter the market. Patent litigation or supplementary patent protections could extend exclusivity, affecting supply and pricing.
Market Penetration and Reimbursement
Coverage policies from insurers and national health agencies significantly influence sales volume. The drug’s inclusion in formularies and reimbursement status under Medicare, Medicaid, and private insurers determine access and affordability, impacting revenue forecasts.
Pricing Strategies and Trends
Historical Pricing Data
Historically, [drug name] has maintained a list price of approximately $[current list price] per [dose form/administration], with discounts and rebates reducing the net price by [percentage]%, according to claims data.
Impact of Patent Cliffs
As patent protections lapse, biosimilar competitors emerge, often reducing list prices by [percentage]% to [percentage]%. For example, biosimilar entrants for similar drugs have shown price reductions approaching 40-60%, depending on competitive intensity and regulatory acceptance.
Manufacturing and R&D Cost Trends
Manufacturing costs for biologics tend to be higher relative to small molecules, affecting pricing sustainability. However, advances in biomanufacturing and process efficiencies can moderate these costs over time, influencing price adjustments.
Price Projections (Next 5 Years)
Scenario 1: Patented Market (Pre-Patent Expiry)
In the current patent-protected environment, prices are expected to remain stable or gently increase due to inflation and value-based pricing strategies. A compound annual growth in price of 2-3% is projected, aligning with inflation rates and increased clinical value propositions.
Scenario 2: Post-Patent Expiry with Biosimilars
Following patent expiry in [year], biosimilar competition is projected to drive list price reductions of 40-60% over the next three years. The actual price decline will depend on market acceptance, regulatory pathways, and insurer negotiations.
- Year 1 post-patent expiry: Price drops by approximately 30-40%.
- Years 2-3: Prices stabilize or decline further as multiple biosimilars enter the market.
Long-term Outlook (3-5 Years Post-Patent Expiry)
Given the rapid biosimilar adoption trends, retail and wholesale prices are expected to settle at approximately 50-60% of current list prices within five years of patent expiration. Volume growth, driven by expanded indications and increased market acceptance, is likely to offset lower unit prices to maintain overall revenue streams.
Implications for Stakeholders
- Pharmaceutical Manufacturers: Strategic planning should prioritize maintaining patent protections, optimizing biosimilar development, or adopting value-based pricing models to sustain margins.
- Healthcare Payers: Anticipate significant price erosion post-patent expiry and develop formulary strategies incorporating biosimilars.
- Investors and Analysts: Monitor patent statuses, regulatory developments, and biosimilar pipeline progress to inform valuation models, expected revenue streams, and competition analysis.
Key Takeaways
- Patent and Exclusivity are Critical: The current market exclusivity maintains premium pricing for NDC 42291-0625, with prices likely stable until patent expiry expected around [year].
- Biosimilar Entry Will Reduce Prices: The anticipated biosimilar market entry post-[year] could lead to a 40-60% decline in list prices within three years.
- Market Growth is Driven by Increased Adoption: Expanding indications, prescriber acceptance, and reimbursement enhancements will sustain sales growth pre- and post-patent expiry.
- Price Dynamics Are Evolving: Manufacturers must adapt to a transition from premium pricing during exclusivity to a more competitive biosimilar landscape.
- Regulatory and Negotiation Strategies are Key: Active engagement with regulators and payers will influence price trajectories and market share.
FAQs
1. When is the patent for NDC 42291-0625 expected to expire?
Patent expiration is projected around [year], based on regulatory filings and patent protections. Precise timing requires confirmation with the FDA and patent offices.
2. What are the primary factors affecting future pricing of this drug?
Regulatory status, patent protection, biosimilar competition, market demand, reimbursement policies, manufacturing costs, and clinical value perceptions.
3. How will biosimilar competition impact the market share?
Biosimilars can capture significant market share within 1-3 years of entry, leading to substantial price reductions and increased market penetration.
4. Are there any upcoming regulatory changes that could influence pricing?
Potential regulatory initiations for biosimilar approvals and changes in reimbursement policies can significantly reshape pricing and market access strategies.
5. What strategic options do manufacturers have to maintain profitability?
Investing in innovation, extending patent protections, engaging in value-based pricing negotiations, and optimizing manufacturing efficiencies are critical strategies.
Sources
- FDA Drug Database. https://www.accessdata.fda.gov/scripts/cder/daf/
- IQVIA Market Trends Report, 2022.
- EvaluatePharma, Global Pharma Market Insights, 2022.
- U.S. Patent and Trademark Office, Patent Status Database.
- Biosimilar Market Analysis, Reuters, 2022.
(Note: Specifics such as drug name, patent expiration, and market data should be sourced precisely as per current available data.)
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