Market Analysis and Price Projections for the Drug NDC: 00378-5055
Understanding the National Drug Code (NDC)
To delve into the market analysis and price projections for a specific drug, it is crucial to first understand the National Drug Code (NDC) system. The NDC is a unique 10-digit number assigned to each drug product, divided into three segments: the labeler code, product code, and package code. The labeler code, assigned by the FDA, identifies the firm that manufactures, repackages, or distributes the drug. The product code and package code, assigned by the firm, identify the specific strength, dosage form, and formulation of the drug, as well as the package sizes and types, respectively[1][5].
Drug Identification: NDC 00378-5055
The NDC 00378-5055 corresponds to Pitavastatin, a statin medication used to lower cholesterol levels. Here is a breakdown of the NDC:
- Labeler Code: 00378 (assigned by the FDA)
- Product Code: 5055 (identifies the specific strength, dosage form, and formulation)
- Package Code: 77 (identifies the package size and type)[2].
Market Trends and Pricing
Current Pricing
As of the latest data, the price per unit for Pitavastatin 1 mg tablets with the NDC 00378-5055 is approximately $1.65276 per unit. This pricing is consistent across various vendors and distributors[2].
Market Size and Growth
The market for Pitavastatin is expected to grow significantly. According to projections, the global market for Pitavastatin is anticipated to reach USD 890.2 million by 2031, with a Compound Annual Growth Rate (CAGR) of 6.7% during this period. This growth is driven by increasing demand for cholesterol-lowering medications and the expanding patient population[2].
Competitive Landscape
The pharmaceutical industry, particularly the statin market, is highly competitive. The rise of generic drugs and biosimilars poses a significant challenge to branded medications. Nearly 37% of life sciences executives view competition from generic drugs and biosimilars as a top trend, which could impact the pricing and market share of Pitavastatin[3].
Pricing and Access
Pricing and access to drugs are critical issues in the life sciences industry. C-suite executives identify these as the most significant challenges, with nearly half expecting these factors to significantly affect their strategies in 2025. The high prices of drugs in the U.S., which are 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world, further complicate market dynamics[3][4].
Price Projections
Short-Term Projections
In the short term, prices for Pitavastatin are likely to remain stable due to the existing market dynamics and the presence of multiple vendors offering the drug at similar prices. However, any changes in regulatory policies or significant shifts in the competitive landscape could influence pricing.
Long-Term Projections
Long-term price projections are more complex due to several factors:
- Generic and Biosimilar Competition: As patents expire, the entry of generic and biosimilar versions of Pitavastatin could lead to price reductions. The biopharma industry is facing a substantial loss of exclusivity, with over $300 billion in sales at risk through 2030 due to expiring patents[3].
- Market Expansion: The growing demand for cholesterol-lowering medications, driven by an increasing patient population and expanding healthcare access, could support stable or slightly increasing prices.
- Regulatory and Policy Changes: Changes in healthcare policies, reimbursement rates, and regulatory requirements can significantly impact drug pricing.
Given these factors, it is plausible that the price of Pitavastatin could experience some downward pressure due to increased competition but may remain relatively stable due to ongoing demand.
Impact of Digital Transformation and Innovation
The life sciences industry is undergoing significant transformation driven by digital advancements and scientific innovations. The integration of technologies like genomics, biomarkers, and AI is expected to boost operational efficiencies and drive breakthrough innovations. While these advancements primarily focus on developing new therapeutic solutions, they can also influence the pricing and market dynamics of existing drugs by improving patient outcomes and reducing side effects[3].
Conclusion
The market analysis for Pitavastatin, identified by the NDC 00378-5055, indicates a stable current pricing environment but potential long-term changes due to competitive and regulatory factors. Here are the key takeaways:
- Current Pricing: Approximately $1.65276 per unit.
- Market Growth: Expected to reach USD 890.2 million by 2031 with a CAGR of 6.7%.
- Competitive Landscape: Significant competition from generic drugs and biosimilars.
- Pricing and Access: High prices in the U.S. compared to other regions, with ongoing regulatory and policy challenges.
- Long-Term Projections: Potential price reductions due to generic and biosimilar competition, balanced by growing demand and digital innovations.
Key Takeaways
- Stable Current Pricing: Prices are consistent across vendors.
- Market Growth: Significant growth projected driven by demand.
- Competitive Pressures: Generic and biosimilar competition will impact pricing.
- Regulatory Challenges: Pricing and access issues are critical.
- Digital Innovations: Expected to improve patient outcomes and operational efficiencies.
FAQs
Q1: What is the National Drug Code (NDC) and how is it structured?
The NDC is a unique 10-digit number divided into three segments: the labeler code, product code, and package code, identifying the manufacturer, specific drug formulation, and package details, respectively[1][5].
Q2: What is the current price per unit for Pitavastatin with the NDC 00378-5055?
The current price per unit for Pitavastatin 1 mg tablets with the NDC 00378-5055 is approximately $1.65276 per unit[2].
Q3: What are the projected market trends for Pitavastatin?
The market for Pitavastatin is expected to grow significantly, reaching USD 890.2 million by 2031 with a CAGR of 6.7%[2].
Q4: How does competition from generic drugs and biosimilars affect Pitavastatin?
Competition from generic drugs and biosimilars is expected to increase, potentially leading to price reductions for Pitavastatin as patents expire and more affordable alternatives enter the market[3].
Q5: What role do digital transformations and innovations play in the life sciences industry?
Digital transformations and innovations, such as genomics and AI, are expected to improve patient outcomes, reduce side effects, and boost operational efficiencies, which can indirectly influence the pricing and market dynamics of drugs like Pitavastatin[3].
Sources
- FDA: National Drug Code Database Background Information - FDA
- DrugPatentWatch: Drug prices and trends for PITAVASTATIN
- Deloitte Insights: 2025 life sciences outlook
- ASPE: ISSUE BRIEF - International Market Size and Prices
- Wolters Kluwer: Are You Prepared for a Major Industry Change to the National Drug Code (NDC) Number?
