Understanding the NDC Code
The National Drug Code (NDC) is a unique identifier assigned to each drug product by the FDA. The NDC code 50268-0526 is broken down into three segments:
- The first segment (50268) is the labeler code, identifying the firm that manufactures, repackages, or relabels the drug.
- The second segment identifies the product code, which includes the specific strength, dosage form, and formulation of the drug.
- The third segment is the package code, indicating the package size and type[1][4].
Drug Identification
For the NDC code 50268-0526, the labeler is AvPAK, a company that manufactures and distributes various pharmaceutical products. This specific NDC code corresponds to a formulation of Loratadine, an antihistamine commonly used to treat allergies[2].
Market Trends
Biopharma and Biotech Industry Outlook
The biopharma and biotech industries are experiencing significant growth, driven by technological advancements, evolving regulatory frameworks, and a shift towards patient-centered care. As of 2024, the biopharma market size was estimated to be over $400 billion, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. The biotech sector is also growing rapidly, with a market size of nearly $500 billion in 2020 and an estimated CAGR of 9.4% between 2021 and 2027[3].
Generic and Biosimilar Competition
The life sciences industry is facing increased competition from generic drugs and biosimilars. This competition is expected to impact pricing strategies significantly, with 37% of surveyed executives viewing competition from generics and biosimilars as a top trend in 2025. The patent cliff, with over $300 billion in sales at risk through 2030 due to expiring patents, is also a significant concern[5].
Price Projections
Impact of Generic Competition
Given that Loratadine is a widely used antihistamine with multiple generic versions available, the price of the drug is likely to be influenced by generic competition. Generic drugs typically enter the market at a lower price point than their branded counterparts, which can lead to a decrease in the overall market price of the drug.
Regulatory and Market Dynamics
The FDA's NDC Directory, which is updated daily, includes information on all listed drugs, including generic and branded versions. This transparency can help in monitoring price trends and ensuring compliance with regulatory requirements. However, the dynamic nature of the pharmaceutical market, with frequent changes in pricing and access, means that prices can fluctuate based on various factors such as production costs, market demand, and regulatory changes[4].
Market Size and Demand
The demand for antihistamines like Loratadine remains steady due to the prevalence of allergies. However, the market size and pricing are also influenced by the availability of alternative treatments and the overall economic conditions. For instance, the COVID-19 pandemic has highlighted the importance of digital health solutions and telemedicine, which can impact the distribution and pricing of pharmaceuticals[5].
Key Factors Influencing Price
- Generic Competition: The presence of multiple generic versions of Loratadine will continue to drive prices down.
- Regulatory Environment: Changes in FDA regulations and the inclusion of new data elements in the NDC Directory can affect pricing transparency and compliance.
- Market Demand: Steady demand for antihistamines, but potential shifts due to new treatments or economic conditions.
- Technological Advancements: Integration of technologies like AI and genomics could lead to more efficient production and distribution, potentially affecting prices.
Price Projection
Given the competitive landscape and the factors influencing the market, here is a general price projection for the drug NDC 50268-0526:
- Short-Term (2025-2026): Prices are likely to remain stable or decrease slightly due to ongoing generic competition and regulatory pressures.
- Medium-Term (2027-2029): Continued competition and potential advancements in production technologies could lead to further price reductions.
- Long-Term (2030 and beyond): The market will likely stabilize with prices reflecting the balance between production costs, demand, and the impact of new technologies and regulatory changes.
Conclusion
The market analysis for the drug NDC 50268-0526 indicates a competitive landscape driven by generic competition, regulatory dynamics, and technological advancements. While prices are expected to remain competitive, the long-term outlook suggests a stable market with potential for further efficiency-driven price adjustments.
Key Takeaways
- Generic Competition: A significant factor in pricing due to multiple generic versions available.
- Regulatory Transparency: The FDA's NDC Directory ensures compliance and transparency in pricing.
- Technological Advancements: Integration of AI and genomics could lead to more efficient production and distribution.
- Market Demand: Steady demand for antihistamines, but subject to changes in economic conditions and new treatments.
- Price Projections: Stable or decreasing prices in the short and medium term, with long-term stability expected.
FAQs
What is the NDC code and how is it structured?
The NDC code is a unique identifier for drug products, structured into three segments: the labeler code, product code, and package code.
Who is the labeler for the NDC code 50268-0526?
The labeler for the NDC code 50268-0526 is AvPAK.
What is the impact of generic competition on drug prices?
Generic competition typically drives prices down as multiple generic versions enter the market at lower price points than branded counterparts.
How does the FDA's NDC Directory affect pricing transparency?
The FDA's NDC Directory, updated daily, includes detailed information on all listed drugs, ensuring transparency and compliance in pricing.
What are the key factors influencing the price of Loratadine?
Key factors include generic competition, regulatory environment, market demand, and technological advancements.
Sources
- YouTube - NDC Directory (March 2015)
- FindACode - Loratadine NDC Codes
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
- FDA - National Drug Code Directory
- Deloitte Insights - 2025 Life Sciences Executive Outlook
