Market Analysis and Price Projections for NDC 72205-007: Capecitabine
Introduction
Capecitabine, identified by the National Drug Code (NDC) 72205-007, is a medication manufactured and distributed by Novadoz Pharmaceuticals LLC. This article provides a comprehensive market analysis and price projections for capecitabine, considering various factors such as market trends, regulatory changes, and industry outlook.
Drug Overview
What is Capecitabine?
Capecitabine is an oral, film-coated tablet used primarily in the treatment of certain types of cancer, including colorectal and breast cancer. It belongs to the class of nucleic acid synthesis inhibitors and works by interfering with the growth of cancer cells[1].
Mechanism of Action
Capecitabine is a prodrug that is converted into its active form, 5-fluorouracil (5-FU), in the body. 5-FU inhibits thymidylate synthase, an enzyme essential for DNA synthesis, thereby preventing cancer cells from replicating[1].
Market Analysis
Current Market Trends
The pharmaceutical market, particularly for generic drugs like capecitabine, is subject to several key trends:
- Price Erosion: Generic drugs typically experience a decline in prices over time due to increased competition. This trend is expected to continue, with mid-single-digit percent annual price erosion anticipated in the generic drug industry[2].
- Regulatory Impact: Changes in regulatory policies, such as those related to Medicare drug price negotiations, can significantly impact pricing. Future inclusions in such programs could result in substantial discounts[2].
- Market Competition: The launch of new treatments and biosimilars increases competition, driving prices down. The loss of patent protection for existing biologics also contributes to a more competitive market environment[2].
Global Pricing Dynamics
The pricing of prescription drugs, including capecitabine, varies significantly across different regions. In the U.S., prices are generally higher compared to other OECD countries and the rest of the world. For example, the average price per unit in the U.S. was 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as in the rest of the world in 2022[4].
Price Projections
Current Pricing
As of the latest data, the pricing for capecitabine (NDC 72205-007) is influenced by its status as a generic drug. While the exact current pricing is not explicitly stated, it is subject to the broader trends affecting generic drugs.
Future Pricing Trends
Given the current market dynamics, here are some key points to consider for future price projections:
- Price Erosion: Expect mid-single-digit percent annual price erosion due to increased competition and market pressures[2].
- Regulatory Impact: Potential future inclusion in Medicare drug price negotiations or other regulatory changes could lead to significant discounts, similar to those seen in other programs (ranging from 38% to 79%)[2].
- Market Competition: Increased competition from new treatments and biosimilars will continue to drive prices down. The pharmaceutical industry's stable credit outlook and modest revenue growth will help mitigate some pressures but are unlikely to reverse the downward price trend[3].
Industry Outlook
Life Sciences Trends
The life sciences industry is poised for significant transformation in 2025, driven by digital advancements and scientific innovations. Despite competitive pressures and business volatility, most global life sciences executives are optimistic about the future. Key trends include:
- Digital Transformation: The integration of technologies like gen AI and increased use of data are expected to boost operational efficiencies and drive breakthrough innovations[3].
- Competition from Generics and Biosimilars: 37% of respondents view competition from generic drugs and biosimilars as a top trend, which will continue to impact pricing and market dynamics[3].
Patent Cliff and M&A Activity
The biopharma industry is facing a substantial loss of exclusivity, with more than $300 billion in sales at risk through 2030 due to expiring patents on high-revenue products. This is likely to drive interest in mergers and acquisitions, with 77% of surveyed executives expecting M&A to increase in 2025[3].
Impact of Global Market Dynamics
U.S. vs. International Pricing
The U.S. market for prescription drugs, including capecitabine, is characterized by higher prices compared to other regions. This is due to both higher prices for the same drugs and a drug mix that skews towards more expensive compounds[4].
Sales Revenue and Volume Trends
In the U.S., sales revenues for prescription drugs have grown significantly, but this growth is largely driven by higher prices rather than increased volume. In contrast, other regions have seen more modest revenue growth and higher volume increases[4].
Conclusion
The market for capecitabine (NDC 72205-007) is influenced by a combination of industry trends, regulatory changes, and competitive market dynamics.
Key Takeaways
- Price Erosion: Expect mid-single-digit percent annual price erosion due to increased competition.
- Regulatory Impact: Potential future inclusion in Medicare drug price negotiations could lead to significant discounts.
- Market Competition: Increased competition from new treatments and biosimilars will drive prices down.
- Industry Outlook: The pharmaceutical industry's stable credit outlook and modest revenue growth will help mitigate some pressures but are unlikely to reverse the downward price trend.
FAQs
What is Capecitabine Used For?
Capecitabine is used primarily in the treatment of certain types of cancer, including colorectal and breast cancer.
Who Manufactures Capecitabine NDC 72205-007?
Capecitabine NDC 72205-007 is manufactured and distributed by Novadoz Pharmaceuticals LLC.
What is the Mechanism of Action of Capecitabine?
Capecitabine is a prodrug that is converted into its active form, 5-fluorouracil (5-FU), which inhibits thymidylate synthase, an enzyme essential for DNA synthesis.
How Does the U.S. Pricing Compare to Other Regions?
The average price per unit in the U.S. is significantly higher compared to other OECD countries and the rest of the world, being 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as in the rest of the world[4].
What Are the Expected Price Trends for Capecitabine?
Capecitabine prices are expected to decrease due to mid-single-digit percent annual price erosion, regulatory impacts, and increased competition from new treatments and biosimilars.
Sources
- FDA.report: NDC 72205-007 Oral Tablet, Film Coated Capecitabine.
- DrugPatentWatch: Market Analysis and Financial Projection for NDC 72205-0050.
- Deloitte Insights: 2025 Life Sciences Executive Outlook.
- ASPE: International Market Size and Prices for Prescription Drugs.