Overview of Darifenacin
Darifenacin, marketed under the NDC code 16571-0768, is a medication manufactured by Rising Pharma Holdings, Inc. It is primarily used to treat overactive bladder symptoms such as frequent urination, urgent need to urinate, and incontinence (urine leakage)[5].
Market Context
The pharmaceutical market, particularly for drugs like Darifenacin, is influenced by several factors including regulatory environments, technological advancements, and global pricing trends.
Global Pharmaceutical Market Trends
The global pharmaceutical market, including both biopharma and biotech sectors, is experiencing significant growth. The biopharma market size was estimated to be over $400 billion in 2024, 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].
Pricing Trends in the U.S.
In the U.S., prescription drug prices have been a subject of considerable discussion. Between 2017 and 2022, the average price per unit of prescription drugs in the U.S. increased by 14%, significantly higher than in other OECD countries and the rest of the world. By 2022, prices in the U.S. were 5.5 times those in the OECD (excluding the U.S.) and 7.7 times prices in the rest of the world[4].
Regulatory Environment
NDC Directory and FDA Regulations
The National Drug Code (NDC) directory, maintained by the FDA, is a critical resource for tracking and managing drug listings. The new NDC directory includes all electronically listed drugs in their final marketed form, including over-the-counter drugs, and provides additional data elements such as the Drug Enforcement Administration schedule and pharmacological class. This directory is updated daily and ensures that all listed drugs in U.S. commercial distribution are accounted for[1].
Price Projections for Darifenacin
Current Pricing
As of the latest available data, specific pricing for Darifenacin (NDC: 16571-0768) is not provided in the sources. However, pricing for similar medications can give some insight. For example, the prices for other medications listed by Rising Pharma Holdings, Inc. can vary widely, reflecting the complex pricing dynamics in the pharmaceutical market[5].
Future Pricing Trends
Given the broader trends in the pharmaceutical market:
- Inflation and Market Growth: With the overall pharmaceutical market experiencing growth, it is likely that prices will continue to rise, albeit at a rate that may be influenced by regulatory and competitive pressures.
- Regulatory Impact: Changes in regulatory frameworks could impact pricing. For instance, efforts to control drug prices or enhance transparency might affect the pricing strategy for Darifenacin.
- Competitive Landscape: The presence of generic or alternative treatments for overactive bladder could influence the pricing of Darifenacin. If competitors offer similar products at lower prices, Rising Pharma Holdings, Inc. might need to adjust their pricing strategy to remain competitive.
Market Analysis
Demand and Supply
The demand for medications like Darifenacin is driven by the prevalence of overactive bladder and the effectiveness of the drug in treating this condition. As the population ages, the demand for such medications is likely to increase.
Competitive Analysis
The market for overactive bladder treatments is competitive, with several drugs available. Darifenacin competes with other antimuscarinic medications and newer therapies. The competitive landscape will continue to evolve with new drug approvals and changes in patient preferences.
Key Takeaways
- Market Growth: The pharmaceutical market, including the segment for overactive bladder treatments, is expected to grow.
- Pricing Trends: Prices in the U.S. are likely to remain higher compared to other regions, but regulatory and competitive pressures may influence future pricing.
- Regulatory Environment: The FDA's NDC directory and evolving regulatory frameworks will continue to shape the market.
- Competitive Landscape: The presence of competitors and new drug approvals will impact the pricing and market share of Darifenacin.
FAQs
Q: What is Darifenacin used for?
A: Darifenacin is used to treat overactive bladder symptoms such as frequent urination, urgent need to urinate, and incontinence (urine leakage).
Q: Who manufactures Darifenacin under NDC 16571-0768?
A: Darifenacin under NDC 16571-0768 is manufactured by Rising Pharma Holdings, Inc.
Q: How does the FDA track and manage drug listings?
A: The FDA uses the National Drug Code (NDC) directory to track and manage drug listings. The new NDC directory includes all electronically listed drugs in their final marketed form and is updated daily.
Q: What are the key factors influencing the price of Darifenacin?
A: The price of Darifenacin is influenced by market growth, regulatory environments, competitive pressures, and global pricing trends.
Q: How is the demand for Darifenacin expected to change?
A: The demand for Darifenacin is likely to increase due to the aging population and the prevalence of overactive bladder.
Sources
- YouTube - NDC Directory (March 2015)
- MISSOURI SPECIALTY MAC NAME OF DRUG (January 2023)
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025 (November 2024)
- ASPE - International Market Size and Prices (December 2024)
- Find-A-Code - Rising Pharma Holdings, Inc. (Accessed 2025)
