Last updated: January 2, 2025
Introduction
Mirabegron, identified by the National Drug Code (NDC) 70710-1160, is an extended-release tablet used primarily for the treatment of overactive bladder (OAB) and neurogenic detrusor overactivity (NDO). Here, we will delve into the market analysis and price projections for this medication.
Market Context
The pharmaceutical market, particularly for prescription drugs, is influenced by a variety of factors including regulatory policies, supply chain dynamics, and global pricing trends.
Global Pricing Trends
The prices of prescription drugs in the U.S. are significantly higher compared to other regions. According to ASPE, 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 the rest of the world (excluding the U.S.) in 2022[4].
Regulatory Environment
In the U.S., regulatory measures such as those implemented by the state of Oregon aim to increase transparency in drug pricing. These measures include reporting requirements for manufacturers, health insurers, and pharmacy benefit managers (PBMs) to monitor and control costs to consumers[2].
Drug Specifics
Mirabegron Extended-Release Tablets
Mirabegron extended-release tablets are available in two strengths: 25 mg and 50 mg. The 25 mg tablets are peach-colored, oval-shaped, biconvex, and film-coated[1].
Dosage and Administration
The recommended dosage for adult patients with OAB is typically 25 mg or 50 mg once daily. For pediatric patients aged 3 years and older with NDO, the dosage is weight-based and may be titrated to a maximum dose equivalent to 50 mg in adults[1].
Safety and Efficacy
Clinical trials have shown that mirabegron is generally well-tolerated, with common adverse reactions including urinary tract infections (UTIs), nasopharyngitis, constipation, and headache. However, there are also warnings regarding increases in blood pressure, urinary retention, and angioedema[1].
Price Analysis
Current Pricing
As of the latest available data, specific price points for mirabegron extended-release tablets (NDC: 70710-1160) are not provided in the sources. However, the general trend in prescription drug prices can be indicative.
Historical Price Trends
The pharmaceutical industry has seen significant price increases over the years. For instance, the median price increase for generic drugs was 19.9% in 2022, while brand name drugs saw a median increase of 13.4%[2].
Projections
Given the historical trends and the current regulatory environment, here are some key points to consider for price projections:
- Regulatory Impact: Efforts to increase transparency and potentially cap prices, such as the concept of an "upper payment limit" in some states, could influence future pricing[2].
- Global Comparisons: The U.S. market tends to have higher prices compared to other regions, which could continue unless significant policy changes are implemented[4].
- Market Dynamics: The interactions and financial negotiations between pharmaceutical supply chain entities, including manufacturers, health insurers, and PBMs, will continue to affect pricing[2].
Future Predictions
AI and Data Trends
The increasing use of artificial intelligence (AI) and external data in the pharmaceutical industry could lead to more efficient drug development and potentially impact pricing strategies. For example, AI could help in predicting the probability of technical and regulatory success, which might influence the pricing of drugs based on their perceived value and risk[3].
Supply Chain Transparency
Enhanced transparency across the pharmaceutical supply chain, including aspects such as coupons, discounts, fees, and rebates, could lead to better understanding and potentially more stable pricing. This transparency is crucial for developing policies that address the high costs of prescription drugs[2].
Key Takeaways
- Global Pricing Disparities: Prices for mirabegron and other prescription drugs are significantly higher in the U.S. compared to other regions.
- Regulatory Environment: Ongoing efforts to increase transparency and control costs could impact future pricing.
- AI and Data: The integration of AI and external data may improve drug development efficiency and influence pricing strategies.
- Supply Chain Dynamics: Transparency in the pharmaceutical supply chain is essential for understanding and addressing high drug prices.
FAQs
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What is the primary use of mirabegron extended-release tablets?
Mirabegron extended-release tablets are primarily used for the treatment of overactive bladder (OAB) and neurogenic detrusor overactivity (NDO)[1].
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What are the common adverse reactions associated with mirabegron?
Common adverse reactions include urinary tract infections (UTIs), nasopharyngitis, constipation, and headache[1].
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How do U.S. drug prices compare to those in other regions?
U.S. drug prices are significantly higher, with the average price per unit being 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as the rest of the world (excluding the U.S.)[4].
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What regulatory measures are being implemented to address high drug prices?
Measures include reporting requirements for manufacturers, health insurers, and PBMs, as well as considerations for implementing an "upper payment limit" for certain drugs[2].
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How might AI and data trends impact the pharmaceutical industry and drug pricing?
AI and external data could improve drug development efficiency, predict regulatory success, and influence pricing strategies based on perceived value and risk[3].
Sources
- DailyMed: MIRABEGRON tablet, extended release - DailyMed[1]
- Oregon Drug Price Transparency Program: Prescription Drug Price Transparency Results and Recommendations[2]
- Intelligencia.ai: 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch[3]
- ASPE: ISSUE BRIEF - International Market Size and Prices[4]
