Introduction
The pharmaceutical market is dynamic and influenced by various factors, including new drug approvals, price inflation, and regulatory changes. This article focuses on the market analysis and price projections for Mesalamine Extended Release Capsules, identified by the National Drug Code (NDC) 63304-089.
Overview of Mesalamine Extended Release Capsules
Mesalamine Extended Release Capsules, with the NDC 63304-089, are a human prescription drug labeled and distributed by Sun Pharmaceutical Industries Inc.[5].
- Product Type: Human Prescription Drug
- Proprietary Name: Mesalamine
- Generic Name: Mesalamine
- Dosage Form: Capsule, Extended Release
- Route of Administration: Oral
- Active Ingredient Strength: 500 mg/1
Market Trends in the Pharmaceutical Industry
The pharmaceutical industry is undergoing significant changes driven by several key trends:
Prevention and Personalization
There is a growing focus on prevention and personalization, with data-driven, customized treatments becoming more prevalent. This shift towards preventive care and personalized medicine could influence the demand for drugs like Mesalamine, which is used to treat conditions such as ulcerative colitis and Crohn's disease[3].
Price Inflation
Drug price inflation is a critical factor in the pharmaceutical market. According to Vizient, Inc., the overall drug price inflation rate for pharmaceuticals in 2025 is projected to be around 3.81%. This inflation is partly driven by the expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies[2].
Regulatory Environment
The FDA's regulatory environment plays a crucial role in the pricing and availability of drugs. The National Drug Code (NDC) Directory, maintained by the FDA, includes information on all finished drugs, including prescription and over-the-counter drugs, approved and unapproved drugs, and repackaged and relabeled drugs. This directory helps in tracking and regulating drug prices and availability[1].
Current Market Conditions
In 2023, overall pharmaceutical expenditures in the U.S. grew by 13.6% compared to 2022, reaching a total of $722.5 billion. This growth was driven by increased utilization (6.5%), new drugs (4.2%), and price increases (2.9%)[4].
Price Projections for Mesalamine Extended Release Capsules
Given the current market trends and projections:
General Price Inflation
With an expected overall drug price inflation rate of 3.81% in 2025, it is likely that the price of Mesalamine Extended Release Capsules will also increase. This inflation rate is influenced by broader market factors, including the introduction of new high-cost therapies and the expanding indications of existing drugs[2].
Utilization and Demand
The demand for Mesalamine is likely to remain stable or increase slightly due to its established use in treating gastrointestinal conditions. However, the exact impact on price will depend on factors such as changes in patient population, treatment guidelines, and competition from other drugs or generics.
Regulatory and Policy Changes
Any changes in regulatory policies or healthcare legislation could impact the pricing and availability of Mesalamine. For instance, policies affecting drug pricing, reimbursement, or the approval process for generics and biosimilars could influence the market dynamics for this drug[3].
Impact of New Drug Approvals and Patent Expirations
New drug approvals and patent expirations can significantly affect the pricing of existing drugs. If new treatments for conditions like ulcerative colitis and Crohn's disease are approved, they could potentially reduce the demand for Mesalamine, leading to price adjustments. Conversely, if patents for competing drugs expire, leading to increased generic competition, prices for Mesalamine might decrease[4].
Conclusion
The price of Mesalamine Extended Release Capsules, identified by NDC 63304-089, is expected to be influenced by several factors, including general drug price inflation, changes in utilization and demand, regulatory and policy changes, and the impact of new drug approvals and patent expirations.
Key Takeaways
- Price Inflation: Expected overall drug price inflation rate of 3.81% in 2025.
- Market Trends: Focus on prevention, personalization, and prediction in healthcare.
- Regulatory Environment: FDA's NDC Directory and regulatory policies impact drug pricing and availability.
- Demand and Utilization: Stable or slightly increasing demand due to established use.
- New Drug Approvals and Patent Expirations: Potential impact on pricing due to new treatments and generic competition.
FAQs
Q: What is the expected overall drug price inflation rate for 2025?
A: The expected overall drug price inflation rate for 2025 is around 3.81%[2].
Q: What are the key trends shaping the future of the pharmaceutical industry?
A: The key trends include a focus on prevention, personalization, prediction, and point of care[3].
Q: How does the FDA's NDC Directory impact drug pricing and availability?
A: The NDC Directory helps in tracking and regulating drug prices and availability by including information on all finished drugs, including prescription and over-the-counter drugs[1].
Q: What factors drive the growth in pharmaceutical expenditures?
A: Growth in pharmaceutical expenditures is driven by increased utilization, new drugs, and price increases[4].
Q: How might new drug approvals and patent expirations affect the price of Mesalamine Extended Release Capsules?
A: New drug approvals could reduce demand, while patent expirations leading to generic competition could decrease prices[4].
Sources
- FDA's National Drug Code Directory - FDA
- Vizient projects drug price inflation at 3.81% - Vizient, Inc.
- Pharma industry trends: PwC - PwC
- National trends in prescription drug expenditures and projections for ... - PubMed
- NDC 63304-089 Oral Capsule, Extended Release Mesalamine ... - FDA Report
