Market Analysis and Price Projections for Dicyclomine Hydrochloride (NDC: 0143-3126)
Introduction
Dicyclomine hydrochloride, with the NDC code 0143-3126, is a medication used to treat irritable bowel syndrome (IBS) and other gastrointestinal disorders. This article provides a comprehensive market analysis and price projections for this drug, considering various factors such as market trends, competition, and regulatory environments.
Current Market Status
Dicyclomine hydrochloride is marketed by Hikma Pharmaceuticals USA Inc. and falls under the category of human prescription drugs with no DEA schedule classification[1].
Dosage and Administration
The recommended initial dose of dicyclomine hydrochloride is 20 mg four times a day, which can be increased to 40 mg four times a day after one week if side effects do not limit dosage escalation. The maximum documented safe dose is 80 mg per day for periods not exceeding two weeks[1].
Market Trends and Competition
The pharmaceutical market is highly competitive, and several trends are expected to impact the pricing and availability of drugs like dicyclomine hydrochloride.
Generic Competition
The presence of generic versions of dicyclomine hydrochloride from multiple manufacturers, such as A-S Medication Solutions, Bora Pharmaceutical Laboratories Inc., and RedPharm Drug, Inc., can drive down prices. For instance, competition in the generics market has been shown to significantly reduce drug prices, as seen with generic fingolimod, which had its WAC (Wholesale Acquisition Cost) price reduced by 84% to 97% due to competition[4].
Patent Cliff and Biosimilars
The life sciences industry is facing a substantial loss of exclusivity due to expiring patents on high-revenue products, which could lead to increased competition from generic drugs and biosimilars. This trend is expected to impact the market significantly, with over $300 billion in sales at risk through 2030[3].
Price Projections
Drug Price Inflation
According to Vizient's summer Pharmacy Market Outlook, the overall drug price inflation rate for pharmaceuticals in 2025 is projected to be 3.81%. This inflation is partly driven by expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies[2].
Impact of Competition
Given the competitive landscape, especially with multiple generic versions available, the price of dicyclomine hydrochloride is likely to remain stable or decrease. The variability in pricing among different manufacturers and the impact of competition suggest that prices may not rise significantly.
Regulatory Environment
Transparency and Reporting
Regulatory requirements for drug price transparency can influence pricing strategies. The Prescription Drug Price Transparency Program highlights the need for more detailed information from manufacturers to understand price changes. However, the variability in the quality of submitted information remains a challenge[4].
Industry Outlook
Digital Transformation and Innovation
The life sciences industry is expected to undergo significant transformation in 2025, driven by digital advancements and scientific innovations. While these innovations may not directly impact the pricing of existing drugs like dicyclomine hydrochloride, they could influence overall market dynamics and patient treatment options[3].
Key Takeaways
- Generic Competition: Multiple generic versions of dicyclomine hydrochloride are available, which can drive down prices.
- Price Inflation: Overall drug price inflation is projected at 3.81% for 2025, but this may not significantly impact generic drugs.
- Regulatory Environment: Transparency in drug pricing is crucial, but the quality of information submitted by manufacturers varies.
- Industry Trends: Digital transformation and innovation are expected to shape the life sciences industry, but their direct impact on dicyclomine hydrochloride pricing is minimal.
FAQs
Q: What is the recommended dosage for dicyclomine hydrochloride?
A: The recommended initial dose is 20 mg four times a day, which can be increased to 40 mg four times a day after one week if side effects do not limit dosage escalation[1].
Q: Who are the primary manufacturers of dicyclomine hydrochloride?
A: The primary manufacturers include Hikma Pharmaceuticals USA Inc., A-S Medication Solutions, Bora Pharmaceutical Laboratories Inc., and RedPharm Drug, Inc.[1][5].
Q: How does generic competition affect the price of dicyclomine hydrochloride?
A: Generic competition can significantly reduce the price of the drug, as seen with other generic medications where prices have been reduced by up to 97% due to competition[4].
Q: What is the projected drug price inflation rate for 2025?
A: The overall drug price inflation rate for pharmaceuticals in 2025 is projected to be 3.81% according to Vizient's summer Pharmacy Market Outlook[2].
Q: How does the regulatory environment impact drug pricing?
A: The regulatory environment, particularly transparency requirements, can influence pricing strategies. However, the quality of information submitted by manufacturers varies, making it challenging to determine the reasons for high drug prices[4].
Sources
- DailyMed: DICYCLOMINE HYDROCHLORIDE capsule - DailyMed.
- Vizient Inc.: Vizient projects drug price inflation at 3.81%.
- Deloitte Insights: 2025 life sciences outlook.
- Oregon Department of Consumer and Business Services: Prescription Drug Price Transparency Program results and annual report 2023.
- FindACode: Dicyclomine Hydrochloride - drugs/pharmaceuticals with NDC code.
