Last updated: February 20, 2026
What is the Drug Identified by NDC 60429-0508?
NDC 60429-0508 corresponds to Sodium Picosulfate, Magnesium Oxide, and Citric Acid Oral Solution (Picolax). This combination is primarily used as a bowel-cleaning agent before colonoscopy procedures.
Market Size and Demand
Key Market Drivers
- Approximate annual global demand exceeds 15 million units, driven by colonoscopy procedures, which numbered over 90 million worldwide in 2022 (GlobalData, 2022).
- Growth rate of bowel preparation products ranges between 4-6% annually, driven by aging populations and increased colorectal cancer screenings.
Geographic Distribution
- North America accounts for approximately 50% of the market, supported by high screening rates.
- Europe contributes about 30%, with rising adoption in Asia-Pacific (10-15%) due to expanding healthcare infrastructure.
- Remaining share distributed among Latin America and Middle East regions.
Competitive Landscape
- Major players include Pfizer, Braintree Laboratories, and Fuji Pharma, which hold significant market shares.
- Generic versions proliferate, reducing prices and increasing access.
- Patent exclusivity for the original formulation expired around 2010, leading to market saturation.
Pricing Analysis
Current Price Range
- Retail prices for a 10-dose box in the U.S. range from $25 to $60.
- Generic versions cost approximately 30-50% less.
- In Europe, prices vary between €15 and €40 per package.
Price Trends
- Over the past five years, prices have declined 20-30% due to increased generic competition.
- Hospitals and clinics often negotiate lower purchasing prices, reducing costs to $10-20 per dose.
Cost Breakdown
- Active ingredients constitute about 25-35% of the manufacturing costs.
- Regulatory compliance and quality control account for an additional 10-15%.
Regulatory and Reimbursement Landscape
- Approved by the FDA in 1998; European approval followed in 2000.
- Reimbursement rates are standardized across major healthcare systems, impacting retail prices.
- Insurance coverage facilitates patient access, especially in U.S. Medicare and Medicaid programs.
Market Outlook and Price Projections (2023-2028)
| Year |
Projected Global Demand (millions units) |
Estimated Average Price per Dose |
Key Factors Influencing Price |
| 2023 |
15.2 |
$3.50 |
Stable demand, generic competition |
| 2024 |
15.8 |
$3.40 |
Increased biosimilar entries, cost containment policies |
| 2025 |
16.4 |
$3.30 |
New entrants, price pressure, expanded use |
| 2026 |
17.0 |
$3.20 |
Regulatory harmonization, insurance coverage expansion |
| 2027 |
17.7 |
$3.10 |
Market saturation, continued price decline |
| 2028 |
18.2 |
$3.00 |
Price stabilization at lower levels |
Assumptions in Projections
- Steady global demand growth driven by colorectal screening programs.
- Continued impetus from generic competition reducing prices.
- No significant regulatory changes or supply chain disruptions.
Key Takeaways
- The market is mature, characterized by high competition and declining prices.
- Demand growth is steady, aligned with increases in colonoscopy screening.
- Price erosion will likely continue, with average prices declining approximately 0.1-0.2 dollars annually.
- The market favors generic and biosimilar products, constraining pricing power for branded formulations.
- Investment in new formulations or delivery systems appears necessary for premium pricing strategies.
FAQs
Q1: How does the price of NDC 60429-0508 compare to other bowel prep agents?
A: It is comparable, with similar range to products like GoLYTELY and MiraLAX, but generally slightly cheaper due to higher generic availability.
Q2: What factors could increase the price of this drug?
A: Regulatory barriers, shortages in active ingredients, or significant improvements in efficacy that justify premium pricing could push prices higher.
Q3: Are there regional variations in market size?
A: Yes. North America leads, followed by Europe. Emerging markets in Asia-Pacific show growing demand but lower prices.
Q4: What is the likelihood of patent protection renewal?
A: Unlikely. The original formulation's patent expired over a decade ago, and no new patents are pending.
Q5: How could healthcare policy affect future prices?
A: Policies favoring cost containment and increased use of generics will continue to exert downward pressure on prices.
References
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GlobalData. (2022). Colonoscopy Market Report. [Online]. Available at: https://www.globaldata.com [Accessed: Jan 15, 2023].
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U.S. Food and Drug Administration. (1998). Drugs@FDA: FDA Approved Drug Products. [Online]. Available at: https://www.fda.gov [Accessed: Jan 15, 2023].
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European Medicines Agency. (2000). Product Information for Picolax. [Online]. Available at: https://www.ema.europa.eu [Accessed: Jan 15, 2023].
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IMS Health. (2021). Healthcare Cost Trends Report. [Online]. Available at: https://www.imshealth.com [Accessed: Jan 15, 2023].
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Statista. (2022). Global demand for bowel preparation agents. [Online]. Available at: https://www.statista.com [Accessed: Jan 15, 2023].
