Last updated: February 17, 2026
Overview
NDC 00054-0742 is a medication marketed as a mesalamine (5-aminosalicylic acid) formulation. It is used primarily for ulcerative colitis and Crohn’s disease management. The product is a delayed-release formulation administered orally. This generic product competes in a market with established branded therapies such as Asacol HD and Lialda, alongside generic formulations.
Market Size and Demand
The inflammatory bowel disease (IBD) market remains steady, driven by increased diagnosis rates and expanded patient populations. The global IBD market was valued at approximately $4.5 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of around 5% through 2027 [1].
Specifically, the U.S. accounts for roughly 60% of the market share, with over 1 million diagnosed IBD patients. Medicare and private insurers cover much of the medication costs, influencing retail and wholesale pricing.
Competitive Landscape
Major competitors include:
-
Brand-name drugs:
- Asacol HD (Allergan), priced approximately $2,700/month (retail) for branded formulations.
- Lialda (Sun Pharma), around $2,900/month retail.
-
Generic formulations:
- The primary market driver for NDC 00054-0742.
- Wholesale acquisition cost (WAC) typically ranges from $250 to $350 per month for generic mesalamine.
The generic market has expanded following patent expirations, increasing price competition and decreasing margins for brand manufacturers.
Pricing Dynamics and Projections
Current price point for NDC 00054-0742 is estimated at approximately $250–$300 per month at wholesale levels. Retail prices can range from $300 to $400, depending on pharmacy and insurance negotiations.
Price Trends
- Generic mesalamine products have seen prices decline by approximately 15% annually over the past three years due to increased competition.
- Anticipate stabilization or slight decline in prices over the next 2–3 years as more generics enter the market and biosimilar options remain limited for mesalamine.
Regulatory and Market Access Factors
- Insurance formularies favor generic versions; achieving formulary inclusion is critical.
- The expiration of certain patent protections in recent years has increased generic market share, exerting downward pressure on prices.
- Customized pricing strategies, including patient assistance and rebates, influence net pricing.
Future Impact Factors
- Potential entry of biosimilars for IBD drugs could reduce overall market revenue for mesalamine products.
- Regulatory changes favoring biosimilar adoption and reimbursement policies will also influence pricing.
| Summary of Price Projections |
Year |
Expected Average Wholesale Price (AWP) |
Notes |
| 2023 |
$250–$300 |
Current market conditions; competition remains high |
| 2024 |
$240–$290 |
Slight downward trend expected due to increased generic competition |
| 2025 |
$230–$280 |
Entry of additional generics could further stabilize or slightly lower prices |
| 2026 |
$230–$270 |
Market equilibrium with moderate price pressure |
Conclusion
NDC 00054-0742 operates within a highly competitive, price-sensitive segment of the IBD treatment landscape. Continued generic proliferation is poised to suppress market prices further. Strategic positioning focusing on formulary access and cost management will be essential for sustained revenue.
Key Takeaways
- The product faces intense generic competition, limiting profit margins.
- Prices have declined steadily, with an average wholesale price around $250–$300 per month.
- Market growth remains steady due to rising IBD prevalence but is moderated by competitive pricing pressures.
- Future price levels are expected to remain stable or decline marginally, influenced by new generic entrants and regulatory dynamics.
- Market access strategies, including formulary negotiations and patient assistance, will significantly impact net revenue.
FAQs
1. What factors most affect pricing for NDC 00054-0742?
Market competition, insurance formulary status, regulatory changes, and patient access programs are the primary influences.
2. How does the market size influence pricing projections?
A larger patient base and higher prescription volume can support slightly higher prices, but competitive pressures tend to limit growth in margins.
3. Are biosimilars impacting mesalamine prices?
Biosimilars primarily target biologic therapies; they have limited impact on mesalamine, which is a small-molecule drug. However, biosimilar adoption for other IBD therapies could indirectly influence market dynamics.
4. What is the outlook for generic mesalamine prices in the next five years?
Prices are expected to decline gradually due to increased generic availability and market saturation.
5. How critical are formulary inclusions for market success?
Highly critical. Favorable formulary placement directly increases prescription volume and revenue, especially in managed care settings.
Sources
[1] IQVIA, "Global and US Inflammatory Bowel Disease Market Analysis," 2022.
