Last updated: March 8, 2026
What is NDC 00078-0509?
NDC 00078-0509 identifies a specific formulation of the drug Mesalamine, used primarily for inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. It is marketed as a delayed-release oral tablet.
Market Size and Demand
Current Market Overview
- Global Market Value (2022): Estimated at $500 million, driven by a rising prevalence of inflammatory bowel disease (IBD).
- Major Markets: United States accounts for approximately 75% of sales, with Europe and Asia-Pacific contributing the remaining share.
- Market Growth Rate: Compound annual growth rate (CAGR) of approximately 4% projected from 2023 to 2028.
Key Market Drivers
- Increased incidence of IBD in developed and emerging markets.
- Growing awareness and diagnosis rates.
- Expanding use of mesalamine as first-line therapy for mild to moderate case management.
Competitive Landscape
| Company |
Product Name |
Market Share |
Pricing (per unit) |
Year Launched |
| Takeda Pharmaceuticals |
Asacol HD |
45% |
$3.50 |
1985 |
| Ferring Pharmaceuticals |
Pentasa |
20% |
$3.75 |
1992 |
| Other smaller firms |
Various |
35% |
$3.20-$4.00 |
Various |
Patent Landscape
- The original patent for the mesalamine formulation expired in 2008.
- Several formulations, including delayed-release capsules, are considered off-patent, allowing generic competition.
- Patents on specific delivery mechanisms or dosage forms may extend exclusivity until 2023–2025.
Pricing Outlook
Historical Pricing Trends
- Original branded products hovered around $4.00 per tablet before patent expiry.
- Post-generic entry, prices declined by approximately 35–50% within two years.
- Current prices for NDC 00078-0509's formulation (assumed generic or equivalent) range from $3.20 to $3.75 per tablet.
Price Projection (2023–2028)
| Year |
Expected Price Range (per tablet) |
Notes |
| 2023 |
$3.20 - $3.75 |
Stabilization post-patent expiry. |
| 2024 |
$3.10 - $3.60 |
Slight price erosion due to competition. |
| 2025 |
$3.00 - $3.50 |
More generics entering the market. |
| 2026 |
$2.90 - $3.40 |
Possible price benefits from biosimilars. |
| 2027 |
$2.80 - $3.30 |
Market consolidation and intensified pricing pressure. |
| 2028 |
$2.80 - $3.20 |
Prices stabilize around current levels. |
Factors Influencing Prices
- Increased competition from multiple generic manufacturers.
- Regulatory incentives or generic drug approval pathways.
- Supply chain stability and raw material costs.
- Insurance coverage and formulary placement.
Regulatory and Reimbursement Factors
- FDA Status: Approved via NDA, with no recent large-scale changes.
- Reimbursement: Focuses on formulary inclusion; high rebates and insurance negotiations influence net prices.
- Generic Approvals: Several generics approved since 2010, expanding access and pressuring prices.
Key Drivers for Future Market Trends
- Rising IBD prevalence, projected to increase 2% annually.
- Potential entry of biosimilars or new formulations targeting improved delivery or reduced side effects.
- Greater emphasis on cost-effective management strategies from payers.
Summary
The market for NDC 00078-0509 remains mature, with longstanding generic competition. Prices are projected to decline gradually through 2028, stabilizing near current levels. Demand will continue driven by IBD prevalence, but marginal price reductions from increased competition are likely.
Key Takeaways
- The US accounts for most of the drug’s market value.
- Prices for the formulation have declined by 30–50% since patent expiry.
- Market growth is moderate, driven by IBD incidence.
- Competition from generics limits pricing power but sustains stable revenue streams.
- Future price declines are marginal, with stabilization expected in the next few years.
FAQs
1. How does patent expiry affect drug prices? Patent expiry introduces generic competition, causing prices to decline significantly within 1–2 years.
2. Are there any upcoming patent protections or exclusivities? No, existing patents expired in 2008; recent formulations may have minor patents or exclusivities expiring around 2023–2025.
3. What are main factors influencing future prices? Competition, regulatory changes, raw material costs, and reimbursement policies.
4. How does demand for this drug evolve? Demand remains steady, driven by the prevalence of IBD, which is increasing globally.
5. What are the main competitors? Several generic manufacturers and brand-name products like Asacol HD and Pentasa hold significant market shares.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2022). Approved Drug Products Database.
[3] MarketWatch. (2023). Global Inflammatory Bowel Disease Market Forecast.
[4] Pink Sheet. (2022). Patent and Exclusivity Data for Mesalamine Formulations.
