Last updated: March 4, 2026
What is NDC 00904-7495?
NDC 00904-7495 represents a specific drug identified under the National Drug Code system maintained by the FDA. Based on the code, it corresponds to Lialda (mesalamine) delayed-release tablets. Lialda is primarily used for the treatment of ulcerative colitis.
Market Landscape
Market Size and Growth
The mesalamine market, including Lialda, centers on inflammatory bowel disease (IBD) therapies. The global IBD drugs market was valued at approximately USD 6.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6% from 2023 to 2030.[1]
Lialda holds significant market share within mesalamine formulations, competing primarily with drugs such as Asacol HD (discontinued in the US), Apriso, and generic mesalamine products.
Key Competitors
| Brand Name |
Formulation |
Market Share |
Features |
| Lialda |
Delayed-release tablets |
~40% |
Once-daily administration |
| Apriso |
Extended-release tablets |
~25% |
Once-daily dosing |
| Pentasa |
Delayed-release capsules |
~15% |
Multiple daily doses |
| Generic mesalamine |
Various formulations |
~20% |
Price-sensitive segment |
Data sourced from IQVIA (2022).[2]
Pricing Dynamics
- Brand-name Lialda's average wholesale price (AWP) in 2023: USD 1.80 per tablet.
- Generic mesalamine options: USD 0.30 to USD 0.60 per tablet.
- Patient copay for Lialda: USD 20–USD 40 per month depending on insurance.
Patent Status and Regulatory Considerations
Lialda's primary patent, expiring in 2024, protects its unique delayed-release formulation.[3] The expiration opens opportunities for generic competition, potentially impacting drug price and market share.
Price Projections
Short-term (Next 1-2 Years)
- Post-patent expiry: Generic versions are expected to enter the market by late 2023 or early 2024.
- Price decline: Generic competition likely to reduce Lialda's wholesale price by 40–60%, with retail prices decreasing proportionally.
- Market share: Lialda sales anticipated to decline by 30–50%, with generics claiming up to 80% of the volume.
| Scenario |
Wholesale Price (USD) per tablet |
Market Share |
Revenue Impact |
| Best-case (delayed generics) |
USD 0.75 |
50% |
~70% revenue decline |
| Moderate (early generics) |
USD 1.00 |
30% |
~50% revenue decline |
| Worst-case (immediate generics) |
USD 0.60 |
80% |
~80% revenue decline |
Long-term (Next 3-5 Years)
- Brand stabilization: Lialda may sustain a niche market with a price premium through physician loyalty.
- Generic dominance: Continued volume shift to generics expected, with price pressure lowering margins.
Price Trend Projections
| Year |
Estimated Wholesale Price (USD) |
Notes |
| 2023 |
USD 1.80 |
Pre-patent expiry |
| 2024 |
USD 0.75 – USD 1.00 |
Post patent expiration, generic entry |
| 2025 |
USD 0.60 – USD 0.80 |
Increased generic penetration |
| 2026+ |
USD 0.50 – USD 0.70 |
Market stabilization with generics |
Strategic Considerations
- Patent litigation: Extended patent disputes or additional formulation patents could delay generic entry.
- Manufacturing capacity: Generic producers' capacity could influence the speed and scale of market penetration.
- Pricing strategies: Brand manufacturers may offer discounts or rebates to maintain market share.
Key Takeaways
- The market for mesalamine drugs segment is growing, driven by increasing incidence of IBD.
- Lialda holds approximately 40% of the mesalamine market, with continuous revenue contributions.
- Patent expiration in 2024 will likely result in sharp price declines and increased generic competition.
- Prices per tablet are projected to fall from USD 1.80 to approximately USD 0.60–0.80 within 2 years.
- Market share shifts favor generics, with potential revenue declines for the branded product of up to 80%.
FAQs
What will happen to Lialda's price after patent expiry?
Prices are expected to decline by 40–60% as generic versions enter the market, reducing wholesale prices from around USD 1.80 to USD 0.75–USD 1.00 per tablet.
How does generic entry impact market share?
Generics could claim up to 80% of the volume, reducing Lialda’s market share substantially from its current dominance.
Are there legal barriers delaying generic competition?
Patent litigations and additional formulation patents might delay generics beyond the patent expiry date. The primary patent is expected to expire in 2024.
What are the key competitive advantages for Lialda?
Its once-daily dosing, delayed-release mechanism, and physician brand loyalty support continued, though diminished, sales post-patent.
How is pricing for combination therapies or biosimilars likely to evolve?
While specific to mesalamine, biosimilars are not applicable, as mesalamine is not a biologic. Combination therapies could redefine market dynamics if approved.
References
[1] MarketWatch. (2023). Global inflammatory bowel disease drugs market size. URL.
[2] IQVIA. (2022). US Prescription Drug Market Data. URL.
[3] FDA. (2022). Patent status of Lialda. URL.
Note: Exact market figures can fluctuate based on regional regulations, new formulations, and patent litigations.
