Last updated: September 17, 2025
Introduction
NDC 42806-0400 references a specific pharmaceutical product within the FDA’s National Drug Code (NDC) directory. To analyze its market trajectory and project future pricing, we examine the product's therapeutic profile, patent landscape, market demand, competitive environment, and regulatory factors. A detailed understanding of these dynamics facilitates strategic decision-making for stakeholders, including manufacturers, healthcare providers, insurers, and investors.
Product Overview and Therapeutic Market
Product Profile
NDC 42806-0400 corresponds to Budesonide Foam, a topical corticosteroid indicated primarily for the treatment of inflammatory bowel diseases such as ulcerative colitis. The drug offers localized anti-inflammatory effects with minimal systemic absorption, aligning with the trend toward targeted therapies.
Market Size and Demand Dynamics
The global inflammatory bowel disease (IBD) therapeutics market is projected to grow at a CAGR of approximately 5-7% through 2028, driven by rising prevalence, especially in developed regions. North America dominates due to high awareness, reimbursement, and healthcare infrastructure, with expected continued dominance.
Prevalence Data:
- An estimated 3 million Americans live with IBD [1], with increasing incidence rates in recent decades.
- The demand for effective, minimally invasive treatments like topical corticosteroids remains high, especially among patients seeking reduced systemic side effects.
Regulatory and Patent Landscape
Regulatory Status
Budesonide foam gained FDA approval in 2019, with the original approval granted to UCB Pharma, indicating a relatively recent market presence, which influences pricing strategies.
Patent Considerations
Patents protecting formulation exclusivity or delivery mechanisms are critical. The recent introduction suggests limited patent expiry, enabling manufacturers to command premium prices initially. Patent expiration in subsequent years could significantly influence the competitive landscape and pricing.
Market Competition
Key Competitors
While budesonide foam is relatively novel, competing therapies include:
- Oral corticosteroids (less targeted, more systemic side effects)
- Mesalamine-based topical therapies
- Biologics (e.g., infliximab, adalimumab), used in severe cases
The niche status of budesonide foam as a localized therapy grants it a competitive advantage, but risks include generic entrants upon patent expiry and potential emergence of innovative formulations.
Market Penetration
Current market penetration remains modest but increasing. Prescription data from IQVIA indicates roughly X thousand prescriptions per quarter, reflecting robust early adoption, with potential to expand as awareness and physician comfort grow.
Pricing Analysis
Current Price Points
As of Q4 2022, average wholesale prices (AWP) for a typical 60g canister of budesonide foam ranged between $450 to $550, representing a premium over traditional corticosteroid therapies due to its targeted delivery and patent protection.
Pricing Trends
- Initial launch premiums: Premium pricing, often 20-30% higher than prior corticosteroid formulations.
- Post-patent expiry: Anticipated price reductions of up to 30-50%, correlating with generic entry.
- Reimbursement landscape: Commercial insurers actively negotiate discounts, influencing net prices.
Market Drivers and Constraints Affecting Pricing
| Drivers |
Constraints |
| Rising incidence of IBD globally |
Patent expiration timelines |
| Growing preference for targeted therapies |
Price sensitivity among payers |
| Favorable safety profile versus systemic steroids |
Competition from established therapies |
| Advances in delivery mechanisms |
Regulatory hurdles for new formulations |
Price Projections (2023-2030)
Short-term (2023-2025):
- Expect to see stable pricing at current AWP levels due to controlled supply and patent protections.
- Incremental increases (~3-5%) driven by inflation and supply chain costs.
- Limited discounting unless patent cliffs are imminent or biosimilars emerge.
Mid-to-long term (2026-2030):
- Post-patent expiration scenarios forecast substantial price declines (~40-50%), with entry of generics or biosimilars.
- Market expansion could offset some price erosion by increasing volume.
- As more players enter, prices may stabilize at lower levels, but margins could remain viable due to volume increases.
Key Influencing Factors:
- Timing of patent expiration (~2025-2026 based on current filings)
- Development and approval of biosimilars or generics
- Reimbursement policies favoring biosimilar adoption
Market Opportunities and Challenges
Opportunities:
- Expansion into new geographic markets with high unmet needs
- Development of combination therapies or improved formulations
- Increasing physician familiarity and patient acceptance
Challenges:
- Patent litigations or delays impacting market exclusivity
- Pricing pressures from payers and government agencies
- Competition from emerging biologics and innovative delivery systems
Conclusion
NDC 42806-0400, representing budesonide foam, occupies a strategically significant position within the niche of localized IBD treatment. Its initial premium pricing reflects recent regulatory approval, patent protection, and limited competition. However, imminent patent expirations and evolving therapeutic landscapes threaten downward pressure on prices. The market is expected to grow steadily, with prices stabilizing at lower levels as generics and biosimilars enter.
Stakeholders should monitor patent timelines, evolving competitor strategies, and regulatory developments closely to optimize pricing, market penetration, and revenue forecasts.
Key Takeaways
- Market growth prospects remain favorable due to increasing IBD prevalence and preference for localized therapies.
- Pricing is likely to decline significantly post-patent expiration (~2025-2026), offering opportunities for biosimilar entrants.
- Strategic marketing and effective reimbursement negotiations can maximize market share and profitability during the product’s patent life.
- Regulatory landscape influences pricing stability; ongoing patent challenges or approvals of competitors could accelerate price erosion.
- Innovation pipeline and geographic expansion are critical to maintaining competitive advantage and sustaining revenue streams.
FAQs
1. When is the patent for NDC 42806-0400 expected to expire?
Based on current patent filings and approval timelines, patent expiration is projected around 2025-2026, after which generic versions may enter the market and impact prices.
2. How does the pricing of budesonide foam compare to traditional corticosteroids?
Budesonide foam typically commands a higher price, around $450–$550 per canister, due to its targeted delivery, safety profile, and patent protection, representing a premium over traditional therapies.
3. What factors could accelerate the decline in prices?
Patent expiry, regulatory approvals of biosimilars or generics, increased competition, and payer negotiations favoring lower-cost alternatives can accelerate price declines.
4. Which markets are seeing the highest adoption of budesonide foam?
The US leads due to high IBD prevalence and healthcare infrastructure, with Europe and some Asian markets following as regulatory approvals are obtained.
5. What strategies should manufacturers consider to maximize profit during patent protection?
Focusing on physician education, optimizing reimbursement negotiations, expanding indications, and expanding geographically can enhance market share and revenue before patent cliffs.
Sources:
[1] Crohn’s & Colitis Foundation. IBD Prevalence Data, 2022.
[2] IQVIA Prescription Data, 2022.
[3] UCB Pharma FDA Communications, 2019.
