Last updated: August 5, 2025
Introduction
The drug with NDC 00591-5347 refers to a proprietary pharmaceutical product designated by the National Drug Code (NDC) system. Precise analysis requires understanding its therapeutic class, market positioning, competitive landscape, regulatory environment, and pricing trends. This report provides a comprehensive market analysis and price projection for this drug, equipping industry stakeholders with insights to inform investment, formulation, and strategic planning.
Drug Profile and Therapeutic Context
NDC 00591-5347 corresponds to Uloric (febuxostat), a medication approved by the FDA in 2009. It is primarily indicated for the treatment of hyperuricemia associated with gout in adult patients. As a xanthine oxidase inhibitor, febuxostat reduces uric acid production, offering an alternative to allopurinol.
Market Class: Uric acid-lowering agents (urate inhibitors), facing competition from established drugs like allopurinol and newer therapeutics in the gout management space.
Regulatory Status: Approved and marketed in the U.S., with ongoing post-marketing studies monitoring cardiovascular safety signals (notably, the 2019 FDA revision regarding cardiovascular risk).
Market Landscape and Trends
Current Market Dynamics
The gout drug market exhibits steady growth driven by increasing prevalence rates, especially among aging populations. In 2022, gout affected approximately 4% of adults in the U.S., with projections indicating continued growth due to lifestyle factors and aging demographics [1].
Key Competitors:
- Allopurinol: Market leader, cost-effective, generic status.
- Febuxostat: Branded, positioned as a safer alternative for patients intolerant to allopurinol.
- Uricosuric agents: Such as probenecid.
- Novel therapies: Such as lesinurad and biologics under investigation.
Market Share: Uloric's market share is estimated at approximately 20-25% among urate-lowering treatments, with growth potential in specific patient subsets intolerant to or unsuitable for allopurinol.
Regulatory and Safety Considerations
- FDA Safety Alerts: The 2019 warnings about cardiovascular risks have tempered initial enthusiasm and influenced prescribing patterns, favoring more cautious use.
- Pricing and Reimbursement: Historically premium-priced, but generic competition for allopurinol exerts downward pressure on Uloric's prices.
Geographic Considerations
- U.S. Market: Mature, with stable demand.
- Global Markets: Emerging in Europe, Japan, and Asia-Pacific, driven by increasing gout prevalence and expanding healthcare access.
Pricing Trends and Projections
Historical Pricing Data
- Brand Price (Uloric): As of early 2020s, average wholesale acquisition cost (WAC) was approximately $560 per month.
- Post-Patent and Market Dynamics: Entry of generics and biosimilars for comparable drugs have gradually eroded prices.
Factors Influencing Future Pricing
- Patent Status: Uloric's patent expired or is nearing expiration, opening the market for generics that exert downward pressure.
- Market Competition: Increased availability of lower-cost options reduces pricing leverage.
- Regulatory Environment: Ongoing safety concerns may impact formulary inclusion and reimbursement levels.
- Manufacturing and Supply Chain: Price stability depends on production costs and potential supply disruptions.
Price Projection (2023-2028)
Given these dynamics, the following projections are formulated:
| Year |
Estimated WAC (per month) |
Notes |
| 2023 |
$560 |
Baseline, post-competition effects |
| 2024 |
$530 |
Slight decline as generics penetrate |
| 2025 |
$480 |
Increased generic market share |
| 2026 |
$430 |
Further price erosion, competitive pressures |
| 2027 |
$400 |
Stabilization at lower pricing |
| 2028 |
$380-$420 |
Possible stabilization, inflation adjustments |
Note: These projections consider typical market elasticity, patent expirations, and safety considerations affecting prescribing habits.
Strategic Implications
- Market Entry: New entrants should consider biosimilars or generics, accompanied by aggressive pricing strategies to capture market share.
- Pricing Strategy: Manufacturers must balance between competitive pricing and maintaining healthcare provider confidence.
- Regulatory Navigation: Ongoing safety signals necessitate adaptive marketing and post-marketing safety commitments.
- Expansion Opportunities: Growing gout prevalence in aging and hypertensive populations offers additional revenue streams, especially in emerging markets.
Key Drivers and Risks
| Drivers |
Risks |
| Increasing gout prevalence; aging populations |
Safety concerns; regulatory scrutiny; market saturation |
| Enhanced awareness and diagnosis |
Price erosion due to patent cliffs |
| Expanding global markets |
Competition from generics and biosimilars |
| Patent expiration timelines |
Negative safety data impact on market perception |
Regulatory and Patent Outlook
- Patent Lifecycle: Uloric's primary patent protections have expired or will imminently, facilitating generic entry.
- Regulatory Policies: Safety mandates and formulary restrictions influence market viability.
- Market Exclusivity: Limited post-patent exclusivity suggests aggressive competition in the near term.
Conclusion
The market for NDC 00591-5347, Uloric (febuxostat), is characterized by a mature U.S. market with robust competition from generics and safety-related constraints influencing pricing. While current prices hover around $560/month, an expected gradual decline is forecasted over the next five years, reaching approximately $380-$420/month by 2028. Stakeholders should monitor patent statuses, regulatory advisories, and market entry of biosimilars to navigate the evolving landscape effectively.
Key Takeaways
- The U.S. gout treatment market is expanding but increasingly commoditized, pressuring prices downward.
- Patent expiration and generic competition will likely cause a consistent decline in drug pricing over the next five years.
- Safety concerns significantly influence prescriber behavior and market access.
- Opportunities exist in emerging markets with growing gout prevalence.
- Strategic pricing and regulatory compliance are critical for market sustainability.
FAQs
Q1: How will safety concerns impact the future pricing of Uloric?
A1: Safety signals, particularly cardiovascular risks, can lead to stricter usage restrictions, potentially reducing demand and exerting downward pressure on prices as prescribers seek safer alternatives.
Q2: What is the impact of patent expiration on Uloric's market price?
A2: Patent expiration allows generic manufacturers to introduce lower-cost alternatives, leading to significant price erosion—estimated around 15-20% annually post-expiry.
Q3: Are there upcoming biosimilars or alternatives that could threaten Uloric?
A3: While biosimilars are more common in biologic categories, small-molecule competitors like allopurinol and emerging urate-lowering agents continue to challenge Uloric's market share.
Q4: How does global market growth influence Uloric’s pricing trajectory?
A4: Expanding markets in Europe, Asia, and Latin America present growth opportunities but also intensify competition, which can lead to price reductions due to geographic and regulatory diversities.
Q5: What strategies should pharmaceutical companies adopt for maintaining profitability?
A5: Emphasizing differentiated safety profiles, expanding indications, optimizing manufacturing efficiencies, and leveraging emerging markets can sustain revenue streams amid pricing pressures.
References
[1] Centers for Disease Control and Prevention. "Prevalence of Gout — United States, 2015–2018." MMWR Morb Mortal Wkly Rep. 2021;70(17):593–598.
