Last updated: March 13, 2026
What is the Drug Identified by NDC 00054-0140?
NDC 00054-0140 corresponds to Uloric (febuxostat), a medication used to manage serum uric acid levels in patients with gout. Introduced by Teijin Pharma in collaboration with Takeda Pharmaceuticals, Uloric was approved by the U.S. Food and Drug Administration (FDA) in 2009. It acts as a non-purine selective xanthine oxidase inhibitor, aimed at reducing uric acid production.
Market Overview: Uloric (Febuxostat)
Clinical and Therapeutic Landscape
- Indications: Chronic management of hyperuricemia in gout.
- Market Size: Urolithiasis and gout collectively impact approximately 4% of adults in the U.S. (Cleveland Clinic, 2021).
- Market Penetration: Uloric competes with allopurinol and febuxostat brands, with access primarily through specialty pharmacies and hospitals.
Regulatory Status
- FDA approval granted in 2009.
- Uloric received a boxed warning in 2019 due to reports of increased cardiovascular mortality, influencing prescribing behavior.
Competitive Landscape
| Drug |
Mechanism |
Approval Year |
Annual Sales (2022) |
Market Share (Estimated) |
| Allopurinol |
Xanthine oxidase inhibitor |
1966 |
$350M |
50% |
| Febuxostat (Uloric) |
Xanthine oxidase inhibitor |
2009 |
$250M |
30% |
| Other (Lesinurad) |
URAT1 inhibitor |
2015 |
<$50M |
5% |
Note: Uloric's market share has plateaued, owing to safety concerns and competing therapies.
Price Trends and Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $3,600 for a 30-day supply of 40 mg tablets (GoodRx, 2023).
- Average Manufacturer’s Price (AMP): Estimated at $2,500 per month.
Price History (2016-2023)
| Year |
Price (Monthly, USD) |
Notes |
| 2016 |
~$3,800 |
Post-approval, high initial pricing |
| 2018 |
~$3,600 |
Price stabilization |
| 2020 |
~$3,500 |
Crop of generic competition (not yet launched) |
| 2022 |
~$3,600 |
Stabilized, despite safety warnings |
| 2023 |
~$3,600 |
No significant change observed |
Price Drivers
- Safety warnings: The FDA boxed warning in 2019 had a negative impact on sales prices.
- Competition: The mainstream use of allopurinol, with its generic status, limits the price uplift for Uloric.
- Manufacturing costs: Remain stable; no significant inflation adjustments.
Future Price Projections (2024-2028)
| Year |
Expected Monthly Price (USD) |
Assumptions |
| 2024 |
$3,600 |
No major policy change; safety concerns persist |
| 2025 |
$3,500 |
Slight decline expected from increased competition |
| 2026 |
$3,300 |
Entry of generic febuxostat potentially lowers pricing |
| 2027 |
$3,200 |
Market saturation; further generic competition |
| 2028 |
$3,000 |
Likely stabilization at lower premium, if generics dominate |
Key Factors Influencing Future Pricing
- Regulatory changes: Any new safety data or label updates affecting prescribing.
- Patent status: Patents on Uloric expired or pending expiration can accelerate generic entry.
- Market dynamics: Adoption rates decrease with the advent of biosimilars or new gout therapies.
- Insurance policies: Shifts toward favoring generics may push prices downward.
Potential Market Growth or Contraction
- The gout therapeutic market is projected to grow at a CAGR of around 2% over the next five years, driven by increasing prevalence in aging populations ([2]).
- Uloric’s share may decline as price-sensitive prescribers favor generics.
- Specialty sector penetration could sustain higher prices in niche markets.
Summary of Pricing and Market Dynamics
- Uloric remains a branded, premium option for gout management but faces pricing pressure from generics.
- Its market share is constrained by safety concerns and more cost-effective therapies.
- Price projections suggest modest declines aligning with generic entry timelines and market saturation.
Key Takeaways
- Uloric (febuxostat) maintains a premium pricing structure due to brand recognition but faces declining market share.
- The average monthly price remains steady at about $3,600, with potential reductions to $3,000 by 2028.
- Market growth is limited; pricing is heavily influenced by safety alerts and competition.
- Cost containment policies will likely favor generic alternatives, pressuring branded prices.
Frequently Asked Questions
Q1: What patents are relevant for Uloric, and when do they expire?
A1: The core patent was issued in 2009 and expired in 2021. Additional formulation patents could extend exclusivity until 2024-2025, depending on jurisdiction.
Q2: How does Uloric compare to allopurinol in price and efficacy?
A2: Uloric costs about $3,600/month, whereas generic allopurinol costs under $20/month. Efficacy is comparable; Uloric offers options for patients intolerant to allopurinol.
Q3: Will safety concerns limit Uloric's market share long-term?
A3: Yes. The FDA boxed warning and cardiovascular risk profile will restrict use primarily to patients who do not tolerate or respond to alternatives.
Q4: How likely is generic competition for Uloric?
A4: Very high. Patent expiration occurred in 2021, and generics are available or imminent, pressuring brand pricing.
Q5: What strategies could extend Uloric's market relevance?
A5: Developing combination therapies, expanding indications, or improving safety profiles could sustain demand and pricing.
References
- Cleveland Clinic. (2021). Gout: Epidemiology and impact. Retrieved from https://my.clevelandclinic.org/health/articles/22063-gout
- IQVIA. (2023). US prescription drug market data.
- GoodRx. (2023). Uloric prices. Retrieved from https://www.goodrx.com/uloric
- FDA. (2019). Uloric boxed warning update. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-brief-febuxostat-gout-drugs-increased-risk-cardiovascular-mortality
