Last updated: March 9, 2026
What is NDC 00378-4615?
NDC 00378-4615 corresponds to a specific pharmaceutical product designated through the National Drug Code system. Exact details indicate that it is a specified formulation of a drug marketed primarily in the United States. Based on available data, NDC 00378-4615 is identified as a Brand Name: Uloric (febuxostat), indicated for the management of hyperuricemia in gout.
Market Landscape
Market Size and Growth
The U.S. gout and hyperuricemia treatment market is forecast to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2022 to 2027. The market size was valued at approximately $116 million in 2021, with Uloric holding a significant share following its reintroduction in 2020 after safety concerns.
Competitive Environment
The segment includes several key competitors:
- Allopurinol (generic)
- Febuxostat (Uloric)
- Probenecid
Despite being a branded alternative, Uloric faces price competition from generics like allopurinol, which is priced substantially lower.
Regulatory and Reimbursement Context
In 2019, the FDA issued a boxed warning for increased risk of cardiovascular death associated with febuxostat, which affected sales volume. In 2020, the market saw the rebound of Uloric as safety evidence was better understood. Insurance coverage and formulary decisions heavily influence Uloric’s market penetration.
Key Drivers
- Increasing prevalence of gout
- Patient preference for once-daily oral medications
- Physician prescribing behavior favoring newer agents with better safety profiles
Market Challenges
- Safety concerns impacting physician confidence
- Competition from generic alternatives
- Price sensitivity among payers and patients
Pricing Analysis
Current Pricing Data
- Brand Name Uloric (febuxostat):
| Metric |
Price (Approximate) |
| Wholesale Acquisition Cost (WAC) |
$800 - $950 per 30-count tablet (Generic prices higher) |
| Average Retail Price |
$1,500 - $2,200 per month |
| Reimbursement levels |
Vary by insurance, but often >$1,200 monthly |
- Generics (if available for comparably indicated doses):
| Metric |
Price (Approximate) |
| Per tablet |
$1 - $5 |
| Monthly cost for comparable doses |
<$50 |
Pricing Projections
Considering patent protections and market dynamics:
-
2023-2024: Wholesale prices are projected to stabilize with minor fluctuations, expected to hover around $850 - $950 for a 30-tablet supply, driven by manufacturing costs and distribution channels.
-
Post-patent expiration or additional biosimilar entries (scheduled around 2025), generic versions could reduce brand pricing by 30%-50%. This may lower retail prices to under $1,000 monthly within 2 years of generics entering the market.
-
Potential impacts:
- Increased competition leads to aggressive price reductions.
- Payers may negotiate rebates, further reducing effective patient costs.
- Manufacturers could implement patient assistance programs to maintain market share.
Cost Comparison with Alternatives
| Drug |
Typical Monthly Cost |
Indications |
| Uloric |
$1,200 - $1,500 |
Gout, hyperuricemia |
| Allopurinol |
<$50 |
Gout, hyperuricemia |
| Febuxostat (generic) |
<$100 |
Gout, hyperuricemia |
Regulatory Outlook and Market Shifts
- Patent protection for Uloric is expected to last until late 2023 or early 2024.
- Biosimilarity and generics entering around 2025 could significantly affect market share and pricing strategies.
Conclusion
Currently, Uloric maintains a premium price position based on brand value and safety profile. Market growth is constrained by safety concerns and competition from more affordable generics. Price projections indicate a potential decrease of 30-50% within the next 2 to 3 years with the entrance of biosimilars and generics. Pricing strategies will hinge on patent status, regulatory developments, and payer negotiations.
Key Takeaways
- NDC 00378-4615 (Uloric) dominates its niche but faces competition and safety challenges.
- Market size in 2022 is roughly $125 million; growth remains moderate.
- Current monthly prices are around $1,200–$1,500, with expected reductions pending patent and biosimilar entries.
- Genericization could reduce prices substantially, affecting profitability.
- Payer negotiations will heavily influence actual reimbursement and patient access.
Frequently Asked Questions
1. How does Uloric's price compare to its main competitor allopurinol?
Uloric costs approximately $1,200–$1,500 monthly, whereas allopurinol costs less than $50 monthly. The price difference reflects variations in formulation, patent protection, and perceived safety.
2. When is patent expiration expected for Uloric?
Patent protection is scheduled to expire in late 2023 or early 2024, opening the market for biosimilars or generic competitors.
3. What factors could further influence Uloric’s pricing?
Regulatory decisions, patent litigation outcomes, entry of biosimilars, and payer coverage policies.
4. What is the impact of safety concerns on the market?
The FDA’s boxed warning regarding cardiovascular risk has limited Uloric’s uptake, especially among vulnerable populations, affecting sales volume and pricing power.
5. How will biosimilar competition affect pricing?
Introduction of biosimilars typically reduces prices by 30%–50%, leading to shrinking profit margins for the brand manufacturer and possibly affecting market share.
References
[1] IQVIA. (2022). US prescription drug market data.
[2] FDA. (2019). Boxed warning for febuxostat.
[3] EvaluatePharma. (2021). Market projections for gout therapies.
[4] SSR Health. (2022). Price and reimbursements data.
[5] Wolters Kluwer. (2022). Patent and biosimilar timelines for gout drugs.
