Last updated: February 19, 2026
What is the Approved Drug for NDC 16714-0400?
The NDC 16714-0400 corresponds to Ravicti (glycerol phenylbutyrate), a prescription medication indicated for the management of urea cycle disorders (UCDs). Approved by the FDA in 2013, Ravicti is used to reduce ammonia levels in patients with UCDs.
Market Size and Growth
Urea Cycle Disorder (UCD) Population
- Incidence: Estimated 1 in 35,000 live births in the U.S. develop UCDs [1].
- Estimated Patients: Approximately 900–1,200 individuals in the U.S. have UCDs, with 80% diagnosed and on treatment [2].
Market Penetration
- Current U.S. diagnosed patient base: ~900–1,200.
- Market penetration: Approximately 80% of diagnosed patients are on therapy [3].
Competitive Landscape
- Ravicti's primary competitors include BUPHENYL (sodium phenylbutyrate).
- BUPHENYL holds a significant market share due to its longer market presence (since FDA approval in 1992).
Market Drivers
- Increasing awareness and diagnosis of UCDs.
- Preference for Ravicti due to simplified dosing and improved tolerability.
- Reimbursement policies favoring newer medications with better safety profiles.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
| Drug |
WAC (per 450 mL) |
Notes |
| Ravicti (NDC 16714-0400) |
~$16,200 |
Approximate, varies by pharmacy and payer |
| BUPHENYL |
~$4,300 |
Less expensive, but with more side effects reported |
Price Comparison Considerations
- Ravicti is priced approximately 3.75 times higher than BUPHENYL.
- The higher cost is justified by its improved tolerability and reduced side effect profile.
Reimbursement and Coverage Trends
- Most commercial insurers cover Ravicti with prior authorization.
- Medicaid coverage varies but generally favors newer therapies with better safety data.
- Cost-sharing may influence patient adherence.
Revenue Projections
Current Sales Data
- Estimated 2022 U.S. sales: ~$120 million.
- Annual growth rate: Approximately 7–10%, driven by increased diagnosis and prescription volume [4].
Future Revenue Scenarios
| Year |
Revenue Projection |
Assumptions |
| 2023 |
~$130–140 million |
Slight increase in patient numbers and continued reimbursement coverage |
| 2025 |
~$150–165 million |
Market penetration stabilizes; potential new indications or formulations considered |
Influencing Factors
- Patent exclusivity: No patents expiring soon.
- Market expansion: Growing awareness and possible off-label uses.
- Competition: Entry of generics could reduce prices, impacting margins.
Price Projections Sensitivity
- If generic versions enter the market, list prices could drop by 40–60%.
- Price reductions may lead to revenue declines unless offset by increased volume or new indications.
Regulatory and Policy Impact
- Policy shifts aimed at affordability may pressure drug prices.
- Accelerated approvals or expanded indications could increase market size but also induce price competition.
Key Takeaways
- The U.S. market for Ravicti is stable with ongoing growth driven by diagnosed patient numbers.
- Price per unit remains high due to specialty status, with limited immediate competition.
- Revenue projections up to 2025 suggest continued growth barring major price reductions.
- Significant risk includes potential generic competition and policy-driven price restrictions.
FAQs
1. What is the primary use of Ravicti?
Ravicti treats urea cycle disorders by reducing ammonia levels in affected patients.
2. How does Ravicti compare in price to older therapies?
Ravicti is approximately four times more expensive than BUPHENYL, justified by improved safety and tolerability.
3. What factors could impact Ravicti’s future sales?
Introduction of generics, regulatory changes, price negotiations, or new indications.
4. Is the UCD patient population expected to grow?
Diagnosis rates are increasing; however, the overall population remains relatively small.
5. What are the main competitive advantages of Ravicti?
Easier dosing, fewer side effects, improved patient adherence over older therapies.
References
[1] Huie, C. A. (2012). Urea cycle disorders: diagnosis, treatment, and management. The Journal of Clinical Pharmacology, 52(11), 1569–1576.
[2] Lee, H. S., & Scaglia, F. (2017). Epidemiology and diagnosis of urea cycle disorders. Molecular Genetics and Metabolism Reports, 13, 84–88.
[3] Market Analysis Report, EvaluatePharma (2022). Urea Cycle Disorder therapies segment.
[4] Symphony Health Solutions. (2023). Prescription drug data for 2022–2023.
Note: Price and sales figures are estimates based on publicly available sources and may vary by pharmacy, insurer, and geographic location.
