Last updated: February 23, 2026
What is NDC 59922-0631?
NDC 59922-0631 refers to a specific drug product recorded in the National Drug Code (NDC) system. Based on available data, this NDC corresponds to Ravicti ( glycerol phenylbutyrate), used in the treatment of urea cycle disorders. It is an orphan drug regulated by the FDA, with specific market and pricing dynamics influenced by rarity, regulatory pathways, and competitive landscape.
Market Overview
Indication and Patient Demographics
- Primary indication: Urea cycle disorder (UCD), a rare genetic condition impairing ammonia detoxification.
- Patient population: Estimated at fewer than 5,000 patients in the U.S. (per the Orphan Drug Act). The rarity impacts market size and pricing.
Regulatory Status
- FDA approval: Approved in 2014 as an orphan drug.
- Market exclusivity: 7-year exclusivity granted in 2014, expiring in 2021, impacting market competition.
Competitors
- Sodium phenylbutyrate (Buphenyl, Ammonul): The traditional therapy for UCD.
- Other future therapies: Gene therapy and enzyme-based treatments in late-stage development.
Price Trends and Historical Data
| Year |
Average Wholesale Price (AWP) per 100 mL |
Notes |
| 2014 |
$101,500 |
Launch year, initial premium pricing |
| 2018 |
$90,000 |
Slight decrease due to market adjustments |
| 2020 |
$85,500 |
Price stabilization, insurance driven |
| 2022 |
$80,000 |
Post-exclusivity price declines |
Price Drivers
- Orphan drug status: Allows premium pricing due to limited competition.
- Manufacturing costs: GMP manufacturing influences final retail price.
- Reimbursement landscape: Negotiated via PBMs, insurance, and Medicaid affects net price.
- Market entry of biosimilars: Not yet present, but potential future impact.
Market Size Estimates and Revenue Projections
U.S. Market
- Estimated U.S. patients: 1,500–2,000.
- Annual treatment costs per patient: $80,000–$100,000.
- Potential market size: $120 million–$200 million annually.
Global Market
- Europe and other regions**: Smaller markets, limited healthcare budgets.
- Estimations: 20–30% of U.S. market, with growth driven by diagnosis rates.
Revenue Projections (2024–2028)
| Year |
Estimated Revenue |
Notes |
| 2024 |
$150 million |
Post-exclusivity, pricing stabilized |
| 2025 |
$140 million |
Potential price pressure, small market expansion |
| 2026 |
$130 million |
Entry of biosimilar candidates? |
| 2027 |
$125 million |
Market maturation, reimbursement adjustments |
| 2028 |
$120 million |
Long-term stability |
Price Projections and Influencing Factors
| Scenario |
Price Outlook |
Key Drivers |
| Optimistic |
$90,000–$95,000 per 100 mL |
Delayed biosimilar entry, high brand loyalty |
| Baseline |
$80,000–$85,000 per 100 mL |
Market stabilization with existing competition |
| Pessimistic |
$70,000–$75,000 per 100 mL |
Biosimilar or alternative therapies gain market share |
Price sustainability
- The drug maintains high price points due to low competition, limited patient numbers, and high unmet needs.
- Price erosion anticipated over 5–7 years, driven by biosimilars and healthcare policy reforms.
Key Market Risks and Opportunities
Risks
- Biosimilar Competition: Entry could erode premium pricing.
- Regulatory Changes: Healthcare reforms or patent challenges.
- Market Access: Insurance coverage limitations could constrain revenue.
Opportunities
- Expansion into Europe: Regulatory approvals could increase demand.
- New formulations: Longer-acting or improved dosing forms.
- Label expansion: Potential for treatment of related metabolic conditions.
Final Considerations
- The price for NDC 59922-0631 (Ravicti) remains high due to orphan drug status, limited competition, and specialized niche.
- Revenue forecasts from 2024 to 2028 suggest a gradual decline in market value as biosimilars or generics approach.
- Companies should monitor regulatory, reimbursement, and competitive developments for proactive positioning.
Key Takeaways
- Ravicti's market is constrained by rare disease status, with steady revenue projections but impending price pressure.
- Price erosion is expected over the next 5–7 years due to biosimilars.
- Market entry barriers preserve current high price levels in the near term.
- Expansion opportunities exist in international markets and for new formulations.
- Regulatory and reimbursement policies will significantly influence pricing dynamics.
FAQs
Q1: What is the primary driver of Ravicti’s high pricing?
The drug’s orphan status limits competition, and high manufacturing costs sustain elevated prices.
Q2: How might biosimilars impact Ravicti’s market?
Biosimilars could enter within the next 3-5 years, potentially reducing prices and market share.
Q3: What is the major regulatory advantage for Ravicti?
Seven-year market exclusivity granted upon approval protects against generic competition until 2021.
Q4: Are there international markets for Ravicti?
Yes, Europe and other regions may approve and adopt the drug, expanding revenue opportunities.
Q5: How does reimbursement outlook affect price projections?
Reimbursement negotiations heavily influence net prices; high coverage supports premium pricing, while restrictions can pressure prices downward.
References
[1] FDA. (2014). Ravicti (glycerol phenylbutyrate) approval announcement. FDA.gov.
[2] IQVIA. (2022). U.S. prescription drug market reports. IQVIA.com.
[3] EvaluatePharma. (2022). Global orphan drug markets. Evaluate.com.
[4] U.S. Food and Drug Administration. (2020). Orphan Drug Designations and Approvals. FDA.gov.
