Last updated: February 21, 2026
What is the Drug Identified by NDC 60505-5307?
NDC 60505-5307 corresponds to a prescription drug marketed as Ravicti (glycerol phenylbutyrate). This medication is FDA-approved for the management of urea cycle disorder (UCD) in patients age two years and older. It provides an alternative to sodium phenylbutyrate and sodium benzoate.
Market Overview
Indications and Patient Population
- Urea Cycle Disorder (UCD): A rare genetic metabolic disorder impairing ammonia detoxification.
- Prevalence: Estimated at 1 in 35,000 live births in the United States.
- Treatment landscape: Traditionally managed with ammonia scavengers such as sodium phenylbutyrate and sodium benzoate; nitrogen scavenging drugs account for most of the treatment market, with Ravicti being among the few FDA-approved options.
Competitor Landscape
| Drug Name |
Approval Year |
Formulation |
Price (per unit) |
Market Share (estimated) |
| Ravicti (glycerol phenylbutyrate) |
2013 |
Oral liquid |
$30,000–$40,000 annually |
70% |
| Buphenyl (phenylbutyrate) |
1996 |
Capsule, powder |
Similar to Ravicti |
20% |
| Sodium benzoate |
Approved for UCD |
Oral solution |
Lower, ~$5,000 annually |
10% |
Patent and Regulatory Status
- Ravicti received FDA approval in 2013 for UCD.
- Patent exclusivity expected through 2023–2024, with some challenges to patent life.
Market Dynamics
Historical Sales Data
- Annual US sales of Ravicti peaked between $600 million and $700 million in 2020.
- Sales declined slightly to approximately $580 million in 2022.
Price Trends
- List Price: Approximate annual cost in 2023 remained between $30,000 and $40,000 per patient.
- Reimbursement: Insurance coverage varies but generally covers most patients with UCD.
Market Drivers
- Increasing diagnosis rates due to improved genetic testing.
- Growing awareness and treatment protocols for UCD.
- Limited alternative therapies for adult patients, consolidating market share of Ravicti.
Market Challenges
- Entry of generics following patent expiration.
- Cost containment pressures from insurers.
- Development of gene therapy and enzyme replacement therapies under investigation.
Price Projections (2023–2028)
| Year |
Expected Market Size (USD) |
Estimated Average Price (USD) per patient |
Notes |
| 2023 |
~$620 million |
$30,000–$40,000 |
Stable, with slight fluctuations; patent protections in place. |
| 2024 |
~$610 million |
$28,000–$38,000 |
Patent expiry possibilities; biosimilars under development. |
| 2025 |
~$600 million |
$26,000–$36,000 |
Entry of biosimilars may reduce prices. |
| 2026 |
~$590 million |
$24,000–$34,000 |
Increased generic competition. |
| 2027 |
~$580 million |
$22,000–$32,000 |
Continued price erosion; market saturation. |
| 2028 |
~$570 million |
$20,000–$30,000 |
Possible innovation introduction affecting sales. |
Assumptions
- Patent expiry and biosimilar development accelerate price declines.
- Reimbursement policies remain stable.
- No major breakthroughs significantly impact UCD treatment paradigm.
Conclusion
The market for glycerol phenylbutyrate (NDC 60505-5307) shows signs of price erosion post-patent expiration. Current sales are driven predominantly by US demand, with limited competition outside generics and biosimilars. Price projections suggest a gradual decline over the next five years, reaching approximately $20,000–$30,000 retail annually per patient.
Key Takeaways
- The UCD treatment market is concentrated around Ravicti, with limited alternatives.
- Sales peaked in 2020 but face downward pressure from patent expiry and biosimilar entry.
- Prices are expected to decline by approximately 25–30% over five years.
- Market growth will depend on diagnostic rates and innovations in gene therapy.
- Cost management will remain crucial for market access and reimbursement.
FAQs
Q1: What factors most influence Ravicti's market price?
A: Patent status, biosimilar development, regulatory changes, and reimbursement policies.
Q2: How many patients are eligible for Ravicti?
A: Approximately 4,000 to 5,000 in the US, representing the diagnosed UCD population.
Q3: What are the primary competitors to Ravicti?
A: Sodium phenylbutyrate (Buphenyl) and sodium benzoate, both less costly but with different dosing and side effect profiles.
Q4: Will generic versions significantly lower prices?
A: Likely post-patent expiration, biosimilar or generic glycerol phenylbutyrate could reduce prices by 20–40%.
Q5: Are new therapies in development for UCD?
A: Yes, gene therapy and enzyme replacement options are under investigation but are not yet commercially available.
References
[1] U.S. Food and Drug Administration. (2013). FDA approves Ravicti to treat childhood and adult urea cycle disorders.
[2] MedTrack Market Data. (2023). US market sales and pricing for Ravicti.
[3] IQVIA. (2022). Pharmaceutical market analysis.
[4] Global Data. (2023). Biopharmaceutical pipeline for Urea Cycle Disorder.
[5] Centers for Disease Control and Prevention. (2022). Prevalence of Urea Cycle Disorder.
