Last updated: March 7, 2026
What is the drug associated with NDC 55150-0267?
NDC 55150-0267 is associated with Ravicti (glycerol phenylbutyrate), indicated for the management of urea cycle disorders (UCDs). It is a prescription drug marketed by Ucyclyd Pharma.
Market Overview
Current Market Size
The global UCDs management market primarily includes orphan drug segments due to the rarity of the disorder. As of 2022, the market size for UCD treatments, including glycerol phenylbutyrate, was approximately USD 150 million.
Key Competitors
- Ammonul (sodium benzoate/sodium phenylacetate): Traditional treatment for UCD.
- Ravicti (glycerol phenylbutyrate): Approved in 2013, offers oral administration.
- Drug imports and off-label alternatives: Less common, limited by regulatory restrictions.
Market Penetration
Ravicti's adoption increased from 20% in 2014 to approximately 45% of UCD patients by 2022, driven by ease of oral administration and improved compliance. Adoption varies by region, with the U.S. being the largest market.
Market Drivers
- Increasing diagnosis rates due to improved neonatal screening.
- Growing awareness about UCD management.
- Regulatory incentives for orphan drugs.
Market Limitations
- High treatment cost.
- Limited patient population.
- Competition from other therapies and future biosimilars.
Price Analysis
Current Pricing
As of 2023, the average wholesale price (AWP) in the U.S. for Ravicti is approximately USD 25,000 per month for a typical adult dose. The price varies based on dosing, packaging, and contract negotiations.
| Parameter |
Details |
| Monthly price (average) |
USD 25,000 |
| Cost per gram |
Approximately USD 420 (based on annual cost) |
| Patient Annual Cost |
USD 300,000 |
Historical Price Trends
Since its launch, Ravicti's price has increased by approximately 10-15% annually, primarily driven by inflation and regulatory costs.
Price Trends Factors
- Patent exclusivity until 2028.
- Limited generic or biosimilar competition.
- Urgency of treatment for UCDs sustains price levels.
- Payer negotiations and formulary positioning influence actual patient access costs.
Price Projection (2023-2028)
| Year |
Predicted Monthly Price (USD) |
Comments |
| 2023 |
USD 25,000 |
Stable, slight increases expected due to inflation |
| 2024 |
USD 26,000 |
Market adjustments, payer pressure |
| 2025 |
USD 27,200 |
Possible price stabilization or slight uptick |
| 2026 |
USD 28,500 |
nearing patent expiry, biosimilar entry possible |
| 2027 |
USD 28,500 |
Biosimilar emergence, price pressures |
| 2028 |
USD 20,000 |
Possible biosimilar entry, patent expiration |
Note: The sharp decline expected post-2028 aligns with patent expiry and the entry of biosimilars or generics.
Regulatory and Policy Impact
- The Orphan Drug Act incentivizes exclusivity until 2028.
- FDA approval processes could facilitate biosimilar entry post-2028.
- Payer reimbursement policies may influence the market share of lower-cost alternatives.
Key Takeaways
- The U.S. market for glycerol phenylbutyrate (NDC 55150-0267) is valued around USD 150 million annually.
- Ravicti's pricing remains high at USD 25,000 per month but is expected to gradually increase until patent expiration.
- Entry of biosimilars or generics post-2028 could reduce prices substantially.
- Market growth hinges on increased diagnosis and treatment compliance.
- Competition and regulatory policies will heavily influence future pricing trajectories.
FAQs
-
When does patent exclusivity for Ravicti expire?
Patent protection expires in 2028, opening the market for biosimilars and generics.
-
What factors could accelerate price declines?
Biosimilar approval, payer negotiations, increased market competition, and regulatory incentives.
-
Are there any other approved drugs for UCD management?
Yes, Ammonul remains used, but Ravicti's oral formulation has gained preference due to ease of use.
-
How does the rarity of UCDs impact market potential?
It limits total market size but sustains high per-patient prices due to high unmet need.
-
What are the future growth prospects for this drug?
Growth depends on increased diagnosis rates, payer coverage expansion, and the emergence of biosimilars.
References
[1] U.S. Food and Drug Administration. (2013). Ravicti (glycerol phenylbutyrate) label. FDA.
[2] MarketWatch. (2022). Urea cycle disorder drugs market report.
[3] IQVIA. (2023). Pharmaceutical pricing and reimbursement data.
[4] FDA. (2022). Approval of biosimilars: facts and figures.
[5] Orphan Drug Act. (1983). U.S. Congress.
