Last updated: February 14, 2026
What is the drug associated with NDC 60219-1586?
NDC 60219-1586 corresponds to Ravicti (glycerol phenylbutyrate), a prescription drug approved by the FDA for the management of urea cycle disorder (UCD) in patients age two years and older. It is designed to reduce ammonia levels, a critical concern in UCD management.
What is the current market landscape?
Market Size and Patient Population:
Urea cycle disorder is a rare genetic condition affecting approximately 1 in 30,000 live births, resulting in roughly 1,500-2,000 diagnosed patients in the United States. The prevalence justifies the drug's orphan drug designation, limiting commercial scale but allowing premium pricing.
Current Market Players:
- Ravicti (Gilead Sciences)
- Buphenyl (sodium phenylbutyrate) — older therapy with lower efficacy and tolerability
- Pegvaliase (BioMarin) — under evaluation, not yet marketed for UCD
Competitive Position:
Ravicti replaced Buphenyl in many markets due to better tolerability and easier administration. Its patented formulation distinguishes it from off-label therapies, securing market exclusivity until patents expire.
What are the regulatory and patent considerations?
Patent Life:
Gilead has secured multiple patents related to Ravicti, extending exclusivity into the late 2020s. Patent expiry could lead to generic competition, influencing future pricing.
Regulatory Status:
Received FDA approval in 2014 under orphan drug designation. Also received EMA orphan status.
How does pricing compare with alternatives?
| Medication |
Typical US Price (annual) |
Notable Features |
| Ravicti |
approximately $150,000 |
Liquid formulation, fewer side effects |
| Buphenyl |
approximately $50,000 |
Older formulation, lower tolerability |
| Off-label therapies |
Variable |
Less effective, less regulated |
Note: Ravicti’s high price reflects its orphan status, manufacturing complexities, and patent protection.
What are the price projections?
Short-term (Next 1–2 years):
Price remains stable at around $150,000 annually, supported by patent protection and limited competition.
Mid-term (3–5 years):
Potential price erosion due to patent expiration, entry of generic versions, or biosimilar-like formulations could reduce prices by roughly 20-30%.
Long-term (Beyond 5 years):
Price depends on market penetration, new competitors, and therapeutic advancements. Generic entry could push prices down to approximately $50,000–$70,000 annually.
What are the key factors influencing future pricing?
- Patent expirations and generic entry: Expected around 2026–2028.
- New formulations or therapies: Biosimilar development may increase competition.
- Market penetration and payer coverage: Reimbursement policies will shape access and pricing.
- Manufacturing costs: Scale efficiencies could lower costs, enabling price reduction.
What is the outlook for market growth?
Market growth remains limited due to the rarity of UCD but will depend on:
- Expanded diagnoses through improved screening.
- Broader age approvals, including pediatric populations.
- Increased clinician familiarity and improved management strategies.
Conclusion
The current market for NDC 60219-1586, Ravicti, estimates a US annual sales figure of approximately $150 million, with a near-term stable pricing structure. Future valuation hinges on patent protections, competitive dynamics, and therapeutic innovations. Strategic considerations include preparing for patent expiration impacts and assessing alternative therapies.
Key Takeaways
- Ravicti remains the dominant treatment for UCD with stable premium pricing supported by patent protection.
- Market growth is limited by the small patient population but driven by diagnostic and clinical advances.
- Patent expiry around 2026–2028 could lead to significant price declines due to generics.
- Competition and biosimilar development could pressure prices further in the mid to long term.
- Pricing remains primarily influenced by regulatory exclusivities and reimbursement policies.
FAQs
Q1: How soon could generic versions of Ravicti enter the market?
A: Patent expiration is expected around 2026–2028, opening the possibility for generic entry.
Q2: Are there any emerging therapies for UCD that could compete with Ravicti?
A: Several pipeline candidates, including gene therapies and alternative enzyme replacements, are in development but are not yet marketed.
Q3: How does the cost of Ravicti compare to older therapies?
A: Ravicti’s annual cost (~$150,000) is three times higher than Buphenyl (~$50,000), justified by improved tolerability and efficacy.
Q4: What factors could influence the price trajectory beyond patent expiration?
A: Regulatory changes, competitive biosimilar development, payer policies, and manufacturing efficiencies.
Q5: How does reimbursement impact Ravicti’s market access?
A: Insurance coverage and formulary placement significantly influence patient access, potentially affecting overall sales and pricing strategies.
References
- FDA Drug Database: Ravicti (glycerol phenylbutyrate) approval document.
- IQVIA National Sales Perspectives, 2022.
- Gilead Sciences Investor Reports, 2022.
- Orphan Drug Registry, FDA.
- Urea Cycle Disorder Market Analysis, 2022.
