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Market Analysis and Price Projections for NDC 62175-0891
Last updated: February 24, 2026
What is the drug identified by NDC 62175-0891?
NDC 62175-0891 refers to the drug Ravicti (guanidine hydrochloride). It is a prescription medication approved by the FDA for the reduction of blood ammonia in patients with urea cycle disorders (UCD). Approved in 2013, Ravicti is an alternative to sodium phenylbutyrate (Buphenyl) and is marketed by Horizon Therapeutics.
What is the current market landscape for Ravicti?
Market size and patient population
Urea cycle disorder prevalence: Estimated at 1 in 30,000 births in the U.S., equating to approximately 300-400 patients.
Treatment adoption: Mostly confined to pediatric and adult patients diagnosed with UCD, with sporadic off-label use for hyperammonemic crises.
Competition
Main competitor: Buphenyl (sodium phenylbutyrate), marketed by Merck & Co.
Market share: Ravicti holds approximately 25-30% of the ammonia scavenger market, with the remaining share held by Buphenyl.
Recent developments: Only two approved drugs are widely used; recent pipeline activity remains minimal for UCD treatments, indicating limited new entrants.
Regulatory and reimbursement factors
Pricing: Ravicti is priced significantly higher than Buphenyl. Exact list prices vary, but estimates range from $250,000 to $300,000 annually per patient.
Coverage: Reimbursement is generally available through Medicaid and commercial insurers, but coverage restrictions are common owing to high costs.
What are current pricing trends?
Parameter
Data Point
Estimated list price per year
$250,000 - $300,000
Cost per capsule (approximate)
$5,000 - $6,000 per dose (depending on dosage)
Cost for branded Buphenyl
~$50,000 per year
Price difference (Ravicti vs. Buphenyl)
4-6 times higher
Pricing trajectory (2013–2023)
Initial launch price in 2013 was approximately $250,000 per year.
Incremental price increases occurred in line with inflation and market dynamics, with small increases (~2-3%) yearly.
Competitive pressures have sustained high prices, with no significant discounts or biosimilar developments.
What are price projections through 2030?
Short-term (2023–2025)
Price stability: Given limited competition and high maintenance costs, the price per patient is expected to remain at approximately $250,000–$300,000 annually.
Reimbursement pressure: Payers may seek discounts; however, high unmet need keeps prices relatively stable.
Mid-term (2026–2030)
Market consolidation: Potential entry of biosimilars or generics might pressure prices.
Regulatory changes: Increased focus on drug affordability could lead to discounts or negotiated pricing, particularly in public plans.
Expected trend: Slight downward pressure possible, with prices declining 10-15% if biosimilar or alternative treatments gain approval and market penetration.
Long-term (beyond 2030)
Biosimilar impact: Entry of biosimilars might reduce prices by up to 40-50%, if regulatory pathways and market acceptance align.
New therapies: Development of gene therapies or enzyme replacement options could replace current treatments, influencing pricing trends.
What factors influence the market trajectory?
Regulatory approvals and pipeline activity: Few recent approvals suggest slow innovation; unless new therapies come to market, pricing trends remain stable.
Market exclusivity: Patent protections extend until 2028-2030, delaying biosimilar competition.
Demand and prescriber behavior: Limited patient pool constrains volume; high per-patient costs offset by low overall sales volume.
Investors and stakeholders should consider:
The stability afforded by limited competition.
The risk of price erosion due to biosimilar developments after patent expiry.
The potential for emerging therapies to disrupt the market significantly after 2030.
Key Takeaways
Ravicti (NDC 62175-0891) commands high prices due to limited competition, with annual costs around $250,000–$300,000.
Market share remains concentrated, primarily competing with Buphenyl.
Price stability is anticipated through 2025, with modest declines possible post-2025 if biosimilars or new treatments gain approval.
Patent exclusivity extends into the late 2020s, delaying biosimilar entry.
Future pricing depends on regulatory developments, market competition, and treatment innovations.
FAQs
What is driving the high cost of Ravicti?
Limited competition, small patient population, and regulatory exclusivity contribute to high per-patient costs.
When could biosimilars or generics enter the Ravicti market?
Patent protections extend into 2028–2030; biosimilars are likely to enter shortly after patent expiry.
How might new therapies impact Ravicti pricing?
Gene therapies or enzyme replacement treatments could replace current drugs, pressuring prices downward.
Are there any recent regulatory changes affecting Ravicti?
No significant recent regulatory changes. Policy focus on drug affordability remains a potential future influencer.
What is the overall market outlook for ammonia scavengers?
Expect continued stability for Ravicti until patent expiration, after which significant price pressure is anticipated due to biosimilars.
References
U.S. Food and Drug Administration (2013). Ravicti approval letter.
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