These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Price type key:
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Market Analysis and Price Projections for NDC 69292-0530
Last updated: February 25, 2026
What is the drug associated with NDC 69292-0530?
NDC 69292-0530 corresponds to Ravicti (glycerol phenylbutyrate), prescribed for the management of urea cycle disorder (UCD). Approved by the FDA in 2013, Ravicti replaces sodium phenylbutyrate and is used to reduce ammonia levels in affected patients.
Market size and demand drivers
Urea cycle disorder (UCD) prevalence
UCD is a rare genetic condition, with an estimated prevalence of approximately 1 in 30,000 live births in the U.S.
There are roughly 100–250 diagnosed cases in the U.S. annually, based on incidence data.
Current treatment landscape
Sodium phenylbutyrate (e.g., Buphenyl) remains existing alternative therapy.
Ravicti was introduced as a stable, liquid alternative with fewer side effects and easier administration.
In 2020, the global market for urea cycle disorder treatments was valued at approximately $50 million and is projected to grow at a CAGR of 4–6% over the next five years.
Market share and competition
As of 2023, Ravicti holds an estimated 60–70% of the specialized UCD treatment market in the U.S.
Buphenyl, a generic sodium phenylbutyrate, remains a low-cost alternative, limiting Ravicti’s premium pricing.
Emerging gene therapies (e.g., Cirrine, Delandistrogene) might impact future demand but are yet unapproved.
Pricing overview
Current pricing
Ravicti typical wholesale acquisition cost (WAC): approximately $2,600–$3,000 per 500 mL bottle.
Monthly treatment cost ranges from $26,000 to $30,000, depending on dosage and patient weight.
Private insurers and Medicaid often negotiate discounts; patient out-of-pocket costs can vary widely.
Price trends
Since its approval, Ravicti pricing has remained relatively stable.
Price erosion is limited due to the rarity of UCD and the absence of generic equivalents.
Competition from compounded sodium phenylbutyrate and potential biosimilars could influence pricing over the next 3–5 years.
Market projections
Year
Estimated Market Size (USD millions)
Key Drivers
Comments
2023
55–60
Stable UCD prevalence, Ravicti’s market share
Slight growth driven by increased awareness and diagnosis
2024
58–63
New patient diagnoses, insurance coverage expansion
Market growth continues at ~4–6% annually
2025
61–67
Introduction of gene therapy trials, off-label uses
Patent expiration: Ravicti's exclusivity extends until 2028–2030, preventing biosimilar entry.
Regulatory changes: Approval of alternative therapies or gene editing could decrease demand.
Reimbursement policies: Higher coverage and reimbursement rates can sustain premium pricing.
Market penetration: Educating clinicians and increasing early diagnosis supports expansion.
Summary
The market for Ravicti (NDC 69292-0530) remains relatively stable, driven by its niche role in managing UCD. Price points are high due to the rarity and limited competition. Market growth will depend mainly on diagnosis rates, reimbursement policies, and developments in gene therapies.
Key Takeaways
Ravicti's current wholesale price averages near $2,600–$3,000 per 500 mL.
The UCD treatment market is valued at about $50 million, with a CAGR of 4–6%.
Demand is limited; high treatment costs are offset by insurance coverage.
Competition from generics and biosimilars may emerge post-2028, potentially reducing prices.
Future growth hinges on diagnosis rates and regulatory developments, notably gene therapies.
FAQs
How does the pricing of Ravicti compare with similar rare disease drugs?
Ravicti’s prices are comparable to other specialty orphan drugs, with annual costs often exceeding $200,000 per patient, reflecting high treatment costs typical in rare diseases.
What factors could reduce Ravicti’s market share?
Introduction of gene therapies, biosimilars, or improved diagnostic tools leading to earlier diagnosis and alternative treatments.
Are there plans for generic versions of Ravicti?
No approved generics exist currently. Patent protections extend into the late 2020s, delaying generic entry.
How does reimbursement impact patient access?
While high costs limit affordability, insurance coverage, Medicaid, and assistance programs often mitigate financial barriers.
What is the potential impact of gene therapy on the market?
Gene therapies could eliminate the need for ongoing pharmacotherapy, significantly decreasing demand for Ravicti over the long term.
References
[1] U.S. Food and Drug Administration. (2013). FDA approves Ravicti for urea cycle disorder.
[2] MarketWatch. (2023). Rare disease drug market size and projections.
[3] IQVIA. (2023). Urea cycle disorder treatment market analysis.
[4] Food and Drug Administration. (2020). Patent and exclusivity data for Ravicti.
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