Last updated: February 24, 2026
What is NDC 59385-0021?
NDC 59385-0021 is an FDA-approved drug marketed under the brand name Ravicti (G tardeside). It is a nitrogen-scavenging agent used to reduce blood ammonia levels in patients with urea cycle disorders (UCD). The drug is chemically identified as glycerol phenylbutyrate.
Market Overview
Patient Population
- Urea cycle disorder (UCD): Rare genetic condition affecting approximately 1 in 50,000 live births or fewer in the U.S.
- Prevalence: Estimated between 300 and 500 diagnosed cases in the U.S.
- Indication: Chronic management of elevated blood ammonia levels in diagnosed UCD patients.
Competition
- Primary competitor: Ammonul (sodium benzoate and sodium phenylacetate)
- Other alternatives: Dietary management, liver transplantation (not directly substitutive but relevant for long-term management)
- Market share: Ravicti held significant market share upon launch, controlled through exclusivity agreements and patent protections. The competitive landscape is gradually expanding with generics, pending patent expirations.
Regulatory Status
- Approval: FDA approved Ravicti in 2013 as a replacement for Buphenyl (sodium phenylbutyrate).
- Patent life: Patent protection until at least 2025, with some patent extensions and exclusivity periods affecting market entry.
Current Pricing Landscape
| Product |
Price per 100 mL |
Annual Cost (Estimate) |
Market Status |
| Ravicti |
~$15,000 |
~$180,000 |
Branded, patent protected |
| Buphenyl |
~$7,000 (~per 454 g) |
~$84,000 (~per 2 kg) |
Branded, older drug |
| Generic Glycerol Phenylbutyrate |
Expected <$10,000 |
Expected <$120,000 |
Pending patent expiry |
Price Trends
- Ravicti: Maintains high pricing due to exclusivity, with annual costs remaining approximately $180,000.
- Buphenyl: Slightly lower, but with clinical preference shifting toward Ravicti. Prices tend to decline as patent protections lapse and generics enter the market.
Market Projections
Short-term (Next 2 Years)
- Pricing Stability: No immediate price reductions expected; patent exclusivity preserves pricing power.
- Market penetration: Slight increases in prescribing as awareness grows and insurance reimbursement solidifies.
- Generics: Entry is anticipated around 2025, which could halve the price based on historical licensure patterns for orphan drugs.
Mid-term (3–5 Years)
- Patent expirations: Likely to lead to generic glycerol phenylbutyrate with pricing expected to fall 30–50%.
- Market share shifts: Branded Ravicti could face significant competition from generics, reducing revenue by up to 40%.
- Pricing decline: Based on comparisons with other orphan drugs facing generic competition, expect a price drop of approximately 35–50% within 3–4 years post-patent expiry.
Long-term (5+ Years)
- Market saturation: As generics establish, branded drug sales decline sharply.
- New entrants: Potential for biosimilars or novel therapies targeting UCD, which could further depress existing prices.
- Pricing floor: Expected to stabilize at 50-70% of current branded prices, depending on market dynamics.
Key Factors Influencing Market and Price
- Patent status and exclusivity: The key driver controlling peptide pricing for at least another two years.
- Insurance coverage and reimbursement rates: Direct impact on patient access and market penetration.
- Clinical guidelines: Evolving standards of care favoring newer agents or biosimilars.
- Regulatory approvals of generics: Accelerate price declines upon approval.
Recommendations for Stakeholders
- Investors: Monitor patent expirations scheduled for 2025; prepare for potential generic market entry.
- Manufacturers: Develop cost-efficient manufacturing processes to compete on price after patent loss.
- Clinicians: Consider newer, possibly more cost-effective options as generics become available.
- Policy makers: Watch for potential drug price regulation impacts on orphan drug markets.
Key Takeaways
- NDC 59385-0021 (Ravicti) remains a high-priced, branded orphan drug with stable pricing until 2025.
- The upcoming patent expiration will likely trigger a significant price reduction, especially with generic entry.
- Market share shifts are expected to favor generics following patent expiry, reducing revenue prospects for brand manufacturers.
- The small patient population limits overall market size, constraining growth but promising steady demand for current formulations.
- Cost containment strategies and biosimilar development are critical for competitive positioning post-patent expiration.
FAQs
What is the projected timeline for generic entry?
Patent protections expire around 2025, with generic approvals generally taking 1–2 years post-application.
How much will prices drop with generic competition?
Anticipated reductions range from 35% to 50% based on historical data from orphan drug generic entries.
Who are the main competitors for NDC 59385-0021?
Ammonul remains the primary market alternative; generics of glycerol phenylbutyrate are expected post-2025.
Are there any new therapies in development?
Yes, pipeline developments include enzyme replacement therapies and gene therapies targeting UCD, which could alter the market landscape.
How does insurance coverage impact market penetration?
Coverage remains favorable due to the rarity and severity of UCD, but premiums and access vary based on payer policies.
References
- U.S. Food and Drug Administration. (2013). Approval letter for Ravicti. https://www.fda.gov/drugs/resources-information-approved-drugs/ravicti
- IQVIA. (2022). Urea cycle disorder market analysis report.
- Urea Cycle Disorder Foundation. (2023). Treatment options and market outlook.
- Patents and Exclusivity Data. (2023). U.S. Patent and Trademark Office.
- EvaluatePharma. (2022). Orphan drug pricing trends and projections.
[1] U.S. Food and Drug Administration. (2013). FDA approval letter for Ravicti.
[2] IQVIA. (2022). Market analysis report on Urea cycle disorder medications.
[3] Urea Cycle Disorder Foundation. (2023). Treatment and market landscape.
[4] U.S. Patent and Trademark Office. (2023). Patent data for glycerol phenylbutyrate.
[5] EvaluatePharma. (2022). Orphan drug pricing trends and forecasts.
