Last updated: March 1, 2026
What Is the Drug Associated With NDC 71093-0139?
The National Drug Code (NDC) 71093-0139 corresponds to Ravicti (glymepraml), a prescription medication approved by the FDA for the management of rare urea cycle disorders in adult and pediatric patients aged two months and older. It serves as an alternative to sodium phenylbutyrate, which has been historically used for similar indications.
Market Landscape Overview
Key Drivers of Growth
- Rare Disease Focus: Ravicti's designation as a treatment for urea cycle disorders (UCD) attracts a niche but steady patient population.
- FDA Approval and Orphan Drug Status: The FDA granted Ravicti Orphan Drug Designation, providing potential market exclusivity until 2031 and potential for market differentiation.
- Market Penetration: Since launch, Ravicti has experienced steady uptake primarily among specialized centers, constrained by high costs and competition from alternatives.
Market Size and Patient Population
- Urea Cycle Disorder Incidence: Approximately 1 in 35,000 live births in the U.S. patients with UCD.
- Estimated U.S. Patients: 150-300 patients, with some estimates reaching 350 based on disease prevalence and diagnosed cases.
- Treatment Penetration Rate: Around 70%-80% of diagnosed patients are treated with Ravicti or alternative therapies.
Competitive Landscape
- Sodium Phenylbutyrate (Buphenyl): The primary comparator, approved since 1996.
- NaPB Alternatives: Amino acid modifications, dietary approaches.
- Emerging Therapies: Gene therapy candidates and novel enzyme-based treatments are in early development.
Pricing and Reimbursement Dynamics
Current Price Point
- Ravicti Wholesale Acquisition Cost (WAC): Approximately $260 per gram (as of late 2022).
- Monthly Treatment Cost: Ranges from $37,500 to $40,000 depending on patient weight and dosing.
Pricing Comparison with Competitors
| Product |
Price per gram |
Monthly Cost |
Approval Year |
Patent/Market Exclusivity |
| Ravicti (glymepraml) |
~$260 |
$37,500–$40,000 |
2013 |
Market exclusivity until 2031 |
| Buphenyl (sodium phenylbutyrate) |
~$200–$220 |
$25,000–$30,000 |
1996 |
Patent expired; generic versions available |
Reimbursement Landscape
- Insurance Coverage: Most commercial insurers reimburse Ravicti with prior authorization.
- Medicaid/Medicare Coverage: Covers eligible patients with varying prior authorization requirements.
- Patient Assistance Programs: The manufacturer offers assistance to mitigate out-of-pocket costs.
Price Projections and Market Trends
Short-Term Outlook (Next 2-3 Years)
- Price Stability: Given market exclusivity and manufacturing costs, prices are expected to remain stable.
- Market Penetration: Incremental increase in treated patients, driven by heightened diagnosis rates.
- Competitive Pressure: Limited, unless new therapies gain FDA approval.
Long-Term Outlook (3-10 Years)
- Potential for Price Decline: Could occur post-patent expiry; generic versions anticipated around 2031.
- Impact of Emerging Therapies: Gene therapies and enzyme replacement treatments could disrupt market dynamics, potentially reducing demand for Ravicti.
- Pricing Strategies: The manufacturer might implement price adjustments aligned with inflation, reimbursement pressures, or value-based pricing models.
Potential Influencers
- Regulatory Changes: FDA incentives for rare diseases may impact drug pricing and market exclusivity.
- Market Expansion: Broader application including additional heterozygous UCD conditions.
- Healthcare Policy: Growing emphasis on cost-effective treatment could influence reimbursement rates.
Summary of Key Financials and Market Dynamics
| Metric |
Value / Detail |
| Estimated U.S. treated patients |
150-350 |
| Current average monthly cost |
$37,500–$40,000 |
| Price per gram (WAC) |
~$260 |
| Market exclusivity until |
2031 |
| Patent expiration for primary competitors |
2020s (gaps filled with generics) |
| Major competitors |
Sodium phenylbutyrate (Buphenyl) |
| Emerging therapies |
Gene/editing therapies (clinical trials) |
Key Takeaways
- Ravicti remains a niche, high-cost treatment primarily constrained by limited patient population and competition from older drugs.
- Despite stable pricing, future market shifts could arise from biosimilars, generics, or innovative therapies.
- Market growth depends on diagnosis rates, treatment adherence, and approval of new treatment modalities for UCD.
FAQs
1. What factors most influence Ravicti’s market pricing?
Market exclusivity, manufacturing costs, and limited competition underpin Ravicti’s high price point.
2. How could emerging therapies impact Ravicti's market?
Gene therapy and enzyme replacement therapies could replace or supplement Ravicti, reducing demand and potentially pressuring prices.
3. When is generic competition expected for Ravicti?
Patent protections extend until 2031; generics are unlikely before this date.
4. What are the primary barriers to market expansion?
Limited diagnosed patient population, high cost, and specialized treatment infrastructure.
5. How are payors managing the high cost of Ravicti?
Use of prior authorization, formulary restrictions, and patient assistance programs mitigate costs.
References
[1] Food and Drug Administration. (2013). FDA approves Ravicti for urea cycle disorder.
[2] IQVIA. (2022). Pharmaceutical Pricing Data.
[3] Urea Cycle Disorder Foundation. (2022). Prevalence and treatment overview.
[4] FDA. (2020). Orphan Drug Designation details.
[5] MarketsandMarkets. (2021). Rare disease therapeutics market report.
