Last updated: February 20, 2026
What is the drug associated with NDC 49702-0237?
NDC 49702-0237 is associated with Ravicti (glycerol phenylbutyrate). It is an orphan drug approved for the management of urea cycle disorders (UCD) — rare genetic conditions impairing ammonia detoxification.
How does the market landscape look for Ravicti?
Current Market Size and Growth
- The global urea cycle disorder market was valued at approximately USD 65 million in 2022.
- Projected compound annual growth rate (CAGR) from 2023 to 2028: around 8%.
- Growth driven by increased awareness, expanded diagnostic capabilities, and the limited treatment options for UCD.
Key Players
- Existing Drugs: Ravicti (approved in 2013), Buphenyl (sodium phenylbutyrate), and experimental therapies.
- Ravicti's Position: It holds a significant share attributed to better tolerability and flexible dosing versus Buphenyl.
Regulatory and Patent Status
- Ravicti's patent expired in 2020 in the U.S.
- The primary patent protection for Ravicti ended but market exclusivity persists under regulatory protections and orphan drug designation.
Price Trends and Financial Dynamics
Current Pricing
| Description |
Price (per 50 mL vial) |
Notes |
| Retail price (U.S.) |
USD 8,500 – USD 9,500 |
Variability due to payer negotiations and discounts |
| Wholesale acquisition cost (WAC) |
USD 7,500 – USD 8,200 |
Used as baseline for pricing calculations |
| Cost per treatment course (monthly) |
USD 25,000 – USD 30,000 |
Based on typical dosing (20-30 mL/day) |
Price Drivers
- Regulatory exclusivity and orphan status support premium pricing.
- Competition from off-label use of Buphenyl keeps market pressure within targeted segments.
- Payer reimbursement landscape influences net prices.
Market Opportunities and Future Price Projection
Factors Influencing Future Pricing
- Patent Expiry: After 2020, generic glycerol phenylbutyrate alternatives may emerge, pressuring Ravicti prices downward.
- Market Expansion: Increasing diagnosis rates and potential expanded indications could sustain revenue.
- Pricing Strategies: Manufacturers may adopt tiered pricing, rebates, or discounts to maintain market share amidst competition.
Price Projection (Next 5 Years)
| Year |
Estimated Price (per 50 mL vial) |
Expected Market Share |
Rationale |
| 2023 |
USD 8,500 |
70% |
Stable, with limited generic competition |
| 2024 |
USD 8,000 – USD 8,300 |
65-70% |
Slow erosion due to generics and biosimilars |
| 2025 |
USD 7,500 – USD 8,000 |
55-60% |
Increased generic penetration |
| 2026 |
USD 7,000 – USD 7,500 |
40-50% |
Market share shifts further toward generics |
| 2027 |
USD 6,500 – USD 7,000 |
30-40% |
Potential biosimilar entry, further price erosion |
Revenue Impact
- Peak revenue estimated in 2022/2023 at USD 200M.
- By 2027, revenues could decline by approximately 30-50%, depending on generic market penetration and price discounts.
Key Challenges and Risks
- Entry of biosimilars or generic glycerol phenylbutyrate formulations.
- Reimbursement barriers or formulary exclusions.
- Changes in orphan drug policies affecting exclusivity and pricing.
Strategic Recommendations
- Innovate with next-generation formulations or delivery methods.
- Pursue expanded indications to prolong patent protection.
- Establish patient assistance programs to maintain market penetration.
Key Takeaways
- NDC 49702-0237 corresponds to Ravicti, with a current high price point supported by orphan drug exclusivity.
- The market is stable but faces downward price pressure from generics post-patent expiration.
- Revenue projections indicate a gradual decline in average price over five years, with significant market share shifts expected.
- Regulatory, competitive, and reimbursement factors are critical to future pricing strategies.
FAQs
1. Will Ravicti's price decline significantly in the next five years?
Yes, due to patent expiration and increased generic competition, prices are projected to decline by about 20-30%.
2. Are there other approved treatments for Urea Cycle Disorders?
Yes. Buphenyl (sodium phenylbutyrate) remains the primary alternative, along with dietary management. Experimental therapies are under development.
3. How does orphan drug designation impact pricing?
Orphan status allows for market exclusivity and premium pricing, supporting higher prices compared to non-orphan indications.
4. What is the likelihood of biosimilar entry?
Low to moderate; glycerol phenylbutyrate is a small molecular entity, not a biologic, making biosimilar entry less relevant but generic formulations more likely.
5. How can companies extend Ravicti's market life?
Through developing new formulations, gaining expanded indications, and engaging in patient access programs.
Sources
- Market data and projections adapted from Transparency Market Research (2023). "Urea Cycle Disorder Market."
- FDA Drug Approval and Patent Data (2022). U.S. Food and Drug Administration.
- Pricing data based on IQVIA National Sales Perspectives (2023).
- Industry reports from EvaluatePharma (2023).
- Orphan Drug Designation and Regulatory Guidelines. U.S. FDA (2022).
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