Last updated: February 28, 2026
What is the Drug with NDC 60687-0527?
The National Drug Code (NDC) 60687-0527 corresponds to Odevixibat, a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive familial intrahepatic cholestasis (PFIC). It is marketed by Albireo Pharma.
Market Overview
Indication and Patient Population
Odevixibat is indicated for PFIC, a rare genetic disorder characterized by impaired bile flow, leading to severe pruritus and liver damage. Incidence rates are approximately 1-2 per million live births, with most cases manifesting in early childhood.
Market Size and Growth Factors
- Target Population: Estimated at 50,000 patients worldwide; around 4,000 in the U.S., considering prevalence and diagnosis rates.
- Rare Disease Market: Growing focus due to regulatory incentives (Orphan Drug Act) and increased awareness.
- Market Drivers:
- Lack of approved therapies prior to odevixibat.
- Recognition of the disease severity.
- Likelihood of expanding indications based on ongoing trials.
Competition
- Currently, no FDA-approved treatments specifically target PFIC.
- Off-label therapies include ursodeoxycholic acid and liver transplantation.
- Emerging therapies in clinical development include:
| Candidate |
Developer |
Mechanism |
Stage |
| Maralixibat |
Mirum Pharmaceuticals |
IBAT inhibitor |
Phase 3 |
| Yellapagatibat |
Yellapagatibat |
IBAT inhibitor |
Phase 2 |
Pricing Dynamics
Current List Price
- Odevixibat: Listed at approximately $450,000 annually per patient (as of early 2023).
- Cost Factors:
- Orphan drug pricing based on rarity.
- High manufacturing costs due to complex chemistry and small-volume production.
- Limited competition, supporting premium pricing.
Reimbursement Environment
- Payer acceptance varies.
- Most payers require prior authorization.
- Special access programs may reduce effective patient cost.
Pricing Trends and Projections
| Year |
Estimated Average Price (USD) |
Notes |
| 2023 |
$450,000 |
Initial listing, high patient and payer negotiations ongoing |
| 2024 |
$470,000 |
Potential price increase due to inflation and increased demand |
| 2025 |
$490,000 |
Anticipated consolidation of payer strategies |
Market Penetration Expectations
- Limited initial adoption due to disease rarity and diagnostic challenges.
- Market penetration forecasted to reach 30-50% of eligible patients within 3 years post-launch.
Revenue and Revenue Growth Projections
| Year |
Estimated Revenue (USD millions) |
Assumptions |
| 2023 |
$10-15 |
Launch year, conservative estimate based on lower market penetration |
| 2024 |
$25-35 |
Increased acceptance, broader payer coverage |
| 2025 |
$40-60 |
Expanded indications and awareness |
Challenges Impacting Market and Pricing
- Small patient pool limits revenue potential.
- High development costs for orphan drugs influence pricing strategies.
- Regulatory shifts or new competitors could pressure prices downward.
- Payer negotiations may moderate list prices over time.
Key Considerations
- The actual realized price may differ substantially from list price due to rebates, discounts, and access programs.
- Future indications (e.g., other cholestatic disorders) could expand the total addressable market.
- The competitive landscape might change as pipeline drugs complete clinical trials.
Key Takeaways
- NDC 60687-0527, Odevixibat, commands high annual list prices, driven by rarity and unmet needs.
- The total addressable market remains small but is expected to grow with increased diagnosis and recognition.
- Revenue projections indicate modest growth, constrained by patient population size.
- Pricing strategies will be shaped by payer negotiations and potential expanded indications.
- Competitive pressures are low initially but could Intensify with emerging therapies.
FAQs
1. How does Odevixibat compare to other IBAT inhibitors?
It is the first FDA-approved IBAT inhibitor for PFIC. Competitors like Maralixibat are in late-stage trials with similar mechanisms.
2. What factors influence the drug’s market entry success?
Disease diagnosis rates, clinician awareness, approval of expanded indications, and payer coverage are key.
3. Will the price decrease over time?
Possible if new competitors emerge or if payers negotiate better rebates. However, orphan drug pricing often remains high.
4. Are there risks that could impact market growth?
Yes. Regulatory delays, clinical trial failures of pipeline drugs, or lower-than-expected market penetration could limit growth.
5. How is the global market different from the U.S.?
Pricing varies extensively; Europe and other regions may have lower prices due to different reimbursement policies and smaller orphan drug markets.
Citations
- FDA (2021). Odevixibat approval announcement. Retrieved from [FDA website].
- Albireo Pharma (2023). Product information and pricing.
- Orphan Drug Designations, FDA (2022). Data on rare disease approvals.
- Market Research Future (2022). Rare disease drugs market analysis.
- Centers for Disease Control and Prevention (2017). Epidemiology of PFIC.
