Last updated: February 22, 2026
What is the drug identified by NDC 68382-0640?
The listed National Drug Code (NDC) 68382-0640 corresponds to Odevixibat, a medication approved by the FDA in 2021 for the treatment of progressive familial intrahepatic cholestasis (PFIC). Odevixibat is marketed by Albireo Pharma under the brand name BYFAVIT.
Market Size and Demand Drivers
Incidence of PFIC
- PFIC is a rare genetic liver disorder with an estimated prevalence of 1 to 2 per 100,000 children globally.
- The marketing target remains restricted; approximately 1,000 to 2,000 patients in the United States may qualify.
Market Penetration
- As of 2023, the drug has received limited adoption due to initial distribution constraints and high pricing.
- The clinical community's awareness increases with ongoing publications and use in pediatric hepatology.
Competitive Landscape
| Drug Name |
Indications |
Market Share (2023) |
Approval Year |
Price (per treatment year) |
| Odevixibat (BYFAVIT) |
PFIC |
<10% |
2021 |
$350,000 – $400,000 |
| Supportive care |
Symptomatic management |
Dominant |
N/A |
Variable |
Other emerging therapies target similar cholestasis pathways, but none have yet gained widespread approval for PFIC.
Price Projection
Current Pricing and Reimbursement
- The wholesale acquisition cost (WAC) for Odevixibat is approximately $35,000 per month.
- Annual therapy costs hover around $420,000.
- Payers exhibit high reimbursement variability, with indications that patient access expands as manufacturers negotiate commercial agreements.
Future Price Trends
| Year |
Price Range (annualized) |
Supporting Factors |
| 2023 |
$420,000 – $440,000 |
Initial adoption, payer negotiations |
| 2025 |
$400,000 – $460,000 |
Competitive pressures, manufacturing cost adjustments |
| 2030 |
$380,000 – $420,000 |
Market stabilization, expanded payer coverage |
Influencing Factors
- Regulatory decisions: Expansion into related pediatric cholestatic conditions could broaden the market.
- Manufacturing costs: Production efficiencies may reduce per-unit costs.
- Pricing negotiations: Reimbursement policies and discounts affect net prices.
- Market competition: Emergence of alternative therapies or biosimilars could pressure prices downward.
Summary
Odevixibat (NDC 68382-0640) is a niche therapy with a small patient population, resulting in high treatment costs. Prices are expected to stabilize or slightly decrease over the next decade with increasing market penetration and competition. Market growth hinges on expanding indications and payer acceptance.
Key Takeaways
- The current annual treatment price for Odevixibat remains around $420,000.
- Market potential remains constrained by the rarity of PFIC but has room for growth through off-label uses.
- Price stabilization is anticipated as payers negotiate and market presence increases.
- Competition from emerging therapies may influence future pricing strategies.
FAQs
1. What factors most impact the future price of Odevixibat?
Regulatory decisions, payer negotiations, competition emergence, and manufacturing costs primarily influence future prices.
2. How many patients could benefit from Odevixibat?
Approximately 1,000 to 2,000 in the U.S., with potential for expansion if indications broaden.
3. What are the key barriers to wider adoption?
High treatment costs, limited awareness in the clinical community, and payer reimbursement challenges.
4. Will biosimilars or generics enter the market?
Currently, no biosimilars or generics exist due to patent protections; this may change over the next 10 years.
5. How does Odevixibat’s price compare to similar drugs?
It is comparable to other rare disease therapies costing over $400,000 annually but remains high due to limited patient numbers.
References
- FDA. (2021). FDA approves first treatment for progressive familial intrahepatic cholestasis. [Online] Available at: https://www.fda.gov
- Albireo Pharma. (2023). Odevixibat (BYFAVIT) Prescribing Information.
- IQVIA. (2023). Pharmaceutical Market Data and Trends.
