Last updated: February 15, 2026
Overview
NDC 60687-0808 corresponds to Odevixibat, an ileal bile acid transporter (IBAT) inhibitor approved by the FDA in November 2021 for the treatment of progressive familial intrahepatic cholestasis (PFIC). Its unique mechanism appeals to a niche patient population, with limited competition and an evolving market landscape.
Market Size and Patient Population
- PFIC affects approximately 1 in 50,000 to 100,000 live births globally.
- The U.S. epidemiology estimates 200-300 patients diagnosed per year.
- Estimated prevalence in major markets: 1,500-2,500 patients.
- Pediatric population predominantly affected, limiting treatment to specialized centers.
Current Market Dynamics
- Pricing: As of 2022, the wholesale acquisition cost (WAC) for Odevixibat is roughly $27,000 per year per patient.
- Pricing benchmarks: Similar drugs (e.g., Maralixibat) are priced in the $25,000–$30,000 range.
- Insurance coverage: Primarily through specialty pharmacy distribution, with high reimbursement hurdles.
Competitive Landscape
| Drug |
Mode of Action |
Approved Indications |
Market Share |
Launch Year |
| Odevixibat (NDC 60687-0808) |
IBAT inhibition |
PFIC |
Emerging |
2021 |
| Maralixibat |
IBAT inhibitor |
Alagille syndrome, PFIC |
Limited |
2020 |
| Ursodeoxycholic acid (Udca) |
Bile acid modulation |
Cholestasis, PFIC |
Ubiquitous |
1970s |
Limited competition persists, with Odevixibat being the only FDA-approved drug specific for PFIC.
Market Penetration and Growth Projections
- Initial penetration remains confined to specialized centers.
- Adoption rate is estimated at 10% of eligible patients in the first two years, increasing to 30% over five years given improved diagnosis and reimbursement.
- The patient volume in the U.S. could reach approximately 100–150 treated patients within five years.
Price Projections (2023-2027)
| Year |
Estimated Price (Per Patient) |
Rationale |
| 2023 |
$27,000 |
Current WAC; initial limited reimbursement |
| 2024 |
$27,500–$28,000 |
Slight price increase, inflation adjustments |
| 2025 |
$28,000–$29,000 |
Potential negotiated discounts; expanded coverage |
| 2026 |
$28,500–$30,000 |
Price stabilization; competition influence |
| 2027 |
$29,000–$31,000 |
Market maturation; potential label expansion |
In scenarios where additional indications for pediatric cholestatic diseases are approved, pricing could escalate by 10–15%.
Revenue Projections
Assuming the US market captures:
- 25 patients in 2023, increasing to 100 patients in 2026.
- Average annual price of $28,000.
Revenue estimates over five years:
| Year |
Patients |
Revenue (USD) |
| 2023 |
25 |
700,000 |
| 2024 |
40 |
1,120,000 |
| 2025 |
70 |
1,960,000 |
| 2026 |
100 |
2,800,000 |
| 2027 |
120 |
3,480,000 |
Key Takeaways
- Market size remains small but specialized, with steady expansion driven by increased awareness and indications.
- Price stability is likely, with modest increases aligning with inflation and value-based negotiations.
- Revenue growth depends on market penetration, reimbursement, and potential label expansions.
FAQs
1. What factors influence the pricing of Odevixibat?
Pricing is driven by R&D costs, competitive landscape, reimbursement negotiations, and value offered to patients. Market exclusivity provides leverage for initial pricing, with discounts expected upon broader payer access.
2. How does the competition impact future pricing?
Limited direct competition supports stable prices. However, entry of similar drugs or generic alternatives could pressure prices downward.
3. What is the potential for expanding indications?
Label expansion to other cholestatic conditions or pediatric indications could significantly increase demand and justify higher prices.
4. How does reimbursement influence market growth?
High reimbursement hurdles in niche markets delay adoption. Successful insurance coverage accelerates growth and revenue potential.
5. Are there regional variations affecting the market?
Yes. U.S. reimbursement policies favor specialty drugs; Europe and Asia may have different approval timelines and pricing strategies impacting global revenue.
References:
- FDA label for Odevixibat (2021).
- Pricing data from First Databank (2022).
- Market size estimates from Orphanet (2022).
- Competitive landscape reports from EvaluatePharma (2022).
- U.S. prevalence data from CDC reports (2022).
