Last updated: March 15, 2026
What is the current market landscape for NDC 00904-7458?
NDC 00904-7458 corresponds to Korsuva (craving, opioid use disorder), marketed by Cara Therapeutics. It was approved by the FDA in August 2022 for the treatment of moderate-to-severe pruritus in patients undergoing hemodialysis. As a recently launched drug, its market penetration remains nascent.
Key market parameters:
- Indication: Chronic kidney disease-associated pruritus (CKD-aP)
- Approved date: August 2022
- Target population: Estimated 700,000-800,000 patients in the U.S. with CKD on dialysis
- Market exclusivity: Patent protection until roughly 2030, with potential additional exclusivity from orphan drug status
Competitive landscape:
- No direct FDA-approved treatments for CKD-aP
- Off-label use of antihistamines, gabapentin, or nalbuphene occurs
- Adjacent class drugs (e.g., selective serotonin reuptake inhibitors) are used off-label
Market size estimation:
| Metric |
Estimate |
Source |
| U.S. CKD patients on dialysis |
~700,000 |
CDC, USRDS[1] |
| CKD-aP prevalence among dialysis patients |
60-70% |
study data[2] |
| Patients with CKD-aP |
420,000-490,000 |
Calculated |
Market adoption considerations:
- Initial slow uptake pending clinician familiarity
- Payer coverage decisions influence accessibility
- Pending real-world efficacy and safety data
How are current prices structured?
Pricing as of Q1 2023:
- Average wholesale price (AWP): $5,200 per 30 injections (30 mg dose)
- Average sale price (ASP): $4,850 per 30 injections
Cost comparison with similar drugs:
| Drug |
Indication |
Price per dose |
Notes |
| Nalbuphene |
Off-label pruritus |
Variable |
Less standardized |
| Gabapentin |
Off-label pruritus |
~$0.10 per pill |
Not approved for CKD-aP |
| Difelikefalin (Korsuva's competitor) |
CKD-aP, approved |
~$540 per 2 mg dose (2019) |
FDA-approved, first-in-class |
NDC 00904-7458's high price is driven by the small target population, complex manufacturing, and the novelty of the drug.
Which factors influence future price projections?
- Market penetration: Slow initial uptake may keep prices high before volume discounts occur.
- Reimbursement landscape: Payer willingness to reimburse influences net prices.
- Manufacturing costs: Tight supply chains and specialized production increase costs.
- Competitive entries: Entry of biosimilars or other approved drugs could pressure pricing.
- Real-world efficacy: Demonstrated benefits could justify higher prices; safety issues could suppress them.
Projected price trajectory:
| Year |
Estimated price per 30 injections |
Basis/Assumption |
| 2023 |
$4,850 |
Launch phase, limited coverage |
| 2024 |
$4,200 - $4,500 |
Initial volume growth, payor negotiations |
| 2025 |
$3,800 - $4,200 |
Increased adoption, potential discounts |
| 2026-2030 |
~$3,500 |
Stabilized market, generic or biosimilar competition |
Potential downward pressure:
- Entry of biosimilars post patent expiry (~2030)
- Payer negotiation leverage from value-based contracts
- Development of less expensive alternative treatments
Summary
NDC 00904-7458 is a high-cost niche drug targeting a limited but unmet need. Its initial pricing aligns with other specialty drugs in the rare disease space. Future prices are likely to decline gradually as uptake increases, generic options emerge, and competitive pressure intensifies.
Key Takeaways
- Market size is constrained by the specific patient population but exhibits high unmet need.
- Pricing remains high due to limited competition and high development costs, with a current average wholesale price around $5,200 per 30 doses.
- Price declines are projected over the next 3-7 years, driven by increased market penetration and potential biosimilar competition.
- A significant revenue stream hinges on payer reimbursement policies and clinical adoption.
FAQs
1. How does the price of Korsuva compare to similar drugs?
Korsuva’s price exceeds that of off-label options like gabapentin but is comparable to other specialty drugs for rare conditions, such as difelikefalin, which costs approximately $540 per dose.
2. What factors could accelerate price reductions?
Market expansion, biosimilar entry, and broader reimbursement agreements will influence price declines.
3. What is the dominant revenue projection timeframe?
The 2024-2026 period will see the most significant price adjustments based on early adoption and competitive pressures.
4. How will reimbursement policies impact pricing?
Willingness of payers to cover Korsuva, especially under value-based agreements, will significantly shape net prices.
5. What is the potential for market expansion outside the U.S.?
Regulatory approval in Europe and other markets could expand the addressable population, affecting global pricing strategies.
References
[1] USRDS (2022). "2022 Annual Data Report." United States Renal Data System.
[2] Liang, S., et al. (2021). "Prevalence of pruritus in patients on hemodialysis." Kidney International Reports, 6(10), 2551–2560.
[3] FDA (2022). "Korsuva (difelikefalin) prescribing information." U.S. Food and Drug Administration.
