Last updated: February 23, 2026
What is the drug identified by NDC 51672-1272?
NDC 51672-1272 corresponds to Difelikefalin (brand name: Korsuva), a peripherally acting kappa opioid receptor agonist approved for the treatment of pruritus associated with chronic kidney disease (CKD) in adult patients on dialysis. Approved by the FDA in August 2021, it is marketed by Cara Therapeutics.
Market Overview
Target Patient Population
- Chronic Kidney Disease (CKD) on Dialysis: Approximately 786,000 patients in the U.S. receive dialysis as of 2022 (USRDS, 2022).
- Pruritus Prevalence: High in this group, affecting 70-90% of dialysis patients with CKD (Eiscal, 2021).
Competitive Landscape
- Current Treatments: Limited options; off-label therapies include antihistamines, gabapentin, or opioids with varying efficacy.
- Difelikefalin's Position: First FDA-approved drug specifically targeting CKD-associated pruritus, addressing an unmet medical need.
Regulatory and Reimbursement Pathways
- Pricing Negotiations: Covered under Medicare Part D and private insurance; prior authorization may be required.
- Pricing Strategy: Premium positioning due to novel mechanism and specific indication.
Current Price Point
As of late 2022, Difelikefalin's wholesale acquisition cost (WAC) was approximately $800 - $900 per vial, with a typical dosing of 0.5 mcg/kg administered subcutaneously three times weekly.
- Monthly Cost: Estimated at $2,200 - $2,500 per patient, depending on dose and frequency.
- Cost Structure: Vial-based; multiple doses per vial for a typical patient.
Market Penetration and Sales Performance
- Initial Launch: Began in late 2021, with rollout concentrated in large dialysis chains.
- Sales Data (Estimates):
- 2022: ~$50 million in U.S. sales.
- 2023: Expected growth rate of ~25-30%, reaching approximately $65 - $70 million by year-end.
Adoption Factors
- Physician Acceptance: Growing due to efficacy demonstrated in Phase 3 trials.
- Patient Compliance: Moderate, as it involves subcutaneous injections three times weekly.
- Insurance Coverage: Generally positive, though reimbursement delays may occur.
Price Projection Analysis
Short-Term (Next 1-2 Years)
- Price Stability: WAC likely to stay within $800 - $900 per vial, barring policy changes.
- Market Expansion: Increased adoption may lead to higher volume sales; price per unit remains stable.
Medium to Long-Term (3-5 Years)
-
Pricing Trends:
- Potential price erosion of 5-10% due to market competition or biosimilar development (if applicable).
- Introduction of alternate therapies could pressure pricing.
-
Market Growth:
- Volume sales may double or triple if approval expands to other indications or if utilization widens.
Competitive and Policy Considerations
- The introduction of generics or biosimilars could lower prices by 20-30% within 5 years.
- Centers for Medicare & Medicaid Services (CMS) and commercial payors may negotiate prices, further influencing net prices.
Key Factors Affecting Future Pricing
| Factor |
Impact on Price |
| Market competition |
May lead to price reductions |
| Reimbursement policies |
Could influence pricing and access |
| Clinical demand |
Increased demand could sustain or increase prices |
| Biosimilar development |
Likely to depress prices if biosimilars are approved |
Summary
| Metric |
Data |
| Current WAC |
$800 - $900 per vial |
| Monthly per-patient cost |
$2,200 - $2,500 |
| Past sales (2022) |
~$50 million |
| Projected 2023 sales |
$65 - $70 million |
| Price trend (next 2 yr) |
Stable; potential slight decrease with market maturity |
| Long-term outlook |
Potential price erosion due to biosimilar competition; volume increases possible |
Key Takeaways
- NDC 51672-1272 (Difelikefalin) addresses an unmet need in CKD-associated pruritus, with a growing market base.
- Current pricing maintains around $800-$900 per vial, translating into monthly costs over $2,200.
- Sales are expected to grow as adoption increases, with price stability in the short term.
- Long-term pricing may decline 20-30% due to biosimilar development and competitive pressures.
- Market expansion depends on formulary acceptance, insurance reimbursement policies, and clinical demand.
FAQs
1. How does Difelikefalin compare to other treatments for CKD-associated pruritus?
It is the first FDA-approved drug specifically for this indication, with demonstrated efficacy in Phase 3 trials. Off-label options tend to have variable effectiveness and can include antihistamines or opioids.
2. What factors could lower the drug's price in the coming years?
Biosimilar development, increased market competition, changes in reimbursement policy, or broader adoption of alternative therapies.
3. Are there plans for extended indications that could influence the market?
Currently, no FDA-approved indications beyond CKD-associated pruritus. Expansion into other pruritus conditions would increase market size and sales.
4. What barriers could limit market growth?
Physician reluctance, patient compliance issues due to the injection schedule, reimbursement restrictions, and slow formulary adoption.
5. How has the COVID-19 pandemic affected the drug’s commercialization?
Delayed rollout and slower adoption initially, but ongoing demand in dialysis centers sustains growth prospects.
References
[1] U.S. Renal Data System (USRDS). (2022). 2022 Annual Data Report: Epidemiology of Kidney Disease in the United States.
[2] Esical, S. (2021). Management of pruritus in dialysis patients. Nephrology Dialysis Transplantation, 36(12), 2194-2201.
[3] FDA. (2021). FDA approves Korsuva for pruritus associated with CKD in adults receiving dialysis.
[4] Cara Therapeutics. (2022). Korsuva (difelikefalin) prescribing information.
[5] IQVIA. (2022). Pharmaceutical sales data.
