Last updated: March 13, 2026
What is NDC 51672-4219?
NDC 51672-4219 corresponds to Revasc (sirolimus), an unbranded version of sirolimus, used as an immunosuppressant for organ transplant recipients. It is a formulation of sirolimus typically used in transplant medicine to prevent organ rejection.
Market Overview
Current Usage and Indications
- Primary indication: Maintenance immunosuppression in kidney, liver, and heart transplant recipients.
- Usage trends: The demand for sirolimus-based immunosuppressants has stabilized due to established clinical protocols and competition from other immunosuppressive agents.
- Market size (2022): Estimated at approximately $350 million worldwide, with key markets in the United States, European Union, and Japan.
Competition Landscape
- Major brand: Rapamune (sircolimus) by Pfizer.
- Biosimilars and generics have entered markets in 2020-2022, increasing price competition.
- Number of competitors: 3 approved generics in the U.S. as of 2023.
Regulatory Environment
- FDA status: Approved for organ transplant immunosuppression.
- Patent landscape: The original patent expired in 2014, encouraging generic entry.
- Pricing policies: Increased scrutiny on drug prices has influenced list prices and reimbursement policies.
Pricing Analysis
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per mg |
Notes |
| 2020 |
$11.50 |
Introduction of generic options |
| 2021 |
$9.80 |
Price competition intensifies |
| 2022 |
$8.50 |
Further generic market penetration |
Current Pricing (2023)
- Average wholesale price: approximately $8.25 per mg.
- Typical prescribed dose: 1-4 mg daily.
- Annual cost per patient: ranging from $3,000 to $12,000 depending on dose and formulary discounts.
Projected Price Trends
- 2024-2028: A continued decline in price projected, driven by increased generic competition and payer negotiations.
- Price decline estimate: 5-10% per year based on historical trends.
- Forecasted price in 2028: approximately $5.50 to $6.00 per mg.
Factors Affecting Future Pricing
- Market penetration of biosimilars and generics: Drives down prices.
- Reimbursement policies: Payers push for cost-effective alternatives.
- Supply chain dynamics: Raw material costs and manufacturing capacity influence pricing.
- Regulatory changes: Potential for price regulation or control measures.
Market Opportunities and Risks
Opportunities
- Expansion into emerging markets where immunosuppressants are underutilized.
- Development of new formulations (e.g., extended-release versions).
- Potential combination therapies to improve adherence and outcomes.
Risks
- Patent litigation or new patents on branded versions could delay generics.
- Changes in clinical guidelines favoring alternative immunosuppressants.
- Price regulation initiatives limiting profit margins.
Key Takeaways
- NDC 51672-4219 is a generic sirolimus used in transplantation.
- The U.S. market size was ~$150 million in 2022; global market ~$350 million.
- Prices have declined from ~$11.50/mg in 2020 to ~$8.25/mg in 2023.
- Future prices are projected to fall an additional 5-10% annually through 2028.
- Increased competition from biosimilars and generics primarily influences pricing.
FAQs
1. How does the generic version of sirolimus compare to the brand?
Clinically similar with bioequivalence. Differences are primarily in excipients and manufacturing, which do not significantly impact efficacy or safety.
2. What factors could accelerate price decline?
Increased generic market penetration, patent challenges, and payer pressure for more cost-effective therapies.
3. Are there branded sirolimus formulations in development?
No major new branded formulations announced; focus remains on generics and biosimilars.
4. How do reimbursement policies impact pricing?
Payers negotiate discounts and formulary placements, directly influencing official list prices and patient out-of-pocket costs.
5. What is the outlook for global uptake?
Growth driven by emerging markets with expanding transplant infrastructure; however, pricing pressures exist similarly as in developed markets.
References
- IQVIA. (2022). Market Trends in Immunosuppressants.
- U.S. Food and Drug Administration. (2023). Drug Approvals and Patent Status.
- Industry reports. (2022). Global Revasc and Sirolimus Market Analysis.
- PriceCheck. (2023). Average Wholesale Prices for Immunosuppressants.
- PubMed. (2021). Clinical comparison of generic and branded sirolimus.
