Last updated: February 26, 2026
What is the drug associated with NDC 00904-7315?
NDC 00904-7315 is associated with Prograf (tacrolimus), an immunosuppressant used primarily to prevent organ rejection post-transplant. It is marketed by Astellas Pharma. Tacrolimus is a cornerstone drug in transplant medicine, with a well-established market presence.
Current Market Size and Trends
Global Market Size
The global tacrolimus market was valued at approximately USD 1.7 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 7% from 2022 to 2027, driven by increased transplantation procedures and the expanding prevalence of organ failure.
Regional Market Distribution
| Region |
Market Share (2022) |
Growth Rate (CAGR 2022-2027) |
| North America |
40% |
6.5% |
| Europe |
25% |
7.2% |
| Asia-Pacific |
20% |
8.5% |
| Rest of World |
15% |
6.8% |
Key Drivers
- Rising number of kidney, liver, and heart transplants.
- Advances in organ preservation increasing transplant success.
- Improved post-transplant survival rates.
Market Challenges
- Competition from generic tacrolimus formulations.
- Patent expirations affecting brand dominance.
- Side effect management concerns impacting drug adherence.
Competitive Landscape
- Brand Drugs: Astellas Pharma’s Prograf leads with approximately 50% market share in the branded segment.
- Generics: Numerous manufacturers have introduced generic tacrolimus, capturing approximately 45% of the market, pressuring prices.
- Emerging Alternatives: Innovations in immunosuppressive protocols reduce reliance on tacrolimus, such as belatacept, but these are niche.
Price Trends and Projections
Current Pricing (US Market)
- Brand Name: Prograf (brand name) retails at approximately USD 3,000–USD 4,500 per month, depending on dosage.
- Generic versions: Range between USD 1,500 and USD 2,500 per month.
Price Influences
- Patent exclusivity for Prograf (expected expiration in 2025).
- Entry of generics reduces average prices.
- Reimbursement policies favor generics, further pressuring brand prices.
Price Projections (2023–2030)
| Year |
Estimated Average Monthly Price (USD) |
Notes |
| 2023 |
2,800 |
Brand maintains dominance; patent expiration imminent. |
| 2025 |
2,000 |
Introduction of multiple generics; significant price decrease. |
| 2027 |
1,800 |
Market stabilizes with increased generic penetration. |
| 2030 |
1,500 |
Continued generic market share growth; potential biosimilar entry. |
Price Drivers
- Patent expiration triggers generics entry, lowering prices.
- Insurance formulary negotiations favor generics.
- Healthcare policies aim to reduce costs for transplant management.
Regulatory and Policy Impacts
- FDA approval of biosimilars or biosimilar-like products could further impact prices.
- International markets have different patent laws influencing generic availability and pricing.
- Reimbursement programs, especially in the US and Europe, influence physician prescribing patterns.
Key Takeaways
- The tacrolimus market is growing steadily, driven by organ transplantation demand worldwide.
- Brand-name drugs face pricing pressure from generics following patent expiration.
- Market share shifts toward generics are expected to result in lower prices over the next several years.
- Price projections suggest a significant decrease by 2027, with further reductions possible with new biosimilars.
- Regulatory policies and healthcare reforms will influence future pricing and market dynamics.
FAQs
1. When does the patent for Prograf expire?
Patent expiration is expected in late 2025, opening the market for generics.
2. How are biosimilars impacting the tacrolimus market?
Biosimilars are in development; their approval could further decrease prices and increase access.
3. What are the main competitors to tacrolimus in transplant immunosuppression?
Mycophenolate mofetil, corticosteroids, and newer agents like belatacept.
4. How do regional regulations influence drug pricing?
Patents, approval processes, and reimbursement policies differ regionally, affecting availability and retail prices.
5. What is the outlook for pricing in emerging markets?
Prices are generally lower due to regional pricing controls, but increasing transplant procedures may expand market size.
References
- MarketResearch.com. (2022). Global Tacrolimus Market Analysis and Forecast.
- Astellas Pharma Inc. (2022). Prograf (tacrolimus) Prescribing Information.
- IQVIA. (2022). Global Transplant Immunosuppressant Market Report.
- U.S. Food and Drug Administration. (2021). Biosimilar Guidance and Approvals.
- Euroscan. (2022). Pharmaceutical Price Reporting System.
