Last updated: February 22, 2026
What is the Drug NDC 49884-0563?
NDC 49884-0563 corresponds to Prograf (tacrolimus), manufactured by Astellas Pharma. It is an immunosuppressant used primarily to prevent organ rejection post-transplantation. The drug is available in various formulations, predominantly as a capsule and an injectable form.
Market Overview
Market Size and Demand
- Prevalence of Organ Transplants: In the U.S., approximately 40,000 solid organ transplants occur annually.[1]
- Use of Tacrolimus: It is a first-line immunosuppressant used in 70-80% of kidney, liver, and cardiac transplant recipients.[2]
- Estimations: The global tacrolimus market was valued at approximately USD 2.1 billion in 2021.[3]
Competitive Landscape
Regulatory Status
- The FDA approved tacrolimus formulations from multiple generics in 2014-2016.
- Pricing regulation: Medicare and private payers heavily influence pricing dynamics.
Price Trends and Projections
Historical Price Trends
| Year |
Average Retail Price (USD) per 5mg capsule |
Notes |
| 2014 |
$15.00 |
Post-patent expiry; initial generic entry |
| 2018 |
$8.50 |
Increased generic competition |
| 2021 |
$8.20 |
Market stabilization |
Current Pricing (2023)
The average retail price for a 5mg tacrolimus capsule ranges from USD 7.50 to USD 8.50 across major pharmacy chains. The price is influenced by manufacturer, formulation (brand vs. generic), and pharmacy discounts.
Future Price Projections (2024-2028)
| Year |
Predicted Price Range (USD) for 5mg capsule |
Assumptions |
| 2024 |
$7.20 - $8.00 |
Slight increase due to inflation and supply chain factors |
| 2025 |
$7.00 - $7.80 |
Further generic market penetration, price stabilization |
| 2026 |
$6.80 - $7.60 |
Potential entry of biosimilar formulations |
| 2027 |
$6.70 - $7.30 |
Market normalization, reduced manufacturing costs |
| 2028 |
$6.50 - $7.00 |
Price convergence across manufacturers |
Factors Likely to Influence Price Trajectory
- Patent expirations and increased generic competition.
- Introduction of biosimilars that could lower prices further.
- Regulatory changes impacting reimbursement policies.
- Supply chain disruptions (e.g., raw material costs, geopolitical factors).
- Increased demand in emerging markets, which may temporarily support higher price points.
Regulatory and Policy Impact
- U.S. policies regulate drug pricing through Medicare Part D and Medicaid programs, exerting downward pressure on prices.
- Interchangeability regulations by the FDA can facilitate easier substitution of generics, accelerating price decline.
- Global variations exist, with some markets maintaining higher prices due to less regulation or patent protections.
Market Entrant and Innovation Outlook
- Biosimilars and generics dominate market growth.
- Innovative formulations (e.g., modified-release capsules) have limited impact on pricing but may improve patient adherence.
- Lack of new therapeutic indications restrains significant price increases.
Key Takeaways
- The original patent for tacrolimus (NDC 49884-0563) expired over a decade ago, leading to widespread generic availability.
- Market prices have stabilized around USD 7.50-8.50 per 5mg capsule as of 2023.
- Price projections suggest a gradual decline to approximately USD 6.50-7.00 by 2028.
- Competitive pressures, regulatory environments, and biosimilar entries will continue to drive downward price trends.
- The market remains sizable, with steady demand driven by organ transplant procedures and expanding indications.
FAQs
1. What factors could cause a sudden increase in tacrolimus prices?
Supply chain disruptions, patent litigations, or restrictions on generic manufacturing could temporarily increase prices.
2. How does biosimilar entry affect tacrolimus pricing?
Biosimilars typically lower prices due to competition, especially in markets with supportive regulatory pathways.
3. Are there significant regional differences in tacrolimus pricing?
Yes. Prices tend to be higher in regions with less regulatory oversight and less competition, such as parts of Asia and Latin America.
4. Will new formulations alter the market size?
Limited impact is expected unless they significantly improve clinical outcomes or patient compliance.
5. How does insurance coverage influence retail prices?
Insurance, co-pay assistance, and formularies significantly affect patient out-of-pocket costs but have less impact on list prices.
References
- United States Organ Transplant Data. (2022). Organ Procurement and Transplantation Network (OPTN).
- Kamali, F. (2020). Tacrolimus in transplantation. British Journal of Clinical Pharmacology, 86(2), 255-257.
- MarketsandMarkets. (2022). Tacrolimus Market by Application and Region.
- U.S. Food and Drug Administration. (2018). Product approval information.
