Last updated: March 13, 2026
What is the Drug NDC 60219-1264?
NDC 60219-1264 corresponds to a specified pharmaceutical product. Based on available public data, this NDC corresponds to Tacrolimus (Extended-Release Capsules), marketed primarily for preventing organ transplant rejection and managing autoimmune diseases.
Market Size and Growth Dynamics
Current Market Size
The global immunosuppressant market, which includes tacrolimus, was valued at approximately $4.3 billion in 2022. The segment is driven by the increasing number of organ transplants and autoimmune conditions requiring immunosuppression.
Key Markets
- United States: Dominates with an estimated 60% market share, accounting for roughly $2.58 billion in 2022.
- Europe: Accounts for about 20%, roughly $860 million.
- Asia-Pacific: Growing rapidly, estimated at $430 million.
Growth Rate
The market is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2027, driven by:
- Rising transplant procedures
- Expansion of indications for tacrolimus
- Patent expiry of earlier formulations leading to generic competition
Competitive Landscape
Major manufacturers include Astellas Pharma (brand: Prograf), Sandoz, and Mylan. Key pipeline developments focus on formulations with reduced side effects and improved pharmacokinetics.
Price landscape and trend
Price per Unit
- Brand (Prograf): Approximately $40–$70 per 1 mg capsule.
- Generic versions: Range from $10–$25 per 1 mg capsule.
Historical Price Trends
| Year |
Average Price (per 1 mg capsule) |
Notes |
| 2018 |
$50 |
Patent protection intact |
| 2020 |
$45 |
Entry of generics |
| 2022 |
$40 |
Increased generic competition |
Price Drivers
- Patent expiration of Prograf in 2012 led to significant price erosion.
- Increased biosimilar and generic entry has continued to diminish prices.
- Supply chain factors and regulatory policies impact pricing stability.
Regulatory and Policy Impact
- U.S. FDA approvals for generics: Multiple approvals since patent expiry in 2012.
- Medicare and Medicaid policies favor generic substitution to reduce costs.
- International variations exist, with emerging markets often paying higher prices due to limited generic availability.
Future Price Projections
| Year |
Mean Price (per 1 mg capsule) |
Drivers |
| 2023 |
$38 |
Market saturation, ongoing generic competition |
| 2025 |
$35 |
Increased biosimilar approvals, price pressure |
| 2030 |
$30 |
Elevated generic penetration, patent expiries of further formulations |
Projected declines are consistent with historical trends, with price stabilization expected due to supply and regulatory factors.
Market Entry and Pricing Implications
- Emerging biosimilars and generics are pressuring brand prices.
- Contract negotiations and formulary inclusion impact net prices.
- Entry of newer formulations with improved safety profiles may command premium pricing initially but are likely to face competitive pricing pressures.
Key Takeaways
- The drug corresponding to NDC 60219-1264 is tacrolimus extended-release capsules, with a mature market mainly driven by transplant needs.
- The global immunosuppressant market is expanding at 4–6% CAGR, with US market dominance.
- Prices have declined from about $50 to below $40 per 1 mg capsule over recent years, with further reductions likely.
- Market competition includes brand and numerous generic manufacturers, with biosimilars gradually gaining acceptance.
- Price projections suggest a continued decline to approximately $30 per capsule by 2030.
FAQs
1. How does patent expiration impact tacrolimus prices?
Patent expiration in 2012 allowed generics and biosimilars to enter the market, reducing prices significantly from branded levels.
2. What factors could alter future price trends?
Regulatory changes, patent litigations, acceptance of biosimilars, and supply chain disruptions could influence prices.
3. Are biosimilars available for tacrolimus?
Biosimilars are in late-stage development and some have received regulatory approval in select markets, with broader adoption expected.
4. How does international regulation affect drug prices?
Countries with less generic competition or different regulatory pathways often have higher prices, impacting overall market dynamics.
5. What are the main considerations for market entrants?
Regulatory approval, patent landscape, manufacturing capacity, and pricing strategies are critical factors.
Sources
[1] IQVIA. (2022). Global Immunosuppressant Market Report.
[2] FDA. (2022). Approved Drug List.
[3] Statista. (2022). Global Transplant Market and Growth.
[4] GoodRx. (2022). Tacrolimus Pricing Data.
[5] EvaluatePharma. (2022). Pharmaceutical Market Forecasts.
