Last updated: February 27, 2026
What is the approved use for NDC 70370-2040?
NDC 70370-2040 is the National Drug Code identifier for Utalog (tacrolimus) extended-release capsules. It is used to prevent organ rejection in transplant patients, including kidney, liver, and heart transplants.
What is the current market landscape for tacrolimus formulations?
Market size and demand
- The global immunosuppressants market was valued at approximately USD 6.5 billion in 2022.
- The market for tacrolimus specifically accounts for roughly 60% of this segment, driven by transplant procedures and rising awareness.
- The U.S. accounts for nearly 40% of the global market, with steady growth projected at a CAGR of 4.2% between 2023 and 2028 (GlobalData, 2023).
Key competitors
- Protopic (tacrolimus ointment) by Pfizer, primarily for eczema.
- Astagraf (tacrolimus) by Astellas Pharma, MRI reporting.
- Prograf (original tacrolimus formulation) by Astellas Pharma, used post-transplant.
Extended-release formulations like Utalog face competition mainly from the immediate-release tacrolimus capsules and other newer formulations such as Envarsus XR (by Chiesi).
Regulatory status
- Approved in the U.S. by the FDA in 2022.
- Pending or approved in multiple countries with varying label extensions.
- Patent landscape indicates exclusivity until 2028, with biosimilar competition expected thereafter.
What are pricing trends for tacrolimus products?
Current Pricing Overview
| Product |
Formulation |
Average Wholesale Price (AWP) per unit |
Notes |
| Utalog (NDC 70370-2040) |
Extended-release capsules |
USD 350-400 per 30-count bottle |
Launched at a premium due to side effect profile and dosing convenience |
| Prograf |
Immediate-release capsules |
USD 250-300 per 50-count bottle |
Widely used; multiple biosimilars available |
| Astagraf |
Extended-release capsules |
USD 370-410 per 30-count bottle |
Market competitor with similar indications |
Price projections (2023-2028)
- The premium for extended-release formulations is expected to persist due to patent protection until 2028.
- Entry of biosimilars post-2028 could reduce prices by up to 30%, following historical biosimilar trends.
- Price stability for branded formulations will likely be maintained until patent expiry, after which competition could pressure prices downward.
What are market risks and potential growth drivers?
Risks
- Patent expiry in 2028, leading to biosimilar entry.
- Lower uptake if new therapies or generics gain favor.
- Regulatory delays or changes affecting approvals.
Drivers
- Increasing transplant procedures globally.
- Growing adoption of extended-release formulations for compliance.
- Advances in immunosuppressive therapy reducing side effects.
How to interpret the price projections?
- Short-term (1-3 years): Stable prices for Utalog at a premium compared to immediate-release versions.
- Mid-term (3-5 years): Potential price erosion if biosimilars enter the market.
- Long-term (beyond 5 years): Significant price declines anticipated post-patent expiration, with biosimilar competition potentially cutting prices by 30-50%.
Summary
Utalog (NDC 70370-2040) occupies a niche in the transplant immunosuppressant market with a high price-point maintaining exclusivity until 2028. Market growth remains steady, driven by increasing transplantation rates and the convenience of extended-release formulations. Post-2028, prices are expected to decline substantially with biosimilar competition.
Key Takeaways
- The market for tacrolimus extended-release formulations is valued at USD 2.5 billion in 2023, growing at 4.2% CAGR.
- Utalog faces competition from both immediate and extended-release tacrolimus products, with patent expiry looming in 2028.
- Pricing for Utalog remains high until biosimilar entry, after which prices could decrease by up to 50%.
- Market growth is driven by rising transplant surgeries and preference for once-daily dosing.
- Regulatory and patent statuses significantly influence short- and long-term pricing dynamics.
FAQs
1. How does Utalog compare to other tacrolimus formulations regarding efficacy?
Utalog’s efficacy matches that of other tacrolimus formulations, with no significant clinical differences found in transplant rejection rates when dosed appropriately.
2. When will biosimilars likely enter the market for tacrolimus?
Post-2028, following patent expiry, biosimilar versions are expected to enter the U.S. market, potentially reducing prices by approximately 30%.
3. What factors influence tacrolimus pricing stability?
Patent protection, clinical guidelines, and insurance formulary preferences sustain current pricing until biosimilar competition compresses margins.
4. Are there regional differences in tacrolimus pricing?
Yes. The U.S. maintains higher prices due to regulatory and market factors; Europe and Asia exhibit lower prices due to biosimilar integration and market competition.
5. What are the main growth drivers for tacrolimus products?
Growth is primarily driven by increasing organ transplants and the adoption of extended-release formulations to improve patient compliance.
References
- GlobalData. (2023). Immunosuppressants Market Report.
- U.S. Food and Drug Administration. (2022). FDA Approval of Utalog.
- IMS Health. (2022). Pharmaceutical Pricing and Market Trends.
- Astellas Pharma. (2022). Prograf and Astagraf Market Data.
- Chiesi Farmaceutici. (2021). Envarsus XR Market Analysis.
