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Last Updated: January 1, 2026

Drug Price Trends for NDC 46122-0743


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Best Wholesale Price for NDC 46122-0743

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
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Market Analysis and Price Projections for NDC 46122-0743

Last updated: August 2, 2025


Introduction

The pharmaceutical landscape is constantly evolving, influenced by regulatory changes, patent statuses, competition, and market demand. This analysis explores the market dynamics and projected pricing for the drug identified by NDC 46122-0743, focusing on its therapeutic class, market positioning, competitive environment, and outlook over the coming years.


Drug Overview & Therapeutic Classification

NDC 46122-0743 corresponds to "Immunosuppressant Therapy"—specifically, Tacrolimus in its formulation and delivery form. Tacrolimus is a calcineurin inhibitor primarily used to prevent organ rejection in transplant recipients and for certain autoimmune conditions. It operates by suppressing T-cell activation, offering a high level of efficacy in transplant medicine.

The drug's primary indications include:

  • Liver, kidney, and heart transplantation
  • Autoimmune disorders such as severe atopic dermatitis or Crohn's disease (off-label uses)

Formulation specifics: The NDC suggests a specific manufacturer’s formulation, most likely branded or generic, with particular delivery mechanisms (capsules, solutions).


Market Landscape and Size

Global Pharmaceutical Market Overview

The global immunosuppressant market was valued at approximately $6 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5-6% over the next five years [1]. Growth drivers include increasing prevalence of organ transplantation, rising autoimmune disease incidence, and expanding healthcare access in emerging markets.

Key Market Drivers for Tacrolimus

  • Increasing transplantation procedures: The number of kidney, liver, and heart transplants worldwide is expanding, with over 50,000 transplants annually globally [2].
  • Chronic autoimmune conditions: The surge in autoimmune diseases necessitating long-term immunosuppressants.
  • Patent expirations and generics: Original branded formulations like Prograf (by Astellas) face patent expiration, paving the way for generics, increasing market competition but also broadening access.
  • Reimbursement landscape: Favorable reimbursement policies in developed nations support continued utilization.

Market Share and Competitive Dynamics

The market for tacrolimus is highly competitive, with key players including:

  • Astellas Pharma (original patent holder, branded Prograf)
  • Torrent Pharmaceuticals, Sagent Pharma (generic manufacturers)
  • Other regional generics producing tacrolimus formulations

The branded drug commands premium pricing, whereas generics are significantly cheaper, affecting overall market revenues.

Regional Variations

  • North America: Dominates the market, accounting for roughly 40-45% of global sales due to advanced healthcare infrastructure and high transplant volumes.
  • Europe: About 30-35%, with substantial transplant rates.
  • Asia-Pacific: Fastest growth rate, driven by increasing healthcare access and transplant procedures, expected to grow at 7-8% CAGR.

Pricing Analysis

Current Pricing Landscape

  • Branded Tacrolimus (Prograf): Average wholesale acquisition cost (WAC) ranges from $1,200 to $1,800 per month [3].
  • Generic Tacrolimus: WAC can be as low as $150 to $300 per month, significantly reducing medication costs and increasing adherence.

Pricing varies based on formulation, dosage strength, supply chain, and regional regulations. Insurance and reimbursement programs further influence out-of-pocket costs.

Factors Impacting Price Trends

  • Patent expirations: The patent for Prograf expired in 2018 in the U.S., leading to a surge in generic options.
  • Regulatory policies: Governments promoting generics to reduce healthcare costs are likely to sustain downward pressure on prices.
  • Market entry of biosimilars: Although biosimilar versions of tacrolimus are under development, their impact on pricing remains uncertain.

Projected Price Evolution (Next 5 Years)

  • Branded formulations: Prices likely to stabilize or slightly decline by 5-8% annually due to generic competition and cost-containment measures.
  • Generics and biosimilars: Expect continued price erosion, with some formulations dropping to $100-$200 per month by 2028.
  • Market segmentation influence: In regions with limited regulation, prices may remain higher, bolstered by less competitive pressure.

Regulatory and Reimbursement Outlook

Regulatory bodies such as the FDA and EMA have streamlined approval pathways for generics and biosimilars, encouraging market penetration and price reductions. Reimbursement policies are increasingly tied to value-based care models, incentivizing providers to prefer cost-effective options. These factors will influence future pricing strategies, especially for non-branded versions.


Market Challenges and Opportunities

Challenges:

  • Patent litigation: Ongoing patent disputes may delay generic entry or influence pricing.
  • Supply chain disruptions: Manufacturing constraints and raw material shortages, especially amid geopolitical tensions, can affect availability and pricing.
  • Drug shortages: Tacrolimus has experienced shortages in some regions, which temporarily increase prices.

Opportunities:

  • Emerging markets: Growing transplant procedures and autoimmune treatments provide expansion avenues.
  • Biosimilar development: Introduction of biosimilar tacrolimus products can alter market dynamics.
  • Personalized medicine: Advances in pharmacogenomics may lead to optimized dosing strategies, influencing prescribing patterns and cost structures.

Conclusion and Price Forecast Summary

Aspect Projection / Outlook Rationale
Branded Tacrolimus (Prograf) Moderate price decline (~5-8% annually); stabilizing near $1,000-$1,200/month by 2028 Patent expiration, generic competition, regulatory pressure
Generic Tacrolimus Significant price reduction (~20-30% within 3 years); stabilizing near $100-$200/month Market saturation, regulatory policies, biosimilar competition
Regional variations Higher prices in emerging markets offset by increased access in developed regions Regulatory environments and healthcare infrastructure influence pricing

In summary, the tacrolimus market is characterized by strong growth, driven by transplantation needs and autoimmune conditions, with rapid price declines expected due to patent expirations and generics' proliferation.


Key Takeaways

  • Market Expansion: The global immunosuppressant market is poised for steady growth, fueled by transplant procedures and autoimmune disease management.

  • Pricing Trends: Expect significant downward pressure on tacrolimus prices over the next five years, especially for generic formulations, with branded drugs maintaining premium pricing initially before gradual reductions.

  • Competitive Environment: Market entry of biosimilars and generics will intensify competition, further compressing profit margins for branded products.

  • Regulatory Impact: Policies favoring generic substitution and biologic biosimilars are central to price dynamics, influencing both manufacturing strategies and healthcare budgets.

  • Strategic Implications: Stakeholders should focus on regional regulatory trends, reimbursement landscape, and biosimilar development to optimize pricing strategies and market positioning.


FAQs

1. What factors influence the pricing of tacrolimus (NDC 46122-0743)?
Drug pricing is affected by patent status, manufacturing costs, competition from generics and biosimilars, regulatory policies, and regional reimbursement schemes.

2. How will generic competition impact future prices for tacrolimus?
The entry and proliferation of generics are expected to lower prices significantly, making treatment more affordable while reducing revenue for branded manufacturers.

3. Are biosimilars a threat to the tacrolimus market?
Yes, biosimilars could further drive down prices and increase accessibility, although their market penetration depends on regulatory approval and physician acceptance.

4. Which regions are expected to see the fastest growth in tacrolimus demand?
The Asia-Pacific region is projected to experience the fastest growth due to expanding healthcare infrastructure and increasing transplant procedures.

5. How might regulatory changes affect the market outlook?
Regulatory acceleration for biosimilars and generics, along with policies promoting cost containment, will likely accelerate price decreases and market expansion.


References

[1] Grand View Research. Immunosuppressant Market Size, Share & Trends. 2022.
[2] International Society for Heart and Lung Transplantation. Transplant Statistics. 2022.
[3] SSR Health. Prescription Drug Data. 2022.

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