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Last Updated: December 22, 2024

Isoniazid; rifampin - Generic Drug Details


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What are the generic sources for isoniazid; rifampin and what is the scope of patent protection?

Isoniazid; rifampin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and Hikma Intl Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for isoniazid; rifampin
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 52
Patent Applications: 19
DailyMed Link:isoniazid; rifampin at DailyMed
Recent Clinical Trials for isoniazid; rifampin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tuberculosis Trials ConsortiumPhase 2/Phase 3
First Affiliated Hospital of Zhejiang UniversityPhase 3
Instituto de Salud Carlos IIIPhase 4

See all isoniazid; rifampin clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for isoniazid; rifampin

US Patents and Regulatory Information for isoniazid; rifampin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us RIFAMATE isoniazid; rifampin CAPSULE;ORAL 061884-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Intl Pharms RIFAMPIN AND ISONIAZID isoniazid; rifampin CAPSULE;ORAL 065221-001 Jul 29, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Isoniazid; rifampin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isoniazid and Rifampin

Introduction to Isoniazid and Rifampin

Isoniazid and rifampin are two crucial antibiotics in the treatment of tuberculosis (TB), a global health concern. Understanding their market dynamics and financial trajectories is essential for pharmaceutical companies, healthcare providers, and policymakers.

Market Overview of Isoniazid

Market Growth and Projections

The isoniazid market is anticipated to grow at a significant Compound Annual Growth Rate (CAGR) between 2023 and 2031. This growth is driven by several factors, including the rising geriatric population and the increasing prevalence of chronic diseases, which often make individuals more susceptible to TB[4].

Market Segmentation

The isoniazid market is segmented based on type (above 98% isoniazid and below 98% isoniazid) and end-user/application (hospitals, clinics, and others). This segmentation helps in understanding the diverse needs of different healthcare settings and the quality standards required for the drug[4].

Regional Analysis

The market is analyzed across major regions such as North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics and growth opportunities[4].

Market Dynamics of Isoniazid

Drivers

  • Government Initiatives: Increased government efforts to enhance healthcare facilities and combat TB are propelling the market growth.
  • Rising Demand: The growing need for effective TB treatments, especially in regions with high TB prevalence, drives the demand for isoniazid[4].

Restraints

  • Stringent Regulations: Strict regulatory requirements can hinder the market growth by imposing rigorous standards on drug manufacturing and approval.
  • Lack of Skilled Personnel: The shortage of skilled healthcare professionals with technical knowledge can limit the effective use and distribution of isoniazid[4].

Financial Trajectory of Isoniazid

Market Size and Forecast

The isoniazid market size is expected to increase significantly from 2023 to 2031, with a projected market size in the millions of US dollars. Historical data from 2021 to 2022 and forecast data up to 2031 provide a comprehensive financial outlook[4].

Key Players and Strategies

Companies involved in the isoniazid market are adopting various growth strategies, including product launches, approvals, partnerships, and acquisitions. These strategies help in expanding their business and customer base, contributing to the overall market growth[4].

Market Overview of Rifampin

Global Market for Rifampin-Containing FDCs

The global market for rifampicin-containing fixed-dose combination (FDC) tablets is substantial, with an estimated potential market of 305 million tablets per year. This includes 105 million tablets in the public sector and 200 million in the private sector[1].

Clinical Significance

Rifampin is a critical drug in TB treatment, especially for its effectiveness against active TB and latent TB infection (LTBI). Its use is recommended by global health organizations like the World Health Organization (WHO)[2].

Market Dynamics of Rifampin

Drivers

  • WHO Recommendations: The WHO's recommendation for the use of rifampin-containing FDCs for TB treatment drives the demand for these formulations.
  • Clinical Efficacy: Rifampin's superior efficacy in treating LTBI, with higher treatment completion rates and better tolerance compared to isoniazid, increases its market demand[2].

Challenges

  • Resistance Concerns: The development of rifampin resistance has serious clinical implications, necessitating careful use and monitoring to prevent multidrug-resistant TB[2].
  • Regulatory and Cost Factors: The cost and regulatory hurdles associated with producing and distributing rifampin-containing FDCs can affect market dynamics[1].

Financial Trajectory of Rifampin

Market Potential

The potential global market for rifampin-containing FDCs indicates a significant financial opportunity for pharmaceutical manufacturers. Encouraging manufacturers to produce these FDCs at affordable prices can help tap into this market[1].

Research and Development

Investments in research to optimize rifampin doses and treatment regimens, such as the use of high-dose rifampin to shorten treatment duration, can also impact the financial trajectory by reducing treatment costs and improving patient outcomes[3].

Regional and Global Impact

Global Health Initiatives

Global health initiatives aimed at eliminating TB rely heavily on the effective use of isoniazid and rifampin. These initiatives drive the demand for these drugs and influence their market dynamics[2].

Economic Impact

The economic impact of TB treatment extends beyond the cost of drugs. Effective treatment regimens that include isoniazid and rifampin can reduce the economic burden on healthcare systems and improve patient productivity[2].

Key Takeaways

  • Growing Demand: Both isoniazid and rifampin markets are expected to grow due to increasing global efforts to combat TB.
  • Regulatory and Resistance Challenges: Stringent regulations and the risk of drug resistance are key challenges that need to be addressed.
  • Financial Opportunities: Significant financial opportunities exist for pharmaceutical manufacturers, especially in producing affordable FDCs.
  • Research and Development: Ongoing research to optimize treatment regimens and doses can improve patient outcomes and reduce treatment costs.

Frequently Asked Questions (FAQs)

1. What is the projected growth rate of the isoniazid market?

The isoniazid market is projected to grow at a significant CAGR between 2023 and 2031, driven by the rising geriatric population and increasing chronic diseases[4].

2. Why is rifampin crucial in TB treatment?

Rifampin is crucial due to its high efficacy in treating both active TB and LTBI, with better tolerance and higher treatment completion rates compared to isoniazid[2].

3. What are the challenges associated with rifampin use?

The main challenges include the risk of developing rifampin resistance, which has serious clinical implications, and the need for careful use and monitoring[2].

4. How does the WHO influence the market for rifampin-containing FDCs?

The WHO's recommendations for using rifampin-containing FDCs drive the demand for these formulations and encourage pharmaceutical manufacturers to produce them at affordable prices[1].

5. What is the impact of high-dose rifampin on TB treatment?

High-dose rifampin can shorten the treatment duration and prevent disease relapse by effectively eradicating persistent bacteria, as demonstrated in studies using the Cornell mouse model[3].

Cited Sources:

  1. Estimate of the global market for rifampicin-containing fixed-dose combination tablets - PubMed.
  2. Responsible use of rifampin for the treatment of latent tuberculosis infection - Canadian Medical Association Journal.
  3. Optimal doses of rifampicin in the standard drug regimen to shorten treatment duration - Journal of Antimicrobial Chemotherapy.
  4. Isoniazid Market Dynamics 2021-2031 - The Insight Partners.

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