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Last Updated: December 22, 2024

RIFAMPIN AND ISONIAZID Drug Patent Profile


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When do Rifampin And Isoniazid patents expire, and when can generic versions of Rifampin And Isoniazid launch?

Rifampin And Isoniazid is a drug marketed by Hikma Intl Pharms and is included in one NDA.

The generic ingredient in RIFAMPIN AND ISONIAZID is isoniazid; rifampin. There are five drug master file entries for this compound. Additional details are available on the isoniazid; rifampin profile page.

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Summary for RIFAMPIN AND ISONIAZID
Drug patent expirations by year for RIFAMPIN AND ISONIAZID
Recent Clinical Trials for RIFAMPIN AND ISONIAZID

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SponsorPhase
Tuberculosis Trials ConsortiumPhase 2/Phase 3
First Affiliated Hospital of Zhejiang UniversityPhase 3
Miguel SantínPhase 4

See all RIFAMPIN AND ISONIAZID clinical trials

US Patents and Regulatory Information for RIFAMPIN AND ISONIAZID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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

RIFAMPIN AND ISONIAZID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rifampin and Isoniazid

Introduction

Rifampin and isoniazid are two of the most critical antibiotics in the treatment and prevention of tuberculosis (TB), a global health concern. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, healthcare providers, and policymakers.

Global Market for TB Treatment

The global market for TB treatment, particularly for rifampin and isoniazid, is influenced by several factors, including the prevalence of TB, treatment guidelines, and market segmentation.

Prevalence of TB

TB remains a significant health issue worldwide, with millions of new cases reported annually. The World Health Organization (WHO) and other global health authorities recommend the use of fixed-dose combination (FDC) tablets that include rifampin, isoniazid, pyrazinamide, and ethambutol for the treatment of TB. This recommendation drives the demand for these drugs[1].

Treatment Guidelines

WHO and other health organizations advocate for the use of FDCs to improve treatment adherence and reduce the risk of drug resistance. Despite these recommendations, more than 75% of rifampicin used in the public sector is still administered as single-drug tablets, indicating a significant potential market for FDCs[1].

Market Segmentation

The market for rifampin and isoniazid can be segmented into public and private sectors, as well as by region.

Public Sector

The public sector market is driven by government health programs and international aid. The potential global market for four-drug FDC tablets in the public sector is substantial, with estimates suggesting 105 million tablets per year could be distributed in this sector[1].

Private Sector

The private sector market, while smaller, is still significant, with an estimated 200 million tablets per year. This sector is influenced by private healthcare providers and patient preferences[1].

Regional Market Analysis

The market for rifampin and isoniazid varies by region due to differences in TB prevalence, healthcare infrastructure, and economic conditions.

Asia-Pacific

The Asia-Pacific region, which includes countries like India and China, has a high prevalence of TB and thus a large market for these drugs. Government initiatives and international aid programs are key drivers in this region[4].

North America and Europe

In these regions, the market is smaller due to lower TB prevalence but is still significant, particularly in urban areas with high immigrant populations. Here, the private sector plays a more prominent role[4].

Middle East and Africa

These regions face challenges related to healthcare infrastructure and funding, but there is still a considerable demand for TB treatments. International aid and government programs are crucial in these areas[4].

Financial Trajectory

Market Size and Growth

The isoniazid market, which is closely tied to the rifampin market, is projected to grow at a significant CAGR between 2023 and 2031. The market size is expected to increase from US$ XX million in 2023 to US$ XX million by 2031[4].

Cost-Effectiveness Analysis

Studies have shown that different treatment regimens for latent TB infection have varying cost-effectiveness profiles. For instance, a 2-month regimen of rifampin and pyrazinamide is generally more expensive than a 9-month regimen of isoniazid but offers better treatment completion rates and lower adverse event rates[2][3].

Treatment Costs

The total costs of therapy are significantly higher for isoniazid when used for 9 months compared to a 4-month rifampin regimen. This cost difference is a critical factor in the financial trajectory of these drugs, especially in resource-limited settings[3].

Drivers and Restraints

Drivers

  • Government Initiatives: Increased government efforts to enhance healthcare facilities and combat TB drive the demand for rifampin and isoniazid.
  • Rising Geriatric Population: The growing geriatric population, which is more susceptible to TB, boosts the market for these drugs[4].
  • Global Health Programs: International aid and global health programs aimed at eradicating TB contribute to the market growth.

Restraints

  • Stringent Regulations: Strict regulatory requirements can hinder the production and distribution of these drugs.
  • Lack of Skilled Personnel: The shortage of skilled healthcare workers, especially in developing countries, can limit market growth[4].

Competitive Landscape

The market for rifampin and isoniazid is competitive, with several key players involved in the production and distribution of these drugs.

Market Players

Companies such as Sanofi, Johnson & Johnson, and other generic drug manufacturers are active in this market. These companies focus on organic growth strategies like product launches and inorganic strategies such as acquisitions and partnerships to expand their market share[4].

Conclusion

The market for rifampin and isoniazid is driven by the global need to combat TB, with significant potential in both public and private sectors. While there are challenges related to regulatory hurdles and healthcare infrastructure, the overall financial trajectory indicates growth, particularly driven by government initiatives and rising demand.

Key Takeaways

  • The global market for rifampin and isoniazid is substantial, with a potential for 305 million FDC tablets per year.
  • The public sector accounts for a significant portion of the market, driven by government health programs.
  • Regional differences in TB prevalence and healthcare infrastructure influence market dynamics.
  • Cost-effectiveness analysis shows that rifampin regimens can be more effective and less costly in the long run compared to isoniazid.
  • Government initiatives and global health programs are key drivers of market growth.

FAQs

What is the estimated global market size for rifampin-containing FDCs?

The potential global market for the four-drug FDC tablet is estimated to be 305 million tablets per year, with 105 million in the public sector and 200 million in the private sector[1].

Which regions have the highest demand for rifampin and isoniazid?

The Asia-Pacific region, particularly countries like India and China, has a high demand due to the high prevalence of TB[4].

How do the costs of rifampin and isoniazid regimens compare?

A 4-month rifampin regimen is generally less costly and has better treatment completion rates compared to a 9-month isoniazid regimen[3].

What are the main drivers of the market for rifampin and isoniazid?

Government initiatives, rising geriatric population, and global health programs are the main drivers of the market[4].

What are the restraints to the market growth of rifampin and isoniazid?

Stringent regulations and the lack of skilled healthcare personnel are significant restraints to market growth[4].

Sources

  1. Estimate of the global market for rifampicin-containing fixed-dose combination tablets. PubMed.
  2. Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection. Oxford Academic.
  3. Treatment completion and costs of a randomized trial of rifampin for 4 months versus isoniazid for 9 months. PubMed.
  4. Isoniazid Market Dynamics 2021-2031. The Insight Partners.
  5. Rifampin and Pyrazinamide vs Isoniazid for Prevention of Tuberculosis in HIV-Infected Persons. JAMA Network.

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