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Last Updated: December 22, 2024

Isoniazid; pyrazinamide; rifampin - Generic Drug Details


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

Isoniazid; pyrazinamide; rifampin is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for isoniazid; pyrazinamide; rifampin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 38
DailyMed Link:isoniazid; pyrazinamide; rifampin at DailyMed
Recent Clinical Trials for isoniazid; pyrazinamide; rifampin

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

SponsorPhase
Tuberculosis Trials ConsortiumPhase 2/Phase 3
Centers for Disease Control and PreventionPhase 2/Phase 3
First Affiliated Hospital of Zhejiang UniversityPhase 3

See all isoniazid; pyrazinamide; rifampin clinical trials

US Patents and Regulatory Information for isoniazid; pyrazinamide; 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 RIFATER isoniazid; pyrazinamide; rifampin TABLET;ORAL 050705-001 May 31, 1994 DISCN Yes 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; pyrazinamide; rifampin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isoniazid, Pyrazinamide, and Rifampin

Introduction to Tuberculosis Treatment

Tuberculosis (TB) is a global health issue, with a significant portion of the world's population either infected or at risk of infection. The primary drugs used in the treatment of TB are isoniazid, pyrazinamide, and rifampin, often administered in combination.

Global Market Overview

The global market for tuberculosis therapeutics is substantial and growing. As of 2023, the market was valued at USD 12.14 billion and is projected to reach USD 24.08 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.9%[4].

Market Segmentation

By Product Type

The market is categorized into several product types, including isoniazid, rifampin, pyrazinamide, hydrazine derivatives, miscellaneous anti-tubercular drugs, and ethambutol. These drugs are the backbone of TB treatment regimens[4].

Demand and Usage

Public and Private Sectors

The demand for these drugs is significant in both the public and private sectors. Despite World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) recommendations to use fixed-dose combination (FDC) tablets, more than 75% of rifampicin used in the public sector is still administered as single-drug tablets. However, the potential global market for FDCs, which include rifampicin, isoniazid, pyrazinamide, and ethambutol, is estimated to be around 305 million tablets per year[1].

Treatment Regimens

The standard treatment regimen for TB typically includes a combination of rifampin, isoniazid, pyrazinamide, and ethambutol. In 2023, 82.6% of patients diagnosed with TB in the United States began treatment with this four-drug regimen[3].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region holds the largest share of the TB therapeutics market, driven by countries such as China, Japan, and India. This region is expected to continue dominating the market due to rising healthcare needs and economic growth[4].

Other Regions

The Middle East and North America are also significant markets, with Western Europe showing moderate growth. Africa, Latin America, and Eastern Europe are anticipated to have moderate growth over the forecast period[4].

Financial Trajectory

Current Market Value

The current market value of TB therapeutics, which includes isoniazid, pyrazinamide, and rifampin, is substantial. The market was valued at USD 12.14 billion in 2023[4].

Future Projections

The market is expected to grow significantly, reaching USD 24.08 billion by 2032. This growth is driven by increasing incidence rates of TB, especially in under-developed and developing regions, and the expanding healthcare infrastructure in these areas[4].

Key Market Players

Several pharmaceutical companies are key players in the TB therapeutics market, including Aventis Pharmaceuticals Limited, Sanofi-Aventis U.S. LLC, Versapharma Incorporated, Sigma Pharmaceutical Pty Limited, Novartis AG, Hoffmann-La Roche Ltd., and Bayer Health Care[4].

Challenges and Opportunities

Challenges

One of the challenges facing the market is the lack of anti-tubercular drugs specifically formulated for children. Additionally, the risk of drug resistance and the need for continuous monitoring of treatment efficacy pose significant challenges[4].

Opportunities

The increasing rate of TB occurrences, particularly in regions with low immune systems and high HIV prevalence, provides lucrative opportunities for market growth. The WHO's 'Directly Observed Treatment, Short Course' (DOTS) program has also contributed to the rapid development of the global TB therapeutics market[4].

Optimal Dosing and Treatment Outcomes

High-Dose Rifampicin

Studies have shown that increasing doses of rifampicin, in combination with isoniazid and pyrazinamide, can lead to faster bacterial clearance and shorter treatment durations. For instance, a rifampicin dose of 30 mg/kg was found to be sufficient to eradicate persistent M. tuberculosis in mice, preventing disease relapse[2].

Safety and Side Effects

Adverse Effects

The combination of rifampin, isoniazid, and pyrazinamide can cause several adverse effects, including blood problems, thrombotic microangiopathy, and liver toxicity. Patients must be monitored closely for these side effects to ensure safe treatment[5].

Conclusion

The market for isoniazid, pyrazinamide, and rifampin is robust and growing, driven by the global need for effective TB treatment. With a projected market value of USD 24.08 billion by 2032, pharmaceutical companies have significant opportunities to invest in these drugs. However, addressing challenges such as drug resistance and the lack of pediatric formulations remains crucial.

Key Takeaways

  • The global TB therapeutics market is valued at USD 12.14 billion in 2023 and is expected to reach USD 24.08 billion by 2032.
  • The Asia Pacific region dominates the market due to high incidence rates and growing healthcare infrastructure.
  • The standard treatment regimen includes rifampin, isoniazid, pyrazinamide, and ethambutol.
  • High-dose rifampicin regimens show promise in shortening treatment durations and preventing relapse.
  • Adverse effects of these drugs necessitate close monitoring.

FAQs

Q: What is the current market value of the TB therapeutics market? A: The current market value of the TB therapeutics market is USD 12.14 billion as of 2023[4].

Q: Which region dominates the TB therapeutics market? A: The Asia Pacific region holds the largest share of the TB therapeutics market[4].

Q: What are the common drugs used in TB treatment regimens? A: The common drugs used are rifampin, isoniazid, pyrazinamide, and ethambutol[3].

Q: What are the potential side effects of rifampin, isoniazid, and pyrazinamide? A: These drugs can cause blood problems, thrombotic microangiopathy, and liver toxicity among other side effects[5].

Q: How does high-dose rifampicin impact TB treatment outcomes? A: High-dose rifampicin can lead to faster bacterial clearance and shorter treatment durations, preventing disease relapse[2].

Sources

  1. Estimate of the global market for rifampicin-containing fixed-dose combination tablets. PubMed.
  2. Optimal doses of rifampicin in the standard drug regimen to shorten treatment duration. Journal of Antimicrobial Chemotherapy.
  3. Tuberculosis Treatment and Case Outcomes. CDC.
  4. Tuberculosis Therapeutics Market Size, Share & Forecast 2032. Zion Market Research.
  5. Rifampin, isoniazid, and pyrazinamide (oral route). Mayo Clinic.

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