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Last Updated: December 22, 2024

RIFAMATE Drug Patent Profile


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When do Rifamate patents expire, and what generic alternatives are available?

Rifamate is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in RIFAMATE 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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US Patents and Regulatory Information for RIFAMATE

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

RIFAMATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rifampicin: A Comprehensive Analysis

Introduction

Rifampicin, a crucial antibiotic in the treatment of tuberculosis (TB), is part of the rifamycin family and is widely used in conjunction with other medications. This article delves into the market dynamics and financial trajectory of rifampicin, highlighting its global demand, pricing trends, and the economic viability of its use in various treatment regimens.

Global Market for Rifampicin-Containing Formulations

The global market for rifampicin-containing fixed-dose combinations (FDCs) is substantial. A study estimated that the potential global market for a four-drug FDC tablet (including rifampicin, isoniazid, pyrazinamide, and ethambutol) could reach 305 million tablets per year, with significant distribution in both public and private sectors[1].

Demand and Prevalence of Tuberculosis

The demand for rifampicin is driven by the prevalence of tuberculosis, particularly in low- and middle-income countries. The global TB drugs market is expected to grow from USD 1.41 billion in 2023 to USD 2.41 billion by 2032, with a CAGR of 6.10% during the forecast period (2024–2032)[4].

Pricing Trends and Factors Influencing Prices

Recent Price Movements

The price of rifampicin has seen significant fluctuations, especially since the COVID-19 pandemic. In the first half of 2023, rifampicin prices surged due to increased demand and disrupted supply chains. The prices have doubled compared to pre-pandemic levels, primarily driven by the rise in raw material active pharmaceutical ingredient (API) costs, particularly from China and India[3].

Government Policies and Market Dynamics

Government initiatives and policies play a crucial role in the pricing and availability of rifampicin. For instance, the capping of drug prices in India to make them more affordable for the general public led to a downfall in the pharmaceutical industry's dynamics and affected the overall price trend of rifampicin[3].

Economic Viability of Rifampicin-Based Regimens

Cost-Effectiveness Analysis

Studies have shown that rifampicin-based regimens can be economically viable, especially when compared to traditional treatment options. For example, a Markov model analysis indicated that a daily isoniazid/rifapentine regimen for one month was cost-saving compared to other options, even with lower efficacy rates. The weekly isoniazid/rifapentine regimen for three months also performed well in terms of cost-effectiveness[2].

Comparison with Standard Therapies

The economic viability of rifampicin-based regimens is often evaluated against standard therapies. For instance, the 3HP-SAT weekly regimen (isoniazid plus rifapentine self-administered once-weekly for three months) was found to be more effective than the standard nine-month isoniazid daily regimen at a cost of $1,415 per quality-adjusted life-year (QALY)[2].

Market Growth Drivers

Increased Healthcare Expenditure

Government initiatives for tuberculosis control programs and increased healthcare expenditure are significant drivers of the rifampicin market. These initiatives boost market growth by ensuring the availability and affordability of TB drugs[3].

Expansion of Pharmaceutical Manufacturing

The expansion of pharmaceutical manufacturing capacities, particularly in regions like Asia, contributes to the market growth of rifampicin. Generic formulations and increased production capacities make rifampicin more accessible and affordable[3].

Regional Market Analysis

Global Market Share

The global TB drugs market is bifurcated into several regions, with North America dominating the market. However, the Asia-Pacific region is expected to be the fastest-growing market due to the high prevalence of TB cases and increasing healthcare expenditure[4].

Regional Pricing Trends

Pricing trends vary across regions, influenced by local demand, government policies, and supply chain dynamics. For example, the prices of rifampicin in India were affected by the capping of drug prices, while global prices were influenced by API costs from China[3].

Challenges and Limitations

Supply Chain Disruptions

Supply chain disruptions, such as those experienced during the COVID-19 pandemic, can significantly impact the availability and pricing of rifampicin. These disruptions can lead to fluctuations in the market and affect the overall financial trajectory of the drug[3].

Multidrug-Resistant Strains

The rise in multidrug-resistant TB strains necessitates the continued use of rifampicin as a treatment option. However, this also presents challenges in terms of maintaining its efficacy and managing resistance[3].

Key Takeaways

  • The global market for rifampicin-containing FDCs is substantial, driven by the prevalence of TB.
  • Pricing trends are influenced by demand, supply chain dynamics, and government policies.
  • Rifampicin-based regimens are economically viable and often more cost-effective than standard therapies.
  • Market growth is driven by increased healthcare expenditure and the expansion of pharmaceutical manufacturing capacities.
  • Regional market dynamics vary, with North America dominating the market and the Asia-Pacific region expected to be the fastest-growing.

FAQs

What is the current global market size for TB drugs?

The global TB drugs market was estimated to be valued at USD 1.41 billion in 2023 and is expected to reach USD 2.41 billion by 2032[4].

How does the COVID-19 pandemic affect the price of rifampicin?

The COVID-19 pandemic led to increased demand and disrupted supply chains, causing rifampicin prices to surge. Prices have doubled compared to pre-pandemic levels due to higher API costs and supply chain disruptions[3].

Are rifampicin-based regimens cost-effective?

Yes, studies have shown that rifampicin-based regimens, such as the daily and weekly isoniazid/rifapentine regimens, are cost-effective compared to standard therapies[2].

What are the main drivers of the rifampicin market?

The main drivers include increased healthcare expenditure, government initiatives for TB control, and the expansion of pharmaceutical manufacturing capacities[3][4].

How do regional market dynamics affect the pricing of rifampicin?

Regional market dynamics, including government policies and local demand, significantly influence the pricing of rifampicin. For example, price capping in India and API costs from China impact global prices[3].

Sources

  1. Estimate of the global market for rifampicin-containing fixed-dose combinations: PubMed, "Estimate of the global market for rifampicin-containing fixed-dose combinations".
  2. Potential Economic Viability of Two Proposed Rifapentine-Based Regimens: PLOS ONE, "Potential Economic Viability of Two Proposed Rifapentine-Based Regimens".
  3. Rifampicin Price Trend, Index, News, Chart, Database: Procurement Resource, "Rifampicin Price Trend, Index, News, Chart, Database".
  4. Tuberculosis (TB) Drugs Market Size, Share and Growth Analysis: Straits Research, "Tuberculosis (TB) Drugs Market Size, Share and Growth Analysis".

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