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Last Updated: January 5, 2025

Azithromycin dihydrate; trovafloxacin mesylate - Generic Drug Details


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What are the generic sources for azithromycin dihydrate; trovafloxacin mesylate and what is the scope of freedom to operate?

Azithromycin dihydrate; trovafloxacin mesylate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for azithromycin dihydrate; trovafloxacin mesylate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:azithromycin dihydrate; trovafloxacin mesylate at DailyMed

US Patents and Regulatory Information for azithromycin dihydrate; trovafloxacin mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TROVAN/ZITHROMAX COMPLIANCE PAK azithromycin dihydrate; trovafloxacin mesylate FOR SUSPENSION, TABLET;ORAL 050762-001 Dec 18, 1998 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

Azithromycin dihydrate; trovafloxacin mesylate Market Analysis and Financial Projection

Azithromycin Dihydrate and Trovafloxacin Mesylate: Market Dynamics and Financial Trajectory

Introduction

Azithromycin dihydrate and trovafloxacin mesylate are two significant antibiotics with distinct market dynamics and financial trajectories. This article delves into the current market size, growth projections, key drivers, and challenges for these drugs.

Azithromycin Dihydrate Market Overview

Market Size and Growth Projections

The azithromycin dihydrate market was valued at USD 42 billion in 2023 and is expected to reach USD 71.98 billion by 2031, growing at a CAGR of 8% from 2024 to 2031[1].

Market Segmentation

The market is segmented by type (API Grade, Pharmaceutical Grade, Research Grade), application (Antibiotics, Respiratory Infections, Sexually Transmitted Diseases, Skin Infections), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Key Drivers

  • Rising Prevalence of Bacterial Infections: The increasing incidence of bacterial infections, including respiratory and skin infections, is a major driver of the market[1][3].
  • Healthcare Spending and Pharmaceutical R&D: Increased healthcare spending and advancements in pharmaceutical research and development are contributing to the market's growth[1].
  • Emergence of Antibiotic-Resistant Bacteria: The growing issue of antibiotic-resistant bacteria is driving the demand for effective antibiotics like azithromycin dihydrate[1][3].

Technological Advancements

  • Efficient Synthesis Pathways: Modern manufacturing techniques, such as continuous flow reactors, are improving the production efficiency and yield of azithromycin dihydrate[3].
  • Nanoformulations and Controlled-Release Formulations: Innovations in drug delivery systems, including nanoformulations and controlled-release formulations, are enhancing the bioavailability and efficacy of azithromycin dihydrate[3].

Trovafloxacin Mesylate Market Dynamics

Market Context

Trovafloxacin mesylate, often used in combination with azithromycin for treating certain infections, has a more niche market presence compared to azithromycin dihydrate.

Indications and Usage

  • Sexually Transmitted Diseases: Trovafloxacin mesylate is used in combination with azithromycin for the single-dose treatment of uncomplicated urethral gonorrhea in males and endocervical and rectal gonorrhea in females[4].
  • Clinical Trials and Safety Profile: Clinical trials have shown that trovafloxacin mesylate has a generally mild side effect profile, with dizziness, nausea, and headache being the most common adverse reactions[4].

Market Challenges

  • Limited Use Cases: Unlike azithromycin dihydrate, which has a broad spectrum of applications, trovafloxacin mesylate is primarily used for specific types of infections, limiting its market scope.
  • Regulatory and Safety Concerns: The use of trovafloxacin mesylate has been subject to regulatory scrutiny due to potential side effects, which can impact its market growth[4].

Financial Trajectory of Azithromycin Dihydrate

Revenue Projections

The global azithromycin dihydrate market is projected to grow significantly, with revenues expected to reach USD 71.98 billion by 2031. This growth is driven by increasing demand for effective antibiotics, particularly in developing regions[1].

Key Market Players

Major players in the azithromycin dihydrate market include Pfizer, Inc., Teva Pharmaceuticals Industries Ltd., Mylan, Zydus Pharmaceuticals, and others. These companies are investing heavily in research and development to improve drug formulations and expand their market presence[2][5].

Regional Market Analysis

Asia-Pacific

  • The Asia-Pacific region, particularly China, is expected to dominate the azithromycin dihydrate market due to its large population, advanced healthcare facilities, and strong presence of major pharmaceutical players[3].

North America

  • North America is also expected to witness significant growth due to the rising healthcare infrastructure, increasing demand for advanced medical treatments, and a large population[3].

Competitive Landscape

Market Competition

The azithromycin dihydrate market is highly competitive, with multiple players vying for market share. Companies are engaging in strategies such as mergers & acquisitions, joint ventures, and collaborations to enhance their market presence[2].

Product Innovations

Key players are focusing on product innovations, including the development of new formulations and delivery systems, to stay competitive in the market[3].

Conclusion

The market for azithromycin dihydrate is poised for significant growth driven by the increasing prevalence of bacterial infections, advancements in pharmaceutical technology, and rising healthcare spending. In contrast, the market for trovafloxacin mesylate is more limited due to its specific use cases and regulatory challenges.

Key Takeaways

  • Growing Demand for Azithromycin Dihydrate: The market is driven by the rising prevalence of bacterial infections and advancements in pharmaceutical technology.
  • Technological Innovations: Modern manufacturing techniques and innovative drug delivery systems are enhancing the efficacy and bioavailability of azithromycin dihydrate.
  • Regional Growth: Asia-Pacific and North America are key regions driving the growth of the azithromycin dihydrate market.
  • Limited Scope for Trovafloxacin Mesylate: The market for trovafloxacin mesylate is limited due to its specific indications and regulatory challenges.

FAQs

Q: What is the projected market size of azithromycin dihydrate by 2031?

A: The azithromycin dihydrate market is expected to reach USD 71.98 billion by 2031[1].

Q: What are the main drivers of the azithromycin dihydrate market?

A: The main drivers include the rising prevalence of bacterial infections, healthcare spending, and advancements in pharmaceutical research and development[1][3].

Q: Which regions are expected to dominate the azithromycin dihydrate market?

A: The Asia-Pacific region, particularly China, and North America are expected to dominate the market[3].

Q: What are the common side effects of trovafloxacin mesylate?

A: Common side effects include dizziness, nausea, headache, and vomiting[4].

Q: How is the competitive landscape of the azithromycin dihydrate market?

A: The market is highly competitive with multiple players engaging in various strategies to enhance their market presence[2].

Sources

  1. Market Research Intellect: Azithromycin Dihydrate Market Size and Projections.
  2. Biospace: Azithromycin Market Insights, Future Trends, On-going Demand.
  3. Data Bridge Market Research: Global Azithromycin Market – Industry Trends and Forecast to 2030.
  4. RxList: Trovan - Zithromax (Trovafloxacin and Azithromycin).
  5. Valuates Reports: Azithromycin Dihydrate Market, Report Size, Worth, Revenue.

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