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Last Updated: December 25, 2024

Dirithromycin - Generic Drug Details


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What are the generic sources for dirithromycin and what is the scope of freedom to operate?

Dirithromycin is the generic ingredient in one branded drug marketed by Lilly Res Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for dirithromycin.

Summary for dirithromycin
Recent Clinical Trials for dirithromycin

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

SponsorPhase
Pharmaceutical Research Unit, JordanPhase 1
Abdi Ibrahim Ilac San. ve Tic A.S.Phase 1
University of LouisvilleEarly Phase 1

See all dirithromycin clinical trials

US Patents and Regulatory Information for dirithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly Res Labs DYNABAC dirithromycin TABLET, DELAYED RELEASE;ORAL 050678-001 Jun 19, 1995 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

Dirithromycin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dirithromycin

Introduction to Dirithromycin

Dirithromycin is a macrolide antibiotic, a class of drugs known for their broad spectrum of activity against various bacterial infections. It is often compared to other macrolides like erythromycin, clarithromycin, and azithromycin due to its similar pharmacokinetic and therapeutic profiles.

Market Size and Growth

The dirithromycin market has been experiencing significant growth in recent years. Here are some key statistics:

  • Current Market Size: The dirithromycin market was valued at USD 123.65 million in 2023 and grew to USD 128.36 million in 2024[4].
  • Forecasted Growth: The market is expected to continue growing at a Compound Annual Growth Rate (CAGR) of 4.18% from 2024 to 2031[4].

Market Segmentation

The dirithromycin market is segmented based on several factors:

  • Type: The market is categorized by purity levels, such as Purity 98% and other purity levels[1].
  • Application: Dirithromycin is used in various applications, including pharmaceutical intermediates, chemical intermediates, and others[1].
  • Geography: The market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the dirithromycin market:

  • Increasing Antibiotic Resistance: The rise in antibiotic resistance has led to an increased demand for alternative antibiotics like dirithromycin[2].
  • Respiratory Infections: The growing incidence of respiratory infections, particularly in the geriatric population, is a significant driver[2].
  • Advancements in Drug Delivery Systems: Improvements in drug delivery systems and formulations are enhancing the efficacy and patient compliance of dirithromycin[3].
  • Government Initiatives: Initiatives from governments and healthcare sectors to combat infectious diseases and promote the use of effective antibiotics contribute to market growth[2].

Challenges and Restraints

Despite the growth, the dirithromycin market faces several challenges:

  • Antibiotic Resistance: While dirithromycin benefits from the need for alternative antibiotics, it also faces the risk of developing resistance over time[3].
  • Competition from Other Macrolides: Dirithromycin competes with other established macrolides like erythromycin, clarithromycin, and azithromycin, which may have similar or superior clinical profiles[5].
  • Regulatory Changes: Evolving regulatory landscapes and changes in antibiotic prescribing guidelines can impact market dynamics and access for dirithromycin manufacturers[3].

Pharmacokinetic and Therapeutic Profile

Dirithromycin has several attractive pharmacokinetic properties:

  • Once-Daily Dosing: Its long elimination half-life allows for once-daily dosing, which enhances patient compliance[5].
  • High Tissue Concentrations: Dirithromycin achieves high and prolonged tissue concentrations, which is beneficial for treating infections[5].
  • Comparable Efficacy: Clinical efficacy and bacteriologic eradication rates of dirithromycin are comparable to those of erythromycin for respiratory and skin infections[5].

Financial Trajectory

The financial trajectory of the dirithromycin market is promising:

  • Revenue Growth: The market is expected to grow from USD 128.36 million in 2024 to a projected value by 2031, driven by the CAGR of 4.18%[4].
  • Market Value: The comprehensive report on the dirithromycin market provides an outlook on the development of the market in terms of revenue throughout the forecast period[1].

Competitive Scenario

The dirithromycin market includes several key players:

  • Prominent Companies: Companies like Chem Reagents, TCI, MedChemexpress, Target Molecule Corp, and others are profiled in the market report[1].
  • Market Share: The report includes detailed lists of companies categorized by the types of products they offer and various market-related factors[1].

Regional Analysis

The dirithromycin market varies significantly across different regions:

  • North America: This region is a significant market due to robust healthcare infrastructure and high healthcare expenditure[3].
  • Europe: Europe holds a substantial share, supported by a well-established pharmaceutical industry and high prevalence of bacterial infections[3].
  • Asia-Pacific: The region exhibits rapid growth driven by rising healthcare expenditure, expanding population, and increasing awareness of infectious diseases[3].

Future Outlook

The future of the dirithromycin market looks promising but also comes with challenges:

  • Emerging Markets: Emerging economies present untapped potential for growth, driven by increasing healthcare infrastructure and a growing patient population[3].
  • Technological Advancements: Continued advancements in drug delivery systems and formulation technologies offer opportunities to enhance the efficacy and delivery of dirithromycin[3].
  • Strategic Partnerships: Collaborations between pharmaceutical companies, research institutions, and government bodies can facilitate the development of innovative dirithromycin products[3].

Key Takeaways

  • Growing Market: The dirithromycin market is experiencing significant growth driven by increasing antibiotic resistance and advancements in drug delivery systems.
  • Competitive Landscape: The market is competitive with several key players, and dirithromycin faces competition from other established macrolides.
  • Regional Variations: The market dynamics vary across regions, with North America, Europe, and Asia-Pacific being key markets.
  • Future Prospects: Emerging markets and technological advancements offer opportunities for further growth.

FAQs

Q: What is the current market size of the dirithromycin market?

  • The dirithromycin market was valued at USD 123.65 million in 2023 and grew to USD 128.36 million in 2024[4].

Q: What is the expected CAGR of the dirithromycin market from 2024 to 2031?

  • The market is expected to grow at a CAGR of 4.18% from 2024 to 2031[4].

Q: What are the key drivers of the dirithromycin market?

  • Key drivers include increasing antibiotic resistance, advancements in drug delivery systems, and government initiatives to combat infectious diseases[2][3].

Q: How does dirithromycin compare to other macrolides in terms of pharmacokinetics and efficacy?

  • Dirithromycin has a similar pharmacokinetic and therapeutic profile to other macrolides like erythromycin and clarithromycin, with advantages such as once-daily dosing and high tissue concentrations[5].

Q: Which regions are the most significant markets for dirithromycin?

  • North America, Europe, and the Asia-Pacific region are the most significant markets for dirithromycin[1][3].

Sources

  1. Market Research Intellect: Dirithromycin Market Size, Scope And Forecast Report[1].
  2. Research and Markets: Macrolide Antibiotics Global Market Size & Competitors[2].
  3. Marketresearch.biz: Erythromycin Market Projected to Reach Valuation of USD 8,194.9 Mn at 5.5% CAGR from 2024-2033[3].
  4. Research and Markets: Dirithromycin Market Size, Competitors & Forecast to 2030[4].
  5. PubMed: Dirithromycin: a new macrolide[5].

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