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Last Updated: December 23, 2024

TRIMETHOPRIM HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for trimethoprim hydrochloride and what is the scope of patent protection?

Trimethoprim hydrochloride is the generic ingredient in one branded drug marketed by Pangea and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for TRIMETHOPRIM HYDROCHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 15
Clinical Trials: 186
Patent Applications: 25
What excipients (inactive ingredients) are in TRIMETHOPRIM HYDROCHLORIDE?TRIMETHOPRIM HYDROCHLORIDE excipients list
DailyMed Link:TRIMETHOPRIM HYDROCHLORIDE at DailyMed
Recent Clinical Trials for TRIMETHOPRIM HYDROCHLORIDE

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

SponsorPhase
Cairo UniversityPhase 4
Johns Hopkins UniversityEarly Phase 1
Chang Gung Memorial HospitalPhase 1/Phase 2

See all TRIMETHOPRIM HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for TRIMETHOPRIM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074973-001 Jan 24, 2000 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074374-001 Jun 23, 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

Expired US Patents for TRIMETHOPRIM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074973-001 Jan 24, 2000 ⤷  Subscribe ⤷  Subscribe
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074973-001 Jan 24, 2000 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

TRIMETHOPRIM HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trimethoprim Hydrochloride

Introduction

Trimethoprim hydrochloride, often used in combination with sulfamethoxazole, is a widely prescribed antibiotic for treating various bacterial infections. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Mechanism of Action and Clinical Use

Trimethoprim is a reversible inhibitor of dihydrofolate reductase, an enzyme essential for bacterial nucleic acid and protein synthesis. Its strong affinity for bacterial dihydrofolate reductase allows it to selectively target bacterial cells, making it an effective treatment for infections such as urinary tract infections, conjunctivitis, and other bacterial infections[2][5].

Market Size and Growth

The market for trimethoprim, particularly when combined with sulfamethoxazole, has experienced significant growth. The Sulfamethoxazole and Trimethoprim Market is projected to expand substantially from 2023 to 2031, with the market value anticipated to reach several billion USD by the end of the forecast period. This growth is driven by increasing demand for effective antibiotics and the rising incidence of bacterial infections[1].

Segmentation and Application

The market is segmented based on the type of formulation (e.g., 80mg Trimethoprim and 400mg Sulfamethoxazole, 160mg Trimethoprim and 800mg Sulfamethoxazole) and application (Adult Use, Pediatric Use). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each segment presents unique opportunities and challenges, influencing the overall market dynamics[1].

Drivers of Market Growth

Several factors drive the growth of the trimethoprim market:

  • Increasing Incidence of Bacterial Infections: The rising number of bacterial infections, particularly in regions with limited access to healthcare, fuels the demand for effective antibiotics like trimethoprim.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing countries, enhance the accessibility and affordability of trimethoprim.
  • Generic and Biosimilar Markets: The expiration of patents for branded drugs and the growth of generic and biosimilar markets contribute to increased competition, leading to lower prices and higher market penetration[3].

Restraints and Challenges

Despite the growth potential, the market faces several restraints:

  • Antibiotic Resistance: The increasing resistance of bacteria to trimethoprim and other antibiotics poses a significant challenge, reducing the drug's effectiveness over time.
  • Regulatory Hurdles: Strict regulatory environments and the need for continuous monitoring of antibiotic use can limit market growth.
  • Side Effects and Adverse Reactions: Trimethoprim can cause adverse effects, such as hypersensitivity reactions and hematologic abnormalities, which may deter some patients and healthcare providers[2][5].

Competitive Landscape

The competitive landscape of the trimethoprim market is characterized by the presence of several key players, including Roche Holding AG, Pfizer, Amneal Pharmaceuticals, Apotex, and Wellona Pharma. These companies engage in various strategies such as new product releases, collaborations, mergers and acquisitions, and regional expansions to maintain their market position[1].

Financial Trajectory

The financial trajectory of the trimethoprim market is promising, with significant revenue growth anticipated over the forecast period. Here are some key financial indicators:

  • Market Value: The Sulfamethoxazole and Trimethoprim Market is expected to reach several billion USD by 2031, indicating a robust growth rate from 2023 to 2031[1].
  • Revenue Streams: Revenue is generated through the sale of trimethoprim in various formulations and applications, with a significant portion coming from generic and biosimilar versions.
  • Cost Structure: The cost structure includes manufacturing costs, research and development expenses, marketing expenditures, and regulatory compliance costs. The rise of generic and biosimilar markets can lead to reduced costs and higher profit margins for manufacturers[3].

Regional Market Analysis

The market for trimethoprim varies significantly across different regions:

  • North America and Europe: These regions have well-established healthcare systems and a high demand for antibiotics, contributing to a substantial market share.
  • Asia-Pacific: This region is experiencing rapid growth due to increasing healthcare infrastructure and a large patient population.
  • South America and Middle East & Africa: These regions present opportunities for growth, driven by improving healthcare access and increasing demand for affordable antibiotics[1].

Future Outlook

The future outlook for the trimethoprim market is positive, driven by several factors:

  • Increasing Demand: The growing need for effective antibiotics in both developed and developing countries will continue to drive demand.
  • Technological Advancements: Improvements in drug formulation and delivery systems can enhance the efficacy and safety of trimethoprim.
  • Regulatory Support: Government initiatives to control healthcare costs and promote the use of generic and biosimilar medicines will support market growth[3].

Key Takeaways

  • The trimethoprim market is expected to grow significantly from 2023 to 2031.
  • The market is driven by increasing demand for antibiotics, advancements in healthcare infrastructure, and the growth of generic and biosimilar markets.
  • Key challenges include antibiotic resistance, regulatory hurdles, and adverse effects.
  • The competitive landscape is characterized by major pharmaceutical companies engaging in various market strategies.
  • The financial trajectory indicates robust revenue growth, with significant market value anticipated by 2031.

FAQs

What is the primary mechanism of action of trimethoprim?

Trimethoprim acts by inhibiting dihydrofolate reductase, an enzyme essential for bacterial nucleic acid and protein synthesis, thereby selectively targeting bacterial cells[2][5].

Which regions are expected to drive the growth of the trimethoprim market?

The Asia-Pacific region, along with North America and Europe, is expected to drive significant growth due to increasing healthcare infrastructure and a large patient population[1].

What are the main challenges facing the trimethoprim market?

The main challenges include antibiotic resistance, regulatory hurdles, and adverse effects associated with the drug[2][5].

How does the rise of generic and biosimilar markets impact the trimethoprim market?

The rise of generic and biosimilar markets increases competition, leading to lower prices and higher market penetration, which can drive growth and reduce costs for manufacturers[3].

Which companies are key players in the trimethoprim market?

Key players include Roche Holding AG, Pfizer, Amneal Pharmaceuticals, Apotex, and Wellona Pharma[1].

Sources

  1. Market Research Intellect: Sulfamethoxazole and Trimethoprim Market Size, Scope And Forecast 2021-2031.
  2. DrugBank: Trimethoprim: Uses, Interactions, Mechanism of Action.
  3. Access to Medicine Foundation: Generic & Biosimilar Medicines Programme 2023.
  4. Market Research Reports: Global Trimethoprim (TMP) Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.
  5. FDA: Trimethoprim tablets, USP.

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