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Last Updated: December 27, 2024

TICARCILLIN DISODIUM - Generic Drug Details


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What are the generic drug sources for ticarcillin disodium and what is the scope of freedom to operate?

Ticarcillin disodium is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ticarcillin disodium.

Summary for TICARCILLIN DISODIUM
Recent Clinical Trials for TICARCILLIN DISODIUM

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Phillip Brian SmithPhase 1

See all TICARCILLIN DISODIUM clinical trials

Medical Subject Heading (MeSH) Categories for TICARCILLIN DISODIUM

US Patents and Regulatory Information for TICARCILLIN DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TICAR ticarcillin disodium INJECTABLE;INJECTION 050497-005 Apr 4, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TICAR ticarcillin disodium INJECTABLE;INJECTION 062690-001 Dec 19, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TICAR ticarcillin disodium INJECTABLE;INJECTION 050497-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TICAR ticarcillin disodium INJECTABLE;INJECTION 050497-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TICAR ticarcillin disodium INJECTABLE;INJECTION 050497-004 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

TICARCILLIN DISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ticarcillin Disodium

Introduction

Ticarcillin disodium, a broad-spectrum antibiotic belonging to the penicillin class, has been a significant player in the pharmaceutical market, particularly in the treatment of various bacterial infections. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism and Therapeutic Use

Ticarcillin disodium works as a cell wall inhibitor, disrupting the bacterial cell wall synthesis, which is essential for bacterial survival. It is commonly used in combination with clavulanate potassium, as seen in the formulation TIMENTIN, to enhance its efficacy against beta-lactamase-producing bacteria[4][5].

Market Position

Therapeutic Areas

Ticarcillin disodium is primarily used in treating systemic and urinary tract infections. Its broad-spectrum activity makes it a valuable option in clinical settings where the causative organism is not yet identified or is known to be resistant to other antibiotics[5].

Competitive Landscape

The antibiotic market is highly competitive, with numerous drugs available for various infections. However, ticarcillin disodium maintains a niche due to its effectiveness against certain Gram-negative bacteria. The combination with clavulanate potassium further strengthens its market position by extending its spectrum of activity[4].

Financial Trajectory

Development and Approval Costs

The development of antibiotics like ticarcillin disodium is costly and time-consuming. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. Ticarcillin disodium was first approved in the US in 1976, and its development costs, although not specified, would have been significant given the regulatory and scientific hurdles involved[3].

Revenue and Sales

While specific revenue figures for ticarcillin disodium are not readily available, it is part of a larger antibiotic market that is substantial. The global pharmaceutical market, which includes antibiotics, is projected to exceed $1.4 trillion by 2028, driven by the increasing burden of chronic and infectious diseases[3].

ROI and Sustainability

The return on investment (ROI) for pharmaceutical R&D has been declining in recent years, posing challenges for the sustainability of current R&D models. For antibiotics, the ROI is particularly low due to short exclusivity periods and the rapid entry of generic competitors once patents expire. This makes it crucial for pharmaceutical companies to continuously innovate and invest in new drug development to maintain profitability[3].

Challenges and Opportunities

Antimicrobial Resistance (AMR)

The growing threat of AMR has highlighted the need for new antibiotics. However, developing these medicines is costly and risky. Initiatives like the AMR Action Fund aim to incentivize investment in this area, but the financial risks remain significant. Ticarcillin disodium, while effective, faces the challenge of bacterial resistance, which can impact its long-term market viability[3].

Regulatory Hurdles

Stricter regulatory hurdles and shorter exclusivity periods contribute to the declining ROI for pharmaceutical R&D. Ticarcillin disodium, approved decades ago, has navigated these challenges but continues to face regulatory scrutiny, particularly regarding its use and potential side effects[3][5].

Side Effects and Safety Profile

Adverse Reactions

Ticarcillin disodium, like other antibiotics, has a range of potential side effects, including Clostridium difficile-associated diarrhea, convulsions, and bleeding associated with coagulation abnormalities. These adverse reactions can impact its market acceptance and require careful medical management[5].

Superinfections and Resistance

The use of ticarcillin disodium can lead to superinfections with fungal or bacterial pathogens, and there is a risk of developing drug-resistant bacteria. These factors necessitate careful prescribing practices and ongoing monitoring of microbial resistance patterns[5].

Market Analysis

Global Demand

The demand for antibiotics, including ticarcillin disodium, is driven by the increasing incidence of bacterial infections and the need for effective treatments. The global antibiotic market is expected to grow, but the specific demand for ticarcillin disodium will depend on its efficacy, safety profile, and the emergence of resistant bacterial strains[3].

Pricing and Affordability

The cost of ticarcillin disodium, particularly in combination with clavulanate potassium, can be significant. The high cost of antibiotics, especially in resource-limited settings, raises concerns about affordability and accessibility. This can impact the drug's market penetration and overall financial performance[3].

Key Takeaways

  • Mechanism and Use: Ticarcillin disodium is a broad-spectrum antibiotic effective against various bacterial infections, often used in combination with clavulanate potassium.
  • Market Position: It holds a niche in the antibiotic market due to its efficacy against certain Gram-negative bacteria.
  • Financial Trajectory: The drug faces challenges related to declining ROI, regulatory hurdles, and the threat of AMR.
  • Challenges and Opportunities: Despite its effectiveness, ticarcillin disodium must navigate the risks of bacterial resistance, regulatory scrutiny, and high development costs.
  • Safety Profile: The drug has a range of potential side effects and requires careful medical management.

FAQs

What is ticarcillin disodium used for?

Ticarcillin disodium is used to treat various bacterial infections, including systemic and urinary tract infections, often in combination with clavulanate potassium.

What are the common side effects of ticarcillin disodium?

Common side effects include Clostridium difficile-associated diarrhea, convulsions, and bleeding associated with coagulation abnormalities.

How does ticarcillin disodium work?

Ticarcillin disodium works as a cell wall inhibitor, disrupting bacterial cell wall synthesis.

What are the financial challenges facing ticarcillin disodium?

The drug faces declining ROI, regulatory hurdles, and the threat of antimicrobial resistance, which impact its long-term market viability.

Is ticarcillin disodium still widely used?

Yes, it remains a valuable option in clinical settings due to its broad-spectrum activity, although its use is subject to careful prescribing practices to mitigate the risk of resistance and side effects.

Sources

  1. RPI Corp: Ticarcillin Disodium Salt, 1 Gram.
  2. PMC: Jejunal perforation secondary to blind insertion of peritoneal dialysis catheter.
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research.
  4. Synapse: Ticarcillin Disodium - Drug Targets, Indications, Patents.
  5. FDA: TIMENTIN (ticarcillin disodium and clavulanate potassium) for Injection.

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