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Last Updated: December 25, 2024

MEZLOCILLIN SODIUM MONOHYDRATE - Generic Drug Details


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What are the generic sources for mezlocillin sodium monohydrate and what is the scope of freedom to operate?

Mezlocillin sodium monohydrate is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for MEZLOCILLIN SODIUM MONOHYDRATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 13
DailyMed Link:MEZLOCILLIN SODIUM MONOHYDRATE at DailyMed
Medical Subject Heading (MeSH) Categories for MEZLOCILLIN SODIUM MONOHYDRATE

US Patents and Regulatory Information for MEZLOCILLIN SODIUM MONOHYDRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms MEZLIN mezlocillin sodium monohydrate INJECTABLE;INJECTION 062372-003 May 13, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Pharms MEZLIN mezlocillin sodium monohydrate INJECTABLE;INJECTION 062333-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Pharms MEZLIN mezlocillin sodium monohydrate INJECTABLE;INJECTION 062697-001 Jan 22, 1987 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

MEZLOCILLIN SODIUM MONOHYDRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mezlocillin Sodium Monohydrate

Introduction to Mezlocillin Sodium Monohydrate

Mezlocillin sodium monohydrate is a broad-spectrum, semisynthetic antibiotic derived from ampicillin. It is active against a wide range of bacteria, including gram-positive, gram-negative, and anaerobic bacteria[2].

Market Size and Growth

The global mezlocillin sodium API market has been experiencing significant growth. As of 2023, the market size was notable, and it is projected to continue growing at a compound annual growth rate (CAGR) from 2024 to 2031[1].

Market Segmentation

The mezlocillin sodium API market is segmented based on type and application.

Type

  • Min Purity Less Than 98%: This segment accounted for a noticeable share of the global market in 2023 and is expected to see significant growth in the near future.
  • Min Purity 98%-99%
  • Min Purity More Than 99%[1].

Application

  • Research: The research segment is expected to expand at a significant CAGR throughout the forecast period.
  • Pharmaceutical: This segment is driven by the increasing demand for broad-spectrum antibiotics in pharmaceutical applications[1].

Regional Analysis

The global mezlocillin sodium API market is segmented into five major regions:

  • North America
  • Europe
  • Asia-Pacific
  • Middle East & Africa
  • Latin America

Each region has its own market dynamics, influenced by local regulatory environments, economic conditions, and healthcare needs[1].

Market Dynamics

Drivers

  • Increasing Demand for Broad-Spectrum Antibiotics: The rising incidence of bacterial infections and the need for effective treatments drive the demand for mezlocillin sodium.
  • Advancements in Manufacturing Technology: Improved manufacturing processes, such as the method described in the patent for preparing mezlocillin sodium, enhance production efficiency and yield, making the product more competitive[3].
  • Regulatory Approvals: Historical approvals by regulatory bodies like the U.S. FDA in 1981 have established a strong market presence for mezlocillin sodium[3].

Restraints

  • Competition from Generic Drugs: The entry of generic versions of mezlocillin sodium can reduce market share and prices, affecting the financial trajectory of the original manufacturers. Generic prices decline as the number of competitors increases, approaching long-run marginal costs with eight or more competitors[4].
  • Beta-Lactamase Stability: Mezlocillin's weak stability to beta-lactamases can limit its effectiveness against certain bacteria, potentially reducing its market appeal[2].

Opportunities

  • Synergistic Effects with Other Antibiotics: Mezlocillin's synergistic effects when combined with aminoglycoside antibiotics present opportunities for combination therapies, expanding its application scope[2].
  • Growing Healthcare Needs: Increasing healthcare needs in emerging markets offer opportunities for growth and expansion.

Trends

  • Technological Advancements: Continuous improvements in manufacturing processes, such as the method that increases the dissolution rate and solubility of mezlocillin sodium, are trends that can enhance market competitiveness[3].
  • Environmental and Safety Regulations: Compliance with environmental and safety regulations is crucial and can influence production costs and market dynamics[1].

Financial Trajectory

Revenue and CAGR

The global mezlocillin sodium API market is expected to grow at a significant CAGR from 2024 to 2031. The revenue is projected to increase as the market expands, driven by growing demand and technological advancements[1].

Competitor Analysis

Key companies such as Tecoland, Clearsynth, Hairuichem, American Elements, and others are focusing on strategy building and product portfolio expansion to strengthen their market positions. The competitive landscape is dynamic, with firms entering and exiting the market based on regulatory approvals and market conditions[1].

Pricing Dynamics

The pricing of mezlocillin sodium is influenced by the number of competitors in the market. As more generic versions enter the market, prices tend to decline, approaching long-run marginal costs. This dynamic can impact the financial performance of original manufacturers and new entrants alike[4].

Clinical and Pharmacological Impact

Pharmacokinetics

Mezlocillin sodium has a half-life of about 1 hour after intravenous injection and 1.5 hours after intramuscular injection. It has a protein binding range of 16 to 42%, and 55% of the dose is excreted in the urine. These pharmacokinetic properties are dose-dependent and conform to a two-compartment open model[2].

Clinical Efficacy

Clinical trials have shown high cure rates for various infections, including bacteremia (78%), respiratory tract infections (62%), urinary tract infections (81%), and others. The frequency of adverse reactions is relatively low at 7.7%[2].

Conclusion

The market for mezlocillin sodium monohydrate is characterized by significant growth potential, driven by increasing demand for broad-spectrum antibiotics and advancements in manufacturing technology. However, it also faces challenges such as competition from generic drugs and regulatory pressures.

Key Takeaways

  • Growing Market: The global mezlocillin sodium API market is expected to grow significantly from 2024 to 2031.
  • Segmentation: The market is segmented by type and application, with the research segment expected to expand significantly.
  • Regional Dynamics: Market dynamics vary by region, influenced by local regulatory and economic factors.
  • Competitive Landscape: Key companies are focusing on strategy and product portfolio expansion.
  • Pricing Dynamics: Prices are influenced by the number of competitors, with generic entries driving prices down.

FAQs

Q: What is the primary use of mezlocillin sodium monohydrate?

A: Mezlocillin sodium monohydrate is primarily used as a broad-spectrum antibiotic to treat various bacterial infections.

Q: Which segments are driving the growth of the mezlocillin sodium API market?

A: The research segment and the segment with a minimum purity of less than 98% are driving the growth of the market.

Q: How does the presence of generic drugs affect the market for mezlocillin sodium?

A: The entry of generic drugs reduces market share and prices, as generic prices decline with the number of competitors.

Q: What are the key pharmacokinetic properties of mezlocillin sodium?

A: Mezlocillin sodium has a half-life of about 1 hour after intravenous injection, protein binding ranges from 16 to 42%, and 55% of the dose is excreted in the urine.

Q: What are the clinical efficacy rates of mezlocillin sodium for different infections?

A: Clinical trials have shown high cure rates for various infections, including bacteremia (78%), respiratory tract infections (62%), and urinary tract infections (81%)[2].

Sources

  1. Cognitivemarketresearch.com - Mezlocillin Sodium API Market Report 2024 (Global Edition)
  2. Pubmed.ncbi.nlm.nih.gov - Microbiology, pharmacology, and clinical use of mezlocillin sodium
  3. Patents.google.com - Mezlocillin sodium compound, its preparation method and ...
  4. Ftc.gov - Generic Drug Industry Dynamics
  5. Pubchem.ncbi.nlm.nih.gov - Mezlocillin Sodium Monohydrate | CID 23677831 - PubChem

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