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Last Updated: December 22, 2024

GENTAMICIN SULFATE; PREDNISOLONE ACETATE - Generic Drug Details


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What are the generic drug sources for gentamicin sulfate; prednisolone acetate and what is the scope of freedom to operate?

Gentamicin sulfate; prednisolone acetate is the generic ingredient in one branded drug marketed by Allergan and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for GENTAMICIN SULFATE; PREDNISOLONE ACETATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
DailyMed Link:GENTAMICIN SULFATE; PREDNISOLONE ACETATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for GENTAMICIN SULFATE; PREDNISOLONE ACETATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan PRED-G gentamicin sulfate; prednisolone acetate OINTMENT;OPHTHALMIC 050612-001 Dec 1, 1989 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan PRED-G gentamicin sulfate; prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 050586-001 Jun 10, 1988 DISCN Yes 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

GENTAMICIN SULFATE; PREDNISOLONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gentamicin Sulfate and Prednisolone Acetate

Introduction

Gentamicin sulfate and prednisolone acetate are key components in various pharmaceutical products, particularly in ophthalmic preparations like PRED-G. This article delves into the market dynamics, financial trajectory, and other critical factors influencing the demand and supply of these drugs.

Market Overview

The global market for gentamicin sulfate has been experiencing a significant upswing. This trend is driven by several factors, including increased demand from the downstream sector and improvements in trade activities from export nations[1].

Demand Drivers

  • End-User Demand: The demand for gentamicin sulfate has seen a consistent increase, particularly from the pharmaceutical, nutraceutical, and healthcare sectors. In regions like Germany, local market inquiries surged moderately from January to February 2023, reflecting higher domestic consumption rates[1].
  • Geographical Expansion: The market is not limited to specific regions; it has seen growth in the United States, Europe, and Asia-Pacific. The Chinese market, for instance, has witnessed a significant surge in demand for antibiotics, including gentamicin sulfate, both domestically and internationally[1].

Market Segmentation

The gentamicin sulfate market is segmented based on type and application. The types include 99% purity, 98% purity, and 95% purity, among others. Applications range from gentamicin sulfate eye drops, tablets, injections, granules, and sustained-release tablets[3].

Financial Trajectory

Current Market Value

The gentamicin sulfate market has undergone rapid growth in recent years. As of 2023, the market value is substantial, and projections indicate further significant expansion from 2023 to 2031. The market is expected to exhibit robust growth rates during this period[3][5].

Price Trends

In February 2023, global gentamicin sulfate prices rose due to increased demand and eased trade activities. However, it is predicted that prices might fall in forthcoming months due to a stable decrease in demand, which is likely to balance with overall supplies[1].

Revenue Projections

The market size of the gentamicin sulfate API market is anticipated to grow from its current value to a higher figure by the end of 2031, measured in USD million. This growth is driven by increasing demand and expanding applications across various regions[5].

Applications and Uses

Ophthalmic Preparations

Gentamicin sulfate, combined with prednisolone acetate, is used in ophthalmic suspensions like PRED-G. This combination product is designed for topical anti-inflammatory and anti-infective use, effective against susceptible strains of microorganisms such as Staphylococcus aureus, Streptococcus pyogenes, and Escherichia coli[2].

Other Applications

Gentamicin sulfate is also used in various other forms, including injections, tablets, granules, and sustained-release tablets. These applications cater to different medical needs, such as treating bacterial infections in various parts of the body[3].

Regulatory and Approval Aspects

FDA Approval

PRED-G, a brand name for gentamicin sulfate and prednisolone acetate ophthalmic suspension, has been approved by the FDA. The approval dates back to June 10, 1988, for the suspension and December 1, 1989, for the ointment formulation[4].

Safety and Precautions

The use of gentamicin sulfate, especially during pregnancy, is subject to careful consideration due to potential risks to the fetus. There are no adequate and well-controlled studies in pregnant women, and the drug should be used only if the potential benefit justifies the risk[2].

Market Dynamics

Drivers

  • Increasing Demand: The rising demand from end-users, particularly in the pharmaceutical and healthcare sectors, is a significant driver.
  • Improving Trade Activities: Eased trade activities from export nations have contributed to the market's growth.
  • Expanding Applications: The versatility of gentamicin sulfate in various medical applications has broadened its market scope[1][3].

Restraints

  • Price Volatility: Predicted reductions in demand could lead to price volatility, affecting market stability.
  • Regulatory Considerations: Strict regulatory requirements and safety precautions, especially regarding use during pregnancy, can act as restraints[1][2].

Opportunities

  • Geographical Expansion: The market has opportunities for growth in regions like Asia-Pacific and the Middle-East and Africa.
  • Technological Advancements: Improvements in production and formulation technologies could enhance product efficacy and reduce costs[3][5].

Challenges

  • Supply Chain Disruptions: Potential shortages and supply chain disruptions can impact market stability.
  • Competition: The presence of generic versions and counterfeit products poses a challenge to the market[1][4].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in shaping the market. The increasing awareness of antibiotic resistance and the need for effective treatments drive the demand for gentamicin sulfate. Additionally, the preference for combination products like PRED-G, which offer both anti-inflammatory and anti-infective properties, influences market trends[2].

Key Players and Market Competition

The market for gentamicin sulfate and prednisolone acetate involves several key players, including Allergan, the manufacturer of PRED-G. The competition is also influenced by the availability of generic versions and the presence of counterfeit products, which can affect market dynamics and consumer trust[4].

Economic, Political, and Social Landscapes

The economic landscape, including factors like consumer price indexes and trade activities, significantly impacts the market. Political and social factors, such as regulatory policies and public health initiatives, also play a role in shaping the demand and supply of these drugs[1].

Conclusion

The market for gentamicin sulfate and prednisolone acetate is poised for robust growth driven by increasing demand, expanding applications, and geographical expansion. However, it is also subject to challenges such as price volatility, regulatory considerations, and supply chain disruptions.

Key Takeaways

  • Growing Demand: Increased demand from the pharmaceutical and healthcare sectors.
  • Geographical Expansion: Growth opportunities in regions like Asia-Pacific and the Middle-East and Africa.
  • Price Trends: Predicted price reductions due to stable decreases in demand.
  • Regulatory Considerations: Strict safety precautions and regulatory approvals.
  • Market Segmentation: Segmentation based on type and application.

FAQs

Q: What are the primary applications of gentamicin sulfate?

A: Gentamicin sulfate is primarily used in ophthalmic preparations, injections, tablets, granules, and sustained-release tablets to treat bacterial infections.

Q: What is the current market trend for gentamicin sulfate?

A: The market is experiencing an upswing trend due to increased demand and eased trade activities, but prices are predicted to fall in forthcoming months.

Q: Who are the key players in the gentamicin sulfate market?

A: Key players include Allergan, the manufacturer of PRED-G, along with other generic and branded product manufacturers.

Q: What are the potential risks associated with using gentamicin sulfate during pregnancy?

A: Gentamicin sulfate use during pregnancy is associated with potential risks to the fetus, and its use should be justified by the potential benefit.

Q: How does the market segmentation of gentamicin sulfate impact its growth?

A: Market segmentation based on type (purity levels) and application (various medical forms) helps in targeting specific needs and expanding the market scope.

Sources

  1. ChemAnalyst: "Gentamicin Sulphate Market Follows an Upswing Trend Across the Globe"[1]
  2. FDA: "PRED-G® (gentamicin and prednisolone acetate ophthalmic suspension, USP)"[2]
  3. Market Research Intellect: "Global Gentamycin Sulfate Market Size, Trends and Projections"[3]
  4. Drugs.com: "Generic Pred-G Availability"[4]
  5. Market Research Intellect: "Gentamicin Sulfate API Market Size, Scope And Forecast Report"[5]

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