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Last Updated: December 23, 2024

NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details


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What are the generic drug sources for neomycin sulfate; prednisolone sodium phosphate and what is the scope of freedom to operate?

Neomycin sulfate; prednisolone sodium phosphate is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE at DailyMed
Recent Clinical Trials for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

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

SponsorPhase
Huro Biotech Joint Stock CompanyN/A
Vietstar Biomedical ResearchN/A

See all NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
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
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT 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
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

US Patents and Regulatory Information for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck NEO-HYDELTRASOL neomycin sulfate; prednisolone sodium phosphate OINTMENT;OPHTHALMIC 050378-001 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

NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neomycin Sulfate and Prednisolone Sodium Phosphate

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including geopolitical tensions, supply chain disruptions, and changing consumer demands. This article delves into the market dynamics and financial trajectory of two significant pharmaceutical compounds: Neomycin Sulfate and Prednisolone Sodium Phosphate.

Neomycin Sulfate Market Dynamics

Market Size and Growth

The Neomycin Sulfate market was valued at USD 1.23 billion in 2023 and is projected to reach USD 3.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.5% from 2024 to 2031[1].

Key Drivers

  • Extensive Use in Medicine: Neomycin Sulfate is widely used in both human and veterinary medicine to treat bacterial infections, driving its steady market expansion.
  • Topical Formulations: Its broad-spectrum antibiotic efficacy makes it a crucial component in various topical formulations such as eye drops, ointments, and creams.
  • Rising Incidence of Infections: The increasing incidence of skin and eye infections, along with the growth of over-the-counter antibiotic medications, stimulates market demand.
  • Healthcare Infrastructure: Rising awareness of antibiotic treatments and the development of healthcare infrastructure in emerging nations are expected to accelerate market growth[1].

Price Trends

  • Global Price Surge: In January 2024, Neomycin Sulfate prices surged due to geopolitical tensions, dwindling supplies, logistical challenges, and depleting inventories. Seasonal factors like winter-related illnesses further exacerbated supply-demand imbalances[3].
  • Regional Variations: In North America, the market experienced a decline in spot rates and demand, leading to an oversupply scenario and downward pressure on prices. In contrast, European countries saw a consistent uptick in prices driven by positive demand from the pharmaceutical and healthcare industries[4].

Supply Chain and Manufacturing

  • China's Impact: China's manufacturing sector, which has been contracting, and the closure of factories ahead of the Lunar New Year, have led to supply constraints and increased operational costs, driving up Neomycin Sulfate prices globally[3].
  • India's Growth: India's manufacturing sector showed significant enhancement in early 2024, with strong demand and a positive outlook, contributing to the growth and subsequent price upturn of Neomycin Sulfate[3].

Prednisolone Sodium Phosphate Market Dynamics

Therapeutic Applications

Prednisolone Sodium Phosphate is a small molecule drug that targets the glucocorticoid receptor (GR), playing a crucial role in regulating immune responses, metabolism, and stress responses. It is used to alleviate symptoms and manage diseases associated with dysregulation in these pathways[5].

Market Landscape

  • Versatility and Potential: Prednisolone Sodium Phosphate has a broad range of therapeutic areas and active indications, making it versatile for treating various diseases. Its approval in Japan highlights its clinical benefits and regulatory compliance[5].
  • Competitive Landscape: The GR target area is competitive, with companies like Novartis AG, Bausch Health Cos., Inc., and Shionogi & Co., Ltd. showing significant growth and development. The United States and China are leading countries in GR drug development[5].

Clinical and Research Aspects

  • Approved Drugs and Indications: As of 2023, there are 348 GR drugs worldwide, covering 427 indications and involving 11,801 clinical trials. Eczema, asthma, psoriasis, and skin diseases have the highest number of approved drugs, indicating a focus on these areas[5].

Financial Trajectory

Neomycin Sulfate

  • Revenue Growth: The Neomycin Sulfate market is expected to grow significantly, driven by increasing demand and expanding healthcare infrastructure. The market's CAGR of 10.5% from 2024 to 2031 indicates a robust financial trajectory[1].
  • Price Volatility: The recent price surge in January 2024, driven by supply chain disruptions and seasonal demand, highlights the potential for price volatility. However, long-term demand and market growth are expected to stabilize prices[3].

Prednisolone Sodium Phosphate

  • Market Potential: While specific financial projections for Prednisolone Sodium Phosphate are not available, its versatility and approval in various therapeutic areas suggest strong market potential. The competitive landscape and ongoing research indicate a dynamic and growing market segment[5].
  • Research and Development: Continuous research and clinical trials in the GR target area are likely to drive innovation and market growth, contributing to a positive financial trajectory for Prednisolone Sodium Phosphate.

Regional Market Insights

Neomycin Sulfate

  • Asia Pacific: The region is a significant player in the Neomycin Sulfate market, with China's manufacturing sector and India's growing demand influencing global supply and prices[3][4].
  • North America and Europe: These regions experience varying market dynamics, with North America seeing a decline in demand and Europe experiencing an uptick due to positive demand from pharmaceutical and healthcare industries[4].

Prednisolone Sodium Phosphate

  • United States and China: These countries are at the forefront of GR drug development, with significant progress in research and clinical trials. This indicates a strong market presence and potential for future growth[5].

Challenges and Opportunities

Neomycin Sulfate

  • Supply Chain Disruptions: Geopolitical tensions, logistical challenges, and depleting inventories pose significant challenges to the Neomycin Sulfate market. However, these disruptions also create opportunities for manufacturers to reassess pricing strategies and maintain profitability[3].
  • Seasonal Demand: Seasonal factors such as winter-related illnesses can exacerbate supply-demand imbalances, but they also highlight the consistent demand for Neomycin Sulfate, ensuring a stable market trajectory[3].

Prednisolone Sodium Phosphate

  • Competitive Landscape: The competitive nature of the GR target area presents both challenges and opportunities. Companies must innovate and expand their product pipelines to remain competitive, which drives market growth and innovation[5].
  • Regulatory Compliance: Ensuring regulatory compliance, as seen with the approval in Japan, is crucial for market success. This compliance also opens up new markets and therapeutic areas for Prednisolone Sodium Phosphate[5].

Key Takeaways

  • Neomycin Sulfate: The market is expected to grow significantly, driven by increasing demand and expanding healthcare infrastructure. However, it faces challenges such as supply chain disruptions and price volatility.
  • Prednisolone Sodium Phosphate: This drug has a broad range of therapeutic applications and a competitive market landscape. Continuous research and clinical trials drive its market potential and financial trajectory.
  • Regional Insights: Asia Pacific, North America, and Europe play crucial roles in the market dynamics of both drugs, with varying factors influencing their growth and challenges.

FAQs

Q: What is the projected market size for Neomycin Sulfate by 2031?

A: The Neomycin Sulfate market is expected to reach USD 3.45 billion by 2031, growing at a CAGR of 10.5% from 2024 to 2031[1].

Q: What are the primary drivers of the Neomycin Sulfate market?

A: The primary drivers include its extensive use in human and veterinary medicine, incorporation into topical formulations, rising incidence of skin and eye infections, and growing healthcare infrastructure in emerging nations[1].

Q: What is the therapeutic target of Prednisolone Sodium Phosphate?

A: Prednisolone Sodium Phosphate targets the glucocorticoid receptor (GR), regulating immune responses, metabolism, and stress responses[5].

Q: Which regions are leading in GR drug development for Prednisolone Sodium Phosphate?

A: The United States and China are the leading countries in GR drug development, with significant progress in research and clinical trials[5].

Q: What challenges does the Neomycin Sulfate market face?

A: The market faces challenges such as supply chain disruptions, logistical challenges, depleting inventories, and seasonal demand fluctuations[3].

Sources

  1. Market Research Intellect: Neomycin Sulfate Market Size, Share & Trends [2031].
  2. Maximize Market Research: Sodium Phosphate Market – Global Industry Analysis and Forecast.
  3. ChemAnalyst: Global Neomycin Sulphate Prices Surge in January Amidst Complex Market Dynamics.
  4. Procurement Resource: Neomycin Sulphate Price Trend and Forecast.
  5. Patsnap Synapse: Exploring Prednisolone Sodium Phosphate's Revolutionary R&D Successes.

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