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Last Updated: December 22, 2024

Chloramphenicol; hydrocortisone acetate - Generic Drug Details


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What are the generic sources for chloramphenicol; hydrocortisone acetate and what is the scope of freedom to operate?

Chloramphenicol; hydrocortisone acetate is the generic ingredient in two branded drugs marketed by Parkedale and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for chloramphenicol; hydrocortisone acetate
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Clinical Trials: 1
DailyMed Link:chloramphenicol; hydrocortisone acetate at DailyMed
Recent Clinical Trials for chloramphenicol; hydrocortisone acetate

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all chloramphenicol; hydrocortisone acetate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for chloramphenicol; hydrocortisone 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
D10AF Antiinfectives for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
G01AA Antibiotics
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01BA Amphenicols
J01B AMPHENICOLS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
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

US Patents and Regulatory Information for chloramphenicol; hydrocortisone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parkedale CHLOROMYCETIN HYDROCORTISONE chloramphenicol; hydrocortisone acetate FOR SUSPENSION;OPHTHALMIC 050202-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale OPHTHOCORT chloramphenicol; hydrocortisone acetate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050201-002 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

Chloramphenicol; hydrocortisone acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chloramphenicol; Hydrocortisone Acetate

Introduction

Chloramphenicol and hydrocortisone acetate, when combined, form a potent ophthalmic formulation used to treat bacterial infections and inflammation of the eye. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting its uses, benefits, and the economic factors influencing its market presence.

Uses and Benefits

Therapeutic Applications

Chloramphenicol 1.0% and hydrocortisone 0.5% eye ointment is prescribed for various ophthalmic conditions, including bacterial conjunctivitis, keratitis, blepharitis, and post-surgical eye inflammation. Chloramphenicol acts as a broad-spectrum antibiotic, inhibiting bacterial growth, while hydrocortisone reduces inflammation and immune responses[2].

Dual-Action Formula

The combination of an antibiotic and a steroid provides comprehensive treatment, addressing both the infection and the associated inflammation. This dual-action formula offers quick relief from symptoms such as itching, redness, and discharge, making it a preferred treatment option for ophthalmic infections[2].

Market Demand

Growing Need for Ophthalmic Care

The demand for ophthalmic products, including chloramphenicol and hydrocortisone acetate eye ointment, is increasing due to several factors:

  • Aging Population: As the global population ages, the incidence of eye conditions such as cataracts, glaucoma, and conjunctivitis rises.
  • Environmental Factors: Increased screen time and environmental pollution contribute to eye health issues.
  • Global Health Trends: The rise in infectious diseases and the need for effective treatments drive the demand for ophthalmic medications[2].

Financial Trajectory

Market Incentives and Challenges

The financial trajectory of chloramphenicol and hydrocortisone acetate is influenced by several market and economic factors:

  • Profit Margins: Despite the growing demand, the profit margins for antibiotic and steroid combinations can be moderate due to the competitive nature of the ophthalmic market. However, products like chloramphenicol and hydrocortisone acetate, which offer a dual-action formula, can command higher prices and margins due to their efficacy and convenience[2].

  • Regulatory Compliance: Products must be manufactured in WHO-GMP-certified facilities, ensuring high-quality standards. This can impact production costs but also enhances the product's market value and trust among consumers[2].

  • Franchise Opportunities: Companies like Advoptic Vision Care offer PCD (Propaganda Cum Distribution) Pharma franchise opportunities, which can provide lucrative business avenues for distributors and healthcare professionals. These franchises often come with exclusive distribution rights, marketing support, and regulatory compliance, making them attractive for investment[2].

Competitive Landscape

Market Competition

The ophthalmic market is highly competitive, with numerous players offering similar products. However, the combination of chloramphenicol and hydrocortisone acetate stands out due to its dual-action formula and the reputation of the manufacturing companies.

  • Brand Loyalty: Established brands like Advoptic Vision Care build trust among healthcare professionals and patients, which can lead to higher market share and customer loyalty[2].

  • Innovation: Continuous innovation in formulation and delivery methods can help companies stay ahead in the market. For example, the combination of an antibiotic and a steroid in a single ointment simplifies treatment regimens and improves patient compliance[2].

Economic Factors

Cost-Benefit Analysis

The economic viability of chloramphenicol and hydrocortisone acetate is determined by several factors:

  • Production Costs: The cost of manufacturing, including the cost of raw materials, labor, and regulatory compliance, affects the final price of the product.
  • Market Demand: High demand, especially in regions with growing ophthalmic needs, can justify higher prices and better profit margins.
  • Competitive Pricing: The pricing strategy must be competitive with other ophthalmic products in the market while ensuring profitability[2].

Franchise and Distribution Opportunities

PCD Pharma Franchise

The PCD Pharma franchise model offered by companies like Advoptic Vision Care provides a low-risk, high-reward opportunity for pharmaceutical professionals and distributors. Key benefits include:

  • Exclusive Distribution Rights: Franchise partners receive exclusive rights to distribute the product in a specific region, reducing competition.
  • Marketing Support: Comprehensive marketing support, including promotional materials and product samples, helps in increasing market penetration.
  • High-Profit Margins: The growing demand for ophthalmic products ensures high-profit margins for franchise partners[2].

Regulatory Environment

Compliance and Certification

The regulatory environment plays a crucial role in the financial trajectory of chloramphenicol and hydrocortisone acetate. Products must be manufactured in WHO-GMP-certified facilities to ensure compliance with international standards. This not only enhances the product's quality but also its marketability and trust among consumers[2].

Future Outlook

Market Growth

The ophthalmic sector is one of the fastest-growing segments in the pharmaceutical industry. With increasing global demand for quality eye care products, the market for chloramphenicol and hydrocortisone acetate is expected to grow steadily.

  • Emerging Markets: Expanding into emerging markets where access to quality eye care is limited can provide significant growth opportunities.
  • Innovative Formulations: Continuous innovation in formulations and delivery methods can help maintain market leadership and attract new customers[2].

Key Takeaways

  • Dual-Action Formula: The combination of chloramphenicol and hydrocortisone acetate offers a comprehensive treatment for ophthalmic infections and inflammation.
  • Growing Demand: The demand for ophthalmic products is increasing due to an aging population, environmental factors, and global health trends.
  • Profitable Franchise Opportunities: PCD Pharma franchise models offer lucrative business opportunities with exclusive distribution rights and marketing support.
  • Regulatory Compliance: Manufacturing in WHO-GMP-certified facilities is crucial for ensuring product quality and market trust.
  • Future Growth: The market for chloramphenicol and hydrocortisone acetate is expected to grow due to increasing global demand for quality eye care products.

FAQs

What are the primary uses of chloramphenicol and hydrocortisone acetate eye ointment?

Chloramphenicol and hydrocortisone acetate eye ointment is primarily used to treat bacterial conjunctivitis, keratitis, blepharitis, and post-surgical eye inflammation.

How does the dual-action formula of chloramphenicol and hydrocortisone acetate work?

The dual-action formula combines the antibiotic properties of chloramphenicol, which fights bacterial infections, with the anti-inflammatory effects of hydrocortisone, which reduces inflammation and immune responses.

What are the benefits of investing in a PCD Pharma franchise for chloramphenicol and hydrocortisone acetate?

Investing in a PCD Pharma franchise offers exclusive distribution rights, marketing support, and high-profit margins, making it a low-risk, high-reward opportunity.

Why is regulatory compliance important for chloramphenicol and hydrocortisone acetate?

Regulatory compliance ensures that the product is manufactured in WHO-GMP-certified facilities, enhancing its quality, marketability, and trust among consumers.

What is the future outlook for the market of chloramphenicol and hydrocortisone acetate?

The market for chloramphenicol and hydrocortisone acetate is expected to grow due to increasing global demand for quality eye care products, driven by an aging population, environmental factors, and global health trends.

Sources

  1. DrugBank: Hydrocortisone: Uses, Interactions, Mechanism of Action.
  2. Advoptic Vision Care: Chloramphenicol 1.0% Hydrocortisone 0.5% Eye Ointment.
  3. Access to Medicine Foundation: Antimicrobial Resistance Benchmark 2018.
  4. PubChem: Chloramphenicol; hydrocortisone acetate.
  5. GWU SMHS: Comprehensive Review for Infectious Disease Board.

More… ↓

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