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Last Updated: December 22, 2024

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM - Generic Drug Details


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

Prednisolone sodium phosphate; sulfacetamide sodium is the generic ingredient in three branded drugs marketed by Bausch And Lomb, Genus, Epic Pharma Llc, and Novartis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Pharmacology for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
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
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
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
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
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01AB Sulfonamides
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
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
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 PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis VASOCIDIN prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 018988-001 Aug 26, 1988 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 074449-001 Dec 29, 1995 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc SULSTER prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 074511-001 Jul 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Genus SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 073630-001 May 27, 1993 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

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednisolone Sodium Phosphate and Sulfacetamide Sodium

Introduction

Prednisolone sodium phosphate and sulfacetamide sodium are key components of an ophthalmic solution used to treat various eye conditions, including infections and inflammation. This article delves into the market dynamics, financial trajectory, and other critical aspects of this drug combination.

Market Overview

The market for sulfacetamide sodium API, a crucial component of the ophthalmic solution, has been experiencing significant growth. Here are some key points:

Market Size and Growth

The sulfacetamide sodium API market reached a substantial value in 2023 and is projected to continue growing until 2031. This growth is driven by increasing demand for ophthalmic solutions and other applications[3].

Segmentation

The market is segmented based on type (purity above 99% and below 99%) and application (eye drops and others), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse market dynamics and opportunities[3].

Demand and Supply

Current Shortages

There is currently a shortage of sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution, with Bausch Health being the sole supplier. The reason for the shortage has not been disclosed, and there is no estimated resupply date[1].

Implications for Patient Care

The shortage has significant implications for patient care, as this medication is crucial for treating conditions like uveitis and other bacterial infections of the eye. Healthcare providers must manage available supplies carefully and consider alternative treatments when necessary[1].

Financial Trajectory

Market Projections

The financial trajectory of the sulfacetamide sodium API market is positive, with projections indicating sustained and significant expansion from 2023 to 2031. This growth is driven by increasing demand, advancements in healthcare, and expanding market opportunities[3].

Revenue and Growth Rates

The market is expected to achieve robust growth rates throughout the forecasted period, driven by both inherent factors such as market drivers and external factors like opportunities and challenges. The revenue is anticipated to increase substantially, reflecting the growing need for ophthalmic solutions[3].

Pricing and Coverage

Medicare Coverage

In the United States, Medicare prescription drug plans generally cover sulfacetamide and prednisolone sodium phosphate ophthalmic solution. It is typically listed on Tier 2 of the formulary, which affects the out-of-pocket costs for patients. Most plans cover this medication, but costs can vary depending on the coverage stage[5].

Pricing Dynamics

The pricing of the drug can be influenced by various factors, including production costs, market demand, and regulatory environments. The current shortage could potentially impact pricing, making the drug more expensive due to limited supply[1].

Market Drivers

Increasing Demand for Ophthalmic Solutions

The growing need for effective ophthalmic treatments drives the demand for sulfacetamide sodium and prednisolone sodium phosphate. This is partly due to an aging population and an increase in eye-related conditions[3].

Advancements in Healthcare

Advancements in healthcare technology and the development of new formulations contribute to the market's growth. These advancements improve the efficacy and safety of ophthalmic solutions, making them more appealing to both healthcare providers and patients[3].

Market Restraints

Regulatory Challenges

Regulatory challenges can impact the production and distribution of the drug. For instance, strict quality control measures and approval processes can delay the release of new batches, contributing to shortages[1].

Competition

The ophthalmic solution market is competitive, with various other treatments available. This competition can affect the market share and pricing of sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution[3].

Opportunities and Challenges

Emerging Markets

Emerging markets in regions like Asia-Pacific and South America offer significant opportunities for growth. These markets are characterized by increasing healthcare spending and a growing demand for advanced ophthalmic treatments[3].

Supply Chain Issues

Supply chain disruptions, such as the current shortage, pose significant challenges. Ensuring a stable supply chain is crucial for maintaining market stability and meeting patient needs[1].

Product Details

Composition and Dosage

The ophthalmic solution combines sulfacetamide sodium (an antibacterial) and prednisolone sodium phosphate (a corticosteroid). The typical dosage involves instilling 2 drops into the conjunctival sac of the affected eye every 4 hours during the day and at bedtime[2][4].

Chemical Structure and Compatibility

The chemical structures of both components are well-defined, and the solution is incompatible with silver preparations and local anesthetics related to p-aminobenzoic acid. This incompatibility is important for healthcare providers to note when prescribing the medication[4].

Conclusion

The market for prednisolone sodium phosphate and sulfacetamide sodium is characterized by significant growth potential, driven by increasing demand and advancements in healthcare. However, challenges such as current shortages and regulatory hurdles must be addressed to ensure a stable supply chain.

Key Takeaways

  • Growing Market: The sulfacetamide sodium API market is projected to grow substantially until 2031.
  • Shortages: Current shortages of the ophthalmic solution pose significant challenges for patient care.
  • Pricing and Coverage: Medicare generally covers the medication, but pricing can be affected by supply and demand.
  • Market Drivers: Increasing demand for ophthalmic solutions and healthcare advancements drive market growth.
  • Regulatory Challenges: Strict regulatory measures can impact production and distribution.
  • Emerging Markets: Regions like Asia-Pacific and South America offer significant growth opportunities.

FAQs

Q: What is the current status of the sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution shortage?

A: The solution is currently in shortage, with Bausch Health unable to estimate a release date for new supplies[1].

Q: How is the medication typically dosed?

A: The usual adult dose involves instilling 2 drops into the conjunctival sac of the affected eye every 4 hours during the day and at bedtime[2].

Q: Is the medication covered by Medicare?

A: Yes, most Medicare prescription drug plans cover sulfacetamide and prednisolone sodium phosphate ophthalmic solution, typically listing it on Tier 2 of their formulary[5].

Q: What are the key components of the ophthalmic solution?

A: The solution combines sulfacetamide sodium (an antibacterial) and prednisolone sodium phosphate (a corticosteroid)[4].

Q: What are the potential challenges in the supply chain of this medication?

A: Supply chain disruptions, regulatory challenges, and competition from other treatments are potential challenges[1][3].

Sources

  1. ASHP: Drug Shortage Detail: Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution.
  2. Drugs.com: Prednisolone / Sulfacetamide Sodium Ophthalmic Dosage.
  3. Market Research Intellect: Global Sulfacetamide Sodium API Market Size, Scope And Forecast Report.
  4. DailyMed: Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution.
  5. GoodRx: Sulfacetamide / Prednisolone Sodium Phosphate Medicare Coverage.

More… ↓

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