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Last Updated: December 22, 2024

PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details


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What are the generic drug sources for prednisolone sodium phosphate and what is the scope of patent protection?

Prednisolone sodium phosphate is the generic ingredient in thirteen branded drugs marketed by Merck, Watson Labs, Novartis, Schering, Pharmafair, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, Rising, and Genus, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for prednisolone sodium phosphate. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for PREDNISOLONE SODIUM PHOSPHATE

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

SponsorPhase
Vietstar Biomedical ResearchN/A
Huro Biotech Joint Stock CompanyN/A
University of OuluPhase 4

See all PREDNISOLONE SODIUM PHOSPHATE clinical trials

Pharmacology for PREDNISOLONE SODIUM PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE SODIUM PHOSPHATE
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
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
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
Paragraph IV (Patent) Challenges for PREDNISOLONE SODIUM PHOSPHATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORAPRED ODT Orally Disintegrating Tablets prednisolone sodium phosphate 10 mg, 15 mg and 30 mg 021959 1 2010-07-22

US Patents and Regulatory Information for 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
Sola Barnes Hind PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 084171-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 083358-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis INFLAMASE FORTE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 080751-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 216715-001 Oct 25, 2022 AA RX 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

Expired US Patents for PREDNISOLONE SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006 5,178,878 ⤷  Subscribe
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 6,740,341 ⤷  Subscribe
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006 6,740,341 ⤷  Subscribe
Seton Pharm PEDIAPRED prednisolone sodium phosphate SOLUTION;ORAL 019157-001 May 28, 1986 4,448,774 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

PREDNISOLONE SODIUM PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednisolone Sodium Phosphate

Introduction

Prednisolone Sodium Phosphate is a versatile corticosteroid with a wide range of therapeutic applications, including immune system diseases, nervous system diseases, digestive system disorders, and more. This article delves into the market dynamics and financial trajectory of this drug, highlighting its approval history, therapeutic indications, competitive landscape, and financial performance.

Approval History and Therapeutic Indications

Prednisolone Sodium Phosphate was granted FDA approval on December 19, 1973, for various indications including allergic states, dermatologic diseases, edematous states, endocrine disorders, gastrointestinal diseases, hematologic disorders, and respiratory diseases among others[3].

The drug is used to treat a broad spectrum of conditions due to its anti-inflammatory, immunosuppressive, anti-neoplastic, and vasoconstrictive effects. Its first approval in Japan in 2002 further signifies its clinical benefits and regulatory validation[2].

Competitive Landscape

The market for Prednisolone Sodium Phosphate is part of a larger competitive landscape targeting the glucocorticoid receptor (GR). Several major pharmaceutical companies, including Novartis AG, Bausch Health Cos., Inc., and Shionogi & Co., Ltd., are actively involved in the development and marketing of GR-targeting drugs[2].

As of 2023, there are 348 GR drugs worldwide, from 464 organizations, covering 427 indications and conducting 11,801 clinical trials. This intense competition and innovation in the GR target area indicate a dynamic and evolving market[2].

Pharmacological and Clinical Significance

Prednisolone Sodium Phosphate targets the glucocorticoid receptor, modulating various physiological processes such as immune responses, metabolism, and stress responses. This makes it a valuable treatment option for a wide range of diseases, from eczema and asthma to psoriasis and rheumatic diseases[2].

The drug's pharmacological effects include promotion of gluconeogenesis, increased glycogen deposition, anti-insulin activity, and inhibition of inflammatory processes. It is rapidly absorbed from the gastrointestinal tract, with a higher peak plasma level and faster onset compared to tablet forms[1].

Market Demand and Growth

The demand for Prednisolone Sodium Phosphate is driven by its broad therapeutic applications and the prevalence of the conditions it treats. For instance, the high incidence of allergic diseases, autoimmune disorders, and inflammatory conditions contributes to a steady market demand.

The global corticosteroid market, which includes Prednisolone Sodium Phosphate, is expected to grow due to increasing healthcare expenditure, rising awareness of chronic diseases, and advancements in pharmaceutical technology.

Financial Performance

The financial performance of Prednisolone Sodium Phosphate is influenced by several factors, including sales volume, pricing strategies, and competition. Given its wide range of indications and approval in multiple regions, the drug generates significant revenue.

For example, the oral solution formulation of Prednisolone Sodium Phosphate, marketed under brands like Orapred and Pediapred, contributes to the overall revenue of the manufacturers. The presence of generic versions also impacts the pricing and market share of the branded products[3].

Regional Market Analysis

The market for Prednisolone Sodium Phosphate is strong in regions like the United States and Japan, where it has been approved and widely used. China has also emerged as a significant player in the GR-targeting drug market, with considerable research and development activities[2].

Challenges and Opportunities

Despite its therapeutic benefits, Prednisolone Sodium Phosphate faces challenges such as side effects, particularly in geriatric patients and children. Osteoporosis, growth suppression in children, and other corticosteroid-induced side effects are significant concerns that can impact long-term use and market growth[1].

However, ongoing research and clinical trials offer opportunities for optimizing dosing regimens, reducing side effects, and exploring new indications. The competitive landscape also drives innovation, with companies continuously seeking to improve formulations and delivery methods to enhance patient compliance and outcomes[2].

Palatability and Patient Compliance

Patient compliance is a crucial factor in the market dynamics of Prednisolone Sodium Phosphate. Studies have shown that the palatability of the oral solution formulation is generally better than that of tablets, which can improve patient adherence, especially in pediatric patients[4].

Regulatory Environment

The regulatory environment plays a significant role in the financial trajectory of Prednisolone Sodium Phosphate. Regulatory approvals and compliance with safety standards are essential for maintaining market presence. The drug's approval in various countries and its inclusion in national formularies contribute to its market stability and growth[3].

Key Takeaways

  • Broad Therapeutic Applications: Prednisolone Sodium Phosphate is used to treat a wide range of diseases, including allergic states, dermatologic diseases, and respiratory diseases.
  • Competitive Landscape: The market is competitive with several major pharmaceutical companies involved in GR-targeting drugs.
  • Financial Performance: The drug generates significant revenue due to its wide use and approval in multiple regions.
  • Regional Market Strength: Strong market presence in the United States, Japan, and China.
  • Challenges and Opportunities: Side effects are a concern, but ongoing research offers opportunities for improvement and new indications.

FAQs

Q: What is Prednisolone Sodium Phosphate used for? A: Prednisolone Sodium Phosphate is used to treat various conditions including allergic states, dermatologic diseases, edematous states, endocrine disorders, and respiratory diseases.

Q: When was Prednisolone Sodium Phosphate approved by the FDA? A: Prednisolone Sodium Phosphate was granted FDA approval on December 19, 1973.

Q: Which companies are major players in the market for Prednisolone Sodium Phosphate? A: Major players include Novartis AG, Bausch Health Cos., Inc., and Shionogi & Co., Ltd.

Q: What are the common side effects of Prednisolone Sodium Phosphate? A: Common side effects include osteoporosis, growth suppression in children, and other corticosteroid-induced side effects.

Q: How does the palatability of Prednisolone Sodium Phosphate affect patient compliance? A: The oral solution formulation of Prednisolone Sodium Phosphate generally has better palatability than tablets, which can improve patient adherence, especially in pediatric patients.

Cited Sources

  1. Prednisolone Sodium Phosphate Oral Solution - FDA Label[1]
  2. Exploring Prednisolone Sodium Phosphate's Revolutionary R&D Successes - Synapse Patsnap[2]
  3. Prednisolone phosphate: Uses, Interactions, Mechanism of Action - DrugBank[3]
  4. Prednisolone sodium phosphate: Topics by Science.gov - Science.gov[4]

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