PREDNISOLONE SODIUM PHOSPHATE Drug Patent Profile

Which patents cover Prednisolone Sodium Phosphate, and what generic alternatives are available?

Prednisolone Sodium Phosphate is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, and Rising. and is included in thirty NDAs.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prednisolone Sodium Phosphate

A generic version of PREDNISOLONE SODIUM PHOSPHATE was approved as prednisolone sodium phosphate by BAUSCH AND LOMB on July 29^th, 1994.

Summary for PREDNISOLONE SODIUM PHOSPHATE

US Patents:	0
Applicants:	20
NDAs:	30
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	10
Patent Applications:	5,152
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREDNISOLONE SODIUM PHOSPHATE
What excipients (inactive ingredients) are in PREDNISOLONE SODIUM PHOSPHATE?	PREDNISOLONE SODIUM PHOSPHATE excipients list
DailyMed Link:	PREDNISOLONE SODIUM PHOSPHATE at DailyMed

Recent Clinical Trials for PREDNISOLONE SODIUM PHOSPHATE

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

Sponsor	Phase
Huro Biotech Joint Stock Company	N/A
Vietstar Biomedical Research	N/A
University of Oulu	Phase 4

See all PREDNISOLONE SODIUM PHOSPHATE clinical trials

Pharmacology for PREDNISOLONE SODIUM PHOSPHATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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
Vintage Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	078416-001	Oct 31, 2007		DISCN	No	No
Pharm Assoc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	078988-001	Jun 9, 2008	AA	RX	No	Yes
We Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075181-001	Dec 23, 2002		DISCN	No	No
Pharm Assoc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	204962-001	Mar 11, 2020		DISCN	No	No
Watson Labs	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	INJECTABLE;INJECTION	080517-001	Approved Prior to Jan 1, 1982		DISCN	No	No

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]