PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details

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

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, Hikma, Mission Pharma, Nesher Pharms, Ph Health, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, Advanz Pharma, 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. Eighteen suppliers are listed for this compound.

Summary for PREDNISOLONE SODIUM PHOSPHATE

US Patents:	0
Tradenames:	13
Applicants:	28
NDAs:	43
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	10
Patent Applications:	8,343
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
Vietstar Biomedical Research	N/A
Huro Biotech Joint Stock Company	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
Epic Pharma Llc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	083358-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sola Barnes Hind	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	084171-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075988-001	May 25, 2004	AA	RX	No	No

Expired US Patents for PREDNISOLONE SODIUM PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006

Market Dynamics and Financial Trajectory for Prednisolone Sodium Phosphate

Last updated: November 19, 2025

Introduction

Prednisolone sodium phosphate, a soluble corticosteroid, is widely used in clinical settings to manage various inflammatory and autoimmune conditions, including allergic reactions, adrenal insufficiency, and certain neoplasms. As an injectable corticosteroid, its rapid onset and potent anti-inflammatory effects have cemented its position within specialty therapeutic areas. This article examines the evolving market landscape and financial prospects of prednisolone sodium phosphate, driven by clinical needs, regulatory developments, and competitive dynamics.

Market Overview and Key Drivers

Clinical Demand and Therapeutic Applications

Prednisolone sodium phosphate remains vital in acute care and emergency settings due to its rapid systemic absorption when administered intravenously. Its efficacy in managing severe allergic reactions, acute asthma exacerbations, and cerebral edema sustains consistent demand. The expanding prevalence of autoimmune diseases, allergies, and respiratory conditions globally fuels a baseline market need.

The increasing adoption of corticosteroids in oncology-related supportive care further amplifies its utilization. Additionally, the rising incidence of autoimmune disorders, such as rheumatoid arthritis and lupus, correlates with steady growth in corticosteroid prescriptions, including formulations like prednisolone sodium phosphate.

Regulatory Environment

Regulatory agencies worldwide have maintained stringent standards for corticosteroid formulations, emphasizing safety and efficacy. Recent approvals of generic versions and biosimilars in emerging markets have heightened competition, leading to price reductions and expanded access. Conversely, regulatory focus on minimizing adverse effects, particularly in long-term use, influences prescribing trends and product development.

Competitive Landscape

The corticosteroid market is highly fragmented, featuring numerous branded and generic products. Prednisolone sodium phosphate competes primarily on rapid onset and bioavailability. Major pharmaceutical companies and local manufacturers dominate the space, with key differentiators including formulation stability, manufacturing quality, and cost.

The advent of targeted drug delivery systems and novel corticosteroid derivatives may reshape competitive dynamics, although prednisolone sodium phosphate continues to hold relevance owing to its well-established profile and manufacturing infrastructure.

Market Challenges

• Safety Concerns: Corticosteroid-related adverse events, such as immunosuppression, osteoporosis, and hyperglycemia, influence prescribing habits and patient management strategies. The potential for long-term adverse effects limits excessive use and prompts interest in alternative therapies.

• Pricing Pressures: Increased generic competition has driven down prices, impacting profit margins for manufacturers. Governments and healthcare providers' emphasis on cost containment further constrains pricing.

• Supply Chain Stability: Manufacturing complexities related to sterile injectable products pose risks. Disruptions in raw materials or manufacturing capacities can impact availability, particularly in emerging markets.

Market Opportunities

• Emerging Markets: Growing healthcare infrastructure and increasing healthcare expenditure in Asia-Pacific, Latin America, and Africa open avenues for expanding access and sales.

• Inhalation and Topical Formulations: Innovations in alternative delivery routes may broaden the therapeutic applications and market footprint.

• Post-Marketing Surveillance and Safety Profiles: Enhanced safety data can bolster confidence among clinicians, leading to sustained or increased utilization.

• Partnerships and Licensing: Strategic alliances for manufacturing, distribution, and R&D can facilitate market penetration and product innovation.

Financial Trajectory and Market Forecast

Revenue Projections

The corticosteroid injectable segment, including prednisolone sodium phosphate, is projected to witness a compound annual growth rate (CAGR) of approximately 3–5% over the next five years. Market value, estimated at USD 200-300 million in 2022, is expected to surpass USD 350 million by 2027, driven by increasing demand in acute care settings.

Regional Outlook

• North America: The mature market benefits from high healthcare expenditure and established regulatory pathways. Growth stems from expanding indications and aging populations.

• Europe: Similar to North America, with additional influence from stringent regulatory standards and biosimilar competition.

• Asia-Pacific: Rapidly growing markets present significant upside, driven by increases in healthcare access and emerging clinical practices.

• Latin America and Africa: Market expansion opportunities are tempered by infrastructural challenges but are increasingly attractive owing to rising disease prevalence and drug affordability initiatives.

Profit Margins and Cost Dynamics

Manufacturing costs are influenced by the complexities of sterile injectable production, raw material sourcing, and quality assurance. Generic manufacturers offer competitive prices, pressuring profit margins for innovator companies. Nonetheless, strong demand in acute and emergency care sustains overall revenue streams.

Strategic Considerations

To capitalize on market opportunities, pharmaceutical entities should prioritize:

• Streamlining Supply Chains: Ensuring manufacturing resilience and raw material sourcing stability.

• Investing in Safety and Efficacy Data: Supporting clinical evidence can bolster market share amid safety concerns.

• Expanding Market Access: Tailoring strategies for emerging markets through partnerships and local manufacturing.

• Innovating Delivery Methods: Developing alternative formulations to expand therapeutic use cases.

Key Market Trends

• Growth in corticosteroid prescribing driven by rising autoimmune and allergic diseases.
• Increasing reliance on biosimilars and generics to reduce costs.
• Emphasis on pharmacovigilance to mitigate safety concerns.
• Technological advancements in production enhancing quality and scalability.
• Regulatory harmonization facilitating international market entry.

Key Takeaways

• Stable Demand: Prednisolone sodium phosphate remains essential in acute medical care, ensuring consistent demand.

• Price Sensitivity: Generic competition and cost containment practices impose pressure on pricing and margins.

• Emerging Market Expansion: Asia-Pacific and Latin America offer high growth potential due to increasing healthcare infrastructure.

• Innovation Focus: Developing delivery systems and safety profiles can sustain and enhance market position.

• Regulatory Dynamics: Ongoing regulatory oversight influences market access and product differentiation strategies.

Conclusion

The market trajectory for prednisolone sodium phosphate is characterized by steady growth, primarily driven by clinical utility, regulatory evolution, and regional expansion. While challenges persist—particularly concerning safety concerns and pricing pressures—strategic innovations and targeted market access initiatives position the pharmaceutical industry well to capitalize on emerging opportunities. The ongoing demand in acute and autoimmune care, combined with advances in manufacturing and formulations, forecast a resilient financial outlook for this critical corticosteroid formulation.

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FAQs

1. What factors are influencing the demand for prednisolone sodium phosphate?
The increasing prevalence of autoimmune, allergic, and inflammatory conditions, alongside its essential role in emergency and acute care, sustains demand. Additionally, expanding healthcare access in emerging markets further amplifies usage.

2. How does generic competition impact the market for prednisolone sodium phosphate?
Generic manufacturers exert downward pressure on prices, reducing profit margins but expanding accessibility. Competition also accelerates innovation in formulations and delivery methods to differentiate products.

3. What are the primary challenges facing the prednisolone sodium phosphate market?
Key challenges include safety concerns related to corticosteroid adverse effects, pricing pressures from generics, manufacturing complexities, and supply chain stability issues.

4. Which regions offer the greatest growth opportunities for prednisolone sodium phosphate?
Emerging markets in Asia-Pacific, Latin America, and Africa present significant growth potential due to increasing healthcare infrastructure and rising disease burdens.

5. How might future innovations influence the market?
Development of alternative delivery systems, improved safety profiles, and biosimilar competition will shape the competitive landscape, potentially unlocking new therapeutic applications and market segments.

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References

[1] Market research reports on corticosteroid injectables.
[2] Regulatory agency publications and updates.
[3] Industry analyst insights and market trend analyses.