Prednisolone - Generic Drug Details

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

Prednisolone is the generic ingredient in thirty-eight branded drugs marketed by Schering, Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Tp Anda Holdings, We Pharms, Teva, Muro, Halsey, Pharmacia And Upjohn, Ferndale Labs, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Pfizer, Bel Mar, Cent Pharms, Epic Pharma Llc, Harrow Eye, Sandoz, Abbvie, Amneal, Lupin Ltd, Sun Pharma Canada, Allergan, Alcon, Pharmafair, Novartis, Bausch And Lomb, Merck, Alcon Pharms Ltd, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Ph Health, Pharmobedient, Vintage Pharms, Advanz Pharma, and Genus, and is included in one hundred and twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighty-eight drug master file entries for prednisolone. Eleven suppliers are listed for this compound.

Summary for prednisolone

US Patents:	1
Tradenames:	38
Applicants:	73
NDAs:	128
Drug Master File Entries:	88
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	836
Patent Applications:	7,706
Drug Prices:	Drug price trends for prednisolone
Drug Sales Revenues:	Drug sales revenues for prednisolone
What excipients (inactive ingredients) are in prednisolone?	prednisolone excipients list
DailyMed Link:	prednisolone at DailyMed

See drug prices for prednisolone

See drug sales revenues for prednisolone

Recent Clinical Trials for prednisolone

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE3
Children's Oncology Group	PHASE2
University of Minnesota	PHASE4

See all prednisolone clinical trials

Pharmacology for prednisolone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for prednisolone

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for prednisolone

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

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

US Patents and Regulatory Information for prednisolone

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
Teva	PREDNISOLONE	prednisolone	TABLET;ORAL	080398-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan	BLEPHAMIDE	prednisolone acetate; sulfacetamide sodium	SUSPENSION;OPHTHALMIC	012813-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Genus	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	073630-001	May 27, 1993		DISCN	No	No
Pharmobedient	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	076895-001	Oct 4, 2004		DISCN	No	No
Nesher Pharms	PREDNISOLONE	prednisolone	SOLUTION;ORAL	040364-001	Apr 10, 2002		DISCN	No	No
Alcon Pharms Ltd	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	081044-001	Oct 24, 1991		DISCN	No	No

EU/EMA Drug Approvals for prednisolone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LE VET B.V.	Equisolon	Prednisolone	EMEA/V/C/002382Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.	Authorised	no	no	no	2014-03-12

Market Dynamics and Financial Trajectory for Prednisolone: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Prednisolone, a synthetic corticosteroid, has long served as a cornerstone in managing inflammatory and autoimmune conditions. Its versatility, well-established efficacy, and cost-effectiveness have entrenched it as a vital drug within the pharmaceutical landscape. As global healthcare systems evolve and novel therapies emerge, understanding prednisolone’s market dynamics and financial trajectory becomes critical for stakeholders including manufacturers, investors, and healthcare policymakers. This analysis offers a comprehensive overview of the factors shaping prednisolone’s market, assessing demand drivers, competitive landscape, regulatory influences, and potential future trends.

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Pharmacological Profile and Therapeutic Applications

Prednisolone exhibits potent anti-inflammatory and immunosuppressive properties, making it indispensable in treating asthma, allergies, rheumatoid arthritis, dermatological conditions, and certain hematologic disorders [1]. The drug’s oral, injectable, and topical formulations provide broad administration versatility, further cementing its widespread use. Its longstanding generic presence ensures affordability, supporting its popularity in both developed and emerging markets.

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Market Demand Drivers

1. Growing Incidence of Chronic Conditions

The global rise in autoimmune diseases and inflammatory disorders propels demand for corticosteroids like prednisolone. Notably, increased prevalence of rheumatoid arthritis and asthma contributes to sustained consumption. According to the Global Burden of Disease Study, these conditions remain among the leading causes of disability worldwide, underpinning a steady need for corticosteroids.

2. Healthcare Accessibility and Affordability

Prednisolone’s status as a low-cost, off-patent medication allows broad access, particularly in low- and middle-income countries (LMICs). As healthcare infrastructure improves in these regions, prescription rates are expected to rise, further boosting demand [2].

3. Emergency and Acute Care Use

The drug’s utility extends to acute allergic reactions and exacerbations of chronic conditions. Its established role in hospital protocols sustains consistent demand, especially amidst global health crises that exacerbate inflammatory responses.

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Market Dynamics

1. Patent Expiry and Generic Competition

Prednisolone’s patent expiry in the early 2000s catalyzed a proliferation of generic formulations, significantly decreasing prices and expanding market reach. This commoditization enhanced accessibility but intensified price competition, compressing profit margins for manufacturers [3].

2. Manufacturing and Supply Chain Considerations

Global supply chains, predominantly based in Asia, especially India and China, produce the bulk of prednisolone supplies [4]. Recent disruptions, including geopolitical tensions and COVID-19-related logistical challenges, have occasionally led to shortages, impacting availability and pricing dynamics.

3. Regulatory and Quality Standards

Regulatory agencies enforce stringent quality standards for corticosteroids. Variations in regulatory environments, especially across emerging markets, influence manufacturing costs and market entry strategies. Conversely, quality concerns have prompted some markets to favor established suppliers or trusted APIs, impacting competitive positioning.

4. Emerging Alternatives and Therapeutic Shifts

While prednisolone remains a primary corticosteroid option, newer drugs with targeted mechanisms and fewer systemic side effects, such as biologics for autoimmune diseases, threaten its market share. However, due to cost and familiarity, prednisolone retains dominance in many settings [5].

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Financial Trajectory and Market Outlook

Historical Revenue Trends

Globally, prednisolone’s annual sales have historically ranged between $500 million and $1 billion, with significant regional variations. The generic drug market’s expansion contributed to consistent revenue streams, particularly in LMICs where cost considerations dominate treatment choices [6].

Future Projections

Forecasts suggest moderate growth for prednisolone over the next five years, driven by:

• Continued demand in developing regions.
• Growing incidence of autoimmune and inflammatory conditions.
• Policy initiatives promoting affordable essential medicines.

However, growth may be tempered by:

• Increasing preferences for targeted biologics.
• Price erosion due to intensified generic competition.
• Regulatory barriers, especially concerning quality assurance.

The compound annual growth rate (CAGR) of prednisolone sales is expected to hover around 2-3% globally, with higher potential in underserved markets. Advanced formulations, such as combined therapies or controlled-release variants, may open niche segments, although their commercial impact remains limited.

Market Players and Investment Opportunities

Major generic manufacturers like Sun Pharma, Teva, and local pharmaceutical companies dominate the prednisolone market. Strategic investments focus on expanding manufacturing capacity, ensuring supply chain resilience, and adhering to quality standards to maintain competitiveness.

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Regulatory and Policy Environment

Global health policies emphasize affordable corticosteroids as essential medicines, reinforcing their market stability. The World Health Organization (WHO) classifies prednisolone as an essential medicine, facilitating subsidies and inclusion in national formularies, especially in LMICs [7].

Regulatory harmonization efforts, including mutual recognition agreements, streamline approval processes and foster market access. Yet, disparities in regulatory rigor can influence market dynamics, creating barriers and opportunities.

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Market Challenges

• Side Effect Profile: Long-term use of prednisolone is associated with adverse effects—osteoporosis, hyperglycemia, adrenal suppression—prompting clinicians to consider alternatives.

• Price Sensitivity: Budget constraints limit the use of corticosteroids in certain markets, pressuring manufacturers to maintain low prices.

• Emerging Disease Contexts: The COVID-19 pandemic underscored corticosteroids’ role, particularly dexamethasone. While prednisolone is similar, shifts in treatment protocols could influence its utilization patterns [8].

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Future Outlook

Prednisolone’s role as an affordable, effective corticosteroid ensures its continued relevance, particularly in resource-constrained settings. Nevertheless, innovation, such as developing formulations with improved safety profiles or targeted delivery systems, could extend its lifecycle. Additionally, a looming focus on personalized medicine may stimulate research into optimized corticosteroid regimens, influencing future demand.

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Key Takeaways

• Prednisolone maintains steady global demand underpinned by its efficacy, affordability, and extensive generic availability.
• Market growth is moderate, primarily fueled by increased autoimmune disease prevalence and expanding healthcare access in LMICs.
• Competitive dynamics are characterized by intense price competition, supply chain considerations, and regulatory standards.
• Emerging alternatives such as biologics pose a long-term threat but currently only complement prednisolone’s role in treatment algorithms.
• Ensuring high-quality manufacturing and regulatory compliance remains critical for market sustainability.

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FAQs

1. How does prednisolone compare to other corticosteroids in terms of efficacy and safety?
Prednisolone offers comparable efficacy to other corticosteroids like prednisone and dexamethasone in managing inflammation. Its safety profile is well-characterized, with long-term use associated with adverse effects typical of corticosteroids. Choice depends on disease indication, dosing, and patient factors.

2. What regional factors influence prednisolone market growth?
Developing countries exhibit higher growth potential owing to increasing disease burden and reliance on affordable treatments. Regulatory environments and healthcare infrastructure quality also impact market expansion.

3. How are supply chain disruptions affecting prednisolone availability?
Disruptions, particularly during the COVID-19 pandemic, have occasionally led to shortages. Given manufacturing primarily in Asia, geopolitical issues and logistical hurdles can impact global supply, influencing availability and pricing.

4. Will the introduction of new drug delivery systems affect prednisolone’s market?
Potentially. Novel formulations with improved safety, targeted delivery, or controlled-release properties could expand indications and improve adherence, sustaining interest in prednisolone derivatives.

5. What role do governmental policies play in prednisolone’s market?
Recognition as an essential medicine enables government subsidies and inclusion in public health programs, fostering market stability and encouraging manufacturers to allocate resources for production and quality compliance.

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References

[1] Katzung, B. G., Masters, S. B., & Trevor, A. J. (2018). Basic and Clinical Pharmacology. McGraw-Hill Education.

[2] World Health Organization. (2017). WHO Model List of Essential Medicines.

[3] IMS Health. (2014). Global Trends in Generic Drug Market.

[4] Indian Pharmaceutical Alliance. (2021). API Manufacturing Landscape.

[5] Smolen, J. S., et al. (2016). "Biologic and targeted synthetic DMARDs for rheumatoid arthritis." The New England Journal of Medicine.

[6] Market Research Future. (2022). Global Corticosteroids Market Analysis.

[7] WHO. (2019). Essential Medicines in Primary Healthcare.

[8] The RECOVERY Collaborative Group. (2020). "Dexamethasone in Hospitalized Patients with Covid-19." The New England Journal of Medicine.