PREDNISONE - Generic Drug Details

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

Prednisone is the generic ingredient in thirteen branded drugs marketed by Hikma, Xttrium Labs Inc, Muro, Actavis Labs Fl Inc, Dr Reddys, Horizon, Halsey, Bayer Pharms, Pharmacia And Upjohn, Ferndale Labs, Schering, Solvay, Parke Davis, Schwarz Pharma, Aiping Pharm Inc, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Geneyork Pharms, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Ph Health, Pharmavite, Phoenix Labs Ny, Pointview Hldings, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and twenty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisone has fifty-three patent family members in twenty-nine countries.

There are sixteen drug master file entries for prednisone. Forty-seven suppliers are listed for this compound.

Summary for PREDNISONE

International Patents:	53
US Patents:	2
Tradenames:	13
Applicants:	64
NDAs:	122
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,178
Patent Applications:	8,460
Drug Prices:	Drug price trends for PREDNISONE
Drug Sales Revenues:	Drug sales revenues for PREDNISONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREDNISONE
What excipients (inactive ingredients) are in PREDNISONE?	PREDNISONE excipients list
DailyMed Link:	PREDNISONE at DailyMed

See drug prices for PREDNISONE

See drug sales revenues for PREDNISONE

Recent Clinical Trials for PREDNISONE

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

Sponsor	Phase
Children's Oncology Group	PHASE2
AbbVie	PHASE2
Christopher John McDougle, M.D.	EARLY_PHASE1

See all PREDNISONE clinical trials

Pharmacology for PREDNISONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for PREDNISONE

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for PREDNISONE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for PREDNISONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAYOS	Delayed-release Tablets	prednisone	5 mg	202020	1	2012-11-26

US Patents and Regulatory Information for PREDNISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scherer Labs	PREDNISONE	prednisone	TABLET;ORAL	080371-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	PREDNISONE	prednisone	TABLET;ORAL	083059-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Jubilant Cadista	PREDNISONE	prednisone	TABLET;ORAL	040362-005	Apr 17, 2023	AB	RX	No	No
Strides Pharma	PREDNISONE	prednisone	TABLET;ORAL	208412-003	Jan 11, 2022	AB	RX	No	No
Roxane	PREDNISONE	prednisone	TABLET;ORAL	017109-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Actavis Labs Fl Inc	PREDNISONE	prednisone	TABLET, DELAYED RELEASE;ORAL	204867-002	Apr 25, 2017		DISCN	No	No
Novitium Pharma	PREDNISONE	prednisone	TABLET;ORAL	211575-001	Nov 15, 2019	AB	RX	No	No

Expired US Patents for PREDNISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012

International Patents for PREDNISONE

Country	Patent Number	Title	Estimated Expiration
Morocco	30665	TRAITEMENT DE MALADIES RHUMATOÏDES AVEC DES GLUCOCORTICOÏDES A LIBERATION RETARDEE.
Russian Federation	2005132451	ТАБЛЕТКА ОСОБОЙ ГЕОРМЕТРИЧЕСКОЙ ФОРМЫ С МЕДЛЕННЫМВЫСВОБОЖДЕНИЕМ АКТИВНОГО ВЕЩЕСТВА
Poland	2049123
Cyprus	1113915
Australia	2004231362	Delayed release tablet with defined core geometry
Hong Kong	1130423	類風濕病的延遲釋放糖皮質激素治療 (DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE)
Australia	2007280636	Delayed-release glucocorticoid treatment of rheumatoid disease

Market Dynamics and Financial Trajectory for Prednisone: A Comprehensive Analysis

Last updated: August 28, 2025

Introduction

Prednisone, a synthetic corticosteroid, remains a cornerstone in the treatment of numerous inflammatory and autoimmune conditions, including asthma, rheumatoid arthritis, and ulcerative colitis. Since its market approval in the mid-20th century, prednisone's role has evolved, influenced by advances in pharmacology, regulatory shifts, and the competitive landscape. This analysis examines the current market dynamics and predictive financial trajectory of prednisone, emphasizing factors shaping its demand, supply, pricing, and regulatory environment.

Market Overview

Historical Context and Current Status

Prednisone, introduced in the 1950s, is renowned for its potent anti-inflammatory and immunosuppressive properties. As a prodrug of prednisolone, it is widely prescribed due to its oral formulation, cost-effectiveness, and longstanding clinical efficacy. The drug is available as a generic, with multiple manufacturing players globally, underpinning its position as a low-cost therapeutic option.

Globally, the prednisone market is closely tied to the prevalence of chronic inflammatory and autoimmune diseases. North America and Europe dominate demand, driven by extensive healthcare infrastructure, high prescription rates, and chronic disease burden. Emerging markets in Asia-Pacific and Latin America exhibit growing adoption fueled by increasing healthcare access and aging populations.

Market Size and Revenue

Recent estimates suggest the global corticosteroids market, encompassing prednisone, was valued at approximately USD 4-5 billion in 2022, with predictions favoring steady growth attributable to expanding disease prevalence. Prednisone specifically constitutes a significant share within this market, owing to its affordability and extensive clinical utility.

Market Drivers

Increasing Prevalence of Autoimmune and Inflammatory Diseases

The persistent rise in autoimmune disorders—such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease—directly fuels prednisone demand. The World Health Organization (WHO) reports a global increase in autoimmune disease prevalence, especially in aging populations [1].

Economic Viability and Generic Availability

As a generic drug, prednisone's low production costs ensure widespread accessibility. The absence of patent protections has led to multiple manufacturers, heightening competition and stabilizing prices. This accessibility sustains its large-volume prescribing pattern.

Established Clinical Efficacy and Regulatory Acceptance

Long-standing clinical evidence supporting prednisone's effectiveness has resulted in its continued inclusion in treatment guidelines globally. Regulatory bodies generally classify prednisone as a well-understood, safe option when used appropriately, further supporting its market stability.

Market Challenges

Side Effect Profile and Safety Concerns

Prednisone's adverse effects—such as osteoporosis, hyperglycemia, and immunosuppression—limitate prolonged use, especially where newer therapies with improved safety profiles exist [2]. This has prompted shifts towards biologics and targeted therapies in certain indications.

Emergence of Alternative Therapies

Biologics and newer immunomodulators have begun replacing corticosteroids like prednisone in some treatment protocols, especially for autoimmune diseases requiring long-term management. Their targeted mechanisms offer improved safety and efficacy, affecting prednisone's market share.

Regulatory and Prescribing Trends

Regulatory agencies increasingly emphasize prudent corticosteroid use, emphasizing dosage and duration limitations. Additionally, clinical guidelines advocate for steroid-sparing approaches, impacting prescriptions.

Future Market Dynamics

Impact of Innovative Drug Development

Ongoing research on corticosteroid formulations (e.g., inhaled or targeted delivery systems) aims to mitigate adverse effects, potentially expanding therapeutic indications or improving compliance. Pharmaceutical companies investing in novel prednisone derivatives or delivery mechanisms could rejuvenate its market relevance.

Regulatory Environment and Patent Landscape

While prednisone remains off-patent, future patenting of new formulations or combination therapies could temporarily influence market exclusivity and pricing. Regulatory agencies’ evolving standards concerning biosimilars and generics may also affect market competition.

Global Market Expansion

Emerging economies, with their rising healthcare access and increasing prevalence of autoimmune conditions, will likely see growing prednisone utilization. However, pricing pressures and local manufacturing capacities will shape the financial depth of these markets.

Market Disruption from Biosimilars and Biologics

The rise of biologics as steroid-sparing agents can diminish prednisone’s prominence in certain indications. Nevertheless, for a broad spectrum of indications, especially in resource-constrained settings, prednisone will retain its position due to cost advantages.

Financial Trajectory and Revenue Outlook

Short-term Forecast (2023-2027)

Forecasts predict modest growth within the corticosteroids market at a compounded annual growth rate (CAGR) of 3-5%, primarily driven by increased diagnosis rates of autoimmune diseases and expanding healthcare access in developing countries. Prednisone, as a key low-cost corticosteroid, benefits from this trend but remains vulnerable to substitution by newer therapies.

Long-term Outlook (2028-2033)

Over the longer term, prednisone’s market share may stabilize or decline marginally due to increasing preference for targeted immunomodulators and biologic therapies. However, its low-cost profile and continued utility in acute care, outpatient treatments, and resource-limited settings will sustain its revenue stream. The global corticosteroid market’s valuation is forecasted to reach USD 6-7 billion by 2030, with prednisone commanding a significant segment, estimated at approximately USD 2-3 billion annually.

Pricing Dynamics

While brand-name prednisone commands a generic-driven price point, increasing regulatory scrutiny and market saturation are likely to continue exerting downward pressure on prices. Nonetheless, in certain markets, government procurement and bulk purchasing agreements can influence pricing strategies favorably.

Regulatory and Patent Considerations

Despite being off-patent for decades, potential innovation in prednisone formulations—such as extended-release versions or combination therapies—could lead to new patent filings, affecting competitive dynamics temporarily. Regulatory agencies’ emphasis on safety and efficacy will continue to shape approved formulations and indications.

Conclusion

Prednisone’s market is characterized by resilience rooted in its affordability, extensive clinical history, and broad therapeutic applications. However, evolving treatment paradigms, safety considerations, and emerging biologic therapies pose challenges to sustained growth. The financial future of prednisone hinges on its ability to adapt—through innovative formulations, strategic market expansion, and positioning within resource-limited healthcare settings.

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Key Takeaways

• Prednisone remains a vital, low-cost corticosteroid with significant global market share rooted in its efficacy and affordability.
• Market growth is steady, driven by rising autoimmune disease prevalence, especially in emerging markets.
• Competition from biologics and targeted therapies presents future challenges, potentially curbing its growth in certain indications.
• Formulation innovations and strategic positioning in resource-constrained environments will influence its long-term demand.
• Pricing pressures and regulatory changes will continue shaping revenue trajectories, with predicted stable or modest declines in mature markets.

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FAQs

1. How does prednisone compare to newer corticosteroids in terms of safety?
Prednisone’s safety profile is comparable to other corticosteroids but with a generally well-characterized adverse effect spectrum. Newer formulations aim to reduce systemic exposure, but prednisone’s long history offers clinicians familiarity with its management.

2. What factors could significantly alter prednisone’s market outlook in the next decade?
Major factors include the development of new drug formulations with improved safety, regulatory changes favoring biologics, shifts in clinical guidelines, and international healthcare infrastructure growth.

3. Are there any upcoming patent protections that could impact prednisone’s market?
While the original molecule is off-patent, novel formulations, combination products, or delivery mechanisms could be protected under new patents, temporarily affecting market competition.

4. How important is prednisone in developing countries’ healthcare systems?
Prednisone remains crucial due to its low cost, availability, and wide spectrum of indications, making it indispensable in resource-limited settings, especially for acute and outpatient care.

5. What is the potential for biosimilars or generics to influence prednisone’s pricing?
Multiple manufacturers ensure a competitive landscape, exerting downward pressure on prices. Future biosimilar developments are less relevant to prednisone but could influence other corticosteroids or related therapies.

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Sources

1. WHO. (2020). Autoimmune Diseases: Global Perspective. World Health Organization Reports.
2. Williams, C. et al. (2021). Assessing the Safety Profiles of Long-Term Corticosteroid Use. Journal of Clinical Pharmacology.