PREDNISOLONE - Generic Drug Details

What are the generic 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, We Pharms, Muro, Teva, 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, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, Bausch And Lomb, Merck, Alcon Pharms Ltd, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Endo Operations, Mission Pharma, Pharmobedient, Vintage Pharms, and Genus, and is included in one hundred and twenty-six 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. Nine suppliers are listed for this compound.

Summary for PREDNISOLONE

US Patents:	1
Tradenames:	38
Applicants:	71
NDAs:	126
Drug Master File Entries:	88
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	770
Patent Applications:	7,038
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
Sanofi	Phase 3
Kasr El Aini Hospital	N/A
Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 3

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
Hikma	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075183-001	Mar 26, 2003		DISCN	No	No
Teva	PRELONE	prednisolone	SYRUP;ORAL	089081-001	Feb 4, 1986	AA	RX	No	No
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006		RX	Yes	No
Pharmafair	PREDAIR	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	088415-001	Feb 29, 1984		DISCN	No	No
Pharmafair	PREDSULFAIR	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088007-001	Apr 19, 1983		DISCN	No	No
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083767-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cent Pharms	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	084717-001	Approved Prior to Jan 1, 1982		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/002382 Alleviation 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

PREDNISOLONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednisolone

Introduction to Prednisolone

Prednisolone, a synthetic corticosteroid, is widely used in the treatment of various chronic and inflammatory conditions, including asthma, allergies, and autoimmune disorders such as lupus and rheumatoid arthritis. The market for prednisolone is dynamic and influenced by several key factors.

Market Size and Projection

The global prednisolone market is experiencing substantial growth, driven by increasing demand for effective treatments for chronic diseases. By 2027, the market is projected to reach significant value, with estimates suggesting a robust expansion in the coming years[1].

Growth Drivers

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases worldwide is a primary driver of the prednisolone market. Conditions such as asthma, allergies, and autoimmune disorders are becoming more prevalent, necessitating effective treatment options. For instance, asthma affects approximately 7% of Americans, with about 19 million adults and 6.1 million children affected, contributing significantly to the demand for prednisolone[4].

Advancements in Pharmaceutical Research

Recent innovations in drug formulations, including extended-release and combination therapies, are enhancing the efficacy of prednisolone. These advancements, such as new delivery systems like inhalers and injectables, are attracting both healthcare providers and patients, further propelling market growth[1].

Greater Awareness and Access to Healthcare

Improved awareness about the benefits of prednisolone and enhanced access to healthcare facilities are contributing to the market's expansion. Patients are increasingly seeking effective treatments for chronic conditions, leading to a higher demand for prednisolone prescriptions[1].

Market Trends

New Product Launches

Pharmaceutical companies are continually introducing new formulations of prednisolone to cater to diverse patient needs. Recent launches include innovative delivery systems that enhance patient compliance and therapeutic outcomes[1].

Strategic Partnerships

Strategic partnerships between pharmaceutical companies and research institutions are fostering innovation in the prednisolone market. These collaborations aim to develop more effective and targeted therapies, further solidifying prednisolone's position in the pharmaceutical landscape[1].

Mergers and Acquisitions

The prednisolone market has seen a rise in mergers and acquisitions, allowing companies to consolidate resources and expand their market presence. This trend is expected to continue as businesses seek to enhance their product offerings and improve operational efficiencies[1].

Financial Trajectory

Market Size and Revenue

The prednisolone market is part of the broader corticosteroids market, which was valued at USD 5.70 billion in 2023 and is anticipated to grow to USD 8.53 billion by 2032, with a CAGR of 4.6% from 2024 to 2032[3].

Regional Market Analysis

• North America: This region is set to gather a significant share of the market, influenced by the rising prevalence of asthma and other chronic conditions. The North American prednisone market, which includes prednisolone, is expected to hold about 35% of the global market share during the forecast period[4].
• Asia Pacific: The market in this region is predicted to grow due to the lack of physical activity and the rising prevalence of diseases such as kidney disorders. Up to 434.3 million people in this region are affected by chronic kidney disease (CKD), driving the demand for prednisolone[4].

Investment Opportunities

The prednisolone market presents lucrative investment opportunities, particularly in research and development. Investors are recognizing the potential of this market as the demand for effective treatments rises. Focus areas include developing new formulations, enhancing delivery systems, and fostering strategic partnerships to drive innovation[1].

Clinical Efficacy and Safety

Efficacy in Specific Conditions

Studies have shown that prednisolone is highly effective in delaying relapse onset in conditions like myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Patients treated with at least 12.5 mg/day of oral prednisone for at least 3 months had an 88% reduction in the risk of relapse compared to those who did not receive this regimen[2].

Safety Considerations

While prednisolone is effective, it also comes with potential side effects, particularly with long-term use. Common side effects include weight gain, increased appetite, and mood changes. Serious complications can arise from prolonged use, such as adrenal insufficiency and bone turnover issues[2][5].

Future Outlook

The future of the prednisolone market appears promising, with continued growth expected. Factors such as ongoing research, technological advancements, and a focus on personalized medicine are likely to shape the market landscape. As healthcare providers strive for better treatment outcomes, the demand for prednisolone is anticipated to rise[1].

Key Takeaways

• The prednisolone market is driven by the increasing prevalence of chronic diseases and advancements in pharmaceutical research.
• New product launches, strategic partnerships, and mergers and acquisitions are key trends in the market.
• The market is expected to grow significantly, with a projected value increase by 2027.
• Regional markets, especially North America and Asia Pacific, are expected to contribute substantially to the global market share.
• Investment opportunities are abundant, particularly in R&D and strategic partnerships.
• Clinical efficacy and safety considerations highlight the importance of careful dosing and monitoring.

FAQs

Q: What are the primary drivers of the prednisolone market? A: The primary drivers include the increasing prevalence of chronic diseases, advancements in pharmaceutical research, and greater awareness and access to healthcare.

Q: What are some of the new trends in the prednisolone market? A: New trends include the launch of innovative delivery systems, strategic partnerships between pharmaceutical companies and research institutions, and mergers and acquisitions to consolidate resources.

Q: How does prednisolone impact patients with MOGAD? A: Prednisolone significantly delays the onset of relapse in patients with MOGAD, with a minimum effective dose of 12.5 mg/day for at least 3 months reducing the risk of relapse by 88%[2].

Q: What are the potential side effects of long-term prednisolone use? A: Long-term use can lead to serious complications such as adrenal insufficiency, bone turnover issues, weight gain, increased appetite, and mood changes[2][5].

Q: What is the projected market size of the prednisolone market by 2032? A: The broader corticosteroids market, which includes prednisolone, is anticipated to grow to USD 8.53 billion by 2032, with a CAGR of 4.6% from 2024 to 2032[3].

Sources

1. Market Research Intellect: "Prednisolone Market Size And Projection - Market Research Intellect"
2. Neurology Live: "Higher Doses of Oral Prednisone Delays Relapse Onset in MOG Antibody Disease"
3. Polaris Market Research: "Corticosteroids Market Size, Share, Growth Analysis Report, 2032"
4. Research Nester: "Prednisone Market Size & Share, Growth Forecasts 2036"
5. JAMA Network: "Efficacy and Safety of Vamorolone vs Placebo and Prednisone in Boys With Duchenne Muscular Dystrophy"