PREDNISONE Drug Patent Profile

When do Prednisone patents expire, and what generic alternatives are available?

Prednisone is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Allied, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, Everylife, Ferrante, Geneyork Pharms, Halsey, 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, Pharmavite, Phoenix Labs Ny, 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 sixteen NDAs.

The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prednisone

A generic version of PREDNISONE was approved as prednisone by WATSON LABS on December 31^st, 1969.

Summary for PREDNISONE

US Patents:	0
Applicants:	54
NDAs:	116
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	2,021
Patent Applications:	4,579
Drug Prices:	Drug price information for PREDNISONE
Drug Sales Revenues:	Drug sales revenues for PREDNISONE
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
Zhejiang University	Phase 3
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

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
Mylan	PREDNISONE	prednisone	TABLET;ORAL	080292-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Sperti	PREDNISONE	prednisone	TABLET;ORAL	080359-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Phoenix Labs Ny	PREDNISONE	prednisone	TABLET;ORAL	083807-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ivax Sub Teva Pharms	PREDNISONE	prednisone	TABLET;ORAL	084133-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Everylife	PREDNISONE	prednisone	TABLET;ORAL	084440-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Duramed Pharms Barr	PREDNISONE	prednisone	TABLET;ORAL	088395-001	Oct 4, 1983		DISCN	No	No

Market Dynamics and Financial Trajectory for Prednisone

Introduction to Prednisone

Prednisone is a synthetic corticosteroid widely used to treat a variety of inflammatory and autoimmune conditions. Its versatility and effectiveness have made it a staple in modern medicine, driving significant market growth.

Global Market Size and Growth

The global prednisone market is projected to experience substantial growth over the coming years. By 2036, the market size is estimated to cross USD 9 billion, expanding at a Compound Annual Growth Rate (CAGR) of around 5% during the forecast period from 2024 to 2036. In 2023, the market size was over USD 6 billion, indicating a steady and robust growth trajectory[1].

Key Growth Drivers

Increasing Prevalence of Skin Diseases

The surge in skin diseases, including skin allergies and infections, is a major driver of the prednisone market. According to the World Health Organization, approximately 1.8 billion people worldwide suffer from skin disorders at any given time. This prevalence is particularly high in tropical and low-resource environments, where skin infections are common[1].

Rising Incidence of Chronic Conditions

The growing prevalence of chronic conditions such as asthma, neurological, pulmonary, and cardiovascular diseases also contributes to the demand for prednisone. For instance, asthma affects about 7% of Americans, with significant implications for the North American market[1].

Advancements in Healthcare

Advancements in healthcare infrastructure and the increasing investment in the healthcare sector are crucial factors. Hospitals, which are expected to generate the highest revenue share of about 50% in the prednisone market, play a significant role in treating a wide range of illnesses, including those requiring corticosteroid treatments[1].

Market Segmentation

By Application

The skin allergies segment is projected to hold a significant share of the global prednisone market, estimated at around 40% by 2036. Acne, which affects over 84% of teenagers, is a major contributor to this segment[1].

By Distribution Channel

Hospitals are poised to generate the highest revenue share due to the increasing number of patients being admitted and the comprehensive care provided for various illnesses, including dermatological conditions[1].

By Region

The North American market is expected to hold the highest share, around 35%, driven by the rising prevalence of asthma and other chronic respiratory disorders. The Asia-Pacific region is also anticipated to experience notable growth due to the lack of physical activity and the increasing prevalence of kidney disorders[1].

Competitive Landscape

The prednisone market is characterized by a competitive landscape with several key players. Companies such as Merck & Co., Inc., GSK plc, Sanofi S.A., AstraZeneca, and Teva Pharmaceutical Industries Ltd. are continuously innovating to develop effective and patient-friendly formulations. For example, Sanofi S.A. is focusing on respiratory health through products like Dupixent (dupilumab), while Teva Pharmaceutical Industries Ltd. is strengthening its position with cost-effective generic corticosteroid sprays[2].

Financial Outlook

The financial trajectory of the prednisone market is promising, driven by the increasing demand for corticosteroid treatments. Here are some key financial highlights:

• Market Size: Expected to cross USD 9 billion by 2036.
• CAGR: Around 5% from 2024 to 2036.
• Revenue Share: Hospitals are expected to generate around 50% of the revenue.
• Regional Growth: North America and Asia-Pacific are expected to be the leading regions[1].

Challenges and Opportunities

Challenges

Despite the growth, the prednisone market faces challenges such as side effects associated with long-term corticosteroid use and the need for continuous innovation to address emerging medical needs.

Opportunities

The increasing prevalence of chronic diseases, advancements in drug formulations, and growing healthcare expenditure present significant opportunities for market growth. Companies are focusing on developing new solutions, enhancing distribution networks, and expanding their global presence to capitalize on these opportunities[1][5].

Comparison with Related Markets

The prednisone market dynamics are closely related to other corticosteroid markets. For example:

• Nasal Corticosteroids Market: This market is projected to grow at a CAGR of 5.2% from 2024 to 2034, reaching USD 11.4 billion by the end of 2034, driven by the increasing prevalence of chronic respiratory disorders[2].
• Corticosteroids Market: The global corticosteroids market is anticipated to grow from USD 5.96 billion in 2024 to USD 8.53 billion by 2032, at a CAGR of 4.6% during the forecast period, driven by rising global healthcare expenditure and technological advancements[5].

Key Takeaways

• The prednisone market is expected to cross USD 9 billion by 2036, growing at a CAGR of around 5%.
• The increasing prevalence of skin diseases and chronic conditions are key drivers.
• Hospitals will generate the highest revenue share due to comprehensive care provided.
• North America and Asia-Pacific are expected to be the leading regions.
• Continuous innovation and expansion by key players are crucial for market growth.

FAQs

1. What is the projected market size of prednisone by 2036? The prednisone market is estimated to cross USD 9 billion by the end of 2036[1].

2. What is the CAGR of the prednisone market from 2024 to 2036? The prednisone market is expected to grow at a CAGR of around 5% during the forecast period[1].

3. Which segment is expected to hold the highest share in the prednisone market? The skin allergies segment is projected to hold around 40% of the global prednisone market by 2036[1].

4. Which region is expected to dominate the prednisone market? The North American market is set to gather the highest share, around 35%, over the forecast period[1].

5. What are the key drivers of the prednisone market? The key drivers include the increasing prevalence of skin diseases, rising incidence of chronic conditions, and advancements in healthcare infrastructure[1].

Sources

1. Research Nester: Prednisone Market Size & Share, Growth Forecasts 2036[1].
2. GlobeNewswire: Nasal Corticosteroids Market to Reach Over $11.4 Billion by 2034 Amid Rising Chronic Respiratory Disorders[2].
3. Dataintelo: Prednisone Market Research Report 2032[3].
4. Business Research Insights: Prednisolone Market Growth, Size, Share and Forecast [2032][4].
5. Polaris Market Research: Corticosteroids Market Size, Share, Growth Analysis Report, 2032[5].