CORTISONE ACETATE - Generic Drug Details

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

Cortisone acetate is the generic ingredient in two branded drugs marketed by Pharmacia And Upjohn, Watson Labs, Merck, Barr, Chartwell Molecular, Elkins Sinn, Everylife, Heather, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Panray, Purepac Pharm, Vitarine, and Whiteworth Town Plsn, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for cortisone acetate. One supplier is listed for this compound.

Summary for CORTISONE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	20
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	10
Patent Applications:	6,331
What excipients (inactive ingredients) are in CORTISONE ACETATE?	CORTISONE ACETATE excipients list
DailyMed Link:	CORTISONE ACETATE at DailyMed

Recent Clinical Trials for CORTISONE ACETATE

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

Sponsor	Phase
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
University Medical Center Groningen	Early Phase 1
Assiut University	Phase 2/Phase 3

See all CORTISONE ACETATE clinical trials

Pharmacology for CORTISONE ACETATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for CORTISONE ACETATE

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for CORTISONE ACETATE

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

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for CORTISONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inwood Labs	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080731-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	009458-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CORTISONE ACETATE	cortisone acetate	INJECTABLE;INJECTION	083147-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	008126-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma Intl Pharms	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080776-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Whiteworth Town Plsn	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080341-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Panray	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	008284-002	Approved Prior to Jan 1, 1982		DISCN	No	No

CORTISONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cortisone Acetate

Introduction to Cortisone Acetate

Cortisone acetate is a synthetic corticosteroid used in various medical applications, including the treatment of inflammatory conditions, autoimmune disorders, and skin allergies. Understanding the market dynamics and financial trajectory of cortisone acetate is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth Projections

The cortisone acetate API market has experienced significant growth in recent years and is expected to continue this trend. Here are some key projections:

• Current Market Size: The market size of the cortisone acetate API market is substantial, with ongoing expansion anticipated from 2023 to 2031[1].
• Growth Rate: The market is forecasted to grow at robust rates over the forecast period, indicating a consistent upward trend in market dynamics[1].
• Forecast Period: The market is expected to grow from 2024 to 2031, with comprehensive assessments conducted over this period to understand market dynamics and trends[1].

Segmentation of the Market

The cortisone acetate API market is segmented based on several key factors:

• Type: The market is segmented into purity levels, including purity above 98% and purity below 98%. This segmentation helps in understanding the demand for different purity levels of cortisone acetate[1].
• Application: The primary applications include creams and other formulations. This segmentation highlights the various uses of cortisone acetate in different medical and cosmetic products[1].
• Geography: The market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This geographical segmentation provides insights into regional demand and market growth[1].

Drivers of Market Growth

Several factors are driving the growth of the cortisone acetate API market:

• Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases such as skin allergies, rheumatology indications, and respiratory conditions is driving the demand for corticosteroids, including cortisone acetate[3].
• Advancements in Drug Delivery: Innovations in drug delivery systems are enhancing the efficacy and convenience of cortisone acetate, contributing to market growth[3].
• Geriatric Population Growth: The increasing geriatric population, which is more prone to various health conditions, is another driver of the market[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Regulatory Compliance: Strict regulatory requirements and compliance issues can affect the production and distribution of cortisone acetate[3].
• Cost-Effectiveness: The high cost of certain corticosteroid treatments, including those involving cortisone acetate, can be a barrier to adoption, especially in cost-sensitive markets[2].

Competitive Landscape

The cortisone acetate API market is characterized by a competitive landscape with several key players:

• Prominent Companies: Companies such as Farmabios SpA, Teva Pharmaceutical Industries, Crystal Pharma SAU, Mylan Laboratories, Novitium Pharma, and Henan Lihua Pharmaceutical are major players in the market[1].
• Market Entry and Product Offerings: These companies have been in the market for various years, offering a range of products with different purity levels and applications[1].

Financial Trajectory

The financial trajectory of the cortisone acetate API market is promising:

• Revenue Projections: The market is expected to see significant revenue growth from 2024 to 2031, driven by increasing demand and expanding applications[1].
• Pricing Analysis: The report includes a comprehensive pricing analysis, which is crucial for understanding the market dynamics and for companies to optimize their pricing strategies[1].

Regional Analysis

The market performance varies across different regions:

• North America and Europe: These regions are significant markets for cortisone acetate due to the high prevalence of chronic diseases and advanced healthcare infrastructure[1][3].
• Asia-Pacific and Middle East: These regions are expected to show substantial growth due to increasing healthcare spending and a growing population with chronic conditions[1][3].

Value Chain and Pricing

The value chain of the cortisone acetate API market involves several stages, from production to end-use applications:

• Production Costs: The cost of producing cortisone acetate, including raw materials and manufacturing processes, influences the final product pricing[1].
• Distribution and Marketing: The costs associated with distribution, marketing, and regulatory compliance also impact the final market price[1].

Porter's 5 Forces Framework

Analyzing the market through Porter's 5 Forces Framework provides insights into the competitive environment:

• Threat of New Entrants: The barrier to entry is moderate due to regulatory requirements and the need for significant investment in research and development[1].
• Bargaining Power of Suppliers: Suppliers have moderate bargaining power due to the availability of raw materials and the competition among suppliers[1].
• Bargaining Power of Buyers: Buyers have significant bargaining power due to the availability of alternative treatments and the sensitivity to pricing[1].

Key Takeaways

• The cortisone acetate API market is expected to grow significantly from 2024 to 2031.
• The market is driven by increasing chronic disease prevalence, advancements in drug delivery, and geriatric population growth.
• Key players include Farmabios SpA, Teva Pharmaceutical Industries, and others.
• Regional growth varies, with North America and Europe being significant markets and Asia-Pacific and the Middle East showing potential for future growth.
• The market faces challenges such as regulatory compliance and cost-effectiveness.

FAQs

Q: What are the primary applications of cortisone acetate? A: The primary applications include creams and other formulations for treating inflammatory conditions, autoimmune disorders, and skin allergies[1].

Q: Which regions are expected to show significant growth in the cortisone acetate API market? A: Asia-Pacific and the Middle East are expected to show substantial growth due to increasing healthcare spending and a growing population with chronic conditions[1][3].

Q: What are the key drivers of the cortisone acetate API market? A: The key drivers include the increasing prevalence of chronic diseases, advancements in drug delivery, and geriatric population growth[3].

Q: Who are the major players in the cortisone acetate API market? A: Major players include Farmabios SpA, Teva Pharmaceutical Industries, Crystal Pharma SAU, Mylan Laboratories, Novitium Pharma, and Henan Lihua Pharmaceutical[1].

Q: What is the expected compound annual growth rate (CAGR) for the cortisone acetate API market? A: The exact CAGR is not specified in the sources, but the market is expected to grow at robust rates over the forecast period[1].

Citations

1. Market Research Intellect, "Cortisone Acetate API Market Size, Scope And Forecast Report", October 2024.
2. NCBI, "Pharmacoeconomic Review - Niraparib and Abiraterone Acetate".
3. The Business Research Company, "Corticosteroids Global Market Report 2024".
4. Valuates Reports, "Hydrocortisone Acetate - Market Size".