Cortisone acetate - Generic Drug Details

What are the generic drug 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:	87
Clinical Trials:	11
Patent Applications:	7,112
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
Panray	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	008284-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	008126-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Elkins Sinn	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080836-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Cortisone Acetate

Last updated: July 27, 2025

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Introduction

Cortisone acetate, a corticosteroid with potent anti-inflammatory and immunosuppressive properties, continues to maintain relevance within the pharmaceutical sector. Its applications range across endocrinology, rheumatology, allergies, and dermatology, driven by a broad spectrum of indications. Market dynamics for cortisone acetate are shaped by demographic trends, regulatory landscapes, technological innovations, and competitive forces that influence its manufacturing, distribution, and commercialization.

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Pharmacological Profile and Therapeutic Indications

Cortisone acetate functions as a prodrug of cortisol, modulating immune responses and reducing inflammation in conditions such as rheumatoid arthritis, allergic reactions, adrenal insufficiency, and certain dermatological disorders. Its efficacy and comparatively favorable safety profile have sustained its use despite advances in biologics and alternative corticosteroids.

While newer formulations and derivatives (e.g., methylprednisolone, prednisolone) have emerged, cortisone acetate remains a staple, particularly in oral and injectable forms for acute and chronic conditions. Its pharmacokinetic properties, including a relatively long half-life and predictable metabolism, underpin its ongoing clinical utilization.

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Market Overview and Regional Dynamics

Global Market Size and Growth Trends

The global corticosteroid market, encompassing cortisone acetate, was valued at approximately USD 2.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2030 [1]. Cortisone acetate accounts for a significant share of this market, bolstered by established manufacturing infrastructure and clinical familiarity.

The growth trajectory is partially attributed to the increasing prevalence of autoimmune and inflammatory disorders. The rise in aging populations, particularly in North America and Europe, propels demand due to age-associated immune dysregulation. Additionally, expanding healthcare access in emerging markets like Asia-Pacific fuels sales, especially as corticosteroids are vital in primary healthcare.

Regional Market Dynamics

• North America: Dominates the market due to high diagnosis rates of autoimmune diseases, sophisticated healthcare infrastructure, and favorable reimbursement policies. The U.S. accounts for roughly 40-45% of global corticosteroid sales [2].

• Europe: Exhibits steady growth, driven by aging demographics and regulatory approval extensions for existing formulations.

• Asia-Pacific: Expected to witness the highest CAGR owing to increased healthcare investment, population growth, and rising awareness. Countries such as China, India, and Japan are critical markets, with government initiatives improving access.

• Latin America and Middle East & Africa: Smaller markets but growing, primarily through increased healthcare spending and expanding distribution networks.

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Manufacturing and Supply Chain Dynamics

Major pharmaceutical firms, including Pfizer, Teva, and Mylan, dominate corticosteroid manufacturing, leveraging economies of scale and established supply chains. Generic production constitutes the majority of market supply, fostering price competition and accessibility.

However, recent geopolitical tensions and supply chain disruptions, particularly affected by the COVID-19 pandemic, have underscored the vulnerability of global manufacturing networks. Reliance on regional raw material sources and geopolitical factors influence costs and availability.

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Regulatory Environment and Patent Landscape

Cortisone acetate, being a generic corticosteroid on the market for decades, faces minimal patent protections, primarily relying on manufacturing processes and formulations for differentiation. Regulatory bodies such as the FDA and EMA maintain stringent standards for quality, efficacy, and safety.

Emerging regulatory trends favor biosimilar and bioequivalent formulations, with a focus on safely expanding access. However, patent expirations for key corticosteroids have intensified generic competition, reducing wholesale prices and pressuring profit margins for branded formulations.

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Pricing and Market Access

Pricing strategies have been driven by generic competition, with unit costs declining significantly over the past decade. In the U.S., the average wholesale price (AWP) for cortisone acetate oral tablets has decreased by over 30% since 2015 [3].

Despite declining prices, demand remains resilient due to the drug’s established efficacy and low cost. Payer negotiations, formulary placements, and reimbursement policies continue to influence accessibility, especially in emerging markets where out-of-pocket expenses constitute a significant barrier.

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Emerging Trends and Innovation

While cortisone acetate is a well-established molecule, ongoing research explores targeted delivery methods, combining corticosteroids with nanotechnology, and novel formulations that optimize tissue penetration and reduce systemic side effects. These innovations could extend its lifecycle and improve market presence.

Additionally, the rise of biologic therapies and targeted immunomodulators for autoimmune diseases indirectly impact cortisone acetate’s market share. The therapeutic landscape is shifting towards more specific agents, but corticosteroids retain a crucial role in initial management and as adjuncts.

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Competitive Landscape

The market is highly competitive among generic manufacturers, with a few branded players maintaining a foothold via formulation enhancements or regional distribution rights. Price competition and regulatory hurdles create high entry barriers for new entrants. Strategic partnerships, such as licensing agreements and regional manufacturing, are prevalent to capture market share.

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Financial Outlook and Future Trajectory

The financial trajectory for cortisone acetate hinges on several factors:

• Pricing Pressures: Continued dominance of generics provides downward pressure but also sustains high-volume sales.
• Market Penetration: Emerging markets offer growth opportunities, driven by increasing healthcare infrastructure.
• Innovation and Formulation Improvements: Incremental innovations could command premium pricing or extend market exclusivity if supported by data.
• Regulatory Environment: Maintains a steady landscape, although stricter biosimilar pathways could influence competition dynamics.

Projections suggest steady revenue streams over the next decade, with moderate growth aligned with aging populations and expanding healthcare access, offset by generic price erosion.

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Key Takeaways

• The global cortisone acetate market remains resilient, supported by its broad therapeutic applications and familiarity in clinical practice.
• Competitive pressures from generic manufacturers dominate pricing strategies, especially in mature markets.
• Emerging markets and healthcare infrastructure enhancements present significant growth avenues.
• Regulatory policies favor biosimilar and generic competition, exerting downward force on prices.
• Innovation in drug delivery may prolong product relevance but faces challenges from evolving therapeutics.

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FAQs

1. What factors are driving global demand for cortisone acetate?
Increasing prevalence of autoimmune and inflammatory diseases, aging populations, and expanding healthcare access in emerging markets are primary drivers.

2. How does the patent landscape influence cortisone acetate’s market?
Patent expirations on branded formulations have led to widespread generic manufacturing, resulting in price reductions but also increased competition.

3. What are the key challenges facing cortisone acetate producers?
Pricing pressures due to generic competition, supply chain vulnerabilities, and regulatory hurdles for new formulations or delivery methods.

4. Will new formulations or delivery systems impact cortisone acetate’s market?
Potentially, if they demonstrate improved efficacy or safety profiles. However, market entry barriers and investment costs are substantial.

5. How does regional regulation affect market growth?
Strict regulatory standards ensure safety but can delay market entry. Conversely, regulatory harmonization in regions like Asia facilitates quicker adoption and market expansion.

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References

[1] Grand View Research. "Corticosteroids Market Size, Share & Trends Analysis," 2022.
[2] IMS Health. "Global Corticosteroid Market Report," 2022.
[3] MediLexicon. "Average Wholesale Price Trends for Cortisone Acetate," 2015-2022.