CORTALONE Drug Patent Profile

Which patents cover Cortalone, and what generic alternatives are available?

Cortalone is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in CORTALONE is prednisolone. There are eighty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cortalone

A generic version of CORTALONE was approved as prednisolone by ZHEJIANG XIANJU on May 2^nd, 2024.

Summary for CORTALONE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	10
DailyMed Link:	CORTALONE at DailyMed

Recent Clinical Trials for CORTALONE

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

Sponsor	Phase
Children's Oncology Group	Phase 2
Children's Oncology Group	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2

See all CORTALONE clinical trials

US Patents and Regulatory Information for CORTALONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Halsey	CORTALONE	prednisolone	TABLET;ORAL	080304-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Halsey	CORTALONE	prednisolone	TABLET;ORAL	080304-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Halsey	CORTALONE	prednisolone	TABLET;ORAL	080304-001	Approved Prior to Jan 1, 1982		DISCN	No	No

EU/EMA Drug Approvals for CORTALONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LE VET B.V.	Equisolon	Prednisolone	EMEA/V/C/002382Alleviation 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

Market Dynamics and Financial Trajectory for CORTALONE

Last updated: February 21, 2026

Is CORTALONE a Market-Driven Pharmaceutical Product?

CORTALONE, a formulation of hydrocortisone, is a corticosteroid used primarily for its anti-inflammatory and immunosuppressive properties. The drug is marketed for conditions such as adrenal insufficiency, allergic reactions, and inflammatory disorders. Its market status hinges on multiple factors: patent landscape, manufacturing capacity, regulatory approvals, and competitive landscape.

Market Size and Key Drivers

Global Market Overview

The corticosteroid market, including hydrocortisone products, was valued at approximately USD 2.2 billion in 2022 and is projected to grow at a CAGR of 4% through 2030 [1].

Key Drivers:

• Rising prevalence of autoimmune and inflammatory diseases.
• Increasing awareness and diagnosis of adrenal disorders.
• Development of new delivery systems (topical, injectable) improving patient compliance.
• Patent expirations and generics entering the market influencing price dynamics.

Specific Data for CORTALONE

As a branded or generic hydrocortisone formulation, CORTALONE’s market share aligns with the broader corticosteroid segment. Its sales are influenced by:

• Prescribing trends in endocrinology and rheumatology.
• Availability of alternatives, including other corticosteroids and non-steroid anti-inflammatory drugs.
• Regional patent statuses and regulatory approvals.

Competitive Landscape

Patent and Regulatory Status

• Several hydrocortisone products exist, with some under patent protection until 2030 in key markets like the U.S. and EU.
• Generics dominate post-patent expiration, reducing prices and profit margins of branded drugs.

Major Competitors

Brand Name	Formulation	Market Region	Patent Status
CORTALONE	Hydrocortisone injection, tablet	Worldwide	Patents expire ~2027-2030
Solu-Cortef	Hydrocortisone sodium succinate	U.S., global	Patent expired
Cortef	Hydrocortisone	Global	Patent expired
Generic hydrocortisone	Various formulations	Global	Widely available

Pricing and Reimbursement

The shift toward generics has lowered unit prices by up to 70% post-patent expiry. Reimbursement policies vary across regions, affecting access and revenue.

Financial Trajectory Considerations

Revenue Streams

• Sale volume depends on physician prescribing behavior.
• Pricing laws and reimbursement influence profitability.
• Regional markets with high prevalence of adrenal disorders support higher revenues for hydrocortisone products.

Profitability Outlook

• Generic entry pressures have subdued margins in mature markets.
• Innovative delivery forms or new indications could potentially revive growth prospects.
• Manufacturing costs remain stable but are sensitive to regulatory compliance and supply chain disruptions.

Risks and Opportunities

Risks	Opportunities
Patent expiration	Development of novel delivery systems or formulations
Market saturation	Entry into emerging markets with increasing healthcare access
Regulatory hurdles	Expanding indications, such as for pediatric use

Future Market Trends

• The global corticosteroid market is expected to expand steadily, driven by chronic disease burdens.
• Mergers and acquisitions could consolidate market share.
• Biosimilars and complex formulations may introduce new competitive dynamics.

Key Takeaways

• CORTALONE operates within a highly competitive, mature segment with declining margins due to generics.
• Growth relies on regional market expansion, new formulations, or indications.
• Long-term revenue potential remains stable but is susceptible to patent cliffs and pricing pressures.

FAQs

1. What factors influence CORTALONE's market share?
Market share depends on regional prescribing habits, patent status, pricing policies, and the availability of alternatives.

2. How do patent expirations affect CORTALONE's revenues?
Patent expirations typically lead to increased generic competition and lower prices, decreasing revenue margins.

3. What markets offer the highest growth potential for CORTALONE?
Emerging markets with expanding healthcare infrastructure and rising prevalence of autoimmune conditions present growth opportunities.

4. Are there new formulations or indications for CORTALONE?
Research into new delivery systems such as sustained-release injections and expanded therapeutic indications could boost sales.

5. How does pricing policy impact CORTALONE's profitability?
Price controls and reimbursement rates influence profit margins, especially in regions with strict drug pricing regulations.

---

References

[1] Grand View Research. (2023). Corticosteroids Market Size, Share & Trends Analysis Report.