HYDROCORTISONE - Generic Drug Details

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

Hydrocortisone is the generic ingredient in seventy-seven branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Chartwell, Ani Pharms, Teva Pharms, Healthpoint, Eton, Pharmacia And Upjohn, Baker Norton, Legacy Pharma, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Sun Pharma Canada, Dow Pharm, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Paddock Llc, Mission Pharma, Pfizer, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hibrow Hlthcare, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Merck, Pfipharmecs, Viatris, Able, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Fera Pharms, Colgate, Mylan Speciality Lp, Genus, Ferndale Labs, Glenmark Pharms Ltd, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, Cosette, Encube Ethicals, Padagis Israel, Sun Pharm Inds Inc, Amneal, Bausch And Lomb, Saptalis Pharms, Casper Pharma Llc, Sciegen Pharms Inc, Schering, Forest Labs, Lederle, and Bioglan, and is included in two hundred and sixty-four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-eight patent family members in twenty-five countries.

There are sixty-seven drug master file entries for hydrocortisone. Forty-one suppliers are listed for this compound.

Summary for HYDROCORTISONE

International Patents:	58
US Patents:	6
Tradenames:	77
Applicants:	116
NDAs:	264
Drug Master File Entries:	67
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	478
Patent Applications:	7,917
Drug Prices:	Drug price trends for HYDROCORTISONE
Drug Sales Revenues:	Drug sales revenues for HYDROCORTISONE
What excipients (inactive ingredients) are in HYDROCORTISONE?	HYDROCORTISONE excipients list
DailyMed Link:	HYDROCORTISONE at DailyMed

See drug prices for HYDROCORTISONE

See drug sales revenues for HYDROCORTISONE

Recent Clinical Trials for HYDROCORTISONE

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	PHASE3
Children's Oncology Group	PHASE2
University of British Columbia	PHASE2

See all HYDROCORTISONE clinical trials

Pharmacology for HYDROCORTISONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for HYDROCORTISONE

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE

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

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

US Patents and Regulatory Information for HYDROCORTISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmafair	NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	062617-001	Sep 18, 1985		DISCN	No	No
Usl Pharma	HYDROCORTISONE	hydrocortisone	OINTMENT;TOPICAL	088039-001	Sep 27, 1983		DISCN	No	No
Teva	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	085191-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bluline	EPICORT	hydrocortisone	LOTION;TOPICAL	083219-002	Approved Prior to Jan 1, 1982		DISCN	No	No

EU/EMA Drug Approvals for HYDROCORTISONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch	Plenadren	hydrocortisone	EMEA/H/C/002185Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).	Authorised	no	no	no	2018-02-09
Diurnal Europe B.V.	Efmody	hydrocortisone	EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.	Authorised	no	no	no	2021-05-27

International Patents for HYDROCORTISONE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2780003	TRAITEMENT DE L'INSUFFISANCE SURRÉNALE (TREATMENT OF ADRENAL INSUFFICIENCY)
Hong Kong	1214131	包含氫化可的松的組合物 (COMPOSITION COMPRISING HYDROCORTISONE)
United Kingdom	201407380
Poland	2978414

Supplementary Protection Certificates for HYDROCORTISONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026

Market Dynamics and Financial Trajectory for Hydrocortisone

Last updated: August 5, 2025

Introduction

Hydrocortisone, a synthetic corticosteroid, has remained a foundational drug within the pharmaceutical landscape for decades. Its potent anti-inflammatory, immunosuppressive, and metabolic effects have underpinned its extensive application in treating a broad spectrum of conditions, including adrenal insufficiency, inflammatory diseases, allergies, and dermatological disorders. This analysis examines the evolving market dynamics and financial trajectory of hydrocortisone, emphasizing the factors shaping its current positioning, future growth prospects, and the overarching economic landscape for stakeholders within this segment.

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Market Overview and Current Position

Hydrocortisone, marketed under various brand names such as Cortef and Solu-Cortef, primarily exists as oral tablets, topical formulations, and injectable preparations. It retains significant market share due to its established efficacy, safety profile, and affordability. According to recent industry reports, the global corticosteroid market, of which hydrocortisone is a critical component, was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 1.7 billion by 2030, growing at a compound annual growth rate (CAGR) of roughly 4.5% [1].

Although newer corticosteroids like dexamethasone and prednisone serve niche applications and exhibit varying potency and pharmacokinetics, hydrocortisone's long-standing status and low cost continue to sustain its relevance. Market penetration is particularly high in regions with limited healthcare resources, cementing its role in global therapeutic particularities.

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Market Drivers

1. Chronic Disease Prevalence

The growing prevalence of autoimmune diseases, allergies, and inflammatory conditions directly fuels hydrocortisone demand. For instance, the rise in conditions such as rheumatoid arthritis and inflammatory bowel disease (IBD) increases the need for corticosteroid therapies, including hydrocortisone, especially in generic forms.

2. Aging Population

Globally, aging demographics are more susceptible to adrenal insufficiency and related disorders, leading to heightened hydrocortisone utilization. The aging population exhibits a higher incidence of conditions requiring hormone replacement therapy, supporting continued demand.

3. Cost-Effective Therapeutics

Hydrocortisone's established, off-patent status makes it a low-cost option, particularly appealing in emerging markets and resource-constrained settings. Health systems favor affordable, effective medications, thereby stabilizing demand.

4. Regulatory Environment

Regulatory frameworks enhancing drug approval processes for generic medicines have facilitated hydrocortisone's availability, especially in developing nations where local production and imports cater to unmet needs.

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Market Challenges

1. Patent Expiry and Generic Competition

The patent expiration of early formulations has led to a proliferation of generic hydrocortisone products, intensifying price competition. While this drives affordability, it compresses profit margins for manufacturers and discourages R&D investments in new formulations.

2. Emergence of Biosimilars and Novel Delivery Systems

Advancements in drug delivery—such as transdermal patches, controlled-release formulations, or injectable depot preparations—pose both an opportunity and a threat. Innovators developing improved formulations might divert demand away from traditional hydrocortisone forms.

3. Regulatory and Quality Concerns

Ensuring consistent quality standards in generic manufacturing varies across regions. Substandard formulations can impact market trust and regulatory actions, potentially hindering expansion.

4. Market Saturation in Established Economies

In mature markets like North America and Europe, the hydrocortisone segment approaches saturation. Growth hinges on demographic shifts and drug repurposing opportunities.

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Future Growth Opportunities

1. Expansion into Emerging Markets

Emerging economies, including India, Brazil, and Southeast Asian countries, present substantial opportunities due to rising healthcare expenditures, increasing disease burden, and easier regulatory pathways for generic drugs.

2. Development of Novel Formulations

Innovation in drug delivery—such as sustained-release capsular forms or topical gels—can improve patient compliance and expand applications, creating niche markets for manufacturers willing to invest.

3. Adjunct Therapy Development

Research into hydrocortisone's synergistic use with other compounds, especially in complex autoimmune therapies, can open up new treatment paradigms and markets.

4. Focus on Quality and Biosimilarity

Adhering to stringent manufacturing standards and developing biosimilars with enhanced efficacy or reduced side effects could differentiate products, especially in markets emphasizing quality.

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Financial Trajectory and Revenue Trends

Hydrocortisone's revenue trajectory aligns with the broader corticosteroid sector’s dynamics, heavily influenced by generic competition and regional demand fluctuations. Key financial insights include:

• Revenue Stability: The extensive use, low-cost profile, and high volume ensure steady revenue streams, especially in the generic sector.
• Profit Margins: Margins are increasingly compressed due to commoditization, necessitating operational efficiencies.
• Investment in Innovation: Limited R&D expenditure focuses on new formulations or delivery methods rather than molecular innovation, suggesting steady but cautious growth.
• Regional Variability: Emerging markets contribute to revenue growth, while mature markets offer limited upside but provide stable cash flows.

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Regulatory and Competitive Landscape

The regulatory environment remains vigorous, with agencies like the FDA and EMA emphasizing manufacturing quality, especially for generics. While early market exclusivity has passed, patent protections for modified-release formulations or specific applications could provide limited exclusivity, incentivizing innovation.

The competitive landscape predominately comprises large pharmaceutical firms producing generic hydrocortisone and regional manufacturers capitalizing on local demand. Strategic alliances and licensing agreements further shape the market, emphasizing supply chain efficiency.

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Conclusion

Hydrocortisone’s market dynamics are characterized by stability tempered with strategic opportunities. Its core position in the corticosteroid market is supported by widespread clinical use, affordability, and global demand for low-cost therapies. However, growth prospects face challenges from patent expiries, intense generic competition, and market saturation within developed economies.

Expanding into emerging markets, developing advanced delivery systems, and ensuring high-quality manufacturing will be pivotal for stakeholders seeking sustained value creation. The financial trajectory suggests a stable revenue base with potential upticks driven by innovation in formulations and regional expansion, making hydrocortisone a resilient yet evolving segment within the pharmaceutical industry.

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Key Takeaways

• Hydrocortisone remains a cornerstone corticosteroid, sustaining a stable market primarily driven by demand in autoimmune, inflammatory, and endocrine conditions.

• The global corticosteroid market, valued at approximately USD 1.2 billion in 2022, is expected to grow at a CAGR of around 4.5%, with hydrocortisone accounting for a significant share.

• Key growth drivers include aging populations, rising disease prevalence, and affordability, especially in emerging markets.

• Challenges stem from patent expiries, intense generic competition, and market saturation in developed regions.

• Opportunities lie in expanding regional presence, innovating delivery systems, and enhancing manufacturing quality standards.

• Financial prospects remain steady but emphasize operational efficiency and strategic innovation to maintain profitability amidst pricing pressures.

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FAQs

1. How does patent expiration influence hydrocortisone’s market?
Patent expirations allow generic manufacturers to enter the market, increasing supply and reducing prices. While this enhances accessibility, it pressures profit margins for brand-name producers and reduces incentives for significant R&D investments in new formulations.

2. Are there upcoming innovations in hydrocortisone formulations?
Yes, emerging research focuses on sustained-release formulations, topical gels, and injectable depots. These innovations aim to improve patient compliance, reduce dosing frequency, and expand therapeutic applications.

3. What are the primary markets for hydrocortisone?
The primary markets include North America, Europe, and Asia-Pacific. Emerging markets like India and Brazil show rapid growth due to increasing healthcare infrastructure and disease burden.

4. How does regulatory quality control impact hydrocortisone markets?
Strict regulatory standards ensure drug safety and efficacy, but variability in quality control across regions can impact market trust and product acceptance, especially for generics.

5. Is hydrocortisone facing competition from other corticosteroids?
While newer corticosteroids like dexamethasone may serve niche roles due to potency and side effect profiles, hydrocortisone’s broad applicability and low cost sustain its dominance in many therapeutic areas.

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References

[1] Research and Markets, “Global Corticosteroid Market Analysis & Trends,” 2022.