Hydrocortisone - Generic Drug Details

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

Hydrocortisone is the generic ingredient in seventy-six 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, 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, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Imperium, Sebela Ireland Ltd, Bel Mar, Epic Pharma Llc, Fera Pharms, Colgate, 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, Amring Pharms, Bausch And Lomb, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-six 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:	56
US Patents:	4
Tradenames:	76
Applicants:	111
NDAs:	259
Drug Master File Entries:	67
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	444
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
University of North Carolina, Chapel Hill	Phase 4
Orion Corporation, Orion Pharma	Phase 3
Merck Sharp & Dohme LLC	Phase 3

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
Alpharma Us Pharms	HYDROCORTISONE	hydrocortisone	LOTION;TOPICAL	087315-001	Jun 7, 1982		DISCN	No	No
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876-002	Sep 29, 2020		RX	Yes	No
Bluline	EPICORT	hydrocortisone	LOTION;TOPICAL	083219-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Inds Inc	WESTCORT	hydrocortisone valerate	CREAM;TOPICAL	017950-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Valeant Intl	HYTONE	hydrocortisone	CREAM;TOPICAL	080472-004	Approved Prior to Jan 1, 1982		DISCN	Yes	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/002185 Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416 Replacement 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/005105 Treatment 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
Japan	2014533679	副腎機能障害の治療
South Africa	201403462	TREATMENT OF ADRENAL INSUFFICIENCY
European Patent Office	2780003	TRAITEMENT DE L'INSUFFISANCE SURRÉNALE (TREATMENT OF ADRENAL INSUFFICIENCY)
United Kingdom	201407380
Poland	2780003

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

Hydrocortisone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone

Market Overview

The hydrocortisone market is experiencing robust growth, driven by several key factors. Here’s a comprehensive look at the market dynamics and financial trajectory of this essential drug.

Market Size and Growth

The global hydrocortisone market is projected to grow significantly in the coming years. As of 2023, the market size was estimated at $1.43 billion, and it is expected to reach $1.52 billion in 2024, growing at a compound annual growth rate (CAGR) of 6.4%[1].

By 2028, the market is anticipated to expand to $1.96 billion, with a CAGR of 6.6% from 2023 to 2028. This growth is attributed to technological advancements, increased demand for over-the-counter (OTC) products, investments in research and development, growing disposable income, and expanded distribution channels[1].

Segmentation

The hydrocortisone market is segmented based on several criteria:

By Type

• Creams
• Injections
• Tablets

Each of these segments contributes to the overall market growth, with creams being a significant portion due to their widespread use in treating skin disorders[1].

By Route of Administration

• Parenteral
• Oral
• Topical

Topical applications, such as creams and ointments, are particularly popular due to their ease of use and effectiveness in treating dermatological conditions[1].

By Application

• Adrenocortical Dysfunction
• Adrenergic Syndrome
• High Blood Calcium
• Thyroiditis
• Rheumatoid Arthritis
• Dermatitis
• Asthma and Chronic Obstructive Pulmonary Disease (COPD)
• Other Applications

The diverse range of applications underscores the versatility and importance of hydrocortisone in various medical treatments[1].

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

The expansion of online pharmacies has significantly contributed to the market's growth, making hydrocortisone products more accessible to consumers[1].

Market Drivers

Several factors are driving the growth of the hydrocortisone market:

Rising Prevalence of Skin Disorders

The increasing incidence of skin conditions such as dermatitis, eczema, and other cutaneous disorders is a major driver. As the population ages and awareness about skin health increases, the demand for hydrocortisone products, especially creams and ointments, is on the rise[1][3].

Technological Advancements

Advancements in formulation and delivery systems, such as hydrocortisone-infused products and combination therapies, are enhancing the efficacy and appeal of hydrocortisone treatments. These innovations are attracting more consumers and healthcare providers to the market[1].

Increased Investment in Research and Development

Pharmaceutical companies are investing heavily in research and development to improve existing products and develop new ones. For instance, Eton Pharmaceuticals has successfully completed a pivotal bioequivalence study for its proprietary oral hydrocortisone formulation, ET-400, which is expected to be submitted for FDA approval in Q2 2024[2].

Growing Disposable Income

As global disposable income increases, more people are able to afford healthcare products, including hydrocortisone. This economic factor is particularly significant in emerging markets where access to healthcare is improving[1].

Financial Performance

Revenue Growth

Companies involved in the hydrocortisone market are experiencing significant revenue growth. For example, Eton Pharmaceuticals reported a 109% year-over-year increase in product sales and royalty revenue in Q4 2023, reaching $7.3 million. This marks the twelfth consecutive quarter of sequential product sales growth for the company[2].

Regional Market Performance

The global hydrocortisone cream market, a subset of the broader hydrocortisone market, is also showing strong regional performance. North America holds a major share, with a market size of $540.88 million in 2024 and a CAGR of 4.7% from 2024 to 2031. Europe and Asia Pacific also have significant market shares, with CAGRs of 5.0% and 8.5%, respectively, over the same period[3].

Market Trends

Natural Ingredient Focus

There is a growing trend towards natural and organic ingredients in healthcare products. Hydrocortisone, being a natural corticosteroid, aligns well with this trend, making it more appealing to consumers seeking natural remedies[1].

Combination Therapies

Combination therapies that include hydrocortisone along with other medications are gaining popularity. These therapies offer enhanced treatment outcomes and are driving the market forward[1].

Personalized Treatments

The move towards personalized medicine is also influencing the hydrocortisone market. Tailored treatments that use hydrocortisone in specific formulations are becoming more common, catering to individual patient needs[1].

Sustainability Emphasis

Sustainability is another key trend, with companies focusing on environmentally friendly packaging and production processes. This emphasis on sustainability is expected to continue driving the market as consumers become more environmentally conscious[1].

Cost Analysis and Economic Impact

Cost Benefits

Adjunctive hydrocortisone therapy has been shown to have significant cost benefits, particularly in the treatment of septic shock. A study estimated that this therapy could result in a monetized benefit of up to $25,539 per patient by reducing ICU stays, vasopressor-free days, and ventilation-free days[4].

Total Estimated Annual Impact

The total estimated annual impact of adjunctive hydrocortisone therapy for septic shock was $2.3 billion in 2019 dollars, highlighting the economic significance of hydrocortisone in critical care settings[4].

Key Takeaways

• The hydrocortisone market is growing at a CAGR of 6.6% from 2023 to 2028.
• Key drivers include rising skin disorder prevalence, technological advancements, and increased investment in R&D.
• The market is segmented by type, route of administration, application, and distribution channel.
• Regional markets, especially North America, Europe, and Asia Pacific, are significant contributors to the global market.
• Trends such as natural ingredient focus, combination therapies, personalized treatments, and sustainability emphasis are shaping the market.
• Hydrocortisone therapy shows significant cost benefits, particularly in critical care settings.

FAQs

What is the projected market size of the hydrocortisone market by 2028?

The hydrocortisone market is expected to reach $1.96 billion by 2028, growing at a CAGR of 6.6% from 2023 to 2028[1].

What are the main drivers of the hydrocortisone market growth?

The main drivers include the rising prevalence of skin disorders, technological advancements, increased investment in R&D, growing disposable income, and expanded distribution channels[1].

Which regions hold significant market shares in the hydrocortisone cream market?

North America, Europe, and Asia Pacific hold significant market shares, with North America accounting for over 40% of the global revenue[3].

What are some of the key trends in the hydrocortisone market?

Key trends include a focus on natural ingredients, combination therapies, personalized treatments, hydrocortisone-infused products, and an emphasis on sustainability[1].

What is the estimated cost benefit of adjunctive hydrocortisone therapy for septic shock?

The estimated cost benefit of adjunctive hydrocortisone therapy for septic shock can be up to $25,539 per patient, driven by reductions in ICU stays, vasopressor-free days, and ventilation-free days[4].

Sources

1. The Business Research Company, Global Hydrocortisone Market Report 2024.
2. Eton Pharmaceuticals, Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results.
3. Cognitive Market Research, Hydrocortisone Cream Market Report 2024 (Global Edition).
4. PubMed, Cost Analysis of Adjunctive Hydrocortisone Therapy for Septic Shock.