HYDROCORTISONE PROBUTATE - Generic Drug Details

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

Hydrocortisone probutate is the generic ingredient in one branded drug marketed by Ani Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for HYDROCORTISONE PROBUTATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
Patent Applications:	2,069
What excipients (inactive ingredients) are in HYDROCORTISONE PROBUTATE?	HYDROCORTISONE PROBUTATE excipients list
DailyMed Link:	HYDROCORTISONE PROBUTATE at DailyMed

Recent Clinical Trials for HYDROCORTISONE PROBUTATE

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

Sponsor	Phase
Fougera Pharmaceuticals Inc.	Phase 4

See all HYDROCORTISONE PROBUTATE clinical trials

Pharmacology for HYDROCORTISONE PROBUTATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE PROBUTATE

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

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

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 PROBUTATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997		DISCN	Yes	No

Expired US Patents for HYDROCORTISONE PROBUTATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997

HYDROCORTISONE PROBUTATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone

Introduction to Hydrocortisone

Hydrocortisone, a synthetic form of the hormone cortisol, is widely used in various medical applications, including dermatological conditions, adrenal insufficiency, and inflammatory diseases. One of its formulations, hydrocortisone probutate, is particularly notable for its topical use.

Global Hydrocortisone Market Overview

The global hydrocortisone market is experiencing robust growth, driven by several key factors:

• Technological Advancements: Improvements in formulation and delivery methods have enhanced the efficacy and user experience of hydrocortisone products[1].
• OTC Demand Surge: The increasing availability of hydrocortisone products over-the-counter (OTC) has boosted consumer access and demand[1].
• Research and Investment: Continuous research and investment in the development of new hydrocortisone products and applications are driving market growth[1].

Market Size and Growth Projections

• The global hydrocortisone market is expected to grow from $1.43 billion in 2023 to $1.52 billion in 2024, with a projected growth to $1.96 billion by 2028 at a compound annual growth rate (CAGR) of 6.6%[1].
• Specifically, the hydrocortisone cream market is estimated to be $1.352 billion in 2024 and is expected to expand to $2.101 billion by 2031, with a CAGR of 6.50% from 2024 to 2031[4].

Segmentation of the Hydrocortisone Market

By Type

The hydrocortisone market is segmented into various types, including:

• Cream: This is one of the most common forms, particularly for dermatological applications[1][4].
• Injection: Used for more severe conditions requiring immediate systemic effects[1].
• Tablet: For oral administration, often used in cases of adrenal insufficiency[1].

By Route of Administration

• Parenteral: Administered via injection or infusion[1].
• Oral: Taken by mouth, typically in tablet form[1].
• Topical: Applied directly to the skin, which includes hydrocortisone probutate creams[1].

By Application

Hydrocortisone is used in a variety of medical conditions, including:

• Adrenocortical Dysfunction
• Adrenergic Syndrome
• High Blood Calcium
• Thyroiditis
• Rheumatoid Arthritis
• Dermatitis: This is a significant application area for hydrocortisone probutate[1][3].

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies: The rise of online pharmacies has expanded the distribution channels for hydrocortisone products[1].

Regional Market Analysis

The global hydrocortisone cream market is distributed across various regions:

• North America: Holds a significant market share, with the United States being a major contributor. The market size in North America is estimated at $540.88 million in 2024, growing at a CAGR of 4.7% from 2024 to 2031[4].
• Europe: Accounts for over 30% of the global revenue, with a market size of $405.66 million in 2024, growing at a CAGR of 5.0% from 2024 to 2031[4].
• Asia Pacific: Represents around 23% of the global revenue, with a market size of $311.01 million in 2024, growing at a CAGR of 8.5% from 2024 to 2031[4].
• Latin America and Middle East & Africa: These regions also contribute to the global market, albeit with smaller shares and growth rates[4].

Market Trends

Several trends are shaping the hydrocortisone market:

• Natural Ingredient Focus: There is an increasing demand for products with natural ingredients, which can influence the formulation of hydrocortisone products[1].
• Combination Therapies: The use of hydrocortisone in combination with other treatments is becoming more prevalent[1].
• Personalized Treatments: Tailoring treatments to individual patient needs is a growing trend[1].
• Hydrocortisone-Infused Products: New products infused with hydrocortisone are being developed, expanding the market[1].
• Sustainability Emphasis: Companies are focusing on sustainable practices in the production and packaging of hydrocortisone products[1].

Financial Trajectory

The financial trajectory of the hydrocortisone market is positive, driven by the factors mentioned above. Here are some key financial metrics:

• Global Market Size: Expected to grow from $1.43 billion in 2023 to $1.96 billion by 2028[1].
• Hydrocortisone Cream Market: Projected to grow from $1.352 billion in 2024 to $2.101 billion by 2031[4].

Key Drivers and Restraints

Drivers

• Increasing Incidence of Cutaneous Conditions: The rising incidence of skin conditions such as atopic dermatitis is driving the demand for hydrocortisone creams[4].
• Growing Disposable Income: Higher disposable incomes in many regions are enabling more people to access hydrocortisone products[1].

Restraints

• Regulatory Challenges: Strict regulatory requirements can slow down the approval and launch of new hydrocortisone products[1].
• Side Effects: Long-term use of hydrocortisone can lead to side effects, which may deter some consumers[3].

Conclusion

The hydrocortisone market, including hydrocortisone probutate, is poised for significant growth driven by technological advancements, increasing demand for OTC products, and expanding distribution channels. The market is segmented by type, route of administration, application, and distribution channel, with regional variations in market size and growth rates.

Key Takeaways

• The global hydrocortisone market is expected to grow to $1.96 billion by 2028.
• The hydrocortisone cream market will expand to $2.101 billion by 2031.
• Key drivers include technological advancements, OTC demand, and growing disposable income.
• Market trends include a focus on natural ingredients, combination therapies, and sustainability.
• Regional markets such as North America, Europe, and Asia Pacific are significant contributors.

Frequently Asked Questions (FAQs)

Q: What is the projected growth rate of the global hydrocortisone market? A: The global hydrocortisone market is expected to grow at a CAGR of 6.6% from 2023 to 2028[1].

Q: Which region holds the largest market share for hydrocortisone cream? A: North America holds the largest market share for hydrocortisone cream, with a market size of $540.88 million in 2024[4].

Q: What are the main types of hydrocortisone products? A: The main types include cream, injection, and tablet forms[1].

Q: What are some of the key applications of hydrocortisone? A: Hydrocortisone is used in conditions such as adrenocortical dysfunction, rheumatoid arthritis, dermatitis, and asthma[1].

Q: What trends are influencing the hydrocortisone market? A: Trends include a focus on natural ingredients, combination therapies, personalized treatments, and sustainability[1].

Cited Sources

1. The Business Research Company: Global Hydrocortisone Market Report 2024.
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Documents.
3. Annals of Allergy, Asthma & Immunology: Optimizing Topical Management of Atopic Dermatitis.
4. Cognitive Market Research: Hydrocortisone Cream Market Report 2024 (Global Edition).
5. Oregon.gov: Health Evidence Review Commission - Meeting Materials.