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Last Updated: December 22, 2024

HYDROCORTISONE; UREA - Generic Drug Details


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What are the generic sources for hydrocortisone; urea and what is the scope of patent protection?

Hydrocortisone; urea is the generic ingredient in two branded drugs marketed by Bioglan and Pharmacia And Upjohn, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for HYDROCORTISONE; UREA
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 8
Clinical Trials: 444
Patent Applications: 3
DailyMed Link:HYDROCORTISONE; UREA at DailyMed
Recent Clinical Trials for HYDROCORTISONE; UREA

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

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Merck Sharp & Dohme LLCPhase 3
Orion Corporation, Orion PharmaPhase 3

See all HYDROCORTISONE; UREA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE; UREA
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; UREA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bioglan ALPHADERM hydrocortisone; urea CREAM;TOPICAL 086008-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn CALMURID HC hydrocortisone; urea CREAM;TOPICAL 083947-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

HYDROCORTISONE; UREA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydrocortisone and Urea/Hydrocortisone Products

Market Overview

The hydrocortisone market, including products that combine hydrocortisone with urea, is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of these essential drugs.

Market Size and Growth

The global hydrocortisone market is projected to grow substantially 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. By 2028, the market is anticipated to expand to $1.96 billion, growing at a compound annual growth rate (CAGR) of 6.6% from 2023 to 2028[1].

Regional Market Performance

The regional performance of the hydrocortisone market is varied but robust across different regions:

  • North America: This region holds a major share of the global hydrocortisone cream market, with a market size of $540.88 million in 2024 and a CAGR of 4.7% from 2024 to 2031[4].
  • Europe: Europe accounts for over 30% of the global revenue, with a market size of $405.66 million in 2024 and a CAGR of 5.0% from 2024 to 2031[4].
  • Asia Pacific: This region holds around 23% of the global revenue, with a market size of $311.01 million in 2024 and a CAGR of 8.5% from 2024 to 2031[4].

Key Drivers of Growth

Several factors are driving the growth of the hydrocortisone market:

Rising Prevalence of Skin Disorders

The increasing prevalence of skin disorders such as eczema, psoriasis, and dermatitis is a significant driver. These conditions often require corticosteroid therapy, making hydrocortisone a crucial treatment option[1].

Technological Advancements

Advancements in drug formulation and delivery techniques are enhancing the efficacy and safety of hydrocortisone products. This includes the development of combination therapies and improved topical formulations[1][3].

Increased Investment in R&D

Companies are investing heavily in research and development to improve existing products and develop new ones. This includes a focus on natural ingredients, personalized treatments, and sustainable practices[1].

Growing Disposable Income

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

Expanded Distribution Channels

The expansion of distribution channels, including online pharmacies and retail stores, is making hydrocortisone products more accessible to a wider audience[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[1].

Market Segmentation

The hydrocortisone market is segmented by type, route of administration, application, and distribution channel. This segmentation helps in targeting specific needs and preferences of different consumer groups[1].

Urea/Hydrocortisone Topical Products

Uses and Dosage

Urea/hydrocortisone topical products, such as Carmol HC and U-Cort, are used for the relief of inflammation and itching associated with corticosteroid-responsive dermatoses. These products are available in various strengths, typically 10%/1%, and are applied to the affected area every 6-12 hours until control is achieved[2].

Side Effects and Interactions

While effective, urea/hydrocortisone topical products can have side effects such as burning, itching, irritation, and dryness. There are also potential interactions with other drugs, although no severe interactions are listed[2].

Market Impact

The combination of urea and hydrocortisone in topical products enhances their therapeutic efficacy, making them a popular choice for treating skin conditions. This combination contributes to the overall growth of the hydrocortisone market by offering a more effective treatment option for patients[2].

Trends Shaping the Market

Focus on Natural Ingredients

There is a growing trend towards using natural ingredients in hydrocortisone products, which appeals to consumers looking for more organic and sustainable options[1].

Combination Therapies

Combination therapies that include hydrocortisone along with other ingredients like urea are becoming more popular due to their enhanced therapeutic benefits[1][2].

Personalized Treatments

The move towards personalized treatments is also influencing the hydrocortisone market. Companies are developing products tailored to individual patient needs, which is driving market growth[1].

Sustainability Emphasis

An increasing emphasis on sustainability is driving the development of eco-friendly packaging and production processes in the hydrocortisone market[1].

Cost Benefits

Hydrocortisone therapy, especially in critical care settings, shows significant cost benefits. The use of hydrocortisone can reduce the need for more expensive treatments and hospital stays, making it a cost-effective option for healthcare providers[1].

Regional Analysis

North America

North America is a significant market for hydrocortisone products, driven by high healthcare spending and a large patient population. The United States and Canada are key contributors to this regional market[4].

Europe

Europe also holds a substantial share of the global hydrocortisone market, with countries like Italy, Spain, and Russia contributing to the regional growth. The CAGR for Europe is expected to be around 5.0% from 2024 to 2031[4].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, driven by increasing healthcare access and spending in countries like China and India. This region has a CAGR of 8.5% from 2024 to 2031, making it a promising market for hydrocortisone products[4].

Key Takeaways

  • The global hydrocortisone market is growing at a CAGR of 6.6% from 2023 to 2028.
  • Key drivers include the rising prevalence of skin disorders, technological advancements, increased investment in R&D, growing disposable income, and expanded distribution channels.
  • 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[4].

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].

How does the combination of urea and hydrocortisone enhance therapeutic efficacy?

The combination of urea and hydrocortisone in topical products enhances their therapeutic efficacy by providing both moisturizing and anti-inflammatory benefits, making them more effective for treating skin conditions[2].

Sources

  1. Drug Patent Watch: Generic HYDROCORTISONE INN entry, drug patent expiration...
  2. RxList: Urea/Hydrocortisone Topical: Side Effects, Uses, Dosage...
  3. Market Research Intellect: Hydrocortisone Sodium Succinate Market Size and Projections
  4. Cognitive Market Research: Hydrocortisone Cream Market Report 2024 (Global Edition)

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