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Last Updated: December 22, 2024

HC (HYDROCORTISONE) Drug Patent Profile


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Which patents cover Hc (hydrocortisone), and what generic alternatives are available?

Hc (hydrocortisone) is a drug marketed by C And M Pharma and is included in two NDAs.

The generic ingredient in HC (HYDROCORTISONE) is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hc (hydrocortisone)

A generic version of HC (HYDROCORTISONE) was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for HC (HYDROCORTISONE)
Drug patent expirations by year for HC (HYDROCORTISONE)
Recent Clinical Trials for HC (HYDROCORTISONE)

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 HC (HYDROCORTISONE) clinical trials

US Patents and Regulatory Information for HC (HYDROCORTISONE)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
C And M Pharma HC (HYDROCORTISONE) hydrocortisone CREAM;TOPICAL 080482-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
C And M Pharma HC (HYDROCORTISONE) hydrocortisone OINTMENT;TOPICAL 080481-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
C And M Pharma HC (HYDROCORTISONE) hydrocortisone CREAM;TOPICAL 080482-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
C And M Pharma HC (HYDROCORTISONE) hydrocortisone OINTMENT;TOPICAL 080481-001 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

EU/EMA Drug Approvals for HC (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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

HC (HYDROCORTISONE) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydrocortisone (HC)

Market Overview

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

Market Size and Growth

As of 2023, the global hydrocortisone 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][2].

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][2].

Segmentation of the Hydrocortisone Market

By Type

The hydrocortisone market is segmented into cream, injection, and tablet forms. Each form has its specific applications and market shares.

  • Cream: Dominates the market, particularly for treating skin conditions such as dermatitis and other cutaneous disorders[3].
  • Injection: Used for severe conditions requiring immediate relief, such as allergic reactions and asthma attacks.
  • Tablet: Commonly used for systemic conditions like adrenocortical dysfunction and rheumatoid arthritis[1].

By Route of Administration

The market is also segmented by the route of administration:

  • Parenteral: Administered intravenously or intramuscularly.
  • Oral: Taken in tablet form.
  • Topical: Applied directly to the skin in the form of creams or ointments[1].

By Application

Hydrocortisone is used in various medical applications:

  • Adrenocortical Dysfunction
  • Adrenergic Syndrome
  • High Blood Calcium
  • Thyroiditis
  • Rheumatoid Arthritis
  • Dermatitis
  • Asthma and Chronic Obstructive Pulmonary Disease (COPD)
  • Other Applications[1].

By Distribution Channel

The distribution channels include:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies[1].

Key Drivers of the Market

Rising Prevalence of Skin Disorders

The increasing incidence of skin disorders such as dermatitis, eczema, and other cutaneous conditions is a significant driver of the hydrocortisone market[1][3].

Aging Population

An aging population contributes to the growth of the hydrocortisone market, as older individuals are more prone to various health conditions that require corticosteroid treatment[1].

Increased Awareness and Accessibility

Improved awareness and accessibility of healthcare services, especially in emerging markets, have boosted the demand for hydrocortisone products[1].

Technological Advancements

Advancements in pharmaceutical technology have led to the development of more effective and convenient forms of hydrocortisone, such as hydrocortisone-infused products and combination therapies[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][2].

Regional Market Performance

North America

North America holds a major share of the hydrocortisone market, driven by the sophisticated healthcare infrastructure and high prevalence of skin conditions. The North American hydrocortisone cream market is expected to grow at a CAGR of 4.7% from 2024 to 2031[3].

Europe

Europe also has a significant market share, with a CAGR of 5.0% from 2024 to 2031. The region's market is driven by similar factors as North America, including advanced healthcare infrastructure and high incidence of skin disorders[3].

Asia Pacific

The Asia Pacific region is expected to make significant gains, with the highest CAGR of 8.5% from 2024 to 2031. This growth is driven by increasing healthcare expenditure, improved access to healthcare services, and growing consumer awareness of skin health in countries like China and India[3].

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[4].

Cost Benefits and Economic Impact

Adjunctive hydrocortisone therapy has shown 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. The total estimated annual impact of adjunctive hydrocortisone therapy for septic shock was $2.3 billion in 2019 dollars[2].

Market Trends and Strategies

Natural Ingredient Focus

There is a growing trend towards natural ingredients in hydrocortisone products, appealing to consumers who prefer organic and natural health solutions[1].

Combination Therapies

Combination therapies that include hydrocortisone along with other medications are becoming more popular, offering enhanced treatment outcomes for various conditions[1].

Personalized Treatments

The market is moving towards personalized treatments, where hydrocortisone is tailored to individual patient needs, enhancing efficacy and reducing side effects[1].

Hydrocortisone-Infused Products

The development of hydrocortisone-infused products, such as creams and ointments, is a significant trend, offering improved delivery and absorption of the medication[1].

Sustainability Emphasis

There is an increasing emphasis on sustainability in the hydrocortisone market, with companies focusing on environmentally friendly packaging and production processes[1].

Macro Economic Scenario

Impact of High Inflation

High inflation can impact the hydrocortisone market by increasing the cost of raw materials and production, potentially affecting the affordability of these products for consumers[1].

Ukraine-Russia War Impact

The Ukraine-Russia war can disrupt supply chains and affect the availability of raw materials, which could impact the production and distribution of hydrocortisone products[1].

COVID-19 Impact

The COVID-19 pandemic has accelerated the demand for hydrocortisone due to its use in treating COVID-19-related conditions such as severe respiratory distress. However, it has also posed challenges in terms of supply chain disruptions and increased costs[1].

"According to the International Agency for Research on Cancer, there were 18.1 million new cancer cases and 9.6 million cancer deaths in 2018, worldwide. One out of five men and one out of six women worldwide develop cancer during their lifetime, and one out of eight men and one out of 11 women die from the disease."[5]

Key Takeaways

  • The global hydrocortisone market is projected to grow significantly, reaching $1.96 billion by 2028.
  • Key drivers include rising skin disorder prevalence, an aging population, increased awareness and accessibility, technological advancements, and growing disposable income.
  • The market is segmented by type, route of administration, application, and distribution channel.
  • Regional markets, particularly North America, Europe, and Asia Pacific, are expected to show strong growth.
  • Companies are experiencing significant revenue growth, and there is a focus on natural ingredients, combination therapies, personalized treatments, and sustainability.

Frequently Asked Questions (FAQs)

1. What is the current market size of the global hydrocortisone market?

The global hydrocortisone market size was estimated at $1.43 billion in 2023 and is expected to reach $1.52 billion in 2024[1][2].

2. What are the main drivers of the hydrocortisone market growth?

The main drivers include rising skin disorder prevalence, an aging population, increased awareness and accessibility, technological advancements, and growing disposable income[1][2].

3. How is the hydrocortisone market segmented?

The market is segmented by type (cream, injection, tablet), route of administration (parenteral, oral, topical), application (various medical conditions), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies)[1].

4. Which region dominates the hydrocortisone cream market?

North America currently dominates the hydrocortisone cream market, with a significant market share and a CAGR of 4.7% from 2024 to 2031[3].

5. What are some of the emerging trends in the hydrocortisone market?

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

Sources:

  1. The Business Research Company. Global Hydrocortisone Market Report 2024.
  2. Drug Patent Watch. Generic HYDROCORTISONE INN entry, drug patent expiration.
  3. Cognitive Market Research. Hydrocortisone Cream Market Report 2024 (Global Edition).
  4. Eton Pharmaceuticals. Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results.
  5. Coherent Market Insights. Hydrocortisone Market - Market Dynamics.

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