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Last Updated: December 22, 2024

Hydrocortisone acetate - Generic Drug Details


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

Hydrocortisone acetate is the generic ingredient in nineteen branded drugs marketed by Mylan Speciality Lp, Fougera Pharms, Able, Cenci, Imperium, Parke Davis, Purepac Pharm, Sebela Ireland Ltd, Taro, Pharmacia And Upjohn, Pfizer, Bel Mar, Epic Pharma Llc, Watson Labs, Merck, Ingram Pharm, Fera Pharms, Colgate, X Gen Pharms, Monarch Pharms, Genus, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for hydrocortisone acetate. Two suppliers are listed for this compound.

Summary for hydrocortisone acetate
Drug Prices for hydrocortisone acetate

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Recent Clinical Trials for hydrocortisone acetate

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 1
Orion Corporation, Orion PharmaPhase 1
University Medical Center GroningenEarly Phase 1

See all hydrocortisone acetate clinical trials

Pharmacology for hydrocortisone acetate
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone acetate
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 acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bel Mar HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083739-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083739-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cenci HYDROCORTISONE ACETATE hydrocortisone acetate CREAM;TOPICAL 080419-001 Jan 25, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 085214-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer CORTRIL hydrocortisone acetate INJECTABLE;INJECTION 009164-001 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 acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone Acetate

Introduction to Hydrocortisone Acetate

Hydrocortisone acetate is a widely used corticosteroid, known for its efficacy in treating various skin conditions, including redness, itching, swelling, and other discomforts associated with skin diseases. Here, we delve into the market dynamics and financial trajectory of hydrocortisone acetate, exploring its current state, future projections, and the factors influencing its growth.

Market Size and Growth Projections

The hydrocortisone acetate market has been experiencing significant growth in recent years. As of 2023, the market size was valued at several billion USD, and it is anticipated to reach even higher figures by 2031. This growth is driven by increasing demand for effective treatments for skin conditions, coupled with the expanding availability of hydrocortisone acetate in various forms such as injections, tablets, ointments, and eye drops[1][3].

Segmentation of the Market

The hydrocortisone acetate market is segmented based on several key factors:

Type

  • The market is categorized into different types, including injections, tablets, ointments, eye drops, and others. Each type has its own market share and growth rate, with ointments and creams being particularly popular due to their ease of use and effectiveness[1][3].

Application

  • The applications of hydrocortisone acetate include hospitals, clinics, and other healthcare settings. The demand from these sectors is driven by the need for reliable and safe treatments for skin conditions[1].

Geographical Regions

  • The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America and Europe are significant contributors to the market, while the Asia-Pacific region is expected to show rapid growth due to increasing healthcare spending and awareness[1][3].

Market Drivers

Several factors are driving the growth of the hydrocortisone acetate market:

Increasing Prevalence of Skin Conditions

  • The rising incidence of skin diseases such as eczema, dermatitis, and psoriasis is a major driver. As more people seek effective treatments, the demand for hydrocortisone acetate increases[2].

Nonprescription Status

  • The availability of hydrocortisone acetate as a nonprescription medication since 1979 has significantly boosted its market. This status allows for wider consumer access and self-medication, which has been a critical factor in its market growth[2].

Advancements in Formulations

  • Continuous improvements in formulations, such as the development of higher concentration products (e.g., 1% hydrocortisone) and various delivery methods, have enhanced the efficacy and user experience, further driving market growth[2].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

Side Effects and Safety Concerns

  • Hydrocortisone acetate can cause side effects such as skin thinning, HPA axis suppression, and other adverse reactions, especially with prolonged use. These concerns can limit its use and impact market growth[4].

Regulatory Scrutiny

  • The FDA and other regulatory bodies closely monitor the use and labeling of hydrocortisone acetate products. Any changes in regulations or labeling requirements can affect market dynamics[2].

Market Opportunities

The hydrocortisone acetate market presents several opportunities for growth:

Emerging Markets

  • Regions like Asia-Pacific and South America offer significant growth potential due to increasing healthcare expenditure and a growing awareness of skin health[1][3].

Pharmacist Intervention

  • Pharmacists play a crucial role in advising patients on the appropriate use of hydrocortisone acetate. This can lead to increased sales and better patient outcomes, especially in cases where patients might misuse the product[2].

Financial Projections

The financial trajectory of the hydrocortisone acetate market is promising:

  • The global hydrocortisone acetate market is expected to grow at a significant CAGR from 2023 to 2031, reaching a substantial value by the end of the forecast period[1][3].
  • The hydrocortisone cream market, a subset of the broader hydrocortisone acetate market, is projected to reach USD 1352.2 million in 2024 and expand at a CAGR of 6.50% from 2024 to 2031[5].

Regional Performance

Different regions are contributing to the market growth in various ways:

  • North America: This region is a major contributor, with the United States and Canada showing significant growth rates. The U.S. market alone is expected to reach USD 426.75 million in 2024, growing at a CAGR of 4.5% from 2024 to 2031[5].
  • Asia-Pacific: This region is expected to show rapid growth, driven by increasing healthcare spending and a large patient population. Countries like Australia are anticipated to have a CAGR of 8.2% during the forecast period[5].
  • South America: Brazil and Argentina are key markets in this region, with Brazil expected to grow at a CAGR of 6.5% from 2024 to 2031[5].

Key Players and Competitive Landscape

The market is competitive, with several key players:

  • Major pharmaceutical companies and generic drug manufacturers are active in the market, offering a range of hydrocortisone acetate products. The competitive landscape is driven by product innovation, pricing strategies, and regulatory compliance[1][3].

Consumer Behavior and Awareness

Consumer behavior plays a crucial role in the market dynamics:

  • Patients are increasingly seeking over-the-counter (OTC) solutions for skin conditions, which has driven the demand for hydrocortisone acetate. However, there is a need for better education on the appropriate use of these products to avoid misuse and adverse effects[2].

Economic, Political, and Social Factors

External factors also influence the market:

  • Economic factors such as healthcare spending and insurance coverage can impact the affordability and accessibility of hydrocortisone acetate products.
  • Political factors, including regulatory changes, can affect the market by altering the approval process or labeling requirements.
  • Social factors, such as awareness campaigns and public health initiatives, can increase demand by educating consumers about the benefits and risks of hydrocortisone acetate[1][3].

Conclusion

The hydrocortisone acetate market is poised for significant growth, driven by increasing demand for effective skin treatments, advancements in formulations, and expanding geographical reach. However, it is crucial to address the restraints such as side effects and regulatory scrutiny to ensure sustained growth.

Key Takeaways

  • The hydrocortisone acetate market is expected to grow substantially from 2023 to 2031.
  • The market is driven by the increasing prevalence of skin conditions and the availability of hydrocortisone acetate as a nonprescription medication.
  • Regional markets, especially in Asia-Pacific and South America, offer significant growth opportunities.
  • Side effects and safety concerns are key restraints that need to be addressed.
  • Pharmacist intervention is crucial for ensuring the appropriate use of hydrocortisone acetate products.

Frequently Asked Questions (FAQs)

1. What is hydrocortisone acetate used for?

Hydrocortisone acetate is used to treat various skin conditions, including redness, itching, swelling, and other discomforts associated with skin diseases such as eczema, dermatitis, and psoriasis.

2. When was hydrocortisone acetate first made available as a nonprescription medication?

Hydrocortisone acetate was first approved for nonprescription use in 1979 by the FDA[2].

3. What are the common side effects of hydrocortisone acetate?

Common side effects include skin thinning, HPA axis suppression, blistering, burning, crusting, dryness, or flaking of the skin, among others[4].

4. How is the hydrocortisone acetate market segmented?

The market is segmented based on type (injections, tablets, ointments, eye drops), application (hospitals, clinics), and geographical regions (North America, Europe, Asia-Pacific, South America, Middle-East and Africa)[1][3].

5. What is the projected growth rate of the hydrocortisone cream market from 2024 to 2031?

The hydrocortisone cream market is projected to grow at a CAGR of 6.50% from 2024 to 2031[5].

Cited Sources:

  1. Market Research Intellect - Hydrocortisone Acetate Market Size, Scope And Forecast Report.
  2. US Pharmacist - Appropriate Use of Nonprescription Hydrocortisone.
  3. Market Research Intellect - Hydrocortisone Acetate API Market Size, Scope And Forecast Report.
  4. Mayo Clinic - Hydrocortisone (topical application route).
  5. Cognitive Market Research - Hydrocortisone Cream Market Report 2024 (Global Edition).

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