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Last Updated: December 22, 2024

HYDROCORTISONE BUTYRATE - Generic Drug Details


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

Hydrocortisone butyrate is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Bausch, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, and Taro, and is included in fifteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for hydrocortisone butyrate. Six suppliers are listed for this compound.

Summary for HYDROCORTISONE BUTYRATE
Drug Prices for HYDROCORTISONE BUTYRATE

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Recent Clinical Trials for HYDROCORTISONE BUTYRATE

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

SponsorPhase
PfizerPhase 4
Peking Union Medical College HospitalPhase 4
AllerdermPhase 4

See all HYDROCORTISONE BUTYRATE clinical trials

Pharmacology for HYDROCORTISONE BUTYRATE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE BUTYRATE
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
D07AB Corticosteroids, moderately potent (group II)
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
Paragraph IV (Patent) Challenges for HYDROCORTISONE BUTYRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOCOID Lotion hydrocortisone butyrate 0.10% 022076 1 2016-08-31
LOCOID LIPOCREAM Cream hydrocortisone butyrate 0.10% 020769 1 2010-06-28

US Patents and Regulatory Information for HYDROCORTISONE BUTYRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yamanouchi LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019819-001 Sep 15, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116-001 Feb 25, 1987 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch LOCOID hydrocortisone butyrate CREAM;TOPICAL 018514-001 Mar 31, 1982 AB1 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate SOLUTION;TOPICAL 076364-001 Jan 14, 2004 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Yamanouchi LOCOID hydrocortisone butyrate CREAM;TOPICAL 018795-001 Jan 7, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Mid Atlantic HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 205134-001 Dec 8, 2017 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 210209-001 Aug 17, 2018 AB RX No Yes ⤷  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 BUTYRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone Butyrate

Introduction to Hydrocortisone Butyrate

Hydrocortisone butyrate is a topical corticosteroid used to treat various skin conditions, including inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available in several forms, such as creams and solutions, and is widely used in medical settings including hospitals and clinics.

Market Size and Growth Projections

The hydrocortisone butyrate market has been experiencing significant growth in recent years, and this trend is expected to continue.

  • Global Market Size: The global hydrocortisone butyrate market is projected to see substantial expansion from 2023 to 2031. According to market research, the market is expected to grow at a compound annual growth rate (CAGR) of around 6-7% during this period[1][4].
  • Revenue Projections: By 2031, the market is anticipated to reach a significant value, with estimates suggesting it could exceed $1.9 billion, up from approximately $1.43 billion in 2023[4].

Market Segmentation

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

By Type

  • Cream: This is one of the most common forms of hydrocortisone butyrate and is widely used for treating skin conditions.
  • Solution: This form is also popular, particularly for areas where a cream might not be as effective.
  • Others: This includes other formulations such as ointments and gels[1].

By Application

  • Hospital: Hydrocortisone butyrate is frequently used in hospital settings for treating various skin conditions.
  • Clinic: It is also widely used in clinics for outpatient treatments.
  • Others: This includes home use and other medical facilities[1].

By Geography

  • North America: This region holds a significant market share, driven by high demand and advanced healthcare infrastructure[3][4].
  • Europe: Europe is another major market, with a substantial share of the global revenue.
  • Asia-Pacific: This region is expected to see high growth rates due to increasing healthcare needs and expanding markets.
  • South America and Middle-East & Africa: These regions also contribute to the global market, with growing demand and improving healthcare systems[1][3].

Market Drivers

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

Rising Prevalence of Skin Disorders

  • The increasing prevalence of inflammatory and autoimmune diseases such as atopic dermatitis and psoriasis is a significant driver for the market[4].

Aging Population

  • An aging population is more susceptible to skin conditions, thereby increasing the demand for hydrocortisone butyrate[4].

Increased Awareness and Accessibility

  • Greater awareness about skin health and easier access to healthcare services are contributing to market growth[4].

Pharmaceutical Industry Growth

  • The overall growth of the pharmaceutical industry, including advancements in topical corticosteroids, is also a key driver[4].

Market Restraints

Despite the positive outlook, there are some restraints to consider:

Side Effects and Safety Concerns

  • Hydrocortisone butyrate can cause systemic effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia, especially with prolonged use or application to large surface areas[2].

Pediatric Considerations

  • Pediatric patients are more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios, which can be a restraint in certain market segments[2].

Market Trends

Several trends are shaping the hydrocortisone butyrate market:

Combination Therapies

  • The development of combination therapies involving hydrocortisone butyrate and other treatments is expanding treatment horizons and driving market growth[4].

Natural Ingredient Focus

  • There is an increasing focus on natural ingredients and safer alternatives, which could influence the market dynamics in the future[4].

Personalized Treatments

  • The trend towards personalized medicine is also impacting the market, with more tailored treatments being developed[4].

Sustainability Emphasis

  • The emphasis on sustainability in pharmaceutical products is another trend that could affect the market in the coming years[4].

Key Players

The hydrocortisone butyrate market is dominated by several key players:

  • Merck: Known for its extensive range of pharmaceutical products, including hydrocortisone butyrate formulations.
  • Taro Pharmaceutical Industries: A major player in the dermatology segment, offering various hydrocortisone butyrate products.
  • Aurisco: Another significant player with a strong presence in the market.
  • Konzon: Known for its high-quality pharmaceutical products, including hydrocortisone butyrate.
  • Tianjin Jinyao Pharmaceutical Co. Ltd: A Chinese company with a growing presence in the global market[1].

Financial Performance

The financial performance of the hydrocortisone butyrate market is robust and expected to continue growing:

  • Revenue Growth: The market is expected to grow from $1.43 billion in 2023 to $1.96 billion by 2028, at a CAGR of 6.6%[4].
  • Regional Revenue: North America holds the largest market share, followed by Europe and Asia-Pacific. Each region is expected to see significant growth over the forecast period[3][4].

Regional Analysis

North America

  • This region is the largest market for hydrocortisone butyrate, driven by high demand and advanced healthcare infrastructure. The market size in North America was estimated at $540.88 million in 2024 and is expected to grow at a CAGR of 4.7% from 2024 to 2031[3].

Europe

  • Europe holds a significant market share, with a market size of $405.66 million in 2024. The region is expected to grow at a CAGR of 5.0% from 2024 to 2031[3].

Asia-Pacific

  • This region is expected to see high growth rates due to increasing healthcare needs and expanding markets. The market size in Asia-Pacific was estimated at $311.01 million in 2024 and is expected to grow at a CAGR of 8.5% from 2024 to 2031[3].

Conclusion

The hydrocortisone butyrate market is poised for significant growth driven by increasing demand for effective treatments for skin conditions, technological advancements, and expanding healthcare markets. Despite some restraints related to side effects and safety concerns, the market is expected to continue its upward trajectory.

Key Takeaways

  • Market Growth: The hydrocortisone butyrate market is expected to grow at a CAGR of around 6-7% from 2023 to 2031.
  • Market Size: The global market size is projected to reach $1.96 billion by 2028.
  • Key Drivers: Rising prevalence of skin disorders, aging population, increased awareness, and pharmaceutical industry growth.
  • Key Players: Merck, Taro Pharmaceutical Industries, Aurisco, Konzon, and Tianjin Jinyao Pharmaceutical Co. Ltd.
  • Regional Growth: North America, Europe, and Asia-Pacific are the major regions driving market growth.

FAQs

What are the primary uses of hydrocortisone butyrate?

Hydrocortisone butyrate is primarily used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

What are the potential side effects of hydrocortisone butyrate?

Potential side effects include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria, especially with prolonged use or application to large surface areas.

Which regions are expected to see the highest growth rates in the hydrocortisone butyrate market?

Asia-Pacific is expected to see the highest growth rates due to increasing healthcare needs and expanding markets.

Who are the key players in the hydrocortisone butyrate market?

Key players include Merck, Taro Pharmaceutical Industries, Aurisco, Konzon, and Tianjin Jinyao Pharmaceutical Co. Ltd.

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

The global market size is projected to reach $1.96 billion by 2028.

Sources

  1. Market Research Intellect, "Global Hydrocortisone Butyrate Market Size, Trends and Projections".
  2. Drugs.com, "Hydrocortisone Butyrate: Package Insert / Prescribing Info".
  3. Cognitive Market Research, "Hydrocortisone Cream Market Report 2024 (Global Edition)".
  4. The Business Research Company, "Hydrocortisone Market Report 2024 - Market Size, Growth Rate, Major Drivers And Key Trends".

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