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Last Updated: March 23, 2025

Hydrocortisone acetate; oxytetracycline hydrochloride - Generic Drug Details


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

Hydrocortisone acetate; oxytetracycline hydrochloride is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for hydrocortisone acetate; oxytetracycline hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:hydrocortisone acetate; oxytetracycline hydrochloride at DailyMed
Recent Clinical Trials for hydrocortisone acetate; oxytetracycline hydrochloride

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all hydrocortisone acetate; oxytetracycline hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone acetate; oxytetracycline hydrochloride
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
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
D06AA Tetracycline and derivatives
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
D06AA Tetracycline and derivatives
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
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
G01AA Antibiotics
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
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
J01AA Tetracyclines
J01A TETRACYCLINES
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J01AA Tetracyclines
J01A TETRACYCLINES
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
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
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for hydrocortisone acetate; oxytetracycline hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pfizer TERRA-CORTRIL hydrocortisone acetate; oxytetracycline hydrochloride SUSPENSION;OPHTHALMIC 061016-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Hydrocortisone Acetate

Market Overview

The hydrocortisone acetate market is experiencing a period of significant 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, which includes hydrocortisone acetate, was estimated to be worth $1.43 billion. This market is projected to grow at a compound annual growth rate (CAGR) of 6.6% from 2023 to 2028, reaching $1.96 billion by 2028[2].

Segmentation

The hydrocortisone acetate market is segmented based on several criteria:

Type

  • Injection
  • Tablet
  • Ointment
  • Eye Drops
  • Others[1]

Application

  • Hospital
  • Clinic
  • Others[1]

Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa[1]

Drivers of Growth

Rising Prevalence of Skin Disorders

The increasing prevalence of skin disorders such as eczema, psoriasis, and dermatitis is a significant driver of the hydrocortisone acetate market. These conditions often require topical or systemic corticosteroid treatments, contributing to the demand for hydrocortisone acetate[2].

Technological Advancements

Advancements in drug formulation and delivery systems have improved the efficacy and stability of hydrocortisone acetate, making it a preferred choice for both prescription and over-the-counter (OTC) applications[2].

Increased Investment in R&D

Pharmaceutical companies are investing heavily in research and development to enhance the properties of hydrocortisone acetate and to develop new formulations. This investment is expected to drive innovation and growth in the market[2].

Growing Disposable Income

As global disposable income increases, more people are able to afford healthcare products, including hydrocortisone acetate. This economic factor is particularly significant in emerging markets where access to healthcare is improving[2].

Financial Performance

Revenue Growth

Companies involved in the hydrocortisone acetate 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, highlighting the robust financial performance of players in this market[2].

Regional Market Performance

North America holds a major share of the hydrocortisone cream market, a subset of the broader hydrocortisone acetate market, with a market size of $540.88 million in 2024 and a CAGR of 4.7% from 2024 to 2031. Europe and Asia Pacific also have significant market shares, with CAGRs of 5.0% and 8.5%, respectively, over the same period[2].

Cost Analysis and Economic Impact

Cost Benefits

Adjunctive hydrocortisone therapy has been shown to have 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[2].

Total Estimated Annual Impact

The total estimated annual impact of adjunctive hydrocortisone therapy for septic shock was $2.3 billion in 2019 dollars, highlighting the economic significance of hydrocortisone acetate in critical care settings[2].

Key Trends

Focus on Natural Ingredients

There is a growing trend towards the use of natural ingredients in pharmaceutical products, including hydrocortisone acetate formulations. This trend is driven by consumer preference for more natural and sustainable products[2].

Combination Therapies

Combination therapies involving hydrocortisone acetate and other drugs are becoming more popular. These therapies aim to enhance treatment efficacy and reduce side effects[2].

Personalized Treatments

The move towards personalized medicine is also influencing the hydrocortisone acetate market. Tailored treatment plans based on individual patient needs are becoming more common, driving demand for customized formulations[2].

Sustainability Emphasis

Pharmaceutical companies are increasingly focusing on sustainability in their operations and product development. This includes the use of eco-friendly packaging and the development of more sustainable manufacturing processes for hydrocortisone acetate[2].

Regional Insights

North America

North America is a significant market for hydrocortisone acetate, driven by high healthcare spending and a large patient population. The region is expected to continue its dominance in the market due to its well-established healthcare infrastructure and high demand for dermatological treatments[2].

Europe

Europe is another major market for hydrocortisone acetate, with a CAGR of 5.0% from 2024 to 2031. The region's strong pharmaceutical industry and stringent regulatory environment contribute to its significant market share[2].

Asia Pacific

The Asia Pacific region is experiencing rapid growth in the hydrocortisone acetate market, driven by increasing healthcare expenditure and a growing patient population. The region's CAGR of 8.5% from 2024 to 2031 makes it a promising market for future growth[2].

Competitive Landscape

The hydrocortisone acetate market is highly competitive, with several major players including Pfizer, Novartis, Akorn Pharmaceuticals, Teva Pharmaceuticals, and XGen Pharmaceuticals. These companies are engaged in continuous R&D to improve product formulations and expand their market share[4].

Conclusion

The hydrocortisone acetate market is poised for significant growth driven by increasing demand for dermatological treatments, technological advancements, and growing disposable income. The market's financial trajectory is robust, with substantial revenue growth expected across various regions.

Key Takeaways

  • The hydrocortisone acetate market is growing at a CAGR of 6.6% from 2023 to 2028.
  • Key drivers include the rising prevalence of skin disorders, technological advancements, and increased investment in R&D.
  • 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 acetate therapy shows significant cost benefits, particularly in critical care settings.

FAQs

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

The hydrocortisone acetate market is expected to reach $1.96 billion by 2028, growing at a CAGR of 6.6% from 2023 to 2028[2].

What are the main drivers of the hydrocortisone acetate 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[2].

Which regions hold significant market shares in the hydrocortisone acetate market?

North America, Europe, and Asia Pacific hold significant market shares, with North America accounting for over 40% of the global revenue[2].

What are some of the key trends in the hydrocortisone acetate market?

Key trends include a focus on natural ingredients, combination therapies, personalized treatments, and an emphasis on sustainability[2].

What is the estimated cost benefit of adjunctive hydrocortisone acetate therapy for septic shock?

The estimated cost benefit of adjunctive hydrocortisone acetate therapy for septic shock can be up to $25,539 per patient, driven by reductions in ICU stays, vasopressor-free days, and ventilation-free days[2].

Oxytetracycline Hydrochloride Market Dynamics

While the primary focus has been on hydrocortisone acetate, it is worth noting that oxytetracycline hydrochloride, another antibiotic, has its own market dynamics.

Market Overview

Oxytetracycline hydrochloride is an antibiotic used to treat various bacterial infections. The market for oxytetracycline hydrochloride is influenced by factors such as antibiotic resistance, regulatory changes, and advancements in antibiotic formulations.

Drivers of Growth

  • Increasing Bacterial Infections: The rise in bacterial infections, particularly in regions with limited access to healthcare, drives the demand for antibiotics like oxytetracycline hydrochloride.
  • Advancements in Formulations: Improvements in drug delivery systems and the development of more effective formulations are key drivers of the oxytetracycline hydrochloride market.
  • Regulatory Support: Regulatory support for the use of antibiotics in both human and veterinary medicine also contributes to market growth.

Financial Performance

The financial performance of the oxytetracycline hydrochloride market is influenced by the sales of antibiotic products, which can vary based on regional demand and competition from other antibiotics.

Regional Insights

  • Asia Pacific: This region is a significant market for oxytetracycline hydrochloride due to the high incidence of bacterial infections and the growing healthcare infrastructure.
  • North America and Europe: These regions also have a substantial market share, driven by the use of oxytetracycline hydrochloride in both human and veterinary medicine.

Competitive Landscape

The market for oxytetracycline hydrochloride is competitive, with several pharmaceutical companies involved in its production and distribution. Companies like Pfizer and Novartis are key players in this market.

Sources

  1. Market Research Intellect: Hydrocortisone Acetate Market Size, Scope And Forecast Report[1].
  2. Drug Patent Watch: Generic HYDROCORTISONE INN entry, drug patent expiration[2].
  3. Wikipedia: Hydrocortisone acetate[3].
  4. Valuates Reports: Hydrocortisone Acetate - Market Size[4].

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