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Last Updated: December 22, 2024

Betamethasone benzoate - Generic Drug Details


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What are the generic sources for betamethasone benzoate and what is the scope of freedom to operate?

Betamethasone benzoate is the generic ingredient in one branded drug marketed by Parke Davis and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for betamethasone benzoate.

Summary for betamethasone benzoate
Anatomical Therapeutic Chemical (ATC) Classes for betamethasone benzoate
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
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XC Corticosteroids, potent, 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
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
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
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for betamethasone benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis UTICORT betamethasone benzoate OINTMENT;TOPICAL 018089-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis UTICORT betamethasone benzoate CREAM;TOPICAL 016998-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis UTICORT betamethasone benzoate LOTION;TOPICAL 017528-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis UTICORT betamethasone benzoate GEL;TOPICAL 017244-001 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

Betamethasone benzoate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betamethasone Acetate and Related Formulations

Market Introduction

Betamethasone, including its various formulations such as betamethasone acetate and betamethasone benzoate, is a synthetic glucocorticoid corticosteroid widely used to treat a range of medical conditions. These include inflammatory skin conditions, autoimmune disorders, and various other diseases such as multiple sclerosis, respiratory, renal, gastrointestinal, ophthalmic, and dermatological diseases[1][3][4].

Market Size and Growth

The global betamethasone acetate market, which is closely related to betamethasone benzoate, is estimated to be valued at US$ 421.4 million in 2022. It is expected to exhibit a Compound Annual Growth Rate (CAGR) of 4.8% between 2022 and 2030, reaching a significant market size by the end of the forecast period[1].

Drivers of Market Growth

Several factors are driving the growth of the betamethasone market:

Increasing Prevalence of Diseases

The increasing prevalence of diseases such as multiple sclerosis, psoriasis, and other skin disorders is a significant driver. For instance, the global prevalence of multiple sclerosis increased by 30% from 2013 to 2020, reaching 35.9 per 100,000 people[1].

COVID-19 Pandemic Impact

The COVID-19 pandemic had a positive impact on the market due to the increased risk of COVID-19-related symptoms such as pain, numbness, and tingling in the hands and feet, which are treated with betamethasone acetate[1].

Growing Geriatric Population

The geriatric population, which is more prone to various diseases that require betamethasone treatment, is increasing. In Asia, the geriatric population nearly tripled from 2015 to 2021, reaching 956 million, which is expected to drive the market growth[1].

Market Segmentation

The betamethasone acetate market is segmented based on several criteria:

Formulation

The market is segmented into suspension, ointment, and gel, with the suspension segment expected to dominate due to increased usage of corticosteroid suspensions[1].

Route of Administration

Intramuscular, intra-articular, and intradermal routes are the main segments, with intramuscular administration expected to dominate due to its use in treating various diseases[1].

Application

The market is segmented into respiratory disease, renal disease, gastrointestinal disease, ophthalmic disease, dermatological disease, and others. Dermatological diseases are expected to dominate due to the high usage of betamethasone acetate for skin conditions[1].

Age Group

The market is segmented into pediatric and geriatric, with the geriatric segment expected to dominate due to the high demand for betamethasone acetate in adults[1].

Distribution Channel

Hospital pharmacies, retail pharmacies, and online pharmacies are the main distribution channels, with hospital pharmacies expected to dominate due to the increasing number of hospital pharmacies[1].

Regional Analysis

North America is expected to dominate the market, holding a 37.8% market share. This is attributed to the increased use of intramuscular suspensions for various treatments in this region[1].

Market Restraints

Despite the growth drivers, there are several restraints to the market:

Side Effects

Betamethasone acetate has various side effects such as dry mouth, fever, and severe or sudden headache, which can hamper market growth[1].

Government Regulations

Government restrictions regulating the safety and efficacy of betamethasone acetate can also impact market growth[1].

Financial Trajectory

The financial trajectory of the betamethasone acetate market is positive, driven by increasing demand and expanding applications.

Revenue Forecast

The market is expected to grow significantly over the forecast period, driven by the increasing prevalence of diseases and the growing geriatric population[1].

Key Players

Major players in the global betamethasone acetate market include Merck & Co., Inc., American Regent, Inc., McKesson Medical-Surgical Inc., and others. These companies are investing in research and development to introduce new formulations and expand their market presence[1].

Market Opportunities

There are several opportunities for growth in the betamethasone market:

Emerging Markets

Untapped market opportunities in emerging nations are expected to benefit the growth of the market in the forecast period[3].

New Formulations

The introduction of different formulations of betamethasone, such as betamethasone dipropionate and betamethasone valerate, offers new avenues for market expansion[3][4].

Key Takeaways

  • The global betamethasone acetate market is expected to grow at a CAGR of 4.8% between 2022 and 2030.
  • Increasing prevalence of diseases and the COVID-19 pandemic are driving market growth.
  • The geriatric population and new formulations are key opportunities for market expansion.
  • North America is expected to dominate the market.
  • Side effects and government regulations are significant restraints.

FAQs

1. What is the expected CAGR of the global betamethasone acetate market between 2022 and 2030?

The global betamethasone acetate market is expected to exhibit a CAGR of 4.8% between 2022 and 2030[1].

2. Which region is expected to dominate the betamethasone acetate market?

North America is expected to dominate the betamethasone acetate market, holding a 37.8% market share[1].

3. What are the main drivers of the betamethasone acetate market growth?

The main drivers include the increasing prevalence of diseases such as multiple sclerosis and skin disorders, the impact of the COVID-19 pandemic, and the growing geriatric population[1].

4. What are the common side effects associated with betamethasone acetate?

Common side effects include dry mouth, fever, and severe or sudden headache[1].

5. Which distribution channel is expected to dominate the betamethasone acetate market?

Hospital pharmacies are expected to dominate the market due to the increasing number of hospital pharmacies[1].

Cited Sources:

  1. Coherent Market Insights - Betamethasone Acetate Market Size, Trends and Forecast to 2030
  2. The Insight Partners - Betamethasone Ointment Market Insights and Growth by 2031
  3. DrugBank - Betamethasone: Uses, Interactions, Mechanism of Action
  4. Wikipedia - Betamethasone benzoate

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