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Last Updated: December 22, 2024

Betamethasone sodium phosphate - Generic Drug Details


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

Betamethasone sodium phosphate is the generic ingredient in two branded drugs marketed by Watson Labs and Schering, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for betamethasone sodium phosphate.

Summary for betamethasone sodium phosphate
Recent Clinical Trials for betamethasone sodium phosphate

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

SponsorPhase
Affiliated Hospital of Nantong UniversityN/A
University of Southern CaliforniaPhase 4
Surface Pharmaceuticals, Inc.Phase 2

See all betamethasone sodium phosphate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for betamethasone sodium phosphate
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
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
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

US Patents and Regulatory Information for betamethasone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs BETAMETHASONE SODIUM PHOSPHATE betamethasone sodium phosphate INJECTABLE;INJECTION 085738-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering CELESTONE betamethasone sodium phosphate INJECTABLE;INJECTION 017561-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 sodium phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betamethasone Sodium Phosphate

Introduction to Betamethasone Sodium Phosphate

Betamethasone sodium phosphate is a corticosteroid used in various medical applications, including the treatment of arthritis, asthma, and other inflammatory conditions. The drug is available in several forms, such as injections, powder injections, and drops, catering to different administration needs.

Market Size and Growth Projections

The global betamethasone sodium phosphate market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market size was valued at approximately USD 607.2 million and is expected to grow to USD 1005.67 million by 2031, with a Compound Annual Growth Rate (CAGR) of 6.51% during the forecast period of 2024-2031[4][5].

Market Segmentation

The market is segmented based on several key factors:

By Type

  • Injection
  • Powder Injection
  • Drops

These forms cater to different medical needs and preferences, influencing market dynamics based on ease of use, efficacy, and patient compliance[1][5].

By Application

  • Intramuscular Injection
  • Intravenous Injection

These applications are critical in treating various conditions such as arthritis, asthma, and severe allergies. The increasing prevalence of these conditions drives the demand for betamethasone sodium phosphate[1][5].

By Geography

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

Regional variations in healthcare infrastructure, disease prevalence, and regulatory environments significantly impact market growth and segmentation[1][5].

Drivers of Market Growth

Several factors are driving the growth of the betamethasone sodium phosphate market:

Increasing Prevalence of Arthritis and Allergies

The rising cases of arthritis and allergies globally are major drivers. For instance, the Centre for Disease Control and Prevention estimates that approximately 5.4% of adults in the United States have reported arthritis, boosting the demand for betamethasone sodium phosphate[4].

Expansion of the Pharmaceutical Industry

The rapid growth of the pharmaceutical industry, particularly in regions like North America and Europe, which accounted for 49.1% and 23.4% of global pharmaceutical sales in 2021, respectively, further propels the demand for betamethasone sodium phosphate[4].

Cost Efficiency and Ease of Handling

The solid form of betamethasone sodium phosphate is preferred due to its ease of handling, transportation, and distribution, making it a cost-efficient option for the pharmaceutical industry[4].

Market Opportunities

Research and Development

Ongoing research, such as the interventional study by Thammasat University, Thailand, to compare the efficacy of intra-articular corticosteroid injections of Triamcinolone acetonide and Betamethasone for treating knee osteoarthritis, is expected to provide lucrative growth opportunities. Such studies will boost the demand for betamethasone sodium phosphate over the forecast period[4].

Increasing Investments in Healthcare

Growing investments in healthcare infrastructure and research will further support the expansion of the market. For example, the pharmaceutical industry in India is expected to reach a value of USD 130 billion by 2030, which will drive the demand for betamethasone sodium phosphate[4].

Challenges and Restraints

Regulatory Hurdles

Stringent regulatory requirements and varying approval processes across different regions can act as restraints to market growth. Compliance with these regulations is crucial but can be time-consuming and costly[5].

Side Effects and Alternatives

Potential side effects of corticosteroids and the availability of alternative treatments can also impact market growth. For instance, ultrasound-guided biceps tenotomy combined with corticosteroids is an emerging alternative for managing shoulder pain, which might divert some demand away from traditional corticosteroid injections[2].

Key Players and Competitive Landscape

The market is dominated by several key players, including:

  • Ikon Remedies
  • AdvaCare Pharma
  • Zoic Pharma
  • Celestone Soluspan
  • B-SOL
  • Malik Lifesciences Pvt. Ltd.
  • Chengdu Tiantai Mount Pharmaceutical
  • Suicheng Pharmaceutical

These companies are profiled based on their market share, business models, and competitive intelligence, providing valuable insights into the market's competitive landscape[1][5].

Financial Trajectory

The financial trajectory of the betamethasone sodium phosphate market is positive, with significant growth projected over the next several years. Here are some key financial highlights:

  • Market Size in 2023: Approximately USD 607.2 million[4].
  • Projected Market Size by 2031: USD 1005.67 million[4].
  • CAGR: 6.51% during the forecast period of 2024-2031[4].

This growth is driven by increasing demand, expanding pharmaceutical industry, and ongoing research and development activities.

Regional Market Analysis

The market is geographically diverse, with different regions contributing significantly to its growth:

  • North America: Accounts for a substantial share due to high prevalence of arthritis and allergies, along with a well-developed pharmaceutical industry[4].
  • Europe: Also a significant contributor, driven by the region's large pharmaceutical market and high healthcare standards[4].
  • Asia-Pacific: Expected to grow rapidly due to increasing healthcare investments and a large patient population[4].

Consumer Behavior and Economic Impact

Consumer behavior, influenced by factors such as awareness of treatment options and healthcare affordability, plays a crucial role in market dynamics. The economic impact of the growing pharmaceutical industry, including job creation and revenue generation, is also substantial.

PEST Analysis

A PEST (Political, Economic, Social, and Technological) analysis highlights the following:

  • Political: Regulatory environments and healthcare policies significantly impact market growth.
  • Economic: Economic stability and healthcare spending are critical factors.
  • Social: Increasing awareness and demand for effective treatments drive market expansion.
  • Technological: Advances in medical technology and research methodologies support market growth[3].
"The increasing prevalence of arthritis and allergies globally are major drivers of the betamethasone sodium phosphate market. For instance, the Centre for Disease Control and Prevention estimates that approximately 5.4% of adults in the United States have reported arthritis from 2019-2021"[4].

Key Takeaways

  • The betamethasone sodium phosphate market is expected to grow significantly, driven by increasing prevalence of arthritis and allergies.
  • The market is segmented by type, application, and geography, with North America and Europe being key regions.
  • Key players include Ikon Remedies, AdvaCare Pharma, and Zoic Pharma.
  • Regulatory hurdles and potential side effects are challenges to market growth.
  • The market is projected to reach USD 1005.67 million by 2031 with a CAGR of 6.51%.

FAQs

1. What are the primary applications of betamethasone sodium phosphate?

Betamethasone sodium phosphate is primarily used for intramuscular and intravenous injections to treat conditions such as arthritis, asthma, and severe allergies.

2. Which regions are expected to drive the growth of the betamethasone sodium phosphate market?

North America and Europe are expected to be significant contributors to the market growth due to their well-developed pharmaceutical industries and high prevalence of relevant diseases.

3. What are the key drivers of the betamethasone sodium phosphate market?

The increasing prevalence of arthritis and allergies, the expansion of the pharmaceutical industry, and the ease of handling and cost efficiency of the drug are key drivers.

4. Who are the major players in the betamethasone sodium phosphate market?

Major players include Ikon Remedies, AdvaCare Pharma, Zoic Pharma, Celestone Soluspan, B-SOL, Malik Lifesciences Pvt. Ltd., Chengdu Tiantai Mount Pharmaceutical, and Suicheng Pharmaceutical.

5. What is the projected CAGR of the betamethasone sodium phosphate market from 2024 to 2031?

The market is projected to grow at a CAGR of 6.51% during the forecast period of 2024-2031.

Sources:

  1. Market Research Intellect - Global Betamethasone Sodium Phosphate Market Size, Trends and ...
  2. ClinicalKey - Nonsurgical Management of Shoulder Pain in Rotator Cuff Tears ...
  3. The Insight Partners - Betamethasone Ointment Market Insights and Growth by 2031
  4. Markets and Data - Betamethasone Sodium Phosphate Market Size, Growth, Report 2031
  5. Market Research Intellect - Global Betamethasone Sodium Phosphate Market Size, Scope And ...

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