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Last Updated: December 25, 2024

PREDNISOLONE TEBUTATE - Generic Drug Details


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What are the generic sources for prednisolone tebutate and what is the scope of freedom to operate?

Prednisolone tebutate is the generic ingredient in two branded drugs marketed by Merck and Watson Labs, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for prednisolone tebutate.

Summary for PREDNISOLONE TEBUTATE
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE TEBUTATE
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
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
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 PREDNISOLONE TEBUTATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs PREDNISOLONE TEBUTATE prednisolone tebutate INJECTABLE;INJECTION 083362-001 Feb 17, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck HYDELTRA-TBA prednisolone tebutate INJECTABLE;INJECTION 010562-001 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

PREDNISOLONE TEBUTATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednisolone Tebutate

Introduction

Prednisolone tebutate, a derivative of the corticosteroid prednisolone, is widely used in the treatment of various inflammatory and autoimmune conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Global Corticosteroid Market Overview

The global corticosteroid market, which includes prednisolone and its derivatives, has been growing steadily. In 2023, the market size was approximately $5.47 billion and is expected to reach $5.7 billion in 2024, with a compound annual growth rate (CAGR) of 4.1%[3].

Prednisolone Market Specifics

The prednisolone market, a subset of the broader corticosteroid market, is also experiencing significant growth. As of 2023, the global prednisolone market size was valued at USD 0.16 billion and is projected to reach USD 0.34 billion by 2032, growing at a CAGR of 8.14%[1].

Driving Factors

Several factors are driving the growth of the prednisolone market:

  • Aging Population: The increasing age of the global population is leading to higher incidences of age-related inflammatory and autoimmune diseases, which are often treated with prednisolone.
  • Increasing Prevalence of Inflammatory Conditions: Conditions such as rheumatoid arthritis, asthma, and skin allergies are becoming more prevalent, driving the demand for corticosteroids like prednisolone[1][3].

Key Players

The prednisolone market is dominated by several key players:

  • Shandong Taihua Bio &Tech
  • Mahima Life Sciences
  • Sanofi
  • Wuhan DKY Technology
  • Xianju Pharma These companies play a significant role in the production, distribution, and innovation within the prednisolone market[1].

Applications and End Users

Prednisolone tebutate is used across various applications:

  • Rheumatology Indications: For conditions like rheumatoid arthritis and lupus.
  • Skin Allergies: For treating dermatitis, eczema, and psoriasis.
  • Endocrinology: In the management of certain endocrine disorders.
  • Acute Respiratory Diseases: Including asthma and COPD.
  • Other Applications: Such as ophthalmology and gastroenterology[3].

The primary end users include:

  • Hospitals
  • Clinics
  • Research Institutes
  • Other End Users such as pharmacies and retail stores[3].

Regional Market Analysis

The corticosteroid market, including prednisolone, varies significantly by region:

  • North America: Was the largest region in the corticosteroids therapy market share in 2023.
  • Middle East: Expected to be the largest growing region during the forecast period.
  • Asia-Pacific: Also showing significant growth due to increasing healthcare expenditure and a large patient population[3].

Financial Trajectory

The financial trajectory of the prednisolone market is promising:

  • Current Market Size: USD 0.16 billion in 2023.
  • Projected Market Size: USD 0.34 billion by 2032.
  • CAGR: 8.14% from 2023 to 2032[1].

Pharmacokinetics and Efficacy

Prednisolone tebutate is known for its rapid absorption and high systemic availability:

  • Absorption: Rapidly absorbed from the gastrointestinal tract with a systemic availability ranging from 75% to 98%[4].
  • Efficacy: Effective in reducing inflammation and suppressing the immune system, making it a valuable treatment option for various conditions[4].

Market Trends and Strategies

Several trends are shaping the future of the prednisolone market:

  • Immunomodulatory Effects: Emphasis on the immunomodulatory effects of corticosteroids.
  • Biosimilar Market Growth: Increasing development and approval of biosimilar corticosteroids.
  • Combination Therapies: Development of combination therapies to enhance efficacy and reduce side effects.
  • Pediatric-Specific Formulations: Growing focus on developing formulations specifically for pediatric patients[3].

Regulatory Compliance

Regulatory compliance is a critical aspect of the corticosteroid market:

  • Guidelines: Adherence to guidelines set by regulatory bodies such as the FDA and EMEA is essential for market approval and continued sales[3][4].

Conclusion

The market for prednisolone tebutate is driven by a combination of factors including an aging population, increasing prevalence of inflammatory conditions, and advancements in drug delivery. With a projected CAGR of 8.14% and key players driving innovation, the market is set for significant growth. Understanding the pharmacokinetics, efficacy, and regulatory landscape is crucial for navigating this market effectively.

Key Takeaways

  • The global prednisolone market is expected to reach USD 0.34 billion by 2032.
  • The market is driven by an aging population and increasing prevalence of inflammatory conditions.
  • Key players include Shandong Taihua Bio &Tech, Mahima Life Sciences, Sanofi, Wuhan DKY Technology, and Xianju Pharma.
  • The drug is used across various applications including rheumatology, skin allergies, and acute respiratory diseases.
  • Regulatory compliance and adherence to guidelines are essential for market success.

FAQs

Q: What is the projected market size of the global prednisolone market by 2032? A: The global prednisolone market is projected to reach USD 0.34 billion by 2032[1].

Q: What are the primary driving factors of the prednisolone market? A: The primary driving factors include an aging population and the increasing prevalence of inflammatory conditions[1][3].

Q: Who are the key players in the prednisolone market? A: Key players include Shandong Taihua Bio &Tech, Mahima Life Sciences, Sanofi, Wuhan DKY Technology, and Xianju Pharma[1].

Q: What are the common applications of prednisolone tebutate? A: Common applications include rheumatology indications, skin allergies, endocrinology, and acute respiratory diseases[3].

Q: What is the systemic availability of prednisolone tebutate after oral administration? A: The systemic availability of prednisolone tebutate after oral administration ranges from 75% to 98%[4].

Sources

  1. Business Research Insights - Prednisolone Market Growth, Size, Share and Forecast [2032]
  2. Science.gov - Epidural corticosteroid injections: Topics by Science.gov
  3. The Business Research Company - Corticosteroids Global Market Report 2024
  4. FIP - Biowaiver monographs for immediate release solid oral dosage forms

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