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Last Updated: December 22, 2024

Dexamethasone acetate - Generic Drug Details


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What are the generic sources for dexamethasone acetate and what is the scope of patent protection?

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

There are seven drug master file entries for dexamethasone acetate.

Summary for dexamethasone acetate
Recent Clinical Trials for dexamethasone acetate

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

SponsorPhase
Orion Corporation, Orion PharmaPhase 1
Merck Sharp & Dohme LLCPhase 1
Assiut UniversityN/A

See all dexamethasone acetate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for dexamethasone acetate
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE 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 dexamethasone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck DECADRON-LA dexamethasone acetate INJECTABLE;INJECTION 016675-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs Teva DEXAMETHASONE ACETATE dexamethasone acetate INJECTABLE;INJECTION 087711-001 May 24, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs DEXAMETHASONE ACETATE dexamethasone acetate INJECTABLE;INJECTION 084315-001 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

Dexamethasone acetate Market Analysis and Financial Projection Experimental

Dexamethasone Acetate Market Dynamics and Financial Trajectory

Introduction

Dexamethasone acetate, a potent synthetic corticosteroid, has been a crucial component in the treatment of various inflammatory and immune-related conditions. The market for dexamethasone acetate has seen significant fluctuations and growth, particularly in recent years due to several key factors.

Market Size and Growth

The dexamethasone acetate market is projected to experience substantial growth over the coming years. By 2032, the market is expected to reach a significant value, driven by a compound annual growth rate (CAGR) from 2024 to 2032[1].

Drivers of Market Growth

Several factors are driving the growth of the dexamethasone acetate market:

Increased Use in COVID-19 Treatment

The rapid adoption of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients has been a major driver. The World Health Organization (WHO) recommends dexamethasone for the treatment of severe and serious COVID-19 infections, which has significantly boosted its demand[3].

Rising Incidence of Inflammatory Ailments

The increasing incidence of various inflammatory conditions such as cancer, allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, and psoriasis also fuels the market growth. Dexamethasone's anti-inflammatory and immunosuppressant effects make it a versatile treatment option for these conditions[3].

Research and Development

Substantial investments in research and development (R&D) in the dexamethasone industry are expected to provide positive opportunities for market participants. This includes the development of new formulations and the exploration of new therapeutic applications[3].

Market Segmentation

By Application

The dexamethasone market is segmented based on its applications, which include:

  • Anti-inflammatory and Immunossuppressant Effects: Dexamethasone is widely used for its anti-inflammatory and immunosuppressant properties, treating conditions such as asthma, conjunctivitis, and various inflammatory diseases[3].
  • Respiratory Distress Syndrome: It is used in the treatment of respiratory distress syndrome, particularly in critically ill patients.
  • COVID-19: The COVID-19 sector is expected to be the fastest-growing segment due to its efficacy in treating severely ill COVID-19 patients[3].
  • Others: This includes treatments for brain tumors, cerebral edema, and other conditions where dexamethasone's potent effects are beneficial.

By End User

The market is also segmented by end users, which include:

  • Hospital Pharmacy: Hospitals are expected to hold the majority of the market share due to the high number of hospital admissions for various diseases, including COVID-19[3].
  • Clinics: Clinics, especially those specializing in orthopedics or rheumatology, also use dexamethasone acetate.
  • Pharmacy & Drug Stores: Retail pharmacies and drug stores are significant distributors of dexamethasone acetate.
  • Online Pharmacies: Online pharmacies are increasingly becoming a viable channel for the distribution of dexamethasone acetate.

Regional Analysis

The global dexamethasone acetate market is classified into several regions:

  • North America: This region dominates the market due to the high incidence of COVID-19 and other inflammatory diseases. The presence of key manufacturers in this region also contributes to its dominance[3].
  • Europe: Europe is another significant market, driven by the widespread use of dexamethasone in various medical conditions.
  • Asia Pacific: The Asia-Pacific region is expected to grow substantially due to the increasing incidence of viral disease outbreaks and the presence of key manufacturers[3].
  • Rest of the World: This includes other regions where the demand for dexamethasone acetate is growing, albeit at a slower pace.

Availability and Compounding

Dexamethasone acetate was previously commercially available in the US as an 8mg/mL and 16mg/mL injection, but these products have been discontinued. This discontinuation has led to a reliance on compounding from bulk substances, which is considered safer and more efficient for outsourcing facilities[2].

Safety and Efficacy

Dexamethasone acetate is more potent and effective than hydrocortisone but also potentially more harmful. It lacks mineralocorticoid activity, making it unsuitable for conditions like adrenal insufficiency but highly effective for inflammation, edema, and cerebral edema[2].

Financial Trajectory

The financial trajectory of the dexamethasone acetate market is promising, driven by the factors mentioned above. Here are some key financial insights:

  • Market Size: The market is expected to grow significantly, reaching a substantial value by 2032[1].
  • Investments: The substantial investment in R&D and the increasing demand for dexamethasone acetate are expected to drive financial growth[3].
  • Revenue Streams: Revenue will come from various segments, including hospital pharmacies, clinics, and retail pharmacies, as well as online sales channels[3].

Challenges and Opportunities

Challenges

Despite the growth, there are challenges such as the potential side effects associated with dexamethasone use, including depression, euphoria, and hypertension. Additionally, the discontinuation of commercial products has created a need for reliable compounding services[3].

Opportunities

The market presents several opportunities, including the development of new formulations and the expansion into new therapeutic areas. The increasing incidence of inflammatory diseases and the ongoing need for effective treatments for COVID-19 patients also offer significant growth opportunities[3].

Key Takeaways

  • The dexamethasone acetate market is expected to grow significantly due to its increased use in COVID-19 treatment and other inflammatory conditions.
  • The market is driven by factors such as R&D investments, rising disease incidence, and the discontinuation of commercial products.
  • Hospital pharmacies and clinics are major end-users, with North America and Asia-Pacific regions leading the market.
  • Despite challenges, the market offers substantial opportunities for growth and innovation.

FAQs

What are the primary drivers of the dexamethasone acetate market?

The primary drivers include the increased use in COVID-19 treatment, rising incidence of inflammatory ailments, and substantial investments in R&D.

Why has the demand for dexamethasone acetate increased during the COVID-19 pandemic?

The demand has increased due to the WHO's recommendation of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients.

What are the common applications of dexamethasone acetate?

Common applications include anti-inflammatory and immunosuppressant effects, treatment of respiratory distress syndrome, and COVID-19 treatment.

Why is compounding from bulk substances preferred for dexamethasone acetate?

Compounding from bulk substances is preferred due to the discontinuation of commercial products and the safety and efficiency it offers for outsourcing facilities.

What regions dominate the dexamethasone acetate market?

North America and Asia-Pacific regions dominate the market due to high disease incidence and the presence of key manufacturers.

Sources

  1. Dexamethasone Acetate Market Size And Analysis Research Report - River Country News Channel Nebraska
  2. Dexamethasone Acetate - University of Maryland, Baltimore
  3. Dexamethasone Market Size, Share, Trends, Opportunities & Forecast - Verified Market Research
  4. Compound Dexamethasone Acetate Cream - Global Market Share - Market Research Reports
  5. Dexamethasone Acetate Pharmaceutical Secondary Standard - Sigma-Aldrich

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