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Last Updated: December 22, 2024

HEXADROL Drug Patent Profile


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Which patents cover Hexadrol, and what generic alternatives are available?

Hexadrol is a drug marketed by Aspen Global Inc and is included in three NDAs.

The generic ingredient in HEXADROL is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

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Summary for HEXADROL
Drug patent expirations by year for HEXADROL
Recent Clinical Trials for HEXADROL

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SponsorPhase
Medical College of WisconsinPhase 2
Southwest Oncology GroupPhase 3
University of Southern CaliforniaPhase 1/Phase 2

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US Patents and Regulatory Information for HEXADROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen Global Inc HEXADROL dexamethasone ELIXIR;ORAL 012674-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen Global Inc HEXADROL dexamethasone TABLET;ORAL 012675-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen Global Inc HEXADROL dexamethasone sodium phosphate INJECTABLE;INJECTION 014694-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen Global Inc HEXADROL dexamethasone TABLET;ORAL 012675-010 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

EU/EMA Drug Approvals for HEXADROL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH & Co. KG Ozurdex dexamethasone EMEA/H/C/001140
Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
Authorised no no no 2010-07-26
THERAVIA Neofordex dexamethasone EMEA/H/C/004071
Treatment of multiple myeloma.
Authorised no no no 2016-03-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

HEXADROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HEXADROL (Dexamethasone)

Introduction

HEXADROL, known generically as dexamethasone, is a potent corticosteroid used in a wide range of medical conditions, including inflammatory diseases, autoimmune disorders, and certain types of cancer. Understanding the market dynamics and financial trajectory of HEXADROL involves analyzing its clinical use, market competition, pricing trends, and the broader pharmaceutical market context.

Clinical Use and Indications

Dexamethasone, the active ingredient in HEXADROL, is a versatile corticosteroid with a broad spectrum of anti-inflammatory activity. It is used to treat various conditions such as rheumatoid arthritis, asthma, and certain types of cancer, including multiple myeloma[1][2].

Market Competition

The corticosteroid market is highly competitive, with multiple generic and branded options available. Dexamethasone, being a generic drug, faces competition from other corticosteroids and alternative treatments. The level of competition can significantly impact the pricing and market share of HEXADROL.

Pricing Trends

Generic drug prices, including those of dexamethasone, are influenced by market competition levels. Studies have shown that higher levels of competition (e.g., quadropoly or duopoly markets) are associated with lower prices, while lower competition levels (e.g., near-monopoly or monopoly markets) can lead to significant price increases[3].

Financial Implications

For patients and healthcare systems, the financial implications of treating conditions with HEXADROL can be substantial. Despite being a generic drug, which generally reduces costs, the overall treatment regimen, especially in complex conditions like multiple myeloma, can be expensive. For instance, combination therapies involving dexamethasone, such as those with lenalidomide and bortezomib, have shown high response rates but also come with significant costs[2].

Market Size and Growth

The market for corticosteroids, including dexamethasone, is substantial and continues to grow due to the prevalence of inflammatory and autoimmune diseases. However, the specific market size and growth rate for HEXADROL would depend on various factors, including the overall demand for corticosteroids, competition from other drugs, and pricing strategies.

Regulatory Environment

Regulatory factors play a crucial role in the market dynamics of pharmaceuticals. Changes in regulatory policies, such as those related to generic drug approvals and pricing controls, can impact the financial trajectory of HEXADROL. For example, increased scrutiny on generic drug pricing could lead to more competitive pricing and potentially lower revenues for manufacturers.

Patient and Healthcare System Impact

The use of HEXADROL can have significant implications for patients and healthcare systems. On one hand, it offers effective treatment for various conditions, improving patient outcomes. On the other hand, the potential for adverse effects, such as increased risk of infections and metabolic changes, necessitates careful monitoring and management, which can add to healthcare costs[1].

Adverse Events and Monitoring

The management of adverse events associated with HEXADROL is crucial for maintaining patient safety and controlling healthcare costs. Monitoring for infections, reactivation of latent tuberculosis, and other side effects is essential to prevent complications that could increase treatment costs and impact the financial trajectory of the drug[1].

Combination Therapies

Dexamethasone is often used in combination with other drugs, such as lenalidomide and bortezomib, for treating conditions like multiple myeloma. These combination therapies have shown improved response rates and survival outcomes but also increase the overall cost of treatment. The financial success of HEXADROL in these regimens depends on the efficacy, safety, and cost-effectiveness of the combination therapy as a whole[2].

Economic Analysis

Economic analyses of treatment regimens involving HEXADROL are critical for understanding its financial trajectory. These analyses consider factors such as the cost of the drug, hospitalization costs, outpatient care, and the impact of adverse events on overall healthcare expenditure.

Future Outlook

The future outlook for HEXADROL is influenced by several factors, including advancements in medical research, changes in regulatory policies, and shifts in market competition. As new treatments emerge, the role of dexamethasone in clinical practice may evolve, potentially affecting its market share and financial performance.

Key Takeaways

  • Clinical Versatility: HEXADROL is used in a wide range of medical conditions, making it a valuable drug in various therapeutic areas.
  • Market Competition: The level of competition in the corticosteroid market significantly impacts the pricing and market share of HEXADROL.
  • Pricing Trends: Higher competition levels are associated with lower prices, while lower competition can lead to price increases.
  • Financial Implications: The overall cost of treatment regimens involving HEXADROL can be substantial, especially in complex conditions.
  • Regulatory Environment: Changes in regulatory policies can affect the financial trajectory of HEXADROL.
  • Patient and Healthcare System Impact: Effective management of HEXADROL is crucial for patient safety and controlling healthcare costs.

FAQs

  1. What is HEXADROL used for? HEXADROL (dexamethasone) is used to treat various inflammatory and autoimmune conditions, including rheumatoid arthritis, asthma, and certain types of cancer.

  2. How does market competition affect the price of HEXADROL? Higher levels of competition are associated with lower prices, while lower competition levels can lead to significant price increases.

  3. What are the potential adverse effects of HEXADROL? HEXADROL can exacerbate systemic fungal infections, reactivate latent tuberculosis, and cause other side effects such as increased intracranial pressure, menstrual irregularities, and metabolic changes.

  4. How is HEXADROL used in combination therapies? HEXADROL is often used in combination with other drugs, such as lenalidomide and bortezomib, for treating conditions like multiple myeloma.

  5. What factors influence the future outlook for HEXADROL? The future outlook for HEXADROL is influenced by advancements in medical research, changes in regulatory policies, and shifts in market competition.

Sources

  1. HEXADROL® - accessdata.fda.gov
  2. pan-Canadian Oncology Drug Review Initial Clinical Guidance ... - cda-amc.ca
  3. High Generic Drug Prices and Market Competition - PubMed
  4. Hemophagocytic Lymphohistiocytosis Treatment Market Size Share ... - DataM Intelligence
  5. i January 12, 2021 Martha Kruhm, MS, RAC Head, Protocol and ... - clinicaltrials.gov

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