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Last Updated: December 24, 2024

Paramethasone acetate - Generic Drug Details


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

Paramethasone acetate is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for paramethasone acetate.

Summary for paramethasone acetate
Recent Clinical Trials for paramethasone acetate

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SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

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Medical Subject Heading (MeSH) Categories for paramethasone acetate

US Patents and Regulatory Information for paramethasone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-005 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

Expired US Patents for paramethasone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-005 Approved Prior to Jan 1, 1982 3,499,016 ⤷  Subscribe
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-006 Approved Prior to Jan 1, 1982 3,499,016 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Paramethasone acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paramethasone Acetate

Introduction

Paramethasone acetate, a synthetic glucocorticoid corticosteroid, has been a part of the pharmaceutical landscape since its approval in 1982. This article delves into the market dynamics and financial trajectory of this drug, exploring its uses, market trends, and the factors influencing its economic performance.

Pharmacological Profile and Uses

Paramethasone acetate is the acetate ester of paramethasone, a glucocorticoid with properties similar to other corticosteroids. It is used in the treatment of various conditions where corticosteroid therapy is indicated, excluding adrenal-deficiency states due to its lack of sodium-retaining properties[1][4][5].

Market Demand and Trends

The demand for glucocorticoids like paramethasone acetate is driven by the prevalence of inflammatory and autoimmune diseases. These conditions, such as rheumatoid arthritis, asthma, and skin allergies, are increasingly common, contributing to a steady demand for corticosteroid treatments.

Growing Prevalence of Chronic Diseases

The rising incidence of chronic inflammatory diseases has been a significant factor in the sustained demand for corticosteroids. For instance, rheumatoid arthritis affects millions worldwide, and the use of glucocorticoids like paramethasone acetate remains a cornerstone in its management.

Advancements in Healthcare

Improvements in healthcare infrastructure and access to medical services have also boosted the market for paramethasone acetate. In regions with better healthcare systems, the diagnosis and treatment of conditions requiring corticosteroids are more prevalent, driving market growth.

Competitive Landscape

The corticosteroid market is highly competitive, with numerous drugs available for various indications. Paramethasone acetate competes with other glucocorticoids such as prednisolone and hydrocortisone.

Generic and Branded Competition

The availability of generic versions of corticosteroids has impacted the market dynamics of branded drugs like paramethasone acetate. Generic alternatives often offer cost savings, which can attract price-sensitive consumers and healthcare providers.

Innovative Formulations

The development of new formulations and delivery systems (e.g., topical creams, inhalers) has also influenced the market. These innovations can enhance patient compliance and efficacy, potentially shifting market share towards newer products.

Financial Performance

The financial trajectory of paramethasone acetate is influenced by several factors, including sales volume, pricing strategies, and regulatory environments.

Sales and Revenue

Historically, paramethasone acetate has generated significant revenue due to its widespread use in treating various inflammatory conditions. However, the revenue has been somewhat stable or slightly declining in recent years due to the rise of generic competitors and newer therapeutic options.

Pricing Strategies

Pricing is a critical factor in the pharmaceutical industry. The cost of paramethasone acetate can vary significantly across different regions and markets. In some countries, government regulations and price controls can impact the profitability of the drug.

Regulatory Environment

Regulatory approvals and compliance are essential for the continued market presence of paramethasone acetate. Changes in regulatory requirements or the introduction of new safety guidelines can affect the drug's financial performance.

Clinical Trials and Research

While paramethasone acetate has been on the market for several decades, ongoing clinical trials and research are crucial for its continued relevance.

Expanding Indications

Research into new indications for paramethasone acetate can expand its market potential. For example, studies exploring its use in ocular conditions or other specialized areas could increase its demand[2].

Safety and Efficacy Studies

Continuous monitoring of the drug's safety and efficacy profile is essential. Positive outcomes from these studies can reinforce its position in the market, while adverse findings could lead to decreased usage.

Pharmacoeconomics

The pharmacoeconomic aspects of paramethasone acetate are vital in understanding its market dynamics.

Cost-Effectiveness

The cost-effectiveness of paramethasone acetate compared to other corticosteroids is a significant factor. Healthcare providers and payers often prefer treatments that offer a favorable balance between efficacy and cost.

Patient Access and Affordability

Patient access and affordability are critical in determining the drug's market success. In regions with limited healthcare resources, the availability of affordable generic alternatives can significantly impact the market share of branded drugs like paramethasone acetate.

Adverse Effects and Safety Profile

The safety profile of paramethasone acetate, including its adverse effects, plays a crucial role in its market dynamics.

Common Adverse Effects

Paramethasone acetate is associated with typical glucocorticoid side effects such as inhibition of bone formation, suppression of calcium absorption, delayed wound healing, immune suppression, and hyperglycemia. These side effects can influence patient and prescriber preferences[1].

Black Box Warnings

Any black box warnings or significant safety concerns can drastically impact the drug's market performance. For paramethasone acetate, the absence of such warnings has helped maintain its position in the market.

Market Projections

Given the current trends, here are some projections for the market dynamics and financial trajectory of paramethasone acetate:

Stable Demand

The demand for paramethasone acetate is expected to remain stable due to the ongoing need for corticosteroid treatments in various inflammatory and autoimmune conditions.

Competitive Pressures

The market will continue to face competitive pressures from generic alternatives and newer therapeutic options. This competition may lead to pricing pressures and potentially reduced revenue.

Regulatory Compliance

Adherence to evolving regulatory requirements will be crucial for maintaining market presence. Non-compliance could result in significant financial penalties and market exclusion.

Key Takeaways

  • Stable Demand: The ongoing need for corticosteroid treatments ensures a stable demand for paramethasone acetate.
  • Competitive Landscape: The market is highly competitive, with generic alternatives and newer formulations impacting market share.
  • Regulatory Environment: Compliance with regulatory requirements is essential for maintaining market presence.
  • Pharmacoeconomics: Cost-effectiveness and patient access are critical factors influencing the drug's market success.
  • Safety Profile: The drug's safety profile, including adverse effects, continues to be a significant factor in its market dynamics.

FAQs

What is paramethasone acetate used for?

Paramethasone acetate is used in the treatment of various conditions where corticosteroid therapy is indicated, excluding adrenal-deficiency states[1][4][5].

What are the common adverse effects of paramethasone acetate?

Common adverse effects include inhibition of bone formation, suppression of calcium absorption, delayed wound healing, immune suppression, and hyperglycemia[1].

How does paramethasone acetate compare to other corticosteroids?

Paramethasone acetate competes with other glucocorticoids such as prednisolone and hydrocortisone. Its lack of sodium-retaining properties makes it less suitable for adrenal-deficiency states compared to hydrocortisone[1].

What are the market projections for paramethasone acetate?

The demand is expected to remain stable, but the market will face competitive pressures from generic alternatives and newer therapeutic options, potentially leading to pricing pressures and reduced revenue.

How does the regulatory environment impact paramethasone acetate?

Adherence to evolving regulatory requirements is crucial for maintaining market presence. Non-compliance could result in significant financial penalties and market exclusion.

References

  1. DrugBank: Paramethasone - Uses, Interactions, Mechanism of Action.
  2. Google Patents: Methods and devices for the treatment of ocular conditions.
  3. PubChem: Paramethasone Acetate | C24H31FO6 | CID 443928.
  4. DrugBank: Paramethasone acetate - Uses, Interactions, Mechanism of Action.
  5. Wikipedia: Paramethasone acetate.

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