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Last Updated: December 22, 2024

Aminoglutethimide - Generic Drug Details


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

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

Summary for aminoglutethimide
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 111
Clinical Trials: 6
Patent Applications: 6,966
DailyMed Link:aminoglutethimide at DailyMed
Recent Clinical Trials for aminoglutethimide

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

SponsorPhase
Columbia UniversityPhase 2
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all aminoglutethimide clinical trials

Medical Subject Heading (MeSH) Categories for aminoglutethimide

US Patents and Regulatory Information for aminoglutethimide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 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

Expired US Patents for aminoglutethimide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Aminoglutethimide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aminoglutethimide

Introduction to Aminoglutethimide

Aminoglutethimide is an adrenocortical steroid synthesis inhibitor, primarily used in the treatment of Cushing's syndrome, certain types of breast cancer, and occasionally for prostate cancer. It works by blocking the production of adrenal steroids and the conversion of androgens to estrogens[2][5].

Market Size and Growth

The global market for aminoglutethimide, although niche, is part of the broader adrenal corticosteroid inhibitors market. As of 2023, the adrenal corticosteroid inhibitors market was valued at USD 2.49 billion and is projected to grow to USD 5.78 billion by 2030, with a CAGR of 12.75%[3].

Segmentation and Coverage

The market for aminoglutethimide can be segmented based on treatment type, drug type, and geographic regions. The drug is particularly significant in the treatment of Cushing's syndrome and breast cancer, with other potential uses such as prostate carcinoma and low renin hypertension still under investigation[2][5].

Key Market Statistics

  • Base Year (2023): The broader adrenal corticosteroid inhibitors market was valued at USD 2.49 billion.
  • Estimated Year (2024): Expected to reach USD 2.80 billion.
  • Forecast Year (2030): Projected to grow to USD 5.78 billion.
  • CAGR: 12.75% from 2023 to 2030[3].

Market Dynamics

Supply and Demand Factors

The market for aminoglutethimide is influenced by several supply and demand factors. On the demand side, the increasing incidence of Cushing's syndrome and breast cancer drives the need for effective treatments. On the supply side, advancements in pharmaceutical technology and the development of new inhibitors are key drivers[3].

Regulatory Environment

The market faces stringent regulatory environments, which can impact the development and approval of new drugs. Companies must navigate these regulations to ensure compliance and avoid delays in bringing products to market[3].

Competitive Landscape

The competitive landscape is characterized by several key players, including AbbVie Inc., Novartis AG, Pfizer Inc., and others. These companies are investing in research and development to innovate and expand their product portfolios. The market is highly competitive, with companies competing on the basis of product efficacy, safety, and regulatory approvals[3].

Financial Trajectory

Revenue Growth

The revenue growth for aminoglutethimide is tied to the overall growth of the adrenal corticosteroid inhibitors market. With a projected CAGR of 12.75%, the market is expected to see significant revenue growth over the next several years. This growth will be driven by increasing demand for effective treatments and advancements in pharmaceutical technology[3].

Production and Cost Analysis

The production of aminoglutethimide involves several steps, including the synthesis of the drug and its formulation into tablets or other forms. The cost analysis includes the cost of raw materials, manufacturing, and distribution. Companies are focusing on optimizing production processes to reduce costs and improve profitability[1].

Market Share and Competition

The market share of aminoglutethimide is part of the broader market share of adrenal corticosteroid inhibitors. Key manufacturers are competing for market share through innovative products, strategic partnerships, and robust marketing strategies. The competitive landscape is dynamic, with companies constantly seeking to improve their market position[1][3].

Challenges and Opportunities

Challenges

  • Regulatory Hurdles: Stringent regulatory environments pose a significant challenge to the development and approval of new drugs.
  • High Development Costs: The high costs associated with drug development can be a barrier to entry for new companies.
  • Potential Side Effects: The drug's side effects, such as respiratory depression and hypotension, can impact patient compliance and overall market acceptance[2][3].

Opportunities

  • Personalized Medicine: Innovating in personalized medicine by leveraging genetic insights can tailor inhibitor profiles and enhance treatment efficacy.
  • Collaboration and Research: Enhancing collaboration between biotech and pharmaceutical companies can foster significant business growth through cutting-edge research and patient-centric solutions.
  • Emerging Markets: Expanding into emerging markets can provide new revenue streams and growth opportunities[3].

Industry Chain Structure

The industry chain for aminoglutethimide includes upstream raw material suppliers, manufacturers, and downstream distributors. Understanding the industry chain structure is crucial for identifying potential bottlenecks and opportunities for optimization[1].

Economic Impact

The economic impact of the aminoglutethimide market is significant, given its role in treating serious medical conditions. The market's growth contributes to the overall pharmaceutical industry's economic performance and has implications for healthcare spending and patient outcomes[3].

Proposals for New Projects

For new projects in the aminoglutethimide market, several strategies are recommended:

  • Market Entry Strategies: Companies should focus on innovative products and strategic partnerships to enter the market effectively.
  • Countermeasures of Economic Impact: Understanding the economic impact and adapting to regulatory changes can help mitigate risks.
  • Marketing Channels: Effective marketing channels, including digital marketing and patient education programs, can enhance product visibility and adoption[1].

Key Takeaways

  • The aminoglutethimide market is part of the broader adrenal corticosteroid inhibitors market, which is projected to grow significantly.
  • The drug is used primarily for treating Cushing's syndrome and breast cancer.
  • Regulatory hurdles, high development costs, and potential side effects are key challenges.
  • Opportunities exist in personalized medicine, collaboration, and emerging markets.
  • Understanding the industry chain structure and economic impact is crucial for strategic decision-making.

FAQs

What is the primary use of aminoglutethimide?

Aminoglutethimide is primarily used in the treatment of Cushing's syndrome and certain types of breast cancer.

What is the projected growth rate of the adrenal corticosteroid inhibitors market?

The market is projected to grow at a CAGR of 12.75% from 2023 to 2030.

What are the key challenges facing the aminoglutethimide market?

Key challenges include stringent regulatory environments, high costs of drug development, and potential side effects.

Which companies are key players in the aminoglutethimide market?

Key players include AbbVie Inc., Novartis AG, Pfizer Inc., and others.

How does aminoglutethimide work?

Aminoglutethimide blocks the production of adrenal steroids and the conversion of androgens to estrogens by inhibiting cytochrome P-450 mediated steroid hydroxylation steps[2][5].

Cited Sources

  1. Prof-Research: Aminoglutethimide Market Size, Share, Trend and Forecast to 2025.
  2. DrugBank: Aminoglutethimide: Uses, Interactions, Mechanism of Action.
  3. 360iResearch: Adrenal Corticosteroid Inhibitors Market by Drug, Treatment Type.
  4. Global Market Vision: Global Aminoglutethimide Market Recent Trends, In-depth Analysis.
  5. PubMed: Aminoglutethimide: review of pharmacology and clinical use.

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