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Last Updated: December 22, 2024

Testolactone - Generic Drug Details


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What are the generic drug sources for testolactone and what is the scope of patent protection?

Testolactone is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for testolactone.

Summary for testolactone
Recent Clinical Trials for testolactone

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

SponsorPhase
Swiss Group for Clinical Cancer ResearchPhase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2

See all testolactone clinical trials

Medical Subject Heading (MeSH) Categories for testolactone

US Patents and Regulatory Information for testolactone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb TESLAC testolactone INJECTABLE;INJECTION 016119-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb TESLAC testolactone TABLET;ORAL 016118-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb TESLAC testolactone TABLET;ORAL 016118-001 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

Testolactone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testolactone

Introduction to Testolactone

Testolactone is an antineoplastic agent derived from progesterone, primarily used in the treatment of advanced breast cancer. It falls under the category of aromatase inhibitors, which are crucial in managing hormone-sensitive cancers.

Market Overview of Aromatase Inhibitors

The global aromatase inhibitors drug market, which includes testolactone, is projected to grow significantly. Here are some key points:

  • Market Size and Growth: The aromatase inhibitors drug market is expected to reach USD 532.04 million by 2030, growing at a CAGR of 5.1% from 2024 to 2030[1].
  • Regional Dominance: North America holds the largest market share, driven by rising health awareness and increased healthcare expenditure. Europe also contributes significantly due to extensive research and development in aromatase inhibitors[1].

Role of Testolactone in the Market

Clinical Use

Testolactone is used specifically for treating advanced breast cancer, particularly in cases where other treatments have failed. Its efficacy in reducing estrogen levels makes it a valuable option in the arsenal against hormone-sensitive cancers[3].

Market Segmentation

The aromatase inhibitors market is segmented by product, with testolactone being one of the key drugs alongside letrozole, exemestane, and anastrozole. Each of these drugs has its own market share and growth trajectory[1].

Drivers of Market Growth

Increasing Prevalence of Breast Cancer

The rising cases of breast cancer in postmenopausal women are a significant driver for the aromatase inhibitors market, including testolactone. As the global population ages, the incidence of breast cancer is expected to increase, thereby boosting demand for these drugs[1].

Research and Development

Major pharmaceutical companies are investing heavily in research and development of aromatase inhibitors. This continuous innovation is expected to improve the efficacy and safety of these drugs, further driving market growth[1].

Strategic Alliances and Mergers

The market is also driven by strategic alliances and mergers among pharmaceutical companies. These collaborations facilitate the sharing of resources, expertise, and risk, leading to more rapid development and commercialization of new drugs[1].

Financial Trajectory

Revenue Impact

The COVID-19 pandemic had a mixed impact on the sales revenue of market leaders and followers. Initially, there was a decline in prescriptions due to lockdowns and healthcare system overload, but the market rebounded as healthcare systems adapted and telemedicine became more prevalent[1].

Regional Financial Performance

  • North America: This region dominates the market with the largest share, driven by high healthcare expenditure and awareness about breast cancer.
  • Europe: Significant contributions from Europe are due to robust research and development activities.
  • Asia Pacific: Emerging economies like China, Japan, India, and Korea are expected to drive growth in this region due to a large patient population and increasing awareness about breast cancer[1].

Competitive Landscape

Key Players

Major players in the aromatase inhibitors market include Novartis AG, Bristol-Myers Squibb and Company, AstraZeneca, Pfizer, Inc., and ANI Pharmaceuticals, Inc. These companies are focusing on clinical collaborations and commercial expansions to tap into various market opportunities[1].

Small Players and Biosimilars

Small players are entering the market by launching biosimilar products, particularly in emerging economies. This strategy helps in meeting the increasing demand for affordable and effective medications[1].

Regulatory Environment

Government Regulations

The market is subject to stringent governmental regulations, which can be challenging for small players. Regulatory approvals and special designations for novel drugs can significantly boost market growth by providing a competitive edge to innovators[1].

Future Outlook

Emerging Markets

Untapped geographies with a high undiagnosed patient base offer lucrative opportunities for innovators. The market in Latin America, for instance, is expected to grow exponentially due to increasing awareness about breast cancer[1].

Technological Advancements

Advancements in drug development, such as improved molecular dynamics and protein-ligand interaction studies, are expected to enhance the efficacy and safety of aromatase inhibitors like testolactone[2].

Key Takeaways

  • The aromatase inhibitors market, including testolactone, is growing at a CAGR of 5.1% from 2024 to 2030.
  • North America and Europe are the dominant regions, with Asia Pacific and Latin America showing significant growth potential.
  • Increasing prevalence of breast cancer, research and development, and strategic alliances are key drivers of market growth.
  • Major pharmaceutical companies are leading the market, while small players are leveraging biosimilars to compete.
  • Stringent regulations and emerging markets present both challenges and opportunities for the future.

FAQs

What is the primary use of testolactone?

Testolactone is primarily used in the treatment of advanced breast cancer, particularly in cases where other treatments have failed.

Which region dominates the aromatase inhibitors market?

North America holds the largest market share in the aromatase inhibitors market.

What is the expected CAGR of the aromatase inhibitors market from 2024 to 2030?

The aromatase inhibitors market is expected to grow at a CAGR of 5.1% from 2024 to 2030.

Who are the major players in the aromatase inhibitors market?

Major players include Novartis AG, Bristol-Myers Squibb and Company, AstraZeneca, Pfizer, Inc., and ANI Pharmaceuticals, Inc.

How do small players compete in the aromatase inhibitors market?

Small players compete by launching biosimilar products, especially in emerging economies.

Sources

  1. Maximize Market Research: "Aromatase Inhibitors Drug Market- Global Industry Analysis, Market Size, Share, Trends, Application Analysis, Growth and Forecast 2024-2030"
  2. ACS Publications: "Comprehensive and Automated Linear Interaction Energy Based Method for Protein–Ligand Binding Affinity Prediction"
  3. PubChem: "Testolactone | C19H24O3 | CID 13769"
  4. DEA Diversion Control Division: "IQVIA Report on Stimulant Trends from 2012-2022"
  5. London School of Economics: "The Role of Funding and Policies on Innovation in Cancer Drug Development"

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