EXEMESTANE - Generic Drug Details

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

Exemestane is the generic ingredient in two branded drugs marketed by Pfizer, Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for exemestane. Thirteen suppliers are listed for this compound.

Summary for EXEMESTANE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	254
Patent Applications:	5,922
Drug Prices:	Drug price trends for EXEMESTANE
What excipients (inactive ingredients) are in EXEMESTANE?	EXEMESTANE excipients list
DailyMed Link:	EXEMESTANE at DailyMed

See drug prices for EXEMESTANE

Recent Clinical Trials for EXEMESTANE

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
QuantumLeap Healthcare Collaborative	Phase 2
NRG Oncology	Phase 2

See all EXEMESTANE clinical trials

Pharmacology for EXEMESTANE

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EXEMESTANE

L02BG	Aromatase inhibitors
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for EXEMESTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	EXEMESTANE	exemestane	TABLET;ORAL	208764-001	Aug 8, 2019		DISCN	No	No
Alvogen	EXEMESTANE	exemestane	TABLET;ORAL	200898-001	Jul 28, 2014		DISCN	No	No
Amneal Pharms	EXEMESTANE	exemestane	TABLET;ORAL	206421-001	Dec 28, 2018		DISCN	No	No
Zydus Pharms	EXEMESTANE	exemestane	TABLET;ORAL	202602-001	Oct 3, 2018	AB	RX	No	No
Rising	EXEMESTANE	exemestane	TABLET;ORAL	203315-001	Mar 10, 2017	AB	RX	No	No
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	AB	RX	Yes	Yes

Expired US Patents for EXEMESTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999

EXEMESTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Exemestane

Introduction to Exemestane

Exemestane, marketed under the brand name Aromasin among others, is a crucial medication in the treatment of breast cancer, particularly for postmenopausal women with hormone-receptor-positive breast cancer. It functions as an aromatase inhibitor, reducing estrogen levels in the body, which in turn slows the progression of the cancer.

Market Drivers

Several factors are driving the growth of the exemestane market:

Increasing Awareness and Advancements in Oncology

The rising awareness about cancer treatment options and advancements in oncology are significant drivers. As more people become informed about the available treatments, the demand for effective medications like exemestane increases[1].

Growing Focus on Women's Health

The global focus on women's health issues, particularly breast cancer, contributes to the market growth. Initiatives and campaigns aimed at early detection and treatment of breast cancer have led to an increased use of exemestane[1].

Clinical Trial Results

Clinical trials have shown promising results for exemestane. For instance, studies like the Intergroup Exemestane Study (IES) and the Tamoxifen, Exemestane, Adjuvant, Multicenter (TEAM) Study have demonstrated a 19% reduction in the risk of breast cancer recurrence when patients switch to exemestane after 2.5 years of tamoxifen[2].

Market Restraints

Despite the positive trends, there are several challenges that could hinder the market growth:

High Treatment Costs

The cost of exemestane can be prohibitive for many patients. Factors such as treatment plans, insurance coverage, and pharmacy prices influence the final cost, making it expensive for some individuals[4].

Potential Side Effects

Exemestane is associated with side effects such as osteoporosis and menopause-like symptoms, which can deter some patients from using the medication. These side effects need to be managed carefully to ensure patient adherence[1].

Regulatory Requirements

Strict regulatory requirements for pharmaceuticals add to the development costs and timeframes, posing barriers to market entry for new players. Compliance with these regulations is crucial but can be challenging[1].

Market Opportunities

The exemestane market presents several opportunities for growth:

Emerging Markets

There is significant potential in emerging markets where healthcare infrastructure is improving, and awareness about cancer is increasing. Expanding into these markets can help increase the global market share of exemestane[1].

Combination Therapies

Research into combination therapies that enhance the efficacy of exemestane or reduce its side effects can broaden its appeal and usability. This innovative approach could lead to new treatment protocols and increased market penetration[1].

E-Prescriptions and Digital Health

The implementation of e-prescriptions can streamline access to exemestane, improving convenience and adherence. This digital transformation in healthcare can make the medication more accessible to a wider patient base[1].

Market Segmentation

The exemestane market is segmented based on several key factors:

Application

The primary application of exemestane is in the treatment of breast cancer, particularly in postmenopausal women. It is also used in preventive measures for high-risk patients[1].

Dosage Strength

Exemestane is available in various dosage strengths, including 25 mg, 35 mg, and 50 mg tablets. The choice of dosage depends on the patient's specific needs and treatment plan[1].

Distribution Channel

The distribution channels include healthcare facilities such as hospitals, specialty clinics, and cancer treatment centers. These channels ensure that the medication is administered under medical supervision[1].

Geographical Regions

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics and growth prospects[3].

Financial Trajectory

Market Size and Growth

The global exemestane market is anticipated to grow at a significant rate. The market size is projected to increase from 2024 to 2031, driven by the factors mentioned above. The compound annual growth rate (CAGR) is expected to be substantial during this period[5].

Revenue and Forecast

The revenue forecast for the exemestane market indicates a steady increase. The market is valued in USD million and is segmented based on application, product, and geographical regions. The report provides detailed data on market size, revenue share, and forecasted growth[5].

Competitive Assessment

The competitive landscape of the exemestane market is analyzed in detail. Key players are assessed based on their market share, strategic approaches, product range, certifications, regulatory approvals, and technological developments. This analysis helps in understanding the competitive dynamics and identifying opportunities for new entrants[1].

PESTLE Analysis

A PESTLE analysis provides a comprehensive view of the external macro-environmental factors affecting the exemestane market:

Political Factors

Regulatory policies and government initiatives play a crucial role in shaping the market. Changes in healthcare policies and reimbursement schemes can impact the market significantly[1].

Economic Factors

Economic conditions, including healthcare spending and insurance coverage, influence the demand for exemestane. The cost of the medication and the overall economic stability of regions also affect market growth[1].

Social Factors

Social awareness about breast cancer and women's health issues drives the demand for exemestane. Cultural attitudes towards healthcare and the availability of healthcare services also impact the market[1].

Technological Factors

Advancements in technology, such as digital health solutions and new manufacturing techniques, can enhance the efficacy and accessibility of exemestane. Research and development in combination therapies also fall under this category[1].

Legal Factors

Legal requirements, including patent laws and regulatory approvals, are critical for the development and marketing of exemestane. Compliance with these laws is essential for market entry and sustainability[1].

Environmental Factors

Environmental factors, though less direct, can influence the production and distribution of exemestane. Sustainability initiatives and environmental regulations can impact the manufacturing process and supply chain[1].

Key Takeaways

• Increasing Demand: The demand for exemestane is driven by increasing awareness about breast cancer treatment and advancements in oncology.
• Clinical Efficacy: Clinical trials have shown significant benefits of exemestane in reducing breast cancer recurrence.
• Market Opportunities: Emerging markets and combination therapies offer significant growth opportunities.
• Challenges: High treatment costs, potential side effects, and strict regulatory requirements are key challenges.
• Financial Growth: The market is expected to grow substantially from 2024 to 2031, driven by increasing revenue and expanding market segments.

FAQs

What is the primary use of exemestane?

Exemestane is primarily used in the treatment of breast cancer, particularly for postmenopausal women with hormone-receptor-positive breast cancer.

What are the key drivers of the exemestane market?

The key drivers include increasing awareness about cancer treatment options, advancements in oncology, and the growing focus on women's health issues.

What are the potential side effects of exemestane?

Potential side effects include osteoporosis and menopause-like symptoms.

How does the cost of exemestane compare to other breast cancer medications?

Exemestane can be more expensive than some medications like letrozole but is generally less expensive than others like Kisqali or Ibrance[4].

What are the opportunities for growth in the exemestane market?

Opportunities lie in emerging markets, combination therapies, and the implementation of e-prescriptions to streamline access to the medication.

Sources

1. 360iResearch: Exemestane Tablets Market Size & Share 2025-2030.
2. Pfizer: Pfizer Announces Updated Trial Results for AROMASIN® (exemestane tablets) In Switch And Upfront Settings.
3. Cognitive Market Research: Exemestane Market Report 2024 (Global Edition).
4. Medical News Today: Exemestane cost 2024: Coupons and more.
5. Market Research Intellect: Global exemestane market size and forecast.