ANASTROZOLE - Generic Drug Details

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

Anastrozole is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex Inc, Beijing Yiling, Chartwell Molecular, Chartwell Rx, Cipla, Eugia Pharma, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Natco Pharma Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, Zydus Pharms Usa Inc, and Ani Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for anastrozole. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ANASTROZOLE

US Patents:	0
Tradenames:	2
Applicants:	20
NDAs:	20
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	316
Patent Applications:	7,080
Drug Prices:	Drug price trends for ANASTROZOLE
Drug Sales Revenues:	Drug sales revenues for ANASTROZOLE
What excipients (inactive ingredients) are in ANASTROZOLE?	ANASTROZOLE excipients list
DailyMed Link:	ANASTROZOLE at DailyMed

See drug prices for ANASTROZOLE

See drug sales revenues for ANASTROZOLE

Recent Clinical Trials for ANASTROZOLE

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
University of Wisconsin, Madison	Phase 2
Verastem, Inc.	Phase 3

See all ANASTROZOLE clinical trials

Generic filers with tentative approvals for ANASTROZOLE

Applicant	Application No.	Strength	Dosage Form
		1MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ANASTROZOLE

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ANASTROZOLE

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

US Patents and Regulatory Information for ANASTROZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	ANASTROZOLE	anastrozole	TABLET;ORAL	091177-001	Jul 15, 2011		DISCN	No	No
Sandoz	ANASTROZOLE	anastrozole	TABLET;ORAL	079007-001	Jun 28, 2010		DISCN	No	No
Chartwell Molecular	ANASTROZOLE	anastrozole	TABLET;ORAL	091331-001	Jan 5, 2011		DISCN	No	No
Norvium Bioscience	ANASTROZOLE	anastrozole	TABLET;ORAL	091051-001	Jun 28, 2010		DISCN	No	No
Watson Labs Teva	ANASTROZOLE	anastrozole	TABLET;ORAL	078984-001	Jun 28, 2010		DISCN	No	No

Expired US Patents for ANASTROZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995

ANASTROZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Anastrozole

Introduction to Anastrozole

Anastrozole, commonly known by the brand name Arimidex, is an aromatase inhibitor used primarily in the treatment of hormone receptor-positive breast cancer, particularly in postmenopausal women. It works by reducing estrogen levels, thereby slowing or stopping the growth of estrogen-dependent breast cancers.

Market Value and Forecast

The global Anastrozole tablets market has been experiencing significant growth. As of 2023, the market was valued at approximately $X billion and is expected to grow at a compound annual growth rate (CAGR) of X% over the next five years. This growth is driven by advancements in cancer treatment protocols and an increasing patient population[1][4].

Prevalence of Hormone Receptor-Positive Breast Cancer

A key driver of the Anastrozole market is the high prevalence of hormone receptor-positive breast cancer, which accounts for around 70% of all breast cancer cases globally. This widespread incidence underscores the critical role of Anastrozole in breast cancer management[1].

New Formulations and Combination Therapies

Recent developments in the Anastrozole market include the introduction of new formulations and combination therapies. These innovations enhance the efficacy of Anastrozole, with clinical trials showing promising results when Anastrozole is combined with other targeted therapies. Such advancements are crucial for expanding treatment options and improving patient outcomes[1].

Personalized Medicine

Advances in personalized medicine are also influencing the market. Tailoring treatment plans based on genetic and molecular profiling helps optimize Anastrozole therapy, leading to better patient outcomes and potentially expanding its market share. This personalized approach ensures that patients receive the most effective treatment based on their specific genetic profiles[1].

Regulatory Approvals and Expansions

Regulatory approvals for new indications and extended use of Anastrozole have broadened its therapeutic applications, contributing to market growth. These approvals reflect ongoing research and the evolving role of Anastrozole in breast cancer management, making it a cornerstone of treatment protocols[1].

Geographical Market Trends

The Asia Pacific region is expected to be the fastest-growing segment of the Anastrozole market during the forecast period. This growth is driven by rising rates of breast cancer due to rapid urbanization and the adoption of Western lifestyles, especially in countries like China and India. Government measures to increase healthcare affordability and accessibility also contribute to market expansion in this region[4].

Key Market Players

The Anastrozole market is dominated by several major pharmaceutical companies, including Zydus Pharmaceuticals, Inc., Hikma Pharmaceuticals PLC, NATCO Pharma Limited, Fresenius Kabi USA, Dr. Reddy’s Laboratories Ltd., Sun Pharmaceutical Industries Ltd., AstraZeneca, Teva Pharmaceutical Industries Ltd., and Aurobindo Pharma. These companies are driving innovation and market growth through strategic partnerships, new launches, and expanded product lines[4].

Financial Performance and Growth Prospects

The financial trajectory of the Anastrozole market is promising, with significant growth prospects driven by the increasing prevalence of hormone receptor-positive breast cancer and advancements in treatment strategies. Pharmaceutical companies can explore opportunities in emerging markets and form strategic partnerships to enhance market presence and drive growth. The market’s growth potential is further supported by ongoing research and development efforts[1][4].

Strategic Partnerships and Collaborations

Collaborations between pharmaceutical companies, research institutions, and healthcare providers are essential for advancing Anastrozole’s applications and driving innovation. These partnerships facilitate research and development efforts, leading to new therapeutic options and market expansion. Recent launches of Anastrozole in novel formulations and combination therapies have expanded treatment options for patients, reflecting ongoing innovation in the field[1].

Market Segmentation

The Anastrozole market is segmented by product type, distribution channel, and region. Key segments include retail pharmacies, online pharmacies, and hospital pharmacies. Understanding these segments helps in tailoring marketing strategies and ensuring better market penetration[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Anastrozole market. While there were initial disruptions in supply chains and healthcare services, the pandemic also accelerated the adoption of telemedicine and online pharmacies, which has benefited the market. The pandemic's influence on consumer behavior and healthcare access has been a significant factor in market dynamics[4].

Pricing Trends and Average Selling Prices

Pricing trends and average selling prices (ASPs) play a crucial role in the Anastrozole market. The competition among major players and the availability of generic versions of Anastrozole have influenced pricing strategies. Affordable choices provided by generic manufacturers have expanded market access, especially in emerging economies[4].

Regional Dominance

North America currently dominates the Anastrozole market with an active share of 48%. This dominance is due to high healthcare spending, advanced cancer treatment protocols, and a large patient population. However, the Asia Pacific region is expected to grow rapidly, driven by increasing healthcare affordability and accessibility[4].

Key Takeaways

• The global Anastrozole market is growing due to the increasing incidence of hormone receptor-positive breast cancer and advancements in treatment strategies.
• New formulations, combination therapies, and personalized medicine are driving market growth.
• Regulatory approvals and strategic partnerships are key factors in expanding Anastrozole’s therapeutic applications.
• The Asia Pacific region is expected to be the fastest-growing segment during the forecast period.
• Major pharmaceutical companies are driving innovation and market growth through new launches and partnerships.

Frequently Asked Questions

1. What is Anastrozole used for?

Anastrozole is used to treat hormone receptor-positive breast cancer, particularly in postmenopausal women, by reducing estrogen levels and preventing cancer progression[1][4].

2. What are the key drivers of the Anastrozole market?

Key drivers include the high prevalence of hormone receptor-positive breast cancer, advancements in treatment protocols, new formulations and combination therapies, and regulatory approvals for expanded indications[1][4].

3. Which region is expected to be the fastest-growing segment of the Anastrozole market?

The Asia Pacific region is expected to be the fastest-growing segment, driven by rising rates of breast cancer and government measures to increase healthcare affordability and accessibility[4].

4. Who are the major players in the Anastrozole market?

Major players include Zydus Pharmaceuticals, Inc., Hikma Pharmaceuticals PLC, NATCO Pharma Limited, Fresenius Kabi USA, Dr. Reddy’s Laboratories Ltd., Sun Pharmaceutical Industries Ltd., AstraZeneca, Teva Pharmaceutical Industries Ltd., and Aurobindo Pharma[4].

5. How has the COVID-19 pandemic impacted the Anastrozole market?

The pandemic has had a mixed impact, with initial disruptions in supply chains and healthcare services, but also accelerating the adoption of telemedicine and online pharmacies, which has benefited the market[4].

Cited Sources:

1. Market Research Intellect, "Anastrozole Tablets Market Surges as New Cancer Treatment Strategies Take Center Stage," September 18, 2024.
2. AstraZeneca, "Full year and Q4 2022 results announcement," February 9, 2023.
3. Maximize Market Research, "Aromatase Inhibitors Drug Market - Global Industry Analysis, Market Size, Share, Growth, Trends, and Forecast 2024-2030."
4. We Market Research, "Anastrozole Market Growth, Share, Segmentation and Trends 2024-2034."
5. Cancer Treatment Reviews, "The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information," July 31, 2021.