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, Pharmobedient, 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-five 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:	25
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	329
Patent Applications:	6,707
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
Novartis	PHASE1
Pfizer	PHASE3
Nagoya City University	PHASE1

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
Cipla	ANASTROZOLE	anastrozole	TABLET;ORAL	091164-001	Jun 28, 2010	AB	RX	No	No
Apotex Inc	ANASTROZOLE	anastrozole	TABLET;ORAL	200654-001	May 11, 2012		DISCN	No	No
Hikma	ANASTROZOLE	anastrozole	TABLET;ORAL	078485-001	Jun 28, 2010		DISCN	No	No
Beijing Yiling	ANASTROZOLE	anastrozole	TABLET;ORAL	206037-001	Nov 9, 2018	AB	RX	No	No
Pharmobedient	ANASTROZOLE	anastrozole	TABLET;ORAL	091051-001	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

Market Dynamics and Financial Trajectory for Anastrozole

Last updated: October 1, 2025

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Introduction

Anastrozole, marketed primarily under the brand name Arimidex, is a selective aromatase inhibitor used predominantly in the treatment of hormone receptor-positive breast cancer in postmenopausal women. Since its FDA approval in 1995, anastrozole has cemented its role within oncology therapeutics, shaping a competitive landscape influenced by evolving treatment guidelines, technological advances, and market forces. This analysis examines the factors influencing its market dynamics and forecasts its financial trajectory over the coming years.

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Market Overview and Existing Therapeutic Context

Anastrozole addresses a significant segment in breast cancer therapy, targeting hormone-sensitive cancers where estrogen deprivation hampers tumor growth. According to the Global Data Report (2022), breast cancer has remained the most diagnosed cancer worldwide, with an increasing prevalence among postmenopausal women globally, especially in developed economies with aging populations.

With the advent of personalized medicine and genomic testing, there has been a shift toward combining anastrozole with other targeted therapies. The standard of care often involves anastrozole as first-line therapy post-surgery, positioning it as a cornerstone in endocrine therapy for hormone receptor-positive breast cancer. The drug's widespread use in both adjuvant and metastatic settings underpins its dominant position within the market.

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Market Drivers

1. Rising Incidence of Breast Cancer
The global increase in breast cancer cases directly boosts demand for anastrozole. The World Health Organization (WHO) reports that breast cancer incidence has doubled over the past three decades, with postmenopausal women constituting the highest risk group. As populations age, the incidence is expected to rise further, igniting sustained demand for hormonal therapies.

2. Favorable Efficacy Profile and Safety
Clinical trials demonstrate that anastrozole's efficacy in reducing recurrence rates surpasses that of tamoxifen in some settings. Its fewer adverse effects, especially related to thromboembolic events, enhance its appeal among clinicians, further cementing its market share.

3. Expanding Indications and Combinations
Recent approvals for extended adjuvant therapy and use in ovarian suppression expand anastrozole's application. Combination regimens involving anastrozole with CDK4/6 inhibitors or targeted agents bolster its therapeutic value, potentially opening new revenue streams.

4. Patent Expiry and Generic Entry
The patent on anastrozole expired in 2003 in the US, leading to the arrival of multiple generic manufacturers that significantly lowered prices and increased accessibility. The transition from brand-name Arimidex to generic versions widened its market penetration, especially in emerging markets.

5. Growing Adoption in Developing Countries
Healthcare infrastructure improvements and increased access to cancer medications in Asia, Latin America, and Africa facilitate heightened consumption. International health organizations’ efforts in cancer awareness and screening contribute to this trend.

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Market Challenges

1. Competition from Alternatives
Tamoxifen remains a viable alternative, especially in premenopausal women, though anastrozole generally outperforms it in postmenopausal settings. Newer aromatase inhibitors such as letrozole and exemestane also compete directly, with some clinical data favoring certain agents over others depending on specific patient profiles.

2. Patent Cliff and Price Sensitivity
While patent expiry in 2003 spurred generic competition, ongoing price erosion continues to pressure profit margins. Gaining access to lower-cost generics in emerging sectors mitigates revenue potential.

3. Emergence of Resistance and Relapse Cases
Understanding mechanisms of resistance limits the drug's long-term utility for some patients. Research into resistance pathways may lead to combination therapies reducing anastrozole's survival advantage in later lines of therapy.

4. Regulatory and Reimbursement Landscape
Healthcare policy shifts, especially in cost-containment initiatives, influence prescribing practices. Variability in reimbursement policies across regions impacts sales volume, particularly in public healthcare systems.

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Financial Trajectory and Future Outlook

Current Market Valuation
The global anastrozole market was valued at approximately USD 950 million in 2022, with projections indicating a compound annual growth rate (CAGR) of around 3.8% through 2030 (ResearchAndMarkets, 2023). While growth is modest compared to blockbuster medications in other domains, consistent demand sustains its revenue streams.

Growth Catalysts
Market expansion hinges on multiple factors: increased adoption in treatment guidelines, expanded indications, and higher penetration in emerging markets. The potential for a new, more potent formulation or combination therapy could further bolster sales.

Impact of Patent Trends and Generics
The bulk of revenue comes from generic sales, which often capture over 80% of volume but at diminished margins. Innovator companies may strategize lifecycle management through new formulations, fixed-dose combinations, or patent extensions on secondary patents to sustain profitability.

Regional Market Dynamics
North America and Europe represent mature markets with stable growth, driven by treatment adherence and standard-of-care protocols. Asia-Pacific exhibits the highest growth potential, fueled by rising breast cancer rates and improving healthcare infrastructure.

Emerging Trends Influencing Market Dynamics
Personalized treatment regimens, biomarkers for endocrine resistance, and combination therapies involving CDK4/6 inhibitors are poised to redefine anastrozole’s role. As clinical trials confirm synergy effects, market share redistribution may ensue.

Revenue Forecasts
By 2030, the anastrozole market is likely to sustain a steady trajectory, with incremental growth reflecting broader adoption and drug innovation. Revenue is expected to approach USD 1.2 billion globally, assuming stable market penetration and ongoing generic competition.

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Strategic Recommendations for Stakeholders

• Pharmaceutical Companies: Invest in biosimilar development and formulation innovation to maintain competitive advantage amid patent expiries.
• Healthcare Providers: Incorporate updated clinical guidelines emphasizing personalized approaches, optimizing anastrozole utilization.
• Policy Makers: Facilitate access through subsidy programs and streamlined approval pathways, especially in emerging markets.
• Investors: Monitor pipeline developments, regulatory changes, and regional penetration strategies to identify growth opportunities.

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Key Takeaways

• Anastrozole remains a critical agent in postmenopausal breast cancer therapy, driven by increasing global incidence and favorable clinical profile.
• Patent expiry and resulting generic competition have compressed margins but broadened access, especially in emerging markets.
• The financial trajectory reflects modest but steady growth, buoyed by expanding indications and regional market penetration.
• Market dynamics are increasingly influenced by personalized medicine, combination therapies, and regional healthcare policies.
• Strategic management of patent cliffs, innovation pipelines, and regional expansion will determine long-term financial stability.

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Frequently Asked Questions

1. What are the primary factors influencing anastrozole's market growth?
Global breast cancer incidence, evolving treatment guidelines favoring aromatase inhibitors, generic availability reducing costs, and expanding use in new indications and regions.

2. How does generic competition impact the profitability of anastrozole?
Patent expiry led to numerous generic entrants, significantly lowering prices and profit margins, although it increased overall market volume and accessibility.

3. Are there notable emerging therapies that could challenge anastrozole's market position?
Yes; newer hormonal agents, targeted therapies, and combination regimens are under clinical development, potentially reshaping the therapeutic landscape.

4. How does regional variation affect anastrozole's sales?
Mature markets like North America and Europe exhibit stable, high-volume sales, whereas emerging markets offer high growth potential due to increasing diagnosis and healthcare expansion.

5. What strategies could pharmaceutical companies employ to extend anastrozole’s commercial lifecycle?
Lifecycle management through new formulations, fixed-dose combinations, secondary patent protections, and expanding indication approvals.

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References

[1] World Health Organization. (2022). Global breast cancer statistics.
[2] ResearchAndMarkets. (2023). Anastrozole Market Analysis and Forecasts, 2023-2030.
[3] Smith, J. et al. (2021). Advances in endocrine therapy for breast cancer. Journal of Clinical Oncology.
[4] FDA. (1995). Approval of Anastrozole for breast cancer.
[5] IMS Health Data. (2022). Market share and regional analysis.

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This comprehensive review provides a strategic foundation for stakeholders seeking to understand the current and projected market dynamics of anastrozole, emphasizing data-driven insights and actionable strategies.