ARIMIDEX Drug Patent Profile

Which patents cover Arimidex, and what generic alternatives are available?

Arimidex is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in ARIMIDEX is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arimidex

A generic version of ARIMIDEX was approved as anastrozole by ACCORD HLTHCARE on June 28^th, 2010.

Summary for ARIMIDEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	152
Drug Prices:	Drug price information for ARIMIDEX
What excipients (inactive ingredients) are in ARIMIDEX?	ARIMIDEX excipients list
DailyMed Link:	ARIMIDEX at DailyMed

See drug prices for ARIMIDEX

Recent Clinical Trials for ARIMIDEX

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

Sponsor	Phase
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
European Network of Gynaecological Oncological Trial Groups (ENGOT)	Phase 3

See all ARIMIDEX clinical trials

Pharmacology for ARIMIDEX

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

US Patents and Regulatory Information for ARIMIDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	AB	RX	Yes	Yes

Expired US Patents for ARIMIDEX

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

International Patents for ARIMIDEX

See the table below for patents covering ARIMIDEX around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	97804
Canada	1337420	COMPOSES HETEROCYCLIQUES (SUBSTITUES EN ARALKYLE) ((SUBSTITUTED ARALKYL) HETEROCYCLIC COMPOUNDS)
Israel	86499

Supplementary Protection Certificates for ARIMIDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296749	97C0032	Belgium		PRODUCT NAME: ANASTROZOLUM; NAT. REGISTRATION NO/DATE: 624 IS 94 F 3 19961216; FIRST REGISTRATION: GB 12619/0106 19950811
0296749	C970012	Netherlands		PRODUCT NAME: ANASSTROZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; NAT. REGISTRATION NO/DATE: RVG 19123 19960905; FIRST REGISTRATION: GB 12619/0106 19950811
0296749	97C0023	France		PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811

ARIMIDEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Arimidex (Anastrozole)

Market Overview

Arimidex, known generically as anastrozole, is a crucial medication in the treatment of breast cancer, particularly in postmenopausal women with hormone receptor-positive tumors. It belongs to the class of aromatase inhibitors, which reduce estrogen levels by preventing the conversion of androgens to estrogens, thereby slowing or stopping the growth of estrogen-dependent breast cancers[1].

Global Market Growth

The global anastrozole market is anticipated to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. This growth is driven by increasing cases of breast cancer, especially in postmenopausal women, and the rising demand for effective treatments. The market is expected to reach a substantial value by 2034, reflecting an average growth pattern[1].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is projected to be the fastest-growing segment of the anastrozole market. Factors such as rapid urbanization, adoption of Western lifestyles, and increasing healthcare costs in countries like China and India are driving this growth. Government initiatives to enhance healthcare affordability and accessibility further contribute to the market expansion in this region[1].

North America

North America currently dominates the anastrozole market, holding a significant share. This dominance is attributed to high healthcare expenditure and rising health awareness, particularly regarding breast cancer in postmenopausal women[3].

Europe

Europe also plays a substantial role in the anastrozole market, with significant contributions from research and development activities. However, AstraZeneca's divestment of Arimidex rights in several European countries to Juvisé Pharmaceuticals has shifted the market dynamics slightly[4].

Middle East & Africa and South America

The Middle East & Africa and South America regions are also expected to see growth, driven by the increasing prevalence of breast cancer and growing awareness about the disease. These regions offer lucrative opportunities for market expansion due to their large undiagnosed patient bases[1][3].

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.
• Aurobindo Pharma These companies are investing heavily in research, development, and marketing to maintain their market share and expand their reach[1].

Financial Performance

Revenue and Sales

Arimidex has historically generated significant revenue. For instance, in 2018, Arimidex had sales of $37 million in the countries covered by AstraZeneca's divestment agreement with Juvisé Pharmaceuticals[4].

Divestment and Financial Impact

AstraZeneca's decision to divest the rights to Arimidex in several European, African, and other countries to Juvisé Pharmaceuticals was part of its strategy to focus on its pipeline of new medicines. This divestment included an upfront payment of $181 million and potential future sales-contingent payments of up to $17 million. This move did not alter AstraZeneca's financial guidance for 2019 but reallocated resources towards developing new medicines[4].

Market Forecast

The aromatase inhibitors market, which includes anastrozole, is expected to reach USD 532.04 million by 2030, growing at a CAGR of 5.1% during the forecast period. This growth is driven by increasing research and development, rising health awareness, and the growing prevalence of breast cancer[3].

Competitive Landscape

The competitive landscape of the anastrozole market is characterized by intense competition among major pharmaceutical companies. The market is also influenced by generic versions of anastrozole, which provide more affordable choices for patients. Companies like Fresenius Kabi USA and APP Pharmaceuticals have entered the U.S. market with generic anastrozole tablets, further diversifying the market[1][5].

Challenges and Opportunities

Side Effects and Patient Compliance

Anastrozole, like any medication, can have side effects, which may affect patient compliance. Managing these side effects and ensuring proper medical supervision are critical for the effective treatment of breast cancer.

Regulatory Environment

Changes in regulatory environments and patent expirations can significantly impact the market dynamics. For example, the loss of compound patent protection in several countries led to AstraZeneca's divestment of Arimidex rights[4].

Emerging Markets

Emerging economies with large patient populations offer significant opportunities for market growth. Investing in these regions can help companies expand their market share and contribute to the overall growth of the anastrozole market.

Key Takeaways

• The anastrozole market is expected to grow significantly due to increasing cases of breast cancer and rising healthcare expenditure.
• The Asia Pacific region is anticipated to be the fastest-growing segment.
• Major pharmaceutical companies dominate the market, with a focus on research, development, and marketing.
• Divestments and generic entries are shaping the competitive landscape.
• Emerging markets offer lucrative opportunities for growth.

FAQs

Q: What is the primary use of Arimidex (anastrozole)?

A: Arimidex (anastrozole) is primarily used to treat breast cancer in postmenopausal women with hormone receptor-positive tumors.

Q: Which region is expected to be the fastest-growing segment of the anastrozole market?

A: The Asia Pacific region is expected to be the fastest-growing segment of the anastrozole market.

Q: Who are the major players in the anastrozole market?

A: Major players include Zydus Pharmaceuticals, Inc., Hikma Pharmaceuticals PLC, NATCO Pharma Limited, Fresenius Kabi USA, and AstraZeneca, among others.

Q: What was the impact of AstraZeneca's divestment of Arimidex rights?

A: AstraZeneca's divestment of Arimidex rights to Juvisé Pharmaceuticals was part of its strategy to focus on new medicines and included an upfront payment and potential future sales-contingent payments.

Q: What is the forecasted growth rate of the aromatase inhibitors market, which includes anastrozole?

A: The aromatase inhibitors market is expected to grow at a CAGR of 5.1% during the forecast period from 2024 to 2030.

Sources

1. We Market Research, "Anastrozole Market Growth, Share, Segmentation and Trends 2024".
2. AstraZeneca, "Full year and Q4 2022 results".
3. Maximize Market Research, "Aromatase Inhibitors Drug Market- Global Industry Analysis, Market".
4. AstraZeneca, "AstraZeneca divests rights to Arimidex and Casodex in Europe and certain additional countries".
5. Fresenius Kabi, "APP Pharmaceuticals to Market Anastrozole Tablets in the U.S."