AstraZeneca Maintains European Product Monopoly for Arimidex (Anastrozole) with the Grant of a Paediatric Extension

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GenericsWeb analyses the patent landscape surrounding Anastrozole, highlighting the need for comprehensive patent information in the development of launch strategies for generic products to minimise the risk of litigation.

GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for Arimidex® (Anastrozole), AstraZeneca's blockbuster drug for the treatment of breast cancer. The article analyses the surrounding patent landscape, highlighting the need for comprehensive, up-to-date information in the development of launch strategies that minimise the cost of litigation and understanding the barriers to launch as to receive the benefits of your generic product being first to market.

Key findings of the article include:

# The term of the European equivalent patent protecting the active ingredient for Arimidex® has been further extended in accordance with article 36(1) of (EC) No. 1901/2006, which allows a 6 months extension to an SPC where appropriate studies have been conducted in accordance with an agreed paediatric investigation plan. The grant of this paediatric extension allows AstraZeneca to maintain product monopoly in some European member states until February 2011.

# A second key family identified protects the use of Anastrozole for reducing recurrence of cancer and of a new contralateral primary tumour in postmenopausal women with early breast cancer, appear to protect at least the indications relating to the use of Anastrozole as an adjuvant treatment of breast cancer. The equivalent patent has been granted in Australia and expires in December 2022. The grant of patent applications in Canada and the US may lead to the launch of products with carved out indications.

# The filing of a divisional patent application EP1997492 shortly after observations were filed by a third party for EP1455781 in June 2008, raises the question of the merit of filing late 3rd party observations in Europe. In this case the filing of the divisional patent has started a new examination process, prolonging the outcome for the patent application.

# With the loss of patent protection in June this year in the US, AstraZeneca has faced stiff generic competition entering the market with their generic products. This is the likely story in other markets as AstraZeneca has not gone to significant lengths to protect Arimidex® beyond these two patent families and the associated extensions.

Anastrozole, an aromatase inhibitor for the treatment of breast cancer in postmenopausal women is marketed by AstraZeneca. For the year 2009, Arimidex sales generated approximately US$1.9 billion worldwide. It is available as a 1 mg film coated tablet.

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GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at

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