Generic Aricept® (Donepezil) – Losing Key Patent Protection

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GenericsWeb analyses the patent landscape surrounding Donepezil, 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 Aricept® (Donepezil), the world's best selling anti-Alzheimer's drug developed by Eisai and co-marketed with Pfizer. The article analyses the patent landscape surrounding Donepezil, highlighting the need for comprehensive patent information in the development of launch strategies for generic products to minimise the risk of litigation.

Key findings of the article include:

  • The patentee Eisai has so far been successful in defending the Donepezil molecule patent from attacks by generic manufacturers in the US; but whilst litigation is ongoing, Eisai has taken measures to prevent early 'at risk' launch following expiry of the 30 month stay.
  • Eisai has embarked on a life-cycle management strategy resulting in key patents being identified for polymorphic forms and formulations protecting certain dosage forms. However, these patents will unlikely delay generic launch beyond the 'molecule' patent, as they appear to be relatively easily circumvented by forward-thinking generic competitors.
  • Generic equivalents of all currently authorised Aricept® dosage forms are likely to become available in the US during November 2010, and in most European countries during February 2012 from numerous suppliers, resulting in substantial pricing pressure.

You can read the full article here: http://www.genericsweb.com/druginfocus/Donepezil

ABOUT GENERICSWEB – THE SEARCH IS OVER
GenericsWeb, the leader in pharmaceutical patent searching and analysis holds an impeccable track record in providing quality patent information, allowing numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. Our technical staff is highly skilled and experienced and has extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

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Yoann Bretonnet

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