Esomeprazole Remains Under Threat

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Following the recent revocation by the EPO of a key patent in the array of protection of AstraZeneca's Nexium (Esomeprazole) there remains a degree of uncertainty as to whether it opens the door for generic competition according to a recent analysis by Generic Patent Intelligence experts at GenericsWeb.com.

Following the recent revocation by the EPO of a key patent in the array of protection of AstraZeneca's Nexium (Esomeprazole) there remains a degree of uncertainty as to whether it opens the door for generic competition according to a recent analysis by Generic Patent Intelligence experts at GenericsWeb.com.

The recent analysis, published in GenericsWeb's free monthly INNsight newsletter is based on one of their Pipeline Selector patent intelligence reports and highlights some key considerations in attempting to understand the effects of the recent EPO decision:

1.    Further patent applications that have been divided out of the revoked 'molecule' patent EP652872 are pending before the EPO and may yet be granted in a form that constrains generic competitions. According to the author Mr. Howard, "Examination of these applications is unlikely to reach a conclusion within the next few years, creating uncertainty about the final scope of their protection."

2.    AstraZeneca have numerous additional patents and pending applications claiming molecular form, process, formulation and use relating to the Esomeprazole suite of products, likely to protect the product from all but the most proactive generic developers. Some of these are already being challenged.

3.    Data exclusivity protection may restrict generic filings in major European markets until 2010 if not challenged with regulators, suggesting earliest entry of late 2011 in these markets.

You can view this analysis here: http://www.genericsweb.com/index.php?object_id=515 or to apply to receive INNsight the GenericsWeb newsletter directly, please visit http://www.genericsweb.com.

About GenericsWeb

GenericsWeb Pipeline Patent Intelligence provides unrivalled patent knowledge required to navigate your generic drug development with confidence, all at the click of a button. Established in 1999, GenericsWeb has customers in over 30 countries including legal practices, government departments, consultants and generic manufacturers. For further information about GenericsWeb Pipeline Patent Intelligence, contact Jesse Tale at tel. +61-2-98186111 or, for European and U.S. customers contact Sweta Lee at tel. +44 870 879 0081.

The website http://www.genericsweb.com also hosts a web portal dedicated to serving the generic pharmaceutical industry. Resources found at GenericsWeb include regularly updated news and articles, careers, business intelligence, industry links and product development services. Receive our free monthly newsletter 'INNsight' by registering online.

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Leighton Howard
GenericsWeb
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