OSI Pharmaceuticals, Inc.

OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva

Published in Health Business Week, February 27th, 2009

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Tarceva® (erlotinib).

OSI is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva and expects to file suit in that time frame. Tarceva is currently protected by three patents that are listed in the FDA’s Approved Drugs Products List (Orange Book). A lawsuit brought with respect...

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Source: Health Business Week (2009-02-27)

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