Food & Drug Law Weekly
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Patents
Barr Confirms Patent Challenge of Ambien CR
April 27th, 2007
Barr Pharmaceuticals, Inc. (NYSE:BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a patent challenge for Sanofi-Aventis U.S. LLC's Ambien CR(R) (Zolpidem Tartrate Extended-Release Tablets), 6.25mg & 12.5mg. Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Ambien CR product with the U.S. Food & Drug Administration (FDA) in December 2006, and received notification of the application's acceptance for filing in February 2007. Following receipt of the notice from the FDA, Barr notified Sanofi-Aventis, the New Drug Application (NDA) and patent owner. On April 5,...
Source: Food & Drug Law Weekly (2007-04-27)
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