Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by a generic filer requesting approval to market and sell a generic version of OYXTROL® (Oxybutynin Transdermal System). In its Notice Letter, the filer alleges that patents covering OXYTROL are invalid, unenforceable and/or will not be infringed by their manufacture, use or sale of the product described in its ANDA.
Watson currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against the filer. Such a lawsuit would automatically prevent the FDA from approving the ANDA until the earlier of a district court decision or 30 months from Watson's receipt of the Notice Letter.
Source: Watson Pharmaceuticals, Inc.
Watson currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against the filer. Such a lawsuit would automatically prevent the FDA from approving the ANDA until the earlier of a district court decision or 30 months from Watson's receipt of the Notice Letter.
Source: Watson Pharmaceuticals, Inc.
0 comments:
Post a Comment