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Progenics Pharma 8-K Says Company Received Notice Of Paragraph IV Certification For Certain Patents For RELISTOR On Oct 7

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On October 7, 2015 Progenics Pharmaceuticals, Inc. ("Progenics") received notification of a Paragraph IV certification for certain patents for RELISTOR® (methylnaltrexone bromide) subcutaneous injection, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Mylan Pharmaceuticals, Inc. of an Abbreviated New Drug Application (ANDA) challenging such patents for RELISTOR subcutaneous injection.

Progenics and its licensee for RELISTOR, Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) are assessing the notification and intend to vigorously enforce RELISTOR intellectual property rights.

In accordance with the Hatch-Waxman Act, Progenics and Valeant have 45 days after effective notice of the Paragraph IV certification to file suit against the ANDA filer in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i) 30 months from receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.

Posted-In: News FDA

 

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