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Acrux Ltd And Eli Lilly and Co File Lawsuit Against Actavis, Inc. For Infringement Of Patents

Tuesday, 12 Nov 2013 05:22pm EST 

Acrux Ltd announced that Eli Lilly and Co, Eli Lilly Export S.A. (Lilly) and Acrux DDS Pty Ltd (Acrux) have filed a lawsuit against Watson Laboratories Inc, Actavis Pharma Inc, and their parent company, Actavis Inc ("Actavis") for infringement of six issued US patents that cover Axiron. The patents are owned by Acrux DDS Pty Ltd, a wholly owned subsidiary of Acrux Limited and are exclusively licensed to Lilly. The lawsuit was filed in the United States District Court for the Southern District of Indiana in response to a notice letter sent by Watson regarding its filing with the FDA of an Abbreviated New Drug Application ("ANDA") for a Testosterone Metered Dose Transdermal Solution. The letter stated that the ANDA contains Paragraph IV certifications with respect to US Patent Numbers 6,299,900, 6,818,226, 6,923,983, 8,071,075, 8,419,307 and 8,435,944, which are expected to expire between 2017 and 2027. These patents include claims relating to the penetration enhancer, the quick drying formulation, the application of testosterone formulations to the underarm and to the applicator used to apply Axiron.