Some info on patent expiry. dated - --2015-10-15-- THE 2016...

Some info on patent expiry.
dated - --2015-10-15--
THE 2016 NATIONAL FORMULARY STATUS FOR AXIRON HAS BEEN SECURED AT TWO OF THE LARGEST COMMERCIAL PRESCRIPTION BENEFIT MANAGERS (PBM).
OPERATING REVIEW
Axiron Litigation The Acrux patent concerning the underarm administration of testosterone formulations was granted by the United States Patent and Trademark Office (USPTO) in May 2013. In the United States, Axiron is now protected by a number of patents which have expiry dates of 2030, 2027, 2026 and 2017. The patents cover 3 different aspects of the product, including the formulation and delivery method, administration to the underarm and the physical applicator. In May 2013, November 2013, December 2014 and July 2015, Acrux DDS Pty Ltd (a wholly-owned subsidiary of Acrux Ltd.) together with Eli Lilly and Company (“Lilly”) filed lawsuits in the United States District Court for the Southern District of Indiana against 1) Perrigo Israel Pharmaceuticals Limited, 2) Watson Laboratories Inc. (“Activis”), 3) Amneal Pharmaceuticals LLC and 4) Lupin Pharmaceuticals Inc., respectively for infringement of issued patents covering Axiron. In each instance, the patents are owned by Acrux DDS and are exclusively licensed to Lilly. The lawsuits were filed in response to notice letters sent by each company regarding its filing with the United States Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a Testosterone Metered Dose Transdermal Solution. The letters each stated that the respective ANDAs contain Paragraph IV certifications with respect to United States patents that include claims relating to the application of testosterone formulations to the underarm and to the applicator used to apply Axiron. Activis further includes paragraph IV certifications with respect to United States patents that include claims relating to the quick-drying formulation. A Paragraph IV certification alleges invalidity, unenforceability and/or noninfringement of a patent. Throughout 2014, a number of pending product liability lawsuits were filed against Acrux and Lilly in the United States District Court for the Northern District of Illinois, including claims that assert injury caused by testosterone replacement therapy. These cases, brought by private plaintiffs, were consolidated for pretrial purposes in the United States District Court for the Northern District of Illinois under the Multi-District Litigation Rules as Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545.