The patent challenge is all part of being the first company to file an Abbreviated New Drug Application (ANDA) for a generic version of Imvexxy. To be the first generic company to lodge an ANDA gives Sun Pharmaceuticals the jump on any other companies ANDA filings as it gains the first generic 6 months of exclusivity. The patents for Imvexxy still have 8 to 10 years to run so if the patents are proved to be valid then the Sun product cannot gain marketing approval for at least 8 years (unless they license it from Mayne). I would be quietly confident that when Mayne paid out $140m for purchase of the range of MD Therapeutics women's products they did extensive due diligence over the validity of the patents. This information will form the basis of Mayne's defense of the patent challenge (30 days to file the defense). Some of the follow on payments to MD Therapeutics such as royalties are based on the patents being held valid. It would not be uncommon for the owner of the innovator product to license out that product to the first generic competitor or launch their own generic product. This is all about protecting their longer term income stream against future generic competition. Despite the past stuff-ups with the purchase of or licensing of products I won't be losing any sleep over this one!
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