in relation to our Jublia Generic. ACR challenged the Jublia Patent - Efinaconazole listed in the FDA's "Orange Book" in 2017 (or there abouts) and that challenge was successful. then that process leads to what's known in the US as Hax Waxman ( spelling?) which requires court litigation, which apparently ACR was successful. ACR announced it's success in that case in 2019. thing is ACR wasn't the only 'First to File" a Generic Jubila Dossier with the FDA. There were some 13 companies all up, and each of them also had to go through the same court process. As far as I'm aware those 13 coys were also successful. Like ACR those court outcomes are also confidential. Early on in this process I'd regularly go onto the FDA website and see who had obtained "tentative approval" for Jublia Generic. Tentative as final approval cannot be given until the terms of the court cases have been played out. When final approval is given these 13 odd companies will have 18 months to grab that largest slice of the Jublia market before anyone else can enter the market. but the new comers all have to go through the same process as the original 13. As far as I'm aware the 'Original" is in the "Orange Book" as they are NDA's and all the ANDA ( abbreviated new drug applications ) are listed under it. I seem to remember I had to look up the original to find those listed under it.
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