Thursday, December 08, 2016 9:15:41 PM
The FDA website is a little inefficient. We know Handa launched on 11-1 but there was no listing of their approvals which is strange since they should have been listed, particularly since they've first filer status, excluding the 400mg. There was a listing of the Accord approval as a first filer of the 400mg, but tentative of the other strengths, and captured correctly listed as a first filer. We also know IPCI has been given T/A on all their strengths but not listed either. Mylan is also listed with T/A status as of 7-28-14. So Handa and IPCI wasn't captured in real time and still missing on the listings 5 weeks later.
The rest of the company's listed, with Mylan, will not be able to launch prior to 11-1-17 but again no-one else is listed for T/A on the website so who knows whether they dropped their pursuit of Seroquel XR or just more inefficient missing listings. I guess we can try and monitor the approvals next yr and perhaps we'll know something or not.
It's interesting that Maxim picked up on IPCI as the 3rd filer and I can't find anyone else that settled with Astra Zeneca prior which bodes well that the (3) companies: Handa, Accord and IPCI should enjoy the XR generic market, May to Nov, exclusively, imo.
BTW, FYI, the latest Seroquel XR sales #'s I found, for the 12 months ending 9-30-16, are $911M if you haven't found anything to the contrary.
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