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numbersarefun

02/20/19 4:17 PM

#38445 RE: AngeloFoca #38443

AngeloFoca, when patent expires, no more exclusivity. I think 180 day exclusivity only applies when there is a patent. Lupin should have agreed to an earlier launch day, which was 6 months before the patent expires on May 27, 2019. So ANDA applicants can wait until all patents expire, not infringe the patents, or challenge the patents to launch earlier.

The rest of Seroquel ANDA applications were approved after patents ran out. I think IPCI got to launch about 6 months before patents expired, and the first filer launched 1 year before it expired.
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wimuskyfisherman

02/20/19 4:24 PM

#38447 RE: AngeloFoca #38443

Angelo-

1. I am guessing MNK is not 100% at fault for Seroquel mess. My belief is the IPCI Seroquel can not be produced cost effectively in Toronto. Thus, MNK cannot compete with products manufactured in India, China, etc. If this is the case, once again poor management decision on IPCI part to manufacture in Toronto...
2. Even if IPCI gets approval on Ranexa, there is no manufacturing partner or sales and marketing partner. How will they sell this. Once again they will be way late to party and market share will be already spoken for and prices will have eroded.
3. Why no full approval on Pristiq? Lets hope it is because they are getting a Chinese manufacturing site approved for this product. That is the only way they will be able to have a cost competitive product that MNK can manufacture. If IPCI can give MNK a product that can be profitable, they will sell and market it. But if it is going to be manufactured in Toronto, forget about it.
4. As you can see there are many things Odidi could be working on. But it sure seems he is not... Looks to me his highest priority is being a politician in Nigeria...