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Re: bluelucky post# 32259

Monday, 01/22/2018 2:45:02 PM

Monday, January 22, 2018 2:45:02 PM

Post# of 38634

On focalin they only own rights on 15 and 30.

Not sure if they ever did the testing on the 40 required for approval of the other strengths. We never were updated on that.

All necessary tests were done and entrusted with PAR - however... PAR chose to do their own studies and submitted the ANDA for their 40mg, so PAR is the one who received approval on all the other doses... although the deal between PAR and IPCI is that IPCI is entitled to royalties on PAR's approvals.

I would imagine that IPCI would have to submit the 40mg data to the FDA to get approval on all the other doses besides 15mg and 30 mg... further the contract is NOT mutually exclusive and IPCI can market Focalin on their own.