Replies to post #26112 on Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

WeeZuhl, List of Pediatric Exclusivity Granted, no Oxycontin. FDA has list of granted Pediatric Exclusivities. There is no Oxycontin listed, nor is there listing for Purdue Pharmaceuticals. So Oxycontin never received "PED".

So the list reinforces that the exclusivity in the Orange Book is not Pediatric. Like I said before, Pediatric Exclusivity only adds 6 months to existing patent exclusivities and FDA marketing exclusivities. That Oxycontin "NPP" exclusivity is for 3 years, and is not Pediatric, and does not block any other drug from getting final approval.

Orange Book listing for Oxycontin shows "NPP" exclusivity, which is for marketing exclusivity for new patient population. Winning Paragraph IV patent challenge can not get around marketing exclusivity that expires August 2018.


Pediatric Exclusivity Granted List (PDF)
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM514985.pdf

Pediatric Exclusivity Granted webpage:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm

WeeZuhl wrote: "I repeatedly have said their best course of action would have been to do nothing and let the FDA block Rexista until at least August 2018."

WeeZuhl wrote: "But what I take exception to is the repeated posts about how Rexista is based on some unique ADF technology that is patented and proprietary. It very simply IS NOT."

We will have to see if any Rexista ADF technology is patented or not. Rexista is not too hard to crush. So that is a different approach than Oxycontin, which is hard to crush.