Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

no such thing as 3 years Pediatric_Exclusivity.

You can call it whatever you want, but it was granted based on Pediatric safety study that was done per Pediatric Written Request from FDA. Whatever you want to call it, it expires in August 2018.


http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/ucm077915.htm

Under certain conditions, however, pediatric exclusivity may be granted to a product without remaining exclusivity IF the supplemental application itself qualifies for a new exclusivity period under the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Amendments). For example, an application to extend an approved adult indication to the pediatric population for a product with no patent life or exclusivity remaining could obtain pediatric exclusivity IF new clinical studies of safety and efficacy are required for approval. In that case, the pediatric supplement would earn 3 years of marketing exclusivity under the 1984 amendments, to which the additional 6 month pediatric exclusivity would be added.

You know the difference between Patents and FDA Exclusivity, but are mixed up. Paragraph IV concerns patents. So winning a Paragraph IV challenge only gets you past the patents, not the FDA Exclusivities. So you are wrong that if IPCI wins a lawsuit against Purdue on the patents, that IPCI would get a free pass around the FDA Exclusivity.

I've explained this several times already. There is a specific provision of Hatch-Waxman that disallows Pediatric Exclusivity to be applied against an applicant who has a successful court decision in a Paragraph IV challenge. This is how Xtampza was approved exactly one week afer expiration of OxyContin's nasal abuse exclusivity. The Pediatric Exclusivity does not apply to Xtampza because they won in court, and that is law. Look it up.

Oxycontin's FDA Exclusivity with code "NPP" and expiration date of August 13, 2018 is for "New Patient Population". A 3 year FDA Exclusivity was given when the sNDA was approved in August 2015. Obviously, it is not Pediatric, since Pediatric only adds 6 months to BOTH existing patents and existing FDA Exclusivities.

Okay, then, what exactly do you think the NPP exclusivity through August 13, 2018 means? You said yourself you could not figure out why Rexista did not get Priority Review when all other ADF's did. I told you last week they did not have Priority Review and would not get it and why. Now here we are a week later, still without Priority Review, still with you telling me how wrong I am, and still with you trying to figure out why they didn't get Priority Review. Let me know when you figure it out.