Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

That's a whole lotta wrong, numbers

WeeZuhl, Oxycontin marketing exclusivity for new patient population. You are incorrect in thinking Oxycontin has full marketing exclusivity until August 2018. It is only marketing exclusivity for the new patient population. If you search, maybe you can figure out what that new patient population is for Oxycontin.

Better do some more reading tonight on Pediatric Exclusivity. You can start here:


http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/07/pediatric-exclusivity-amazingly-powerful-essentially-ironclad-and-often-overlooked.html

July 07, 2015
Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked
By Kurt R. Karst –
...
Pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity (e.g., five-year, three-year, and orphan drug exclusivity) an application holder may have under the FDC Act, provided that the exclusivity is granted with not less than nine months of term remaining.
...
An important aspect of pediatric exclusivity is that it provides additional marketing exclusivity not just for the pediatric indications or formulations, but for all protected indications and formulations of that sponsor’s drug.[/
...
Thus, pediatric exclusivity attaches to the patent and non-patent marketing exclusivity for any of the sponsor’s approved drug products (including certain combination products) that contain the active moiety for which pediatric exclusivity was granted, and not to a specific drug product. See National Pharmaceutical Alliance v. Henney, 47 F. Supp. 2d 37 (D.D.C. 1999) (here).

FDA will not grant a 6 month Priority Review for any drug that cannot receive Full Approval for another 19 months. But I do agree with you that it does not matter, since Rexista as it is currently formulated, will never make it out of AdComm.