Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Not quite.

1)are u implying that labeling is dependant on patent expiration ?

2)are u saying that COLL drug for oral abuse will be approved before Rexista? Was NDA already filed?

Labeling is not dependent on patent expiration but rather marketing exclusivity. Patents are protected in court with lawsuits, but the FDA administers marketing exclusivity by refusing to approve other drugs during the period of exclusivity. The Arymo example shows precisely that ADF labeling is dependent on FDA marketing exclusivity. They are letting them sell the drug now but not with a nasal abuse ADF label, at least not until MorphaBond's marketing exclusivity expires. Exclusivity information, along with patent information, is found in the FDA Orange Book. Know the difference.


Collegium Xtampza is already approved but not yet with ADF label for oral abuse by chewing. If the FDA believes the COLL study that was PR'ed last week is sufficient, then they will add on ADF label for chewing, maybe with an additional 3 years of marketing exclusivity. This is how OxyContin extended their exclusivity for ADF OxyContin from 2013-2016, by doing nasal abuse study and getting nasal abuse tacked on to their ADF label for IV abuse. (Then OxyContin exclusivity was extended again August 2015-August 2018 when they got Pediatric label.) Rexista could have gotten approval with carved-out label for chewing abuse, but if Xtampza gets the chewing ADF label first, then Rexista likely will not be able to get the chewing label for at least 3 years of marketing exclusivity.


Again, Exclusivity is not Patent Protection.

PATENT=COURT DECISION
EXCLUSIVITY=FDA DECISION