Replies to post #23230 on Intellipharmaceutics International Inc. (IPCI)

[fabius]

WZ Happy to hear you back. Each time means an increase in ipci share price.

Two questions:
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?

TIA

[numbersarefun]

WeeZuhl, no such thing as 3 years Pediatric_Exclusivity. You seem to have half-baked ideas, where the information is there but you put them together wrong. You are wrong, because you are still thinking Oxycontin has Pediatric Exclusivity. And you do not understand Pediatric Exclusivity only adds 6 months to existing exclusivities.

WeeZulh wrote: "2. OxyContin enjoys marketing exclusivity until August 2018."

First, reformulated Oxycontin does NOT have Pediatric Exclusivity. We already discussed that the exclusivity code is "NPP" not "PED", but you are still thinking Pediatric. From the FDA NDA review docs for reformulated Oxycontin, the reason FDA did not grant Pediatric Exclusivity was because reformulated Oxycontin was not a new dosage form therefore did not trigger required Pediatric studies.

In the Orange Book, Pediatric Exclusivity has code "PED" and is recorded on a separate line which adds 6 months to both patents and FDA Exclusivity. For example, Seroquel XR, a drug which IPCI has a generic, for list Patent Data:

Patent_No: 5948437
Expiration_Date: May 28, 2017

Patent_No: 5948437*PED
Expiration_Date: Nov 28, 2017

WeeZuhl wrote: "3. Per the Hatch-Waxman Act, a successful Paragraph IV challenge is an automatic bypass around Pediatric Exclusivity, which is the only way an OxyContin RLD drug can get Full Approval prior to August 2018."

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. Pediatric Exclusivity add 6 months to BOTH patents and FDA Exclusivities. But Oxycontin does not have Pediatric Exclusivity.

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.

WeeZuhl wrote : "4. They would not get IV or nasal label until OxyContin's market exclusivity expires."

Oxycontin's FDA Exclusivity with code "M-153" expired Apr 16, 2016, which was for "ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN"