Replies to post #234252 on Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

That. Is incorrect.

[WeeZuhl]

If only there was a resource to check...

Exclusivity is only granted to A new chemical entity that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act. Oxycodone isnt new chemical entity.

The FDA Orange Book:

http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=207621&Appl_type=N

Patent and Exclusivity for: N207621

NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE (TROXYCA ER) CAPSULE, EXTENDED RELEASE 1.2MG;10MG



Exclusivity Data

Product No
001
Exclusivity Code
NC
Exclusivity Expiration
Aug 19, 2019

If Nasrat goes ANDA route with Troxyca as RLD, earliest market date possible is August 2019, with likely approval date being further out than out. If he goes 505b2 NDA pathway with Troxyca as RLD, he will have a patent fight-out in court before FDA will approve.

But! If he uses 505b2 NDA pathway with OxyContin as RLD, he would likely get Priority Review (6 month review). The NDA application is more expensive, but the review is years faster. Also, we know there will be no patent or exclusivity challenge from Purdue. This is the pathway he used for SequestOx, with Roxicodone as RLD plus naltrexone in a "new combination." At this point, I'm not sure why he would not do both. He gets his own NDA OxyNal 12HR in 2018 and gets first to file exclusivity generic Troxyca in 2019-2020.

It all costs money, though. I just wish there were 100 million shares of ELTP sitting somewhere doing nothing that we could use to get ADF products to market. Hmmmmmmmmm.

1. Elite sues Mikah. (Insert legalese gobbledygook here: …in consideration therefore… bleh bleh bleh… breach of nonsuckitude… bleh bleh bleh… whatever… it doesn’t matter what it says.)

2. Mikah immediately settles by agreeing to refund 100,000,000 shares to Elite.

3. Nobody admits to anything other than everything is awesome.

4. Share price significantly increases upon settlement. Share price increases again when Nasrat announces in PR that he will use the shares to fund within 1 year the final applications for both ELI-201 and ELI-216, as well as to fix SequestOx. The very acheivable goal will be to have a complete platform (I.R., 12HR, and 24HR) of ADF-labeled oxycodone by end of 2018.

5. In 2018, the share price increases by multiples with each approval. BOOM SequestOx. BOOM ELI-201. BOOM ELI-216. LOL they could have 1 AdComm meeting for all three drugs.