Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

The next one will be one of these Monsters:

Unleash The Kraken !!!

1. SunGen ANDA #2-THE MONSTER $1.6 Billion dollar market with one Name Brand and 3 generic competitors. FDA filed and under review. Site inspection completed Approval soon along with SunGen#1

Quote Nasrat:
“The last ANDA that was filed in May was an extended-release CNS stimulant that we co-developed with our partner SunGen. The branded and generic sales of this product are approximately $1.6 BILLION and there are currently just FOUR manufacturers which includes the branded and its authorized generics.“

2. SunGen ANDA #5 -GODZILLA Bigger than SunGen #2 also a CNS stimulant greater than $1.6 Billion Market
unknown number of competitors at this time.

Quote Nasrat : “We have another product (SunGen ANDA #5) that we're partnering with SunGen, that’s bigger than this one (SunGen ANDA #2).”

Transcript for June, 15, 2018 Conference Call

https://seekingalpha.com/article/4182056-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-q4-2018-results-earnings-call-transcript?part=single

3. Reformulated Patent Pending SequestOx- THE BEAST will be the first ADF Immediate Release(IR) Opioid that will have Oral (chewing), Intranasal, and Intravenous(IV) Abuse Deterrent Labeling.
New patent to extend exclusivity
Elite will own the market

http://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=86991&GoTopage=1&Category=2163&BzID=2258&t=2180&G=939

4.Unique Patent Pending Novel IR ADF-THE GOLIATH (new patent pending drug platform) which is 90% cheaper to produce

Quote Nasrat: on new ADF platform
“I am extremely excited about this formulation because it is also a platform that applies to all the IRs and its about 10% of the cost. So we're extremely excited about this, but it's still early, in the next few months once Dr. Smith files a patent and we do a few more trials, we’ll update everyone more about it. “


5.Generic ADF OxyContin-THE BEHEMOTH will the First Ever Generic ADF Opioid : Filed Sept 2017 and under review by FDA No generic competition - $2.3 Billion Dollar market

http://www.4-traders.com/ELITE-PHARMACEUTICALS-INC-19343831/news/Elite-Pharmaceuticals-Files-ANDA-for-Oxycodone-Hydrochloride-Extended-Release-25147703/

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622252.htm?utm_campaign=10022018_Statement_FDA%20Commissioner%20on%20deterring%20gaming%20of%20generic%20drug%20approval%20process&utm_medium=email&utm_source=Eloqua

“It is important to note that there are no FDA approved generic ADFs. A clear business opportunity for the well positioned firm willing to engage in a strategic investment.”


6. Isradipine -THE WILDCARD : Approved and Launched Positive Isradipine-Parkinson PH III Study ONE competitor 1 million patients
Study completion end of Nov. 2018 https://clinicaltrials.gov/ct2/show/NCT02168842

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141631365

7.Generic Troxyca ER Oxycodone: If FDA gives pathway to approval

https://www.in-pharmatechnologist.com/Article/2018/07/11/Elite-Pharma-Eyes-on-Troxyca-but-Pfizer-blocking-generic-release.
On hold till FDA guidance is obtained. No competition name brand abandoned

8. If the Departmentbof Justice reduces the number of abused non-ADF opioids produced each year and increasing ADF opioid production .

DOJ could issue stricter limits on certain opioids (non-ADFs) if federal authorities believe they are being misused.

http://thehill.com/policy/healthcare/396566-new-regulation-gives-doj-more-power-to-limit-production-of-opioids


 ELTP