Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

Elites 2018-2019 DollarLand Catalysts

Elite has 6 ANDAs filed and will be filing one per quarter going foward
One Approval a quarter expected

Nasrat, November 10, 2017: "We will continue to do what we are doing and we will get to NASDAQ in a couple of years and we are going to get to dollar land around that time within couple of years."


1. SunGen ANDA #2 $1.6 Billion dollar market with one Name Brand and 3 generic competitors. FDA filed and under review. Approval in 10-12 months

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.“

Quote N2K:
“For a product entering a growth market with existing product with market leaders having more than a three year lead time,there has been a first year average market capture of 8.7%. If we extrapolate that to Elite and the CNS ER product for the $1.6 B market it is (that's right) $139.2 Million in the first year.”

http://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=87711&GoTopage=1&Category=2163&BzID=2258&t=2180&G=939


2. SunGen ANDA #3 Bigger than SunGen #2 greater than $1.6 Billion Market
unknown number of competitors at this time.

Quote Nasrat : “We have another product (SunGen ANDA #3) 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 SequestOx 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 Novel ADF (new technology) which is 90% cheaper than the competitions

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 will the First Ever Generic ADF Opioid : Filed and under review by FDA

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


6. Isradipine THE WILDCARD : Approved and Launched Positive Isradipine-Parkinson PH III Study 1 competitor 1 million patients
Study nearly completed.

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

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