Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

I doubt that. One of Elite's Monster ANDAs could get us to DollarLand.

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 Patented 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 Patented 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 Sept 2017 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://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

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

FDA will back up the DOJ
Quote:
“The FDA outlined several steps for speeding up the development of generic abuse-deterrent opioids.
The agency plans to help companies navigate the regulatory process in order to produce abuse-deterrent opioids sooner.
In its guidance, the FDA also provided recommendations for the types of studies that drugmakers could do to ensure that generic drugs are just as abuse-deterrent as brand-name versions.
Gottlieb emphasized that this is not a push by the FDA to “encourage more opioid use.” Instead, the agency hopes to shift opioid prescribing toward abuse-deterrent versions .”

50¢Land Catalyst:


9. SunGen ANDA #1 Generic Adderall Immediate Release Stimulant for ADHD with $400 million market 9-10 competitors
Filed Feb 2018

ELTP