---- $$$$$ Elite's Multi-Billion Dollar LineUp: $$
Post# of 2146
6 Approvals over next 1 1/2 years 2-3 Imminent
1-2 Approvals per quarter expected, and one to two Launch per quarter
Short to mid term products are entering an IMS market value
of $6 + Billion Dollar$
Elite working on 7+ ADF opiods concurrently
$ Launched Generic Products $$$$
1. Hydromorphone Hydrochloride non-AD
8 mg Tablets
Dilaudid®
Pain
2. Naltrexone Hydrochloride
50 mg Tablets
Revia®
Opioid Antagonist
3. Phentermine HCl
37.5 mg Tablets
Adipex-P®
Bariatric
4. Phentermine HCI
15 mg and 30 mg Capsules
Adipex-P®
Bariatric
5. TWO * Phendimetrazine Tartrate one to sell and one to divest
35 mg Tablets, USP
Bontril®
Bariatric
6. ISRADAPINE- ONE Competitor Positive Parkinson’s study could send PPS skyward
2.5 mg and 5 mg Capsules
N/A
Cardiovascular
7. Hydroxyzine HCI
10 mg, 25 mg, 50 mg Tablets
Atarax®, Vistaril®
Antihistamine
8. Dantrolene Sodium
25 mg, 50 mg and 100 mg Capsules *
Dantrium®
Skeletal Muscle Relaxant
9. Loxapine
5 mg, 10 mg, 25 mg, 50 mg Capsules *
N/A
Antipsychotic
10. Additional Approved ANDA's *
Undisclosed
Undisclosed
* pending manufacturing site transfer
11. Trimipramine
12. Methadone HCL Generic -
5mg, 10mg
$30 million market GlenMark distribution
13. Oxycodone & Acetaminophen
5mg/325mg, 7.5mg/325mg, 10mg/325m
Generic Percocet
$500 million market
14. Hydrocodone and Acetaminophen tablet
2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets
Norco
Pain
$700 million market
15 Generic Adderall tablets
5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg, and 30mg
CNS Stimulant
$365 Million market
$ GENERIC PIPELINE $$$$
16. ELI-300 Opioid
Undisclosed
Pain
Early Development
17. ELI-301 Opioid
Undisclosed
Pain
Early development
18. Codeine and Acetaminophen tablet
Pain
Generic Tylenol APAP
Filed Pending FDA Approval
19. SunGen ANDA #2 ———ELITE’S NEW AVATAR $1.6 Billion Dollar Market———
Undisclosed ER CNS Stimulant 4 Competitors which includes the name brand
Filed and under FDA Review 10-12 months from Approval Concerta ANDA
20. Elite/SunGen Generic #3 $110 million market
Undisclosed
IR Antibiotic
In Development
21. Elite/SunGen Generic #4
Undisclosed
Anti-depressant
In Development
22. SunGen ANDA #5 Elites MONSTER ANDA it is Bigger than SunGen ANDA #2
Undisclosed CNS stimulant market greater than $1.6 Billion
Will be filed first half 2019, largest SunGen product to date
23. Elite/SunGen Generic #6
Undisclosed
Antibiotic
In Development
24. Elite/SunGen Generic #7
Undisclosed
Antibiotic
In Development
25. Elite/SunGen Generic #8
Undisclosed
Antispasmodic
In Development
26. ELI-201 Generic ER Opioid
Troxyca equivalent
Pain
Waiting for FDA guidance for an equivalent comparator
27. Generic Embeda
Needs to be filed ASAP may be undisclosed
Pain
28. Generic ADF OxyContin First EVER Generic ADF opioid
Filed pending approval
Pain
29. Generic Opana Oxymorphone
Pain
$ BRANDED PIPELINE $$$$
Development Stage
Partner
30. $SequestOx™ (ELI-200) IR Opioid
Pain Filed with FDA
Being reformulated to decrease fed Tmax
31. IR ADF (2 bead) Hydrocodone
32. IR ADF (2 bead) Oxymorphone
33. IR ADF (2 bead) Hydromorphone
34. ELI-202 Opioid
Pain
Pivotal Bio-equivalence
35. ELI-216 Opioid ER 24hr (once/day)
Pain
Process Development Phase II completed
36. ELI-400 Opioid
Pain
Process Development
37. ELI-500 Opioid
Pain
Process Development
38. ELI-501 Opioid
Pain
Early Development
D
39. ELI-600 Opioid
Pain
Process development ELTP
40. GlenMark ANDA #1
In development
41. GlenMark ANDA #2
In development
A Chinese ADF opiod being discussed