Friday, October 19, 2018 9:13:58 PM
---- $$$$$ Elite's Multi-Billion Dollar LineUp: $$$$$ ----
6 Approvals over next 1 1/2 years 2-3 Imminent
1-2 Approvals per quarter expected, and one Launch per quarter
Short to mid term products are entering an IMS market value
of $6 + Billion Dollar$
Elite working on 7+ ADF opiods concurrently
$ Launched Generic Products $$$$
1. Hydromorphone Hydrochloride non-AD
8 mg Tablets
Dilaudid®
Pain
2. Naltrexone Hydrochloride
50 mg Tablets
Revia®
Opioid Antagonist
3. Phentermine HCl
37.5 mg Tablets
Adipex-P®
Bariatric
4. Phentermine HCI
15 mg and 30 mg Capsules
Adipex-P®
Bariatric
5. TWO * Phendimetrazine Tartrate one to sell and one to divest
35 mg Tablets, USP
Bontril®
Bariatric
6. ISRADAPINE- ONE Competitor Positive Parkinson’s study could send PPS skyward
2.5 mg and 5 mg Capsules
N/A
Cardiovascular
7. Hydroxyzine HCI
10 mg, 25 mg, 50 mg Tablets
Atarax®, Vistaril®
Antihistamine
8. Dantrolene Sodium
25 mg, 50 mg and 100 mg Capsules *
Dantrium®
Skeletal Muscle Relaxant
9. Loxapine
5 mg, 10 mg, 25 mg, 50 mg Capsules *
N/A
Antipsychotic
10. Additional Approved ANDA's *
Undisclosed
Undisclosed
* pending manufacturing site transfer
11. Trimipramine
$ GENERIC PIPELINE $$$$
12. ELI-300 Opioid
Undisclosed
Pain
Early Development
13. ELI-301 Opioid
Undisclosed
Pain
Early Development
14. Oxycodone HCl and Acetaminophen, USP 325 mg
5 mg, 7.5 mg, 10 mg Tablets
Percocet
Pain
FDA Approval Launch Pending
15. Hydrocodone and Acetaminophen tablet
2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets
Norco
Pain
Filed Pending FDA Approval
16. Codeine and Acetaminophen tablet
Pain
Generic Tylenol APAP
Filed Pending FDA Approval
17. SunGen ANDA #1 Filed
Undisclosed
CNS Stimulant
In Development
18. SunGen ANDA #2 ———ELITE’S AVATAR $1.6 Billion Dollar Market———
Undisclosed CNS Stimulant 4 Competitors which includes the name brand
Filed and under FDA Review 10-12 months from Approval
19. SunGen ANDA #3 Elites MONSTER ANDA it is Bigger than SunGen ANDA #2
Undisclosed
Beta-Blocker
Will be filed late 2018
20. Elite/SunGen Generic #4
Undisclosed
Beta-Blocker
In Development
21. Elite/SunGen Generic #5
Undisclosed
Anti-depressant
In Development
22. Elite/SunGen Generic #6
Undisclosed
Antibiotic #1
In Development
23. Elite/SunGen Generic #7
Undisclosed
Antibiotic #2
In Development
24. Elite/SunGen Generic #8
Undisclosed
Antispasmodic
In Development
25. ELI-201 Generic ER Opioid
Troxyca equivalent
Pain
Waiting for FDA guidance for an equivalent comparator
26. Generic Embeda
Needs to be filed ASAP may be undisclosed
Pain
27.Generic ADF OxyContin First EVER Generic ADF opioid
Filed pending approval
Pain
28. Generic Opana Oxymorphone
Pain
29. Generic Methadone tablet
Pain
FDA Approved Pending Launch
$ BRANDED PIPELINE $$$$
Development Stage
Partner
30. $SequestOx™ (ELI-200) IR Opioid
Pain Filed with FDA
Being reformulated to decrease fed Tmax
31. IR ADF (2 bead) Hydrocodone
32. IR ADF (2 bead) Oxymorphone
33. IR ADF (2 bead) Hydromorphone
34. ELI-202 Opioid
Pain
Pivotal Bio-equivalence
35. ELI-216 Opioid ER 24hr (once/day)
Pain
Process Development Phase II completed
36. ELI-400 Opioid
Pain
Process Development
37. ELI-500 Opioid
Pain
Process Development
38. ELI-501 Opioid
Pain
Early Development
39. ELI-600 Opioid
Pain
Process development ELTP
40. GlenMark ANDA #1
In development
41. GlenMark ANDA #2
In development
Chinese ADF opiod one or more of the above
Canadian ADF opiod one or more of the above
European ADF opiod one or more of the above
ELTP $$$$$$$$$
Everyone you meet is fighting a battle you know nothing about BE KIND
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