Tuesday, October 18, 2016 12:28:51 PM
SequestOx will be approved...we are still in the red zone about to reach the end zone!
$$Generic Products$$
Commercial Product
Branded Product Equivalent
Therapeutic Category
1. Hydromorphone Hydrochloride
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. Phendimetrazine Tartrate
35 mg Tablets, USP
Bontril®
Bariatric
6. Isradipine
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
$$Branded Products$$
Commercial Product
Therapeutic Category
Partner
11. Lodrane D®
OTC Allergy
Valeant Pharmaceuticals International, Inc.
$$Contract Manufacturing $$
Commercial Product
Branded Product Equivalent
Therapeutic Category
Partner
12. Methadone Hydrochloride
10 mg Tablets
Dolophine®
Pain
Ascend Laboratories, LLC
$$Generic Pipeline$$
Programs Under Development
Branded Product Equivalent
Therapeutic Category
Development Stage
13. ELI-300 Opioid
Undisclosed
Pain
Early Development
14. ELI-301 Opioid
Undisclosed
Pain
Early Development
15. Oxycodone HCl and Acetaminophen, USP 325 mg
5 mg, 7.5 mg, 10 mg Tablets
Percocet
Pain
Pending FDA Approval
16. Undisclosed Generic
Undisclosed
Undisclosed
Pending FDA Approval
$$Branded Pipeline$$
Development Stage
Partner
17. SequestOxTM (ELI-200) Opioid
Pain
NDA Submitted
PDUFA date: July 14, 2016
Epic Pharma LLC
18. ELI-201 Opioid
Pain
Pivotal Bio-equivalence
19. ELI-202 Opioid
Pain
Pivotal Bio-equivalence
20. ELI-216 Opioid
Pain
Process Development
21. ELI-400 Opioid
Pain
Process Development
22. ELI-500 Opioid
Pain
Process Development
23. ELI-501 Opioid
Pain
Early Development
24. ELI-600 Opioid
Pain
Process Development
25. ELI-601 Opioid
Pain
Early Development
$$26. Elite Announces Development and License Agreement with SunGen Pharma LLC$$
Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced it has entered into a Development and License Agreement (“Agreement”) with SunGen Pharma, LLC (“SunGen”) to collaborate to develop and commercialize four generic pharmaceutical products.
Under the terms of the agreement, Elite and SunGen will share in the responsibilities and costs in the development of the products. Upon approval, the products will be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell two of the products using SunGen’s label and Elite shall have the exclusive right to market and sell two of the products using Elite’s label. Elite will manufacture and package all four products on a cost plus basis.
Two of the products are classified as CNS stimulants and two of the products are classified as beta blockers. For the twelve months ending June 30, 2016, the four products and their generic equivalents had total U.S. sales of more than $3 billion according to IMS Health Data.
“We are excited to collaborate with SunGen on the development of these four important generic products,” said Nasrat Hakim, Chairman and CEO of Elite.
“We are thrilled to have this long term strategic partnership with Elite and collaborate in a broad range of product portfolio in development, manufacturing and marketing,” said Dr. Jim Huang, CEO of SunGen.
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