ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry Into A Material Definitive Agreement.
On March 7, 2019, Elite Pharmaceuticals Inc. (“Elite”) signed a License, Supply and Distribution Agreement with Lannett Company, Inc., (“Lannett”) to market two Elite generic products in the United States. Lannett will be the exclusive U.S. distributor for two generic products that Elite and SunGen Pharma (Princeton, NJ) co-developed and co-own.
The first product that Lannett will launch is a generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets. The second product is an extended-release CNS stimulant which is under review by the FDA.
Under the Agreement, Lannett will provide sales, marketing, and distribution for the products and Elite will manufacture the product. Lannett, Elite and SunGen will each receive a share of the profits. The term of the License Agreement is three years
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated March 11, 2019 |
ELITE PHARMACEUTICALS INC /NV/ Exhibit
EX-99.1 2 f8k030719ex99-1_elitepharma.htm PRESS RELEASE Exhibit 99.1 Elite Pharmaceuticals Enters into Strategic Marketing Alliance with Lannett For Generic Adderall® NORTHVALE,…
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About ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is principally engaged in the development and manufacture of oral, controlled-release products. The Company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA’s) for generic products and New Drug Applications (NDA’s) for branded products. The Company owns approximately six different approved ANDA’s. The Company’s product, SequestOx, is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. SequestOx is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.