Elite Pharmaceuticals Inc (ELTP)

[Gman24]

Elite’s financials getting lean and mean...

Now estimate the potential numbers for next quarter when we add these..

Adderall XR... $1.3 - $1.5 billion

Loxapine 5mg, 10mg, 25mg and 50mg capsules (“Loxapine Capsules”)
 
A PAS has been filed with the FDA for transfer of manufacturing of this product to the Northvale Facility, with such PAS being under review by the FDA. The approved ANDAs for Loxapine Capsules were acquired as part of the 2013 ANDA acquisition between the Company and Mikah Pharma. Please see the section below titled “Asset Acquisition Agreements” for further details on the 2013 ANDA acquisition agreement.
 
Acetaminophen and Codeine Phosphate, USP CII (generic version of Tylenol® with Codeine)
 
On September 18, 2018, the Company filed an ANDA with the FDA for a generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate) 300mg/15mg, 300mg/30mg and 300mg/60mg tablets. Acetaminophen with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Acetaminophen with codeine products have annual U.S. sales of approximately $45 million according to IQVIA (formerly QuintilesIMS Health Data). The Company received approval of this ANDA in September 2019. Elite has not yet launched this product and is seeking a partner for this product.