Elite Pharmaceuticals Inc (ELTP): Acetaminophen and Codeine Phosphate, USP...

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Elite Pharmaceuticals Inc (ELTP)

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Monday, 02/10/2020 6:13:59 PM

Monday, February 10, 2020 6:13:59 PM

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.

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