Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

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PHILADELPHIA, April 30, 2019 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it expects to launch later this quarter Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths, an AB-rated generic equivalent to the brand Concerta®. Total U.S. sales of Methylphenidate Hydrochloride ER tablets were approximately $1.4 billion for the 12 months ended February 2019, according to IQVIA, although actual generic market values are expected to be lower.

"The market for AB-rated Methylphenidate is sizable," said Tim Crew, chief executive officer of Lannett. "We expect this product will generate modest sales in our fiscal 2019 fourth quarter and grow to be one of our more significant revenue contributors in fiscal 2020."

Lannett's strategic alliance partner, Andor Pharmaceuticals, LLC, recently received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) of Methylphenidate Hydrochloride ER tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths, the therapeutic equivalent to the reference listed drug (RLD), Concerta® Extended-Release Tablets, 18 mg, 27 mg, 36 mg and 54 mg, of Janssen Pharmaceuticals, Inc.

In August 2018, Lannett announced that it entered into a licensing agreement with Andor for Methylphenidate Hydrochloride ER tablets. Under the agreement, Lannett will primarily provide sales, marketing and distribution support of Andor's Methylphenidate ER product, for which it will receive a percentage of the net profits.