Lannett Company, Inc. (NYSE: LCI) today announced that it has commenced marketing 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.
“Our launch of AB-rated Methylphenidate is ahead of schedule,” said Tim Crew, chief executive officer of Lannett. “Of the more than 20 new products we have launched over the last 18 months, we expect the AB-rated Methylphenidate product to be one of our top contributors. Since January 1st of this year, we have now launched six products and expect to launch several more products over the coming months.”
As previously announced, 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. Lannett entered into a licensing agreement with Andor for Methylphenidate Hydrochloride ER tablets, under which Lannett provides sales, marketing and distribution support of Andor’s Methylphenidate ER product and receives a percentage of the net profits.
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