Lannett Company, Inc. announced that it has entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals, LLC for Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths.
Andor's pending Abbreviated New Drug Application (ANDA) of Methylphenidate included all bioequivalence metrics recommended by FDA and is expected to be approved as an AB-rated generic equivalent to the brand Concerta®. Total U.S. sales of Methylphenidate Hydrochloride Extended Release (ER) tablets were approximately $1.8 billion for the 12 months ended June 2018, according to IMS.
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.
"We look forward to returning to this AB-rated Methylphenidate market," said Tim Crew, chief executive officer of Lannett. "Based on Andor's target action date of February 1, 2019, we are optimistic about launching the product well within calendar 2019. The product adds to the sizable number of products we expect to launch in the near term. In June, we commenced marketing four products and, in the coming months, expect to begin marketing several others. While we build out our pipeline, we remain focused on near-term growth opportunities, which include commercializing the products in our portfolio and forming strategic alliances to in-license / acquire products."
About Lannett Company, Inc.
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com