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Lannett, Andor partner to launch methylphenidate hydrochloride ER tablets

Lannett has entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals for a potential generic of Concerta ER (methylphenidate hydrochloride extended-release tablets), the company announced Tuesday.

Andor's pending Abbreviated New Drug Application of methylphenidate included all bioequivalence metrics recommended by the Food and Drug Administration and is expected to be approved as an AB-rated generic equivalent to Concerta. 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 Lannett CEO Tim Crew. "Based on Andor's target action date of Feb. 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."

Methylphenidate is s a central nervous system stimulant primarily used to treat attention deficit hyperactivity disorder, or ADHD, in children between the ages of 6 years old to 12 years old, adolescents, and adults up to age 65 years old. The Andor generic will be available in 18-, 27-, 36- and 54-mg dosage strengths.

Methylphenidate hydrochloride extended-release tablets had a market value of approximately $1.8 billion for the 12 months ended June 2018, according to IQVIA.
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