Lannett Company announced that it has entered into an agreement with Sinotherapeutics Inc., a China-based specialty pharmaceutical company, to be the exclusive U.S. distributor of Posaconazole Delayed-Release Tablets 100mg. Sinotherapeutics has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Posaconazole Delayed-Release Tablets 100mg, which is an AB-rated generic equivalent of Merck’s Noxafil® Delayed-Release Tablets. Lannett expects to commence shipping the product shortly.
The brand product’s annual U.S. sales were approximately $325 million for the twelve months ended June 2019, according to IQVIA, although actual generic market values are expected to be lower.
“The Sinotherapeutics team is highly skilled at formulating particularly difficult to develop products, such as Posaconazole Delayed-Release Tablets,” said Tim Crew, chief executive officer of Lannett. “Given the market dynamics of the product, we expect Posaconazole to be a meaningful contributor to our business.”
Under the agreement, Lannett will make milestone payments based on market dynamics and performance. The company will provide sales, marketing and distribution and will receive a share of the profits. Other terms were not disclosed.