Amneal announced a 5-year supply and distribution agreement with American Regent for the preservative-free generic alternative to Makena (hydroxyprogesterone caproate injection, USP, 250mg/mL). The injectable is used to reduce the risk of preterm birth in certain women. According to IQVIA, the U.S. brand market for Makena is estimated to be approximately $323 million in annual sales for the 12 months ended June 2018.
Under the terms of the agreement, Amneal will distribute a generic version of Makena to retail consortiums while American Regent will market the product in all other channels including hospital and specialty channels.
Amneal also announced that it has received approvals for two new topical products that treat a variety of skin conditions. This includes generic versions of Temovate (clobetasol propionate) ointment 0.05% and Lidex (fluocinonide) cream 0.05%. The Company is preparing to commercialize fluocinonide cream in the fourth quarter of 2018. According to IQVIA, annual sales for topical fluocinonide cream were $34 million, for the 12 months ended June 2018.
In addition, Amneal recently launched a generic version of Lodine (etodolac) IR 400 mg and 500 mg tablets. Etodolac had annual U.S. sales of approximately $36 million according to IQVIA for the 12 months ended June 2018.
"Today's announcements are important steps forward in advancing Amneal's strategy to enhance our portfolio in order to grow our addressable markets and deliver enhanced value to our customers and shareholders," said Rob Stewart, President and CEO of Amneal. "With a first-to-market 500m injectable solution, the Makena generic has the opportunity to capture share in an established $323 million market. In addition, with full approval on 35 products and 23 products now launched year-to-date, we are well-positioned to achieve our goal of launching up to 47 new products by the end of the year."