Amneal partners with American Regent for generic Makena

8/31/2018
Amneal Pharmaceuticals has reached a five-year supply and distribution agreement with American Regent for the only preservative-free generic alternative to Makena (hydroxyprogesterone caproate injection, 250mg/mL. The injectable is used to reduce the risk of preterm birth in certain women.

The product had a market value of approximately $323 million for the 12 months ended June 2018, according to IQVIA data.

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.

"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," Amneal president and CEO Rob Stewart said, in a press statement. "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."

In a separate development, the Food and Drug Administration has given Amneal the green light 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%. Topical fluocinonide cream had a market value of $34 million, for the 12 months ended June 2018.
according to IQVIA data.

Amneal recently launched a generic version of Lodine (etodolac) IR 400 mg and 500 mg tablets. The product had a market value of approximately $36 million, for the 12 months ended June 2018, according to IQVIA data.
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