Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced a 5-year supply and distribution agreement with American Regent for the only 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 500minjectable 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."
See the Full Prescribing Information and Patient Information leaflet for hydroxyprogesterone caproate injection at http://www.americanregent.com/HPC_FullPI_Carousel_Ad.html.
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has approximately 6,500 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States, with an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. The Company markets a portfolio of branded pharmaceutical products through its Impax Specialty Pharma division focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.
About American Regent
American Regent is a leader in the development, manufacturing and sales of generic and branded IV products. With a history of 50 years in generic specialty injectables, American Regent has sales approaching one billion dollars. American Regent strives for continuous improvement to bring to market high quality innovative medications to meet unmet medical needs, and produces high quality accessible generic medications covering a wide array of therapeutic areas. American Regent is a member of the Daiichi Sankyo Group; and is headquartered in Shirley, NY. For more information, please visit americanregent.com.
