AMAG Pharmaceuticals Halts Marketing of Makena IM
August 7, 2019 – AMAG Pharmaceuticals has announced that it will discontinue marketing of Makena® (hydroxyprogesterone caproate) for intramuscular (IM) injection, as well as the product’s authorized generic. It will continue to market the Makena subcutaneous (SC) auto-injector, which was launched in 2018.
The announcement follows the rise of significant generic competition for Makena IM. Generics for the product first entered the market in 2018. During the same year, AMAG began to experience supply issues with Makena IM and its authorized generic. True generics now hold over 90% of the hydroxyprogesterone caproate IM market.
In contrast, Makena’s SC auto-injector, also launched in 2018, now holds 63% of the market share of all FDA-approved hydroxyprogesterone prescription products in the United States. Like Makena IM, Makena SC is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth, and must be administered by a healthcare provider.