Branded vs. Compounded 17-alpha Hydroxyprogesterone Caproate for Preventing Preterm Birth: Not Getting More for the Money

Note: U.S. FDA approval of 17-OHPC products (Makena and generic equivalents) was withdrawn on April 6, 2023.

Weekly intramuscular injection of 17-alpha hydroxyprogesterone caproate (17-OHPC) during pregnancy in women with prior histories of preterm birth has been associated with reduced risk for preterm birth and is endorsed by relevant professional societies. KV Pharmaceutical's successful FDA application for manufacturing rights came with a large increase in per-dose price that many criticized (NEJM JW Womens Health Jul 2011 and Obstet Gynecol 2011; 117:1408). Following a public-health catastrophe involving fungal infections arising from (nonobstetric) use of compounded medications, prescription and coverage of compounded 17-OHPC has been…