ANI Pharma files U.S. application for competitor to Mallinckrodt’s Acthar Gel

ANI Pharmaceuticals (ANIP +13.1%) has filed a marketing application with the FDA seeking approval to reintroduce Purified Cortrophin Gel (repository corticotropin injection USP) (80 U/mL) into the U.S. market aimed at taking market share from Mallinckrodt’s (MNK +0.6%) top seller Acthar Gel (repository corticotropin injection) 80 U/mL.

Cortrophin Gel, with over 54 indications, was originally approved in the U.S. in 1954 and was last used in the 1980s. The company acquired the rights from Merck (MRK +1.9%) in January 2016.

If approved, it plans to sell the product at a “substantial discount” to Mallinckrodt’s offering.

https://seekingalpha.com/news/3554715-ani-pharma-files-u-s-application-for-competitor-to-mallinckrodts-acthar-gel