ANI’s Misoprostol Tablets are the generic version of the Reference Listed Drug (RLD) Cytotec®. The current annual U.S. market for Misoprostol Tablets, 100 mcg and 200 mcg is approximately $15.3M, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
"We are pleased to announce the launch of AB rated Misoprostol Tablets. The AB rating indicates that our product meets necessary bioequivalence requirements, thus is therapeutically equivalent to the RLD. This rating provides us with an advantage versus other available generics. In light of the recent drug shortage, the commercialization of Misoprostol Tablets highlights our commitment to rapidly bringing limited market competitive generic products to our patients in need and to our customers,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.