Lotus Pharmaceutical Co. Ltd. (Lotus) announced that the U.S. Food and Drug Administration (USFDA) has granted the tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, generic version of Boehringer Ingelheim Pharmaceuticals Inc's OFEV. Lotus/Alvogen expects to prepare to launch the product after the patent has expired.

According to IQIVIA data, the total sales of OFEV in the US were approximately USD 1.8billion for the 12 months ended December 31, 2021. Based on the public information currently available, 4 companies, including Glenmark, Accord, Eugia and Lotus/Alvogen, have received tentative approvals separately.