Alembic Pharmaceuticals Limited announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and mg/1000 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer Ingelheim).
Empagliflozin and Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.
Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, mg/500 mg, and 12.5 mg/1000 mg have an estimated market size of US$ 172 million for twelve months ending March 2020 according to IQVIA. Alembic is currently in litigation with Boehringer Ingelheim in District Court of Delaware and launch of the product will depend on litigation outcome.
Alembic now has a total of 126 ANDA approvals (111 final approvals and 15 tentative approvals) from USFDA.