Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Empagliflozin and Linagliptin Tablet is 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 Linagliptin is appropriate.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of Empagliflozin and Linagliptin Tablets on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established. Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of US$ 244 million for twelve months ending June 2020 according to IQVIA.
Alembic is currently in litigation with Boehringer in District Court of Delaware and launch of the product will depend on litigation outcome. Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.