Alembic Pharmaceuticals gets USFDA's tentative approval for type 2 diabetes drug

NEW DELHI: Drug firm Alembic Pharmaceuticals on Thursday said it has received tentative approval from the US health regulator for Empagliflozin and Linagliptin tablets, used for management of type-2 diabetes.

Empagliflozin and Linagliptin Tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.


In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval from the US Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin tablets in the strengths of 10 mg/5 mg and 25 mg/5 mg.

Alembic Pharma said it is currently in litigation with Boehringer in District Court of Delaware and launch of the product will depend on litigation outcome.

Quoting IQVIA data, Alembic Pharma said Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of USD 244 million for 12 months ending June 2020.

Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals were trading 1.95 per cent higher at Rs 1,010.10 apiece on the BSE.