Alembic Pharma jumps after tentative USFDA nod for diabetes drug

Alembic Pharmaceuticals spurts 5.28% to Rs 1,028.50 after the company said it received tentative approval from the US drug regulator for empagliflozin and metformin hydrochloride tablets.

Alembic Pharmaceuticals on Monday (20 July) announced that it 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 12.5 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 lngelheim Pharmaceuticals, Inc. (Boehringer lngelheim).

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. The drug has an estimated market size of $172 million for twelve months ending March 2020 according to IQVIA.

Alembic is currently in litigation with Boehringer lngelheim 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.

The drug maker's consolidated net profit jumped 54.8% to Rs 203.52 crore on a 30.2% rise in net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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