Alembic Pharmaceuticals gained 3.25% to Rs 1023 after the company said it received US drug regulator's tentative approval for Empagliflozin and Linagliptin tablets in multiple strengths.
Alembic Pharmaceuticals announced that 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 $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 theproduct will depend on litigation outcome.
Alembic Pharmaceuticals reported a 143.7% surge in consolidated net profit to Rs 301.46 crore on 41.4% rise in net sales to Rs 1,341.32 crore in Q1 June 2020 over Q1 June 2019.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.
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