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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets (60 mg and 90 mg), of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are indicated to: i) Reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. ii) Reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. iii) Reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. iv) Reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Alembic was among the first ANDA applicants to file a substantially complete application with a Paragraph IV certification for Ticagrelor Tablets, 90 mg. According to IQVIA, Ticagrelor Tablets, 90 mg, have an estimated market size of US$1,062 million for the twelve months ending March 2025, while the 60 mg variant is estimated at US$242 million for the same period. With this approval, Alembic's total USFDA-approved ANDAs now stand at 222, including 197 final and 25 tentative approvals. The company's consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). Shares of Alembic Pharmaceuticals shed 0.31% to Rs 873.65 on the BSE. Powered by Capital Market - Live News |