Alembic Pharmaceuticals Limited has announced that it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 60 mg.
The approved product is therapeutically equivalent to the reference listed drug, Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP, it said in a statement here.
Ticagrelor is prescribed to 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 has been shown to be superior to clopidogrel.
The drug also helps reduce the risk of stent thrombosis in patients who have undergone stent placement for ACS. Additionally, it is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk, and to lower the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA), said the statement here
Citing data from IQVIA for the twelve months ending June 2025, Alembic said Ticagrelor Tablets, 60 mg, have an estimated market size of about USD 236 million. The company had earlier received USFDA approval for Ticagrelor Tablets, 90 mg.
With this approval, Alembic’s cumulative tally of USFDA-approved ANDAs stands at 227, comprising 206 final and 21 tentative approvals.
The company manufactures and markets generic pharmaceutical products globally and is among the leaders in the branded generics segment in India. Its state-of-the-art research and manufacturing facilities are approved by major regulatory authorities, including the USFDA.
