Alembic Pharmaceuticals, a leading Indian company in branded generics, has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is therapeutically equivalent to Brilinta Tablets, 60 mg, from AstraZeneca.

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. The drug is known to be superior to clopidogrel for at least the first 12 months following ACS and also helps reduce the risk of stent thrombosis in patients treated with stents for ACS.

Additionally, Ticagrelor is indicated to lower the risk of a first MI or stroke in patients with coronary artery disease (CAD) who are at high risk of such events, and to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA).

According to IQVIA, Ticagrelor Tablets, 60 mg, have an estimated market size of USD 236 million for the twelve months ending June 2025.

Alembic had earlier received final approval for Ticagrelor Tablets, 90 mg. With this approval, the company now has a cumulative total of 227 ANDA approvals, comprising 206 final and 21 tentative approvals.