Alembic Pharma gets USFDA approval for Ticagrelor Tablets

Alembic Pharmaceuticals Limited today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. This approval signifies that the company's product is therapeutically equivalent to AstraZeneca's Brilinta Tablets, 60 mg.

Ticagrelor Tablets, 60 mg, are indicated for reducing the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of MI. Additionally, it helps reduce the risk of stent thrombosis in patients stented for ACS, and the risk of a first MI or stroke in high-risk CAD patients. The tablets also address the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack. The estimated market size for Ticagrelor Tablets, 60 mg, was $236 million for the twelve months ending June 2025.

This latest approval adds to Alembic's growing portfolio, bringing their cumulative total to 227 ANDA approvals from the USFDA, comprising 206 final and 21 tentative approvals. The company had previously secured final approval for Ticagrelor Tablets, 90 mg.