Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg, a generic version of AstraZeneca’s Brilinta. The approval allows Alembic to market the product in the US, expanding its cardiovascular drug portfolio.
Drug Details
The approved formulation is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg, by AstraZeneca Pharmaceuticals LP. Ticagrelor is indicated for:
- Reducing the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
- Reducing the risk of stent thrombosis in patients who have been stented for ACS.
- Reducing the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk.
- Reducing the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA).
Market Size and Previous Approvals
According to IQVIA data for the 12 months ending June 2025, Ticagrelor Tablets, 60 mg, have an estimated market size of US$ 236 million in the United States.
Alembic had earlier received final approval for Ticagrelor Tablets, 90 mg, strengthening its presence in the cardiovascular therapeutic category.
Regulatory Milestone
With this latest approval, Alembic’s cumulative tally from the USFDA stands at 227 ANDA approvals — comprising 206 final approvals and 21 tentative approvals.
Founded in 1907, Alembic Pharmaceuticals is a vertically integrated R&D-driven pharmaceutical company, with manufacturing and research facilities approved by major global regulatory authorities, including the USFDA.
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