Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The approved product is therapeutically equivalent to Brilinta Tablets, 60 mg, marketed by AstraZeneca Pharmaceuticals LP.
Ticagrelor Tablets are indicated for multiple cardiovascular conditions. They are prescribed to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For the first 12 months following ACS, Ticagrelor has demonstrated superiority over clopidogrel. The tablets also help reduce the risk of stent thrombosis in patients treated with stents for ACS. Additionally, they are used to lower the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk, and to reduce stroke risk 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 US$ 236 million for the twelve months ending June 2025. This approval adds to Alembic’s growing portfolio of cardiovascular therapies and strengthens its presence in the US generics market.
Alembic had previously received final approval for Ticagrelor Tablets, 90 mg. With this latest approval, the company’s cumulative total of ANDA approvals from the USFDA stands at 227, comprising 206 final approvals and 21 tentative approvals.
This milestone reflects Alembic’s continued commitment to expanding its high-quality generic offerings and meeting global healthcare needs through regulatory excellence and product innovation.
