Alembic Pharmaceuticals announced it has received USFDA final approval for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction and stroke.
USFDA Approval Received
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 60 mg. The announcement was made on October 29, 2025.
About Ticagrelor Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca).
Ticagrelor tablets are indicated for:
- 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 is superior to clopidogrel. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS.
- To reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events.
- To reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA).
Market Size
Ticagrelor Tablets, 60 mg, have an estimated market size of US$ 236 million for twelve months ending June 2025, according to IQVIA.
Prior Approvals
Alembic had previously received final approval for Ticagrelor Tablets, 90 mg.
ANDA Approvals
Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.
Source: BSE
