Alembic Pharmaceuticals Receives FDA Approval for Generic Ticagrelor 60mg Tablets for Acute Coronary Syndrome

Key Insights

• Alembic Pharmaceuticals Limited received final FDA approval for its generic ticagrelor tablets 60mg, therapeutically equivalent to AstraZeneca's Brilinta.
• The medication is indicated to reduce cardiovascular death, myocardial infarction, and stroke risk in patients with acute coronary syndrome or history of MI.
• The approved generic has an estimated market size of $236 million for the twelve months ending June 2025 according to IQVIA data.

Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ticagrelor tablets, 60 mg, marking another significant milestone in the company's generic drug portfolio expansion.

Therapeutic Equivalence and Market Position

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta tablets, 60 mg, manufactured by AstraZeneca Pharmaceuticals LP. According to IQVIA data, ticagrelor tablets, 60 mg, represent an estimated market size of US$ 236 million for the twelve months ending June 2025.

Clinical Indications and Superior Efficacy

Ticagrelor tablets are indicated 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. Notably, for at least the first 12 months following ACS, the medication demonstrates superior efficacy compared to clopidogrel.

The therapeutic applications extend beyond acute coronary syndrome management. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. Additionally, the medication is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA).

Regulatory Portfolio Expansion

This approval represents an expansion of Alembic's ticagrelor portfolio, as the company had previously received final approval for ticagrelor tablets in the 90 mg strength. The latest approval brings Alembic's cumulative total to 227 ANDA approvals from the US FDA, comprising 206 final approvals and 21 tentative approvals.

Market Performance Context

Alembic Pharma shares were trading flat at ₹905.15 around 12:20 pm on Wednesday following the announcement. The stock has declined 13.7% year-to-date, reflecting broader market conditions affecting pharmaceutical companies despite regulatory approvals.