Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is the generic equivalent of Brilinta Tablets, 60 mg, developed by AstraZeneca Pharmaceuticals LP. This approval allows Alembic to market the product in the United States, expanding its cardiovascular therapy portfolio and reinforcing its presence in the U.S. generics market.
Ticagrelor Tablets are prescribed to lower the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of heart attack. The medication is also indicated for reducing the risk of stent thrombosis following treatment for acute coronary syndrome, preventing first-time heart attacks or strokes in patients with high-risk coronary artery disease, and reducing stroke risk in patients with mild acute ischemic stroke or transient ischemic attack.
According to IQVIA data, the U.S. market for Ticagrelor Tablets, 60 mg, is valued at approximately USD 236 million for the twelve months ending June 2025. Alembic previously obtained final approval for Ticagrelor Tablets, 90 mg, strengthening its portfolio of cardiovascular care products. With this latest approval, Alembic now holds a total of 227 ANDA approvals, comprising 206 final and 21 tentative approvals from the USFDA.
Established in 1907, Alembic Pharmaceuticals is a vertically integrated, research-driven company with a strong global footprint. Headquartered in India, Alembic manufactures and markets high-quality generic medicines across multiple therapeutic areas. The company’s state-of-the-art facilities have received approvals from major global regulatory agencies, including the USFDA. In India, Alembic is recognized as a leader in branded generics, with a dedicated team of over 5,500 professionals serving healthcare providers and patients nationwide.
