Alembic Pharmaceuticals has received U.S. Food and Drug Administration final approval for an abbreviated new drug application for Ticagrelor Tablets 90 mg and tentative approval for Ticagrelor Tablets 60 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome or a history of MI.
For Ticagrelor Tablets 90 mg, Alembic was one of the first to submit a substantially complete ANDA with a paragraph IV certification. The estimated market size of Ticagrelor Tablets 90 mg was $1,062 million for twelve months ending March 2025. Ticagrelor Tablets 60 mg had an estimated market size of $242 million during the same period, the company said citing IQVIA numbers.
The tablet is also indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS; to reduce risk of a first MI or stroke in patients with coronary artery disease; and to reduce the risk of stroke in patients with acute ischemic stroke.
Published – May 02, 2025 08:30 pm is
