Alembic gets USFDA nod for generic drug

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic medication for the prevention of heart attack and stroke. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg, Alembic Pharma said in a statement.

The company's approved ANDA is therapeutically equivalent to AstraZeneca Pharmaceuticals's Brilinta Tablets, 60 mg and 90 mg, it added.

Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome.


For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drug firm said.

According to IQVIA, Ticagrelor Tablets (90 mg) have an estimated market size of USD 1,062 million for twelve months ending March 2025.

Ticagrelor Tablets, 60 mg have an estimated market size of USD 242 million for twelve months ending March 2025.

Alembic shares were trading 0.03 per cent down at Rs 876.10 apiece on BSE.