Alembic Pharmaceuticals Scores Double Win: USFDA Greenlights Both 90 mg and 60 mg Ticagrelor Tablets

Alembic Pharmaceuticals Ltd has won a major regulatory achievement as the US Food and Drug Administration (USFDA) has granted final approval to its Ticagrelor Tablets, 90 mg, and tentative approval to the 60 mg strength. 90 mg is licensed as a therapeutically similar generic version of AstraZeneca's Brilinta, which is a top antiplatelet drug for lowering cardiovascular mortality, heart attack, stroke, and stent thrombosis in high-risk patients with acute coronary syndrome or past history of myocardial infarction.

 

The 60 mg Ticagrelor tablets have been tentatively approved subject to patent expiry or exclusivity clearance, preparing Alembic to enter quickly as soon as market conditions are favorable. Alembic filed an ANDA for the 90 mg dosage with a Paragraph IV certification being one of the first, marking a patent challenge to the innovator.

 

As per IQVIA, the US size for Ticagrelor 90 mg stands at $1.06 billion, while the 60 mg segment is worth $242 million for the period ending March 2025. These launches represent Alembic's 222nd USFDA approval, further solidifying its strong footprints in regulated markets and dedication to strengthening its global generics portfolio.

 

Source: Business Upturn, NSE India, Alembic Pharmaceuticals