Alembic Pharmaceuticals Limited announced on May 2, 2025, that it has received final approval from the US Food and Drug Administration (USFDA) for its Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg.
The 90 mg dosage has been approved as a therapeutically equivalent generic to AstraZeneca’s Brilinta, and is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), stroke, and stent thrombosis in certain high-risk patients. The 60 mg variant has also received tentative approval pending patent expiry or exclusivity clearance.
Alembic was among the first ANDA applicants to file for the 90 mg dosage with a Paragraph IV certification, indicating it is contesting the innovator’s patent.
According to IQVIA data, the estimated market size in the U.S. for the 90 mg Ticagrelor tablets is approximately US$ 1,062 million, and for the 60 mg tablets is around US$ 242 million, for the twelve months ending March 2025.
With this development, Alembic’s cumulative USFDA approvals now stand at 222 ANDAs, comprising 197 final approvals and 25 tentative approvals.
The company reaffirmed its long-standing focus on regulated markets, with robust R&D and vertically integrated manufacturing capabilities. Alembic continues to expand its presence in global generics with a strong pipeline and established regulatory track record.
