Alembic Pharmaceuticals Secures Final US FDA Approval for Ticagrelor Tablets

Alembic Pharmaceuticals announced on Wednesday, October 29, that it has obtained the final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Ticagrelor tablets, 60mg.

These tablets are prescribed to patients to significantly lower the risks of cardiovascular death, myocardial infarction (MI), and stroke, especially for individuals suffering from acute coronary syndrome (ACS) or those with a history of MI. The company highlighted that for the initial 12 months post-ACS, these tablets demonstrate superior effectiveness compared to clopidogrel. Furthermore, they aid in reducing the risk of stent thrombosis in patients who have undergone stenting, and also help prevent first MI or stroke in high-risk coronary artery disease patients and stroke in those with acute ischemic stroke or transient ischemic attack.

The approved ANDA is therapeutically equivalent to the reference-listed drug, Brilinta Tablets, 60 mg, manufactured by AstraZeneca Pharmaceuticals LP.

The market for these tablets is substantial, estimated by IQVIA to be worth $236 million for the 12 months concluding in June 2025. Alembic Pharmaceuticals had previously gained approval for the 90mg strength of these tablets.

This latest approval adds to Alembic Pharmaceuticals' robust portfolio, bringing their total ANDA approvals from the USFDA to 227, with 206 final approvals and 21 tentative approvals.

Impact This USFDA approval represents a significant commercial opportunity for Alembic Pharmaceuticals, granting them access to the large and lucrative US pharmaceutical market. Successful commercialization of these tablets is expected to drive revenue growth and enhance profitability, potentially boosting investor confidence and the company's stock valuation. It also underscores the company's capabilities in developing and gaining regulatory approval for generic drugs.

Impact Rating: 7/10

Difficult Terms Explained: USFDA: United States Food and Drug Administration, the agency responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other medical products. ANDA: Abbreviated New Drug Application, a pathway for generic drugs to show they are bioequivalent to an existing brand-name drug. Ticagrelor: An antiplatelet medication that helps prevent blood clots. Cardiovascular Death: Death resulting from diseases of the heart or blood vessels. Myocardial Infarction (MI): Commonly known as a heart attack, caused by blocked blood flow to the heart muscle. Stroke: Occurs when blood supply to the brain is interrupted, leading to brain cell damage. Acute Coronary Syndrome (ACS): A term for heart problems caused by sudden, reduced blood flow to the heart. Clopidogrel: Another antiplatelet medication used to prevent blood clots. Stent Thrombosis: The formation of a blood clot inside a coronary stent. Coronary Artery Disease (CAD): A condition where arteries supplying blood to the heart become narrowed or blocked. Therapeutically Equivalent: Two drugs that have the same active ingredients and produce the same therapeutic effect. IQVIA: A global company providing market research and data analytics for the pharmaceutical industry. Reference-Listed Drug (RLD): The original brand-name drug to which generic versions are compared for approval.