In a major win for the pharmaceutical industry, Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg. This milestone strengthens Alembic’s position in the generic drug market, offering a cost-effective alternative to AstraZeneca’s Brilinta Tablets.
A Breakthrough in Cardiovascular Treatment
Ticagrelor Tablets are used to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction. The USFDA approval confirms that Alembic’s generic version is therapeutically equivalent to Brilinta, providing healthcare providers and patients with a high-quality, affordable option for cardiovascular treatment.
According to IQVIA, the market size for Ticagrelor Tablets, 90 mg, is estimated at US$1,062 million, while the 60 mg variant holds a market size of US$242 million for the twelve months ending March 2025. Alembic’s early submission of a substantially complete ANDA with a paragraph IV certification for the 90 mg tablets highlights its competitive edge in pharmaceutical manufacturing.
Real Also – Alembic Pharmaceuticals Limited announces USFDA Final Approval for Ticagrelor Tablets (Press Release)
Impact on the Generic Drug Market
This approval bolsters Alembic’s portfolio, which now includes a cumulative total of 222 ANDA approvals (196 final and 26 tentative) from the USFDA. It underscores the company’s commitment to healthcare innovation and its role in making life-saving medications accessible. The launch of generic Ticagrelor Tablets is poised to increase competition, potentially reducing costs for patients and healthcare systems.
1 thought on “Alembic Pharma’s USFDA Approval for Ticagrelor Tablets Boosts Generic Drug Market”