Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated May 02, 2025, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Ticagrelor Tablets, 90 mg and Tentative Approval for Ticagrelor Tablets, 60 mg".
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Alembic Pharmaceuticals has received USFDA final approval for its generic Ticagrelor Tablets 90 mg and tentative approval for the 60 mg version, used for heart-related conditions like reducing risk of heart attacks and strokes. The 90 mg product is therapeutically equivalent to AstraZeneca's Brilinta, and Alembic was one of the first applicants to file for this generic, which could give it 180-day marketing exclusivity in the US. The combined US market for Ticagrelor Tablets is estimated at around US$ 1.3 billion (90 mg: ~US$ 1,062 million; 60 mg: ~US$ 242 million) for the 12 months ending March 2025. Alembic now has 222 total ANDA approvals from USFDA (197 final and 25 tentative).
This is a positive development for Alembic as it opens a potentially large revenue stream in the US generic market, with possible exclusivity benefits on the 90 mg version. Shareholders should note that tentative approval for 60 mg means it cannot be launched yet (likely due to patent/exclusivity restrictions on the brand), but the 90 mg final approval can translate to near-term revenue.