The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, of Alcon Laboratories, Inc.
Olopatadine Hydrochloride Ophthalmic Solution USP is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
According to IQVIA, Olopatadine Hydrochloride Ophthalmic Solution USP has an estimated market size of $22 million for twelve months ending September 2024.
Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA.
Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients.
The pharmaceutical company’s consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.
The scrip rose 0.06% to currently trade at Rs 1,101.05 on the BSE.