Date: 4th November, 2026
Regulatory Approval Details
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (Over-the-Counter). The approval was granted on 4th November, 2026.
Product Information
The approved product is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief, 0.7%, manufactured by Alcon Laboratories, Inc. (Alcon). Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Market Size
According to IQVIA data, Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% had an estimated market size of US$20 million in the United States for the twelve months ending September 2026.
Development Collaboration
The ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd.
Cumulative Approvals
With this approval, Alembic Pharmaceuticals now has a cumulative total of 248 ANDA approvals from the USFDA, comprising 229 final approvals and 19 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide and is one of the leaders in branded generics in India. Alembic markets its brands through a field force of over 5,800 representatives. The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.