APAlembic Pharmaceuticals533573Regulatory approval

Alembic Pharmaceuticals receives USFDA final approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

Alembic Pharmaceuticals received USFDA final approval on 4 November 2026 for its ANDA for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

By ScoutQuest · Wed 4 Nov 2026, 9:57 PM IST · 1 min read

Cumulative USFDA ANDA approvals

248, comprising 229 final approvals and 19 tentative approvals

Estimated US market size (IQVIA)

US$20 million in the United States for the twelve months ending September 2026

USFDA final approval date

4 November 2026

Release

Press release

📌 Alembic Pharmaceuticals says the approved ANDA is therapeutically equivalent to the reference listed drug product Pataday Once Daily Relief, 0.7%, of Alcon Laboratories, Inc.

📌 Alembic Pharmaceuticals says the product is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.

📌 Alembic Pharmaceuticals' cumulative USFDA ANDA approvals stand at 248, comprising 229 final approvals and 19 tentative approvals.

📌 According to IQVIA, 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, the company cites.

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