Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). This approval is therapeutically equivalent to Pataday Once Daily Relief, 0.7%. The product is indicated for the temporary relief of itchy eyes. The market for this solution is estimated at US$20 million annually in the US.
USFDA Final Approval Granted
Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). This marks a significant milestone for the company’s product development and market entry strategy in the United States.
Product Equivalence and Indication
The approved ANDA for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is recognized as therapeutically equivalent to Alcon Laboratories, Inc.’s Pataday Once Daily Relief, 0.7%. The solution is intended for the temporary relief of itchy eyes caused by common allergens such as pollen, ragweed, grass, and animal dander. Detailed indication and usage information will be available on the product label.
Market Potential
Market data from IQVIA indicates a substantial market for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%. For the twelve months ending in September 2026, the estimated market size in the United States was valued at US$20 million. This approval positions Alembic Pharmaceuticals to capture a share of this market.
Development Collaboration
The development of this ANDA was a collaborative effort, with Alembic Pharmaceuticals working alongside Orbicular Pharmaceutical Technologies Pvt Ltd. This partnership has contributed to the successful attainment of this USFDA approval.
Company Achievements
With this latest approval, Alembic Pharmaceuticals has reached a cumulative total of 248 ANDA approvals from the USFDA. This includes 229 final approvals and 19 tentative approvals, highlighting the company’s consistent success in navigating the US regulatory landscape and expanding its product portfolio.
Source: BSE
