Alembic Pharmaceuticals has secured USFDA final approval for its Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). This approval allows Alembic to market a therapeutically equivalent version of Travatan Z, used to reduce elevated intraocular pressure in glaucoma and ocular hypertension patients. The market size for this solution is estimated at US$ 61 million.
USFDA Approval Secured
Alembic Pharmaceuticals Limited has announced it received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). The announcement was made on December 18, 2025.
Therapeutic Equivalence
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. (Sandoz). Travoprost ophthalmic solution is indicated for reducing elevated intraocular pressure (IOP) in patients diagnosed with open-angle glaucoma or ocular hypertension.
Market Opportunity
The announcement highlights a substantial market opportunity, estimating the market size for Travoprost Ophthalmic Solution USP, 0.004%, to be approximately US$ 61 million based on the twelve months ending in September 2025, as reported by IQVIA.
ANDA Approvals
With this approval, Alembic Pharmaceuticals now holds a cumulative total of 232 ANDA approvals, comprising 212 final approvals and 20 tentative approvals from the USFDA.
Source: BSE
