Alembic Pharmaceuticals Ltd has received final approval from the USFDA for Travoprost Ophthalmic Solution USP, 0.004%. The drug, used to lower intraocular pressure in glaucoma and ocular hypertension patients, is therapeutically equivalent to Travatan Z. With a U.S. market size of $61 million, the approval strengthens Alembic’s ophthalmology portfolio.
Alembic Pharmaceuticals Ltd announced that it has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). This approval allows Alembic to market a generic version of Travatan Z, a widely prescribed treatment for glaucoma and ocular hypertension.
Travoprost is a prostaglandin analog that reduces elevated intraocular pressure, a major risk factor for vision loss. The approval is significant as it expands Alembic’s ophthalmology offerings in the U.S., where the market size for Travoprost Ophthalmic Solution is estimated at $61 million annually. Alembic continues to strengthen its generics pipeline, with multiple approvals across therapeutic areas.
Key Highlights
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Drug approved: Travoprost Ophthalmic Solution USP, 0.004%.
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Indication: Used to reduce elevated intraocular pressure in glaucoma and ocular hypertension patients.
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Reference drug: Therapeutically equivalent to Travatan Z (Alcon).
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Market size: Estimated at $61 million in the U.S.
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Strategic impact: Enhances Alembic’s ophthalmology portfolio and U.S. generics presence.
This approval underscores Alembic’s focus on specialty generics and its ability to capture opportunities in niche therapeutic segments.
Sources: InvestyWise, MarketScreener, MoneyWorks4Me