Alembic Pharma Gets FDA Approval for Ophthalmic Drug With Exclusivity

Alembic Pharmaceuticals has received final FDA approval for its Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, a generic version of the branded eye treatment Zylet.

This achievement enhances the pipeline of U.S. generics at the company and preconditions a successful arrival in a competitive ophthalmic market.

The drug comes in 0.5%/0.3 strength of both 5 and 10ml bottles. It manages steroid–responsive inflammatory eye diseases, which have the risk of bacterial infection and thus has an anti-inflammatory effect and antibiotic effect. It is clinically equal to the reference product, Bausch & Lomb, which is a measure of its therapeutic equivalence of the products to the U.S. safety and effectiveness standards.

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Another designation achieved by Alembic is a Competitive Generic Therapy (CGT) and this designation will grant the product up to 180 days of market exclusivity when it is commercialized. Such exclusivity will provide a strong first-mover advantage of the company in the U.S. generic ophthalmic market before other competitors come in.

Industry-wise, this license will increase the presence of Alembic in the U.S. generics. The introduction of the most recent ANDA into its collection of products helps emphasize that the company can meander its way across complicated regulations and introduce high-valued generic drugs to the market.

The market observers perceive the CGT exclusivity period as one of the major opportunities through which Alembic can gain early market share and solidify revenues in a segment in which there is a strong demand of cost-effective ophthalmic therapies.

This is one of the wider strategies that Alembic has to develop scale and power in regulated segments by means of specific approvals and regulatory designations that contribute to competitive positioning.