Alembic Pharma gets USFDA nod for eye drug, wins 180-day exclusivity

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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AI summary

Alembic Pharmaceuticals has received USFDA final approval for its generic version of Zylet Ophthalmic Suspension (Loteprednol Etabonate and Tobramycin, 0.5%/0.3%), used for steroid-responsive inflammatory eye conditions. The product comes in 5 mL and 10 mL pack sizes. Alembic was granted a Competitive Generic Therapy designation, making it eligible for 180 days of market exclusivity in the US upon launch. The company now holds 231 cumulative ANDA approvals (211 final, 20 tentative).

Likely market impact

180-day CGT exclusivity positions Alembic as one of the first generic launches in the US, likely boosting near-term US revenue from this product.