Lupin Bags US FDA Nod for Travoprost Ophthalmic Solution USP

Lupin Limited (Lupin) announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application for travoprost ophthalmic solution USP, 0.004% (ionic buffered solution), to market a generic equivalent to Sandoz Inc.'s reference listed drug (RLD) Travatan Z ophthalmic solution, 0.004%. The product will be manufactured at Lupin's Pithampur plant in India.

Travoprost ophthalmic solution USP, 0.004%, is used to reduce high intraocular pressure in individuals with open angle glaucoma or ocular hypertension. Travoprost ophthalmic solution USP, 0.004% (RLD Travatan Z) has an expected annual sales value of USD 77 million in the United States (IQVIA MAT March 2024). Lupin is an innovative global pharmaceutical firm based in Mumbai, India. The firm develops and commercializes a diverse variety of branded and generic formulations, biotechnology products, and APIs in over 100 markets including the United States, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

Lupin's research program includes the full pharmaceutical product cycle. The Lupin Research Park, near Pune and Aurangabad, is home to around 1,400 scientists and serves as the company's R&D headquarters. Paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and tuberculosis are among the company's primary emphasis areas.