June 27, 2024 Lupin Receives Tentative Approval from U.S. FDA for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

Mumbai, Naples, June 27, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received a tentative approval from the United States Food and Drug Administration (U.S. FDA)for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC),to market a generic equivalent of Pataday® Once Daily Relief, 0.7% (OTC), of Alcon Laboratories Inc. This product will be manufactured at Lupin's Pithampur facility in India.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Olopatadine Hydrochloride Ophthalmic Solution USP (RLD Pataday®) had an estimated annual sale of USD22 million in the U.S. (IQVIA MAT April 2024).

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
Follow us on:
LinkedIn: https://www.linkedin.com/company/lupin
Facebook: https://www.facebook.com/LupinWorld/
Twitter: https://twitter.com/LupinGlobal

For further information or queries please contact -
Heena Dhedhi
Deputy General Manager - Corporate Communications
Email: [email protected]

*Safe Harbor Statement
Pataday® is a registered trademark of Novartis AG