Lupin receives FDA approval for generic Lidex® Ointment


Mumbai, August 01, 2017: Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Fluocinonide Topical Ointment USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of County Line Pharmaceuticals, LLC’s Lidex® Ointment, 0.05%.

Lupin’s Fluocinonide Topical Ointment USP, 0.05% is AB rated generic equivalent of County Line Pharmaceuticals, LLC’s Lidex® Ointment, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Lidex® Ointment had US sales of USD 40.3 million (IMS MAT March 2017).

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 4th and the 6th largest generics pharmaceutical company by market capitalization and revenues globally (March 31st, 2017, Bloomberg). The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); the 2nd largest Indian pharmaceutical company by global revenues; the 6th largest generic pharmaceutical player in Japan and the 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT March 2017).

For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com  for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited

CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.

For further information or queries please contact – Pooja ThakranVP – Corporate CommunicationsPh: +91-22-66402531 / 9811665000Email: poojathakran@lupin.com  Arvind BothraHead – Investor Relations and M&APh: +91-22-66402137      Email: arvindbothra@lupin.com

*Safe Harbor Statement

Lidex® is a registered trademark of County Line Pharmaceuticals, LLC.