Lupin Receives FDA Approval for Generic Nuvigil® Tablets

The filing is from Lupin’s Goa manufacturing facility

MUMBAI, India & BALTIMORE--(BUSINESS WIRE)--Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc.’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg. LPI shall commence promoting the product in the US shortly.

Lupin’s Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg are the AB rated generic equivalents of Cephalon, Inc.’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD).

Nuvigil® Tablets had US sales of USD 515.6 million (IMS MAT September 2016).

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 6^th and the 8^th largest generics pharmaceutical company by market capitalization and sales globally (September 30^th, 2016, Bloomberg). The Company is the 5^th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 3^rd largest Indian pharmaceutical company by revenues; the 6^th largest generic pharmaceutical player in Japan and the 4^th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).

For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 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, 3^rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.

*Safe Harbor Statement

Nuvigil® is the registered trademark of Cephalon, Inc.