Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received tentative approval for its Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg from the United States Food and Drug Administration (FDA) to market a generic version of Kowa Company Limited’s (Kowa) Livalo® Tablets 1 mg, 2 mg, and 4 mg. The filing is from Lupin’s Pithampur (Indore) manufacturing facility.
Lupin’s Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg are the AB rated generic equivalent of Kowa’s Livalo® Tablets, 1 mg, 2 mg, and 4 mg. Pitavastatin Tablets are indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.
Livalo® Tablets had US sales of USD 245.3 million (IMS MAT Sep 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 6th and the 8th largest generics pharmaceutical company by market capitalization and sales globally (September 30th, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 3rd largest Indian pharmaceutical company by revenues; the 6th largest generic pharmaceutical player in Japan and the 4th 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, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Corporate Communications
Ph: +91 98 20 338 555
Head – Investor Relations and M&A
Ph: +91-70 45 656 895
Livalo® is the registered trademark of Kowa Group of Companies