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Lupin receives sANDA approval from US FDA for Levothyroxine Sodium Tablets USP AB ratingto Reference Listed Drug, LEVOXYL®
Mumbai, Baltimore, November 01, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approvalfor its sANDA forLevothyroxine Sodium Tablets USPfrom the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of LEVOXYL® 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg,150 mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by King Pharmaceuticals Research and Development LLC.
Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg was originally approved on January 18, 2019 as generic equivalent of SYNTHROID® manufactured by ABBVIE Inc.
Earlier, Lupin also received sANDA approval dated September 19, 2019 for its Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of UNITHROID® manufactured by Jerome Stevens Pharmaceuticals Inc.
With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID®, UNITHROID® and LEVOXYL® and are the only product approved with FDA’s new Narrow Therapeutic Index guidance for Levothyroxine.
Lupin’s Levothyroxine Sodium Tablets are indicated for:
Cumulatively, Levothyroxine Sodium Tablets USP (RLDs: SYNTHROID®, UNITHROID® and LEVOXYL®) had annual sales of approximately USD 2,581 million in the US (IQVIA MAT June 2019).
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 8thlargest generics pharmaceutical company by revenues (31stMar 2019, Bloomberg LTM) respectively. The Company is the 3rdlargest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rdlargest Indian pharmaceutical company by global revenues (31stMar 2019, Bloomberg LTM); 5thlargest generic pharmaceutical player in Japan and 6thlargest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).
For the financial year ended 31stMarch 2019, Lupin’s Consolidated sales and Net profits were at Rs. 163,694 million (USD 2.34 billion) and Rs. 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal
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 – Investor Relations and M&A / Corporate Communications
*Safe Harbor Statement
LEVOXYL®is the registered trademark of King Pharmaceuticals Research and Development LLC.
UNITHROID®is the registered trademark of Jerome Stevens Pharmaceuticals Inc.
SYNTHROID® is the registered trademark of AbbVie Inc.
Vinita Gupta is the CEO of Lupin Limited (Lupin) and Chairperson of Lupin Inc., (LI) and its US subsidiary, Lupin Pharmaceutical Inc. (LPI).
Vinita is a graduate in pharmacy from the University of Mumbai and earned an MBA degree at the Kellogg School of Management at Northwestern University. Vinita has been instrumental in formulating and executing a strategy that has helped the company emerge as a global pharmaceutical powerhouse; amongst the most exciting growth stories in the pharmaceutical industry. Through a combination of organic growth and strategic acquisitions, she has led the company’s global expansion plans. In particular, she founded, led and established Lupin’s largest region, the United States.
Vinita has been regularly named by Forbes Asia in its Top 50 Power Business women listings for Asia Pacific. Vinita was also recognized by Business Today Hall of Fame – Most Powerful Women in Business in 2016 and was recently named Outstanding Business Woman Leader of the Year by CNBC India Business Leader Awards. She was the winner of the inaugural EY, U.S. 2012 Family Business Award of Excellence and EY Entrepreneur Of the Year® 2012 award winner for Health Services and Technology in Maryland. She is regarded as amongst the most influential Indian Business Women globally.
Vinita along with her brother Nilesh (Managing Director, Lupin Limited) were named Ernst & Young (EY) Entrepreneur of The Year 2015 and won the Forbes India Leadership Awards 2016, Entrepreneur of the Year.
In 2017 Vinita was appointed to the board of directors for Intrexon Corporation. She is also a member of the Global Advisory Board at the Kellogg School of Management at Northwestern University.
Mr. Nilesh Gupta is the MD of Lupin Limited and a member of the Board of Directors. Having joined Lupin in 1996, Mr. Gupta led Lupin’s research, supply chain, manufacturing, quality and regulatory operations, and took charge as the company’s Managing Director in 2013. He has not only been responsible for transforming Lupin’s research program and expanding the company’s manufacturing operations but has also been instrumental in formulating and executing the core strategy that has helped Lupin emerge as a global specialty pharmaceutical major.
Mr. Gupta, along with his sister Vinita Gupta, won the Entrepreneur of the Year award at Forbes India Leadership Awards in 2016 as well as Ernst & Young ‘Entrepreneur of the Year Award’ in India in 2015, also with his sister Vinita Gupta.
Mr. Gupta is a Chemical Engineer from the University Department of Chemical Technology (UDCT) (now ICT), Mumbai, and a graduate with honours from the Wharton School, University of Pennsylvania, USA, where he specialized in healthcare, strategic management and finance.