Mumbai: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg from the United States Food and Drug Administration (FDA) to market a generic version of Mallinckrodt Inc.’s Roxicodone® Tablets.
Lupin’s Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is the AB rated generic equivalent of Mallinckrodt Inc.’s Roxicodone® Tablets. Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Roxicodone® Tablets had US sales of USD 344 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 (March 31st, 2017, Bloomberg) and sales globally (December 31st, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT Feb 2017); the 2nd largest Indian pharmaceutical company by global revenues; the 6th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (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 –
Head – Investor Relations and M&A
Roxicodone® is a registered trademark of Mallinckrodt LLC Limited.