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Lupin Receives FDA Approval for Generic Percocet® Tablets

 

Mumbai, February 28, 2017: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Oxycodone and Acetaminophen Tablets USP, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) to market a generic version of Vintage Pharmaceuticals LLC’s Percocet® Tablets, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. Lupin shall commence promoting the product shortly.

Lupin’s Oxycodone and Acetaminophen Tablets USP, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg is the AA rated generic equivalent of Vintage Pharmaceuticals LLC’s Percocet® Tablets, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. Oxycodone and Acetaminophen Tablets USP, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg are indicated for relief of moderate to moderately severe pain.

Percocet® Tablets had US sales of USD 838.7 million (IMS MAT December 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 5th and the 6th largest generics pharmaceutical company by market capitalization (December 31st, 2016, Bloomberg) 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 2nd 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 –

Arvind Bothra
Head – Investor Relations and M&A
Ph: +91-22-6640 2137
Email: arvindbothra@lupin.com 

*Safe Harbor Statement

Percocet® is the registered trademark of Endo Pharmaceuticals Inc.