Lupin gets US FDA nod for marketing generic Percocet tablets

India's second-largest pharmaceutical company, Lupin has received approval from the US Food and Drug Administration (US FDA) for marketing a generic version of Braintree Laboratories' Suprep Bowel Prep Kit.

Lupin said it has received final approval for its Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces from the USFDA to market a generic version of Braintree Laboratories' Suprep Bowel Prep Kit.

Lupin's Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces is the AA rated generic equivalent of Braintree Laboratories' Suprep Bowel Prep Kit. Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces is indicated for cleansing of the colon in preparation for colonoscopy in adults, says Lupin.

Suprep Bowel Prep Kit had US sales of $207.2 million (IMS MAT December 2016).

Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults.

Suprep Bowel Prep Kit has a market of $207 million in the USA and Lupin will launch the generic version under a 180-day exclusivity period. The Indian pharma major is expected to generate sales of $30 million through this product launch.

Lupin is an innovation-led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID space and holds global leadership position in the anti-TB segment.

Lupin is the fifth largest generics pharmaceutical company by market capitalisation and and the sixth-largest by sales globally. The company is the fifth-largest pharmaceutical player in the US by prescriptions (4.68 per cent market share – IMS Health, National Prescription Audit); the second-largest Indian pharmaceutical company by revenues; the sixth-largest generic pharmaceutical player in Japan and the fourth-largest generic pharmaceutical company in South Africa (IMS Health).

For the financial year ended 31 March 2016, Lupin reported a net profit of Rs2,261 crore ($345 million) and consolidated sales of Rs13,653.9 crore.