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Lupin Launches Generic Activella® Tablets in the US

 

Mumbai, Baltimore, November 15, 2016: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals, Inc. has launched its Amabelz™ Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) having received an approval from the United States Food and Drug Administration (FDA) earlier to market a generic version of Amneal Pharmaceuticals’ Activella® Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg).

Lupin’s Amabelz™ Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg) are the AB rated generic equivalent of Amneal Pharmaceuticals’ Activella® Tablets (Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg / 0.1 mg and 1 mg / 0.5 mg).

Amabelz™ Tablets 0.5 mg / 0.1 mg and 1 mg / 0.5 mg are indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis.

Amabelz™ Tablets 1 mg / 0.5 mg is also indicated in a woman with a uterus for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Activella® had US sales of USD 91.1 million (IMS MAT June 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.

    

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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 –

Shamsher Gorawara
Head – Corporate Communications
Ph: +91-98 20 338 555
Email: shamshergorawara@lupin.com

Arvind Bothra
Head – Investor Relations and M&A
Ph: +91-70 45 656 895
Email: arvindbothra@lupin.com

*Safe Harbor Statement

Activella® is the registered trademark of Novo Nordisk Health Care AG.