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Mumbai, Baltimore, July 20, 2016: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals Inc. has launched its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg having received an approval from the United States Food and Drug Administration (FDA) earlier to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho Tri-Cyclen® Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg).
Lupin’s Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.’s Ortho Tri-Cyclen® Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg / 0.035 mg, 0.215 mg / 0.035 mg and 0.25 mg / 0.035 mg). It is indicated for use by females of reproductive potential to prevent pregnancy.
It is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Ortho Tri-Cyclen® had US sales of USD 177.6 million (IMS MAT March 2016).
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing 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 largest generics player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2nd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th 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 turnover and Profit after Tax stood at Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 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 – Corporate Communications
Ph: +91-98 20 338 555
*Safe Harbor Statement
Ortho Tri-Cyclen® is the registered trademark of Johnson & Johnson Corporation.