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1st product launch from the GAVIS pipeline with 180 days exclusivity
Mumbai, Baltimore, April 5, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Lupin Pharmaceuticals Inc. (collectively Lupin) has launched the first product from its GAVIS pipeline, Zolpidem Sublingual Tablets, 1.75 mg & 3.5 mg to market a generic equivalent of Purdue Pharma L.P’s Intermezzo® Sublingual Tablets, 1.75 mg & 3.5 mg, having received final approval from the United States Food & Drug Administration (FDA) earlier, as well as final clearance from the FTC with 180 days of exclusivity.
Zolpidem Sublingual Tablets, 1.75 mg & 3.5 mg are AB-rated generic equivalent of Purdue Pharma L.P’s Intermezzo® Sublingual Tablets, 1.75 mg & 3.5 mg and is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Intermezzo® had US sales of USD 9.46 million (IMS MAT December 2015).
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 positions in the Anti-TB and Cephalosporin segment.
Lupin is the 6th largest and fastest growing top 10 generics player in the US (5.5% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales globally. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan (ranked 9th) and South Africa (ranked 4th – IMS Health).
For the financial year ended 31st March 2015, Lupin's Consolidated turnover and Profit after Tax were Rs. 125,997 million (USD 2.06 billion) and Rs. 24,032 million (USD 393 million) respectively.
About Lupin Pharmaceuticals Inc. (LPI)
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality,
affordable generic medicines and branded formulations trusted by healthcare professionals and patients across
Please visithttp://www.lupin.com for more information.
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For more information on LPI, please visit http://www.lupinpharmaceuticals.com.
CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai - 400 098
For more information, please contact –
Head - Corporate Communications
Ph: +91-22- 98 20 338 555
Head - M & A and Investor Relations
Ph: +91 98 20 023 511
Safe Harbor Statement
Intermezzo® is the registered trademark of Purdue Pharmaceutical Products L.P.