Lupin‘s arm launches Zolpidem Sublingual Tablets in the US

05 Apr 2016 Evaluate

Lupin‘s 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).

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. 

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