Lupin launches generic insomnia drug in the US

This is the first product launched from GAVIS pipeline with 180 days exclusivity

Lupin’s US subsidiary, Lupin Pharmaceuticals, has launched the first product from its GAVIS pipeline, Zolpidem Sublingual tablets, 1.75 mg and 3.5 mg to market a generic equivalent of Purdue Pharma’s Intermezzo Sublingual tablets, 1.75 mg and 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 and 3.5 mg are AB-rated generic equivalent of Purdue Pharma’s Intermezzo Sublingual tablets, 1.75 mg and 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 $9.46 million.