Lupin's GAVIS pipeline brings generic insomnia treatment to market

BALTIMORE - Lupin Limited announced Tuesday that its U.S. subsidiary, Lupin Pharmaceuticals, has launched the first product from its GAVIS pipeline, Zolpidem Sublingual Tablets, 1.75 mg & 3.5 mg. The new entry is the generic equivalent of Purdue Pharma’s Intermezzo Sublingual Tablets, 1.75 mg & 3.5 mg. 

 

Lupin received final approval from the United States Food & Drug Administration earlier, as well as final clearance from the FTC with 180 days of exclusivity.

 

Zolpidem Sublingual Tablets 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 U.S. sales of $9.5 million, according to IMS for the moving annual total ended December 2015.