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Lupin receives final approval to gXenazine

This is a low competition drug and a sizable revenue opportunity for Lupin.
Lupin has announced that it has received a final USFDA approval for Tetrabenazine Tablets, 12.5 and 25 mg. This is a generic version of Valeant Pharma’s Xenazine tablet 12.5 mg and 25 mg. Xenazine is indicated for the treatment of chorea associated with Huntington’s disease.

As per IQVIA, Tetrabenazine Tablets (12.5 mg and 25 mg) had annual sales of ~$288.1mn in the US for the 12 months ended Jan 2018.

This drug has already gone off-patent. Current, there are 8 generic companies in this market with Indian companies like Sun Pharma, Dr. Reddy’s lab and Hetero drugs. Sun Pharma has the highest market share in this drug. Lupin should be able to gain sizable revenue from this drug.

Lupin Ltd is currently trading at Rs808.80 up by Rs10.45 or 1.31% from its previous closing of Rs798.35 on the BSE.