Lupin shares climbed nearly 2 percent intraday Wednesday after receiving approval from the US health regulator for Nuvigil tablets that improves wakefulness.
"US subsidiary Lupin Pharmaceuticals Inc has received approval for its Armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food & Drug Administration," the pharma major said, adding it will commence promoting the product in US shortly.
Armodafinil is the AB rated generic equivalents of Cephalon Inc's Nuvigil tablets. The drug is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder.
Nuvigil tablets had US sales of USD 515.6 million, according to IMS MAT report of September 2016.
Lupin had filed this drug from its Goa plant that was cleared and received Establishment Inspection Report in November from USFDA.
Mylan, Actavis and Natco Pharma are other companies selling this drug. Natco Pharma announced approval for Armodafinil tablets yesterday.
Analysts say Lupin could generate sales of USD 20-23 million and profit of USD 10-12 million from Nuvigil drug.
Meanwhile, Credit Suisse said Lupin's market share in diabetes drug Fortamet's is down only 10 percent post Mylan's entry.
"This suggests a price cut of only 10 percent against 20 percent we have built-in. We will wait for one more month of data to take a call on price erosion," it said.
At 10:19 hours IST, the stock was quoting at Rs 1,533.60, up Rs 16.55, or 1.09 percent on the BSE.
Posted by Sunil Shankar Matkar