Lupin set to market Betamethasone Dipropionate Ointment

Pharma major Lupin Limited (Lupin) announced that it has received approval for its Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Diprolene® Ointment, 0.05%, of Merck Sharp and Dohme Corp. The product will be manufactured at Lupin’s Pithampur (Unit 3) facility, India. 

Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. 

Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, (RLD: Diprolene®) had an annual sales of approximately USD 22 million in the U.S. (IQVIA MAT September 2019).