PRINCETON, N.J. — Sandoz on Tuesday announced the U.S. market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex Ointment.
Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of psoriasis vulgaris in adults 18 years and older.
Psoriasis affects approximately 2% of the U.S. population. Plaque psoriasis is the most common form of the condition.
"Sandoz is proud to be first-to-market with a generic version of this important therapy,” stated Peter Goldschmidt, president of Sandoz U.S. “This launch further broadens our strong offering of differentiated generic dermatology products.”
Sandoz will market calcipotriene and betamethasone dipropionate through a partnership with Tolmar, which owns the abbreviated new drug application for the product and was the first company to receive FDA approval for a generic version.
According to IMS Health, aggregate U.S. sales for the branded version of calcipotriene and betamethasone dipropionate ointment were approximately $96 million for the 12 months ending December 2013. Sandoz is marketing calcipotriene and betamethasone dipropionate ointment in 60 g and 100 g tubes, the same strengths that are marketed as Taclonex Ointment.