Applicant, as named in the Orange Book

Leo Pharma As

Next listed expiry: Finacea on 28 Feb 2029. 3 products with live protection, 6 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Finacea azelaic acid	azelaic acid	207071	28 Feb 2029	patent, carve-out possible
Anzupgo delgocitinib	delgocitinib	219155	19 Sep 2031	patent
Enstilar betamethasone dipropionate; calcipotriene	betamethasone dipropionate; calcipotriene	207589	10 Dec 2031	patent

Recent events

25 Oct 2026Finacea · Generic tentatively approved 26 Jun 2026

Products without listed protection (6)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Dovonex calcipotriene	calcipotriene	020273	open now	no listed protection
Dovonex calcipotriene	calcipotriene	020554	open now	no listed protection
Finacea azelaic acid	azelaic acid	021470	open now	no listed protection
Protopic · 2 strengths tacrolimus	tacrolimus	050777	open now	no listed protection
Taclonex betamethasone dipropionate; calcipotriene	betamethasone dipropionate; calcipotriene	021852	open now	no listed protection
Taclonex betamethasone dipropionate; calcipotriene	betamethasone dipropionate; calcipotriene	022185	open now	no listed protection