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

Recent events

Finacea · Generic tentatively approved · ANDA 212581, Taro Pharm Inds LtdTentative approval 26 Jun 2026Detected 25 Oct 2026

Products without listed protection (6)

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