Applicant, as named in the Orange Book

Galderma Labs Lp

Next listed expiry: Oracea on 19 Dec 2027. 4 products with live protection, 11 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Oracea doxycycline	doxycycline	050805	19 Dec 2027	patent
Mirvaso brimonidine tartrate	brimonidine tartrate	204708	13 Jun 2031	patent
Aklief trifarotene	trifarotene	211527	30 May 2033	patent
Soolantra ivermectin	ivermectin	206255	13 Mar 2034	patent, carve-out possible

Recent events

25 Oct 2026Metrogel · Generic approved 13 Feb 2026
25 Oct 2026Differin · Generic approved 30 Jun 2026
24 Oct 2026Epiduo · Enters 12-month window basis: patent18 Jul 2027

Products without listed protection (11)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Clobex clobetasol propionate	clobetasol propionate	021835	open now	no listed protection
Clobex clobetasol propionate	clobetasol propionate	021535	open now	no listed protection
Differin adapalene	adapalene	020748	open now	no listed protection
Differin adapalene	adapalene	020380	open now	no listed protection
Differin adapalene	adapalene	021753	open now	no listed protection
Differin Epiduo adapalene; benzoyl peroxide	adapalene; benzoyl peroxide	220736	open now	no listed protection
Metrocream metronidazole	metronidazole	020531	open now	no listed protection
Metrogel metronidazole	metronidazole	021789	open now	no listed protection
Metrolotion metronidazole	metronidazole	020901	open now	no listed protection
Tri-Luma fluocinolone acetonide; hydroquinone; tretinoin	fluocinolone acetonide; hydroquinone; tretinoin	021112	open now	no listed protection
Vectical calcitriol	calcitriol	022087	open now	no listed protection