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
- Metrogel · Generic approved · ANDA 220095, Zydus LifesciencesApproved 13 Feb 2026·Detected 25 Oct 2026
- Differin · Generic approved · ANDA 219565, RisingApproved 30 Jun 2026·Detected 25 Oct 2026
- Epiduo · Enters 12-month window basis: patentListed date 18 Jul 2027·Detected 24 Oct 2026
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 |