Viewing data from:

TRI-LUMA

NDA

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN | N021112 | GALDERMA LABORATORIES LP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma NCT00472966	Phase 4	Completed	Galderma R&D	20	2006-11 → 2007-04
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma NCT00469183	Phase 4	Completed	Galderma R&D	70	2006-05 → 2007-04
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma NCT00669071	Phase 4	Terminated	Galderma R&D	56	2008-01 → 2008-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.82

per gm

Lowest NADAC/Unit

$7.82

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00299595030TRI-LUMA CREAM	$7.82	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$175.60

Highest Price

$234.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00299-5950-30TRI-LUMA CREAM	$234.85	FSS	Galderma Laboratories LP	03/31/2026
00299-5950-30TRI-LUMA CREAM	$175.60	Big4	Galderma Laboratories LP	03/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.01%;4%;0.05%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jan 18, 2002

No patent or exclusivity listings for this strength.