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TOBRADEX

NDA

DEXAMETHASONE; TOBRAMYCIN | N050616 | NOVARTIS PHARMACEUTICALS CORP

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

18 trials from ClinicalTrials.gov, 16 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia NCT02528123	N/A	Completed	London Vision Clinic	114	2016-04 → 2020-12-07
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery NCT01103401	N/A	Completed	Veroia General Hospital	145	2009-10 → 2010-01
Early Changes Among FLEx, LASIK and FS-LASIK NCT02551796	N/A	Completed	Sun Yat-sen University	75	2015-09 → 2016-04
Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction NCT02958514	N/A	Completed	Peking University Third Hospital	20	2016-11 → 2017-03
Tobramycin Tear Concentrations NCT00695435	Phase 1	Completed	Alcon Research	21	2008-06
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery NCT00992355	N/A	Completed	Veroia General Hospital	97	2009-01 → 2009-04
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis NCT01028027	Phase 3	Completed	Bausch & Lomb Incorporated	357	2009-10 → 2010-03
Zylet vs TobraDex in Blepharokeratoconjunctivitis NCT00447577	Phase 4	Completed	Bausch & Lomb Incorporated	276	2007-01 → 2007-06
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension NCT00576251	Phase 3	Completed	Alcon Research	221	2007-10 → 2008-03
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery NCT02137161	Phase 4	Completed	Azienda USL Reggio Emilia - IRCCS	62	2013-11 → 2014-10

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

$89.78

per gm

Lowest NADAC/Unit

$89.78

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078087601TOBRADEX EYE OINTMENT	$89.78	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

$197.63

Highest Price

$237.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0876-01TOBRADEX OINT, OPH	$237.77	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0876-01TOBRADEX OINT, OPH	$197.63	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
May 17, 2021	SUPPL -40	View Letter (PDF)
May 17, 2021	SUPPL -41	View Letter (PDF)
Apr 28, 2020	SUPPL -39	View Letter (PDF)
Jul 21, 2004	SUPPL -21	View Letter (PDF)
Jul 21, 2004	SUPPL -22	View Letter (PDF)
Jun 28, 2004	SUPPL -16	View Letter (PDF)
Jun 28, 2004	SUPPL -17	View Letter (PDF)
Mar 26, 2003	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%;0.3%

RLD

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Sep 28, 1988

No patent or exclusivity listings for this strength.