Viewing data from:

TOBREX

NDA

TOBRAMYCIN | N050555 | 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

90 trials from ClinicalTrials.gov — 3 recruiting, 69 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 NCT04678154	Phase 3	Recruiting	Major Extremity Trauma Research Consortium	600	2021-05-07 → 2029-03-31
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.NCT05169229	Phase 2	Recruiting	University Hospital, Linkoeping	1,100	2022-04-01 → 2031-12
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities NCT05361941	N/A	Recruiting	Elute, Inc.	204	2023-08-31 → 2029-12-31
Topical Antibiotics in Chronic Rhinosinusitis NCT03673956	Phase 1/2	Completed	Mayo Clinic	19	2018-09-26 → 2021-02-01
Chalazion Conservative Treatment Trial NCT01230593	N/A	Completed	McMaster University	150	2010-11 → 2016-03
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study NCT00420836	Phase 1	Completed	Novartis	20	2006-04
Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients NCT03341741	Phase 3	Completed	University Hospital Tuebingen	26	2014-03-11 → 2016-11-25
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery NCT03739528	Phase 3	Completed	NTC srl	808	2018-09-03 → 2018-12-19
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis NCT00004829	Phase 3	Completed	FDA Office of Orphan Products Development	200	1995-06 → 1998-05
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)NCT00105469	Phase 3	Completed	Merck Sharp & Dohme LLC	743	2004-07 → 2005-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 1 NDC

Highest NADAC/Unit

$84.52

per gm

Lowest NADAC/Unit

$84.52

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078081301TOBREX 0.3% EYE OINTMENT	$84.52	GM	Brand	—	2026-08-19

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

$185.94

Highest Price

$242.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0813-01TOBREX 0.3% OINT, OPH	$185.94	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0813-01TOBREX 0.3% OINT, OPH	$242.34	FSS	Novartis Pharmaceuticals Corporation	08/31/2026

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

API Supply Chain5 active DMFs9 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVTOBRAMYCIN

DMF 137131998

CHONGQING DAXIN PHARMACEUTICAL CO LTDTOBRAMYCIN USP

DMF 137741998

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, NON-STERILE BULK

DMF 150212000

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, USP STERILE BULK

DMF 156292001

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDTOBRAMYCIN

DMF 350422020

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN BASE

DMF 75781988

GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 121281996

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137391998

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137401998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 137701998

ALPHARMA APSInactiveTOBRAMYCIN SULPHATE USP (NON-STERILE BULK)

DMF 190302005

ALPHARMA APSInactiveTOBRAMYCIN BASE USP (NON-STERILE BULK)

DMF 190292005

CHONGQING DAXIN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN FORM-1 USP

DMF 195062006

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN (NON-STERILE, BULK FORM)

DMF 207242007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 17, 2021	SUPPL -38	View Letter (PDF)
Apr 27, 2020	SUPPL -37	View Letter (PDF)
Jul 21, 2004	SUPPL -21	View Letter (PDF)
Jul 21, 2004	SUPPL -22	View Letter (PDF)
Mar 26, 2003	SUPPL -17	View Letter (PDF)
Mar 26, 2003	SUPPL -19	View Letter (PDF)
Mar 26, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%

RLD

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.