TOBRADEX Drug Patent Profile

Which patents cover Tobradex, and what generic alternatives are available?

Tobradex is a drug marketed by Novartis, Sandoz, and Harrow Eye. and is included in three NDAs. There are three patents protecting this drug.

The generic ingredient in TOBRADEX is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

DrugPatentWatch^® Generic Entry Outlook for Tobradex

Indicators of Generic Entry

Summary for TOBRADEX

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TOBRADEX
Drug Sales Revenues:	Drug sales revenues for TOBRADEX
What excipients (inactive ingredients) are in TOBRADEX?	TOBRADEX excipients list
DailyMed Link:	TOBRADEX at DailyMed

See drug prices for TOBRADEX

See drug sales revenues for TOBRADEX

Recent Clinical Trials for TOBRADEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sutphin Drugs	Early Phase 1
NTC srl	Phase 3
Democritus University of Thrace	N/A

See all TOBRADEX clinical trials

Pharmacology for TOBRADEX

Drug Class	Aminoglycoside Antibacterial Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TOBRADEX

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for TOBRADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988		RX	Yes	Yes
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	AB	RX	Yes	Yes
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y

Expired US Patents for TOBRADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988

International Patents for TOBRADEX

See the table below for patents covering TOBRADEX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	606515
Japan	H08231405	COMBINATION OF TOBRAMYCIN AND STEROID FOR LOCAL OPHTHALMOLOGICAL APPLICATION
Japan	H02503439
Austria	122564
Japan	2617139
Denmark	173326

Supplementary Protection Certificates for TOBRADEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003