TOBRADEX ST Drug Patent Profile

When do Tobradex St patents expire, and what generic alternatives are available?

Tobradex St is a drug marketed by Eyevance and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in TOBRADEX ST 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 St

Indicators of Generic Entry

Summary for TOBRADEX ST

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TOBRADEX ST
What excipients (inactive ingredients) are in TOBRADEX ST?	TOBRADEX ST excipients list
DailyMed Link:	TOBRADEX ST at DailyMed

See drug prices for TOBRADEX ST

Recent Clinical Trials for TOBRADEX ST

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

Sponsor	Phase
Sutphin Drugs	Early Phase 1
NTC srl	Phase 3
Naval Hospital, Athens	N/A

See all TOBRADEX ST clinical trials

Pharmacology for TOBRADEX ST

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

Anatomical Therapeutic Chemical (ATC) Classes for TOBRADEX ST

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 ST

TOBRADEX ST is protected by three US patents.

Patents protecting TOBRADEX ST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyevance	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y
Eyevance	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y
Eyevance	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y

Expired US Patents for TOBRADEX ST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eyevance	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009

International Patents for TOBRADEX ST

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

Country	Patent Number	Title	Estimated Expiration
Australia	3347689
European Patent Office	0365613	TOBRAMYCINE ET STEROIDES COMBINES DESTINES A UNE UTILISATION OPHTALMIQUE TOPIQUE. (COMBINATION OF TOBRAMYCIN AND STEROIDS FOR TOPICAL OPHTHALMIC USE.)
Germany	68922688
Denmark	561989
Mexico	9203503	COMBINACION DE LA TOBRAMICINA Y LA DEXAMETASONA PARA USO OFTALMICO TOPICO.
South Korea	960009262

Supplementary Protection Certificates for TOBRADEX ST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727