Dexamethasone; tobramycin - Generic Drug Details

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What are the generic drug sources for dexamethasone; tobramycin and what is the scope of patent protection?

Dexamethasone; tobramycin is the generic ingredient in three branded drugs marketed by Novartis, Sandoz, Harrow Eye, Amneal, Bausch And Lomb, and Padagis Us, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for dexamethasone; tobramycin

US Patents:	3
Tradenames:	3
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	13
Clinical Trials:	15
DailyMed Link:	dexamethasone; tobramycin at DailyMed

Recent Clinical Trials for dexamethasone; tobramycin

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

Sponsor	Phase
Tianjin Medical University Eye Hospital	Phase 1
Sutphin Drugs	Early Phase 1
University Hospital Fattouma Bourguiba	Phase 4

See all dexamethasone; tobramycin clinical trials

Pharmacology for dexamethasone; tobramycin

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

Anatomical Therapeutic Chemical (ATC) Classes for dexamethasone; tobramycin

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 dexamethasone; tobramycin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	TOBRAMYCIN AND DEXAMETHASONE	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	212991-001	Jul 15, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	TOBRAMYCIN AND DEXAMETHASONE	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	212715-001	Feb 11, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for dexamethasone; tobramycin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988	⤷ Sign Up	⤷ Sign Up
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009	⤷ Sign Up	⤷ Sign Up
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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