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Last Updated: October 21, 2021

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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, Eyevance, Amneal, and Bausch And Lomb, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for dexamethasone; tobramycin. Eight suppliers are listed for this compound.

Summary for dexamethasone; tobramycin
Recent Clinical Trials for dexamethasone; tobramycin

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

SponsorPhase
Sutphin DrugsEarly Phase 1
NTC srlPhase 3
Athinaiki General ClinicN/A

See all dexamethasone; tobramycin clinical trials

Pharmacology for dexamethasone; tobramycin
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

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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592-001 Aug 18, 1988 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 212991-001 Jul 15, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch And Lomb TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 064134-001 Oct 27, 1999 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis TOBRADEX dexamethasone; tobramycin OINTMENT;OPHTHALMIC 050616-001 Sep 28, 1988 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eyevance TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818-001 Feb 13, 2009 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

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

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Johnson and Johnson
AstraZeneca
Colorcon
Boehringer Ingelheim

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