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Last Updated: December 11, 2019

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Tobramycin - Generic Drug Details

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

Tobramycin is the generic ingredient in eleven branded drugs marketed by Novartis, Mylan Speciality Lp, Akorn, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Sandoz Inc, Chiesi Usa Inc, Pulmoflow Inc, Akorn Inc, Amneal Pharms, Dr Reddys Labs Sa, Lupin, Mylan, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in fifty-two NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has two hundred and seventy-five patent family members in forty-four countries.

There are eighteen drug master file entries for tobramycin. Twenty-eight suppliers are listed for this compound.

Drug Prices for tobramycin

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Drug Sales Revenue Trends for tobramycin

See drug sales revenues for tobramycin

Recent Clinical Trials for tobramycin

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

SponsorPhase
Sutphin DrugsEarly Phase 1
University of DundeePhase 2
Maisonneuve-Rosemont HospitalPhase 1

See all tobramycin clinical trials

Recent Litigation for tobramycin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Chiesi U.S.A., Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-07
Novartis AG v. Lee2013-01-14
NOVARTIS AG v. KAPPOS2011-05-03

See all tobramycin litigation

Pharmacology for tobramycin
Medical Subject Heading (MeSH) Categories for tobramycin
Synonyms for tobramycin
(1S,2S,3R,4S,6R)-4,6-diamino-3-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyloxy)-2-hydroxycyclohexyl 3-amino-3-deoxy-alpha-D-glucopyranoside
(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl)oxy]-2-hydroxycyclohexyl 3-amino-3-deoxy-alpha-D-glucopyranoside
(2S,3R,4S,5S,6R)-4-amino-2-(((1S,2S,3R,4S,6R)-4,6-diamino-3-(((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(hydroxymethyl)tetrahyd
(2S,3R,4S,5S,6R)-4-amino-2-(((1S,2S,3R,4S,6R)-4,6-diamino-3-(((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,5-diol
(2S,3R,4S,5S,6R)-4-amino-2-((1S,2S,3R,4S,6R)-4,6-diamino-3-((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yloxy)-2-hydroxycyclohexyloxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,5-diol
(2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxy-tetrahydropyran-2-yl]oxy-2-hydroxy-cyclohexoxy]-6-(hydroxymethyl)tetrahydropyran-3,5-diol
(2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol
(2S,3R,4S,5S,6R)-4-amino-2-{[(1S,2S,3R,4S,6R)-4,6-diamino-3-{[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy}-2-hydroxycyclohexyl]oxy}-6-(hydroxymethyl)oxane-3,5-diol
1-Epitobramycin
11098-01-4
11111-45-8
3'-Deoxykanamycin B
32986-56-4
34337-51-4
37321-13-4
4-(2,6-Diamino-2,3,6-trideoxy-alpha-D-glycopyranosyl)-6-(3-amino-3-deoxy-alpha-D-glycopyranosyl)-2-deoxystreptamine
4-AMINO-2-[4,6-DIAMINO-3-(3-AMINO-6-AMINOMETHYL-5-HYDROXY-TETRAHYDRO-PYRAN-2-YLOXY)-2-HYDROXY-CYCLOHEXYLOXY]-6-HYDROXYMETHYL-TETRAHYDRO-PYRAN-3,5-DIOL
49842-07-1 (Sulfate)
54330-95-9
70322-33-7
986T564
A-8891
AB00052438_13
AB00052438_14
AB00052438-12
AB00513858
AB2000616
AC1L1VI0
AC1Q2AOW
AKOS016339662
Aktob
AN-9578
AOB5629
API0004434
BDBM50366778
Bethkis
Bethkis (TN)
BIDD:GT0503
BIT0802
BPBio1_000647
BRD-K05619559-001-12-7
BRN 1357507
Brulamycin
BSPBio_000587
BSPBio_002036
C-22669
C00397
C18H37N5O9
CAS-32986-56-4
CC-35084
CCG-39936
CHEBI:28864
CHEMBL1747
CPD000058793
CS-2547
D-Streptamine, O-3-amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[2,6-diamino-2,3,6-trideoxy-.alpha.-D-ribo-hexopyranosyl-(1->4)]-2-deoxy-
D-Streptamine, O-3-amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[2,6-diamino-2,3,6-trideoxy-.alpha.-D-ribohexopyranosyl-(1->4)]-2-deoxy-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1->6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1->4))-2-deoxy-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1-4))-2-deoxy-
D00063
DB00684
Deoxykanamycin B
Distobram
DSSTox_CID_3680
DSSTox_GSID_23680
DSSTox_RID_77144
DTXSID8023680
EINECS 251-322-5
Gernebcin
Gotabiotic
HMS2090B16
HMS2092M17
HMS2096N09
HMS3713N09
HSDB 3259
HY-B0441
J10405
KBio2_001552
KBio2_004120
KBio2_006688
KBio3_001536
KBioGR_001104
KBioSS_001552
Kitabis Pak
KS-1405
Lilly 47663
LS-146940
LS-187329
MFCD00077885
MLS000069544
MolPort-003-665-548
NCGC00016814-01
NCGC00178852-01
NCGC00178852-02
Nebcin
Nebcin (Sulfate)
Nebicin
NEBRAMYCIN
Nebramycin 6
Nebramycin factir 6
Nebramycin factor 6
Nebramycin VI
Nebramycin-Faktor 6
NLVFBUXFDBBNBW-PBSUHMDJSA-N
NSC 180514
NSC-757352
NSC757352
O-[3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-->6)]-O-[2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-->4)]-2-deoxy-D-streptamine
O-[3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1->6)]-O-[2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1->4)]-2-deoxy-D-streptamine
O-3-Amino-3-deoxy-?-D-glucopyranosyl-(1-6)-O-[2,6-diamino-2,3,6-trideoxy-?-D-ribohexopyranosyl-(1-4)]-2-deoxy-D-streptamine
O-3-Amino-3-deoxy-a-D-glucopyranosyl-(1-6)-O-[2,6-diamino-2,3,6-trideoxy-a -D-ribo-hexopyranosyl-(1-4)]-2-deoxy-D-streptamine
O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1-6))-2-deoxy-L-streptamine
O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-4))-2-deoxy-D-streptamine
O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-4))-2-deoxy-D-streptamine
Obramycin
Pharmakon1600-01500579
Prestwick3_000544
Q-201837
ro-2H-pyran-3,5-diol
s2514
SAM001246911
SBI-0051915.P003
SC-45657
SCHEMBL2838
SMR000058793
SPBio_000295
Spectrum_001072
SPECTRUM1500579
Spectrum2_000078
Spectrum3_000588
Spectrum4_000752
Spectrum5_001038
SPRC-AB01
SR-01000721898
SR-01000721898-2
SR-05000001726
SR-05000001726-1
SR-05000001726-2
Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-6))-2-deoxy-, D-
Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-tyrideoxy-alpha-D-ribohexopyranosyl-(1-6))-2-deoxy-, D-
Sybryx
Tenebrimycin
Tenemycin
TOA-(1-6)2TB-(4-1)TOC
TOA-(1-6)TOB-(4-1)TOC
Tobacin
Tobi
Tobi (TN)
Tobi Podhaler
Tobracin
Tobracin (TN)
Tobradex
Tobradistin
Tobralex
Tobramaxin
Tobramicin
Tobramicina
Tobramicina [INN-Spanish]
Tobramitsetin
Tobramycetin
Tobramycin (JP17/USP)
Tobramycin [2M+H]
Tobramycin [USAN:BAN:INN:JAN]
Tobramycin [USAN:USP:INN:BAN:JAN]
Tobramycin Base
Tobramycin for Inhalation
tobramycin solution for inhalation
TOBRAMYCIN SULFATE
Tobramycin, 97%
Tobramycin, Antibiotic for Culture Media Use Only
Tobramycin,(S)
Tobramycine
Tobramycine [INN-French]
Tobramycinum
Tobramycinum [INN-Latin]
Tobrased
Tobrasone
Tobrex
Tobrex (TN)
torbamycin
Tox21_110626
TOY
UNII-NQJ13I4Z9U component NLVFBUXFDBBNBW-PBSUHMDJSA-N
UNII-VZ8RRZ51VK
VZ8RRZ51VK
ZINC8214692
ZX-AFC000193
Paragraph IV (Patent) Challenges for TOBRAMYCIN
Tradename Dosage Ingredient NDA Submissiondate
BETHKIS SOLUTION;INHALATION tobramycin 201820 2017-08-31
TOBI SOLUTION;INHALATION tobramycin 050753 2009-06-29

US Patents and Regulatory Information for tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Lilly NEBCIN tobramycin sulfate INJECTABLE;INJECTION 062008-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER tobramycin sulfate INJECTABLE;INJECTION 063081-006 Jun 2, 1993 RX No Yes   Start Trial   Start Trial   Start Trial
Lupin TOBRAMYCIN tobramycin SOLUTION;INHALATION 208964-001 Mar 22, 2017 AN RX No No   Start Trial   Start Trial   Start Trial
Hospira TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063111-001 Apr 30, 1991 AP RX No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 064052-001 Nov 29, 1993 AT RX No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 AN RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for tobramycin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1273292 C01273292/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520 122015000021 Germany   Start Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 300722 Netherlands   Start Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 CA 2015 00017 Denmark   Start Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520 14/2015 Austria   Start Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 C01280520/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520 C300722 Netherlands   Start Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey
Harvard Business School
Dow
Boehringer Ingelheim
Colorcon

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