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Generated: July 22, 2018

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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 tobramycin patent protection?

Tobramycin
is the generic ingredient in eleven branded drugs marketed by Novartis Pharms Corp, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Sandoz Inc, Chiesi Usa Inc, Pulmoflow Inc, Novartis Pharms, Akorn Inc, Amneal Pharms, Dr Reddys Labs Intl, Lupin Atlantis, Mylan Pharms Inc, 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 NDAs. There are ten 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 thirty patent family members in forty countries.

There are eighteen drug master file entries for tobramycin. Twenty-six suppliers are listed for this compound.
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-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
AK481288
AKOS016339662
Aktob
AN-9578
AOB5629
API0004434
BDBM50366778
Bethkis (TN)
BIDD:GT0503
BIT0802
BPBio1_000647
BRN 1357507
Brulamycin
BSPBio_000587
BSPBio_002036
C-22669
C00397
C18H37N5O9
CA006492
CA009438
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
DR002903
DSSTox_CID_3680
DSSTox_GSID_23680
DSSTox_RID_77144
DTXSID8023680
EINECS 251-322-5
Gernebcin
Gotabiotic
HMS2090B16
HMS2092M17
HMS2096N09
HSDB 3259
HY-B0441
J10405
KBio2_001552
KBio2_004120
KBio2_006688
KBio3_001536
KBioGR_001104
KBioSS_001552
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
NF 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-?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-?-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-05000001726
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 [USAN:BAN:INN:JAN]
Tobramycin Base
Tobramycin for Inhalation
tobramycin solution for inhalation
TOBRAMYCIN SULFATE
Tobramycin, Antibiotic for Culture Media Use Only
Tobramycine
Tobramycine [INN-French]
Tobramycinum
Tobramycinum [INN-Latin]
Tobrased
Tobrasone
Tobrex
Tobrex (TN)
torbamycin
Tox21_110626
TOY
UNII-VZ8RRZ51VK
vantobra
VZ8RRZ51VK
ZINC8214692
ZX-AFC000193

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 TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Igi Labs Inc TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063121-001 Oct 31, 1994 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063111-001 Apr 30, 1991 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 065120-001 Nov 29, 2002 RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tobramycin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,421,166 Pulmonary delivery of aminoglycoside ➤ Try a Free Trial
6,309,623 Stabilized preparations for use in metered dose inhalers ➤ Try a Free Trial
6,433,040 Stabilized bioactive preparations and methods of use ➤ Try a Free Trial
6,565,885 Methods of spray drying pharmaceutical compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for tobramycin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
00722 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
678 Luxembourg ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Teva
Farmers Insurance
McKesson
Fish and Richardson
Boehringer Ingelheim
Merck

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