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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.

Summary for tobramycin

International Patents:	230
US Patents:	10
Tradenames:	11
Applicants:	29
NDAs:	50
Drug Master File Entries:	18
Suppliers / Packagers:	26
Bulk Api Vendors:	52
Clinical Trials:	92
Patent Applications:	6,588
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tobramycin
DailyMed Link:	tobramycin at DailyMed

Pharmacology for tobramycin

Ingredient-type	Aminoglycosides
Drug Class	Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for tobramycin

Anti-Bacterial Agents

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			Y
Igi Labs Inc	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063121-001	Oct 31, 1994		DISCN	No	No
Hospira	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063111-001	Apr 30, 1991	AP	RX	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE (PHARMACY BULK)	tobramycin sulfate	INJECTABLE;INJECTION	065120-001	Nov 29, 2002		RX	No	Yes

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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
Novartis Pharms	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997

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
6,309,623	Stabilized preparations for use in metered dose inhalers
6,433,040	Stabilized bioactive preparations and methods of use
6,565,885	Methods of spray drying pharmaceutical compositions

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International Patents for tobramycin

Country	Document Number	Estimated Expiration
South Korea	100845445
Spain	2195415
Denmark	1610850
Poland	339732

Supplementary Protection Certificates for tobramycin

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