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TOBI PODHALER Drug Profile

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When do Tobi Podhaler patents expire, and what generic alternatives are available?

Tobi Podhaler is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and forty patent family members in forty-three countries.

The generic ingredient in TOBI PODHALER is tobramycin. There are eighteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

US ANDA Litigation and Generic Entry Outlook for Tobi Podhaler

A generic version of TOBI PODHALER was approved as tobramycin by BAUSCH AND LOMB on January 24^th, 2020.

Summary for TOBI PODHALER

International Patents:	240
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	64
Clinical Trials:	8
Patent Applications:	6,450
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TOBI PODHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOBI PODHALER
DailyMed Link:	TOBI PODHALER at DailyMed

See drug prices for TOBI PODHALER

Recent Clinical Trials for TOBI PODHALER

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

Sponsor	Phase
University Medical Center Groningen	Phase 1/Phase 2
Novartis Pharmaceuticals	N/A
Cystic Fibrosis Foundation Therapeutics	N/A

See all TOBI PODHALER clinical trials

Recent Litigation for TOBI PODHALER

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Novartis AG v. Lee	2013-01-14
NOVARTIS AG v. KAPPOS	2011-05-03
NOVARTIS AG v. KAPPOS	2010-07-06

See all TOBI PODHALER litigation

Pharmacology for TOBI PODHALER

Drug Class

Aminoglycoside Antibacterial

Synonyms for TOBI PODHALER

(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)

Tobracin

Tobracin (TN)

Tobradex

Tobradistin

Tobralex

Tobramaxin

Tobramicin

Tobramicina

Tobramicina [INN-Spanish]

Tobramitsetin

Tobramycetin

tobramycin

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

US Patents and Regulatory Information for TOBI PODHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes

Expired US Patents for TOBI PODHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013

International Patents for TOBI PODHALER

Country	Patent Number	Estimated Expiration
European Patent Office	1458360
Canada	2432319
New Zealand	503464
European Patent Office	1019021
Poland	378270
South Korea	20050114720

Supplementary Protection Certificates for TOBI PODHALER

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