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Last Updated: June 2, 2020

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TOBI PODHALER Drug Profile


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When do Tobi Podhaler patents expire, and when can generic versions of Tobi Podhaler launch?

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-four 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-eight 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 November 29th, 1993.

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Drug patent expirations by year for TOBI PODHALER
Drug Prices for TOBI PODHALER

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Recent Clinical Trials for TOBI PODHALER

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SponsorPhase
University Medical Center GroningenPhase 1/Phase 2
Novartis PharmaceuticalsN/A
Cystic Fibrosis Foundation TherapeuticsN/A

See all TOBI PODHALER clinical trials

Recent Litigation for TOBI PODHALER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis AG v. Lee2013-01-14
NOVARTIS AG v. KAPPOS2011-05-03
NOVARTIS AG v. KAPPOS2010-07-06

See all TOBI PODHALER litigation

PTAB Litigation
PetitionerDate
2016-10-06

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Pharmacology for TOBI PODHALER
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
3'-Deoxykanamycin B
32986-56-4
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
986T564
A-8891
AB00052438_13
AB00052438_14
AB00052438-12
AB00513858
AB2000616
AKOS016339662
Aktob
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
DSSTox_CID_3680
DSSTox_GSID_23680
DSSTox_RID_77144
DTXSID8023680
EINECS 251-322-5
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
NCGC00016814-01
NCGC00178852-01
NCGC00178852-02
Nebcin
Nebcin (Sulfate)
Nebicin
NEBRAMYCIN
Nebramycin 6
Nebramycin factir 6
Nebramycin factor 6
Nebramycin VI
NLVFBUXFDBBNBW-PBSUHMDJSA-N
NSC 180514
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
Q1758380
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-
Tenebrimycin
Tenemycin
Tobacin
Tobi
Tobi (TN)
Tobracin
Tobracin (TN)
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)
Tobramycin(free-base)
Tobramycine
Tobramycine [INN-French]
Tobramycinum
Tobramycinum [INN-Latin]
Tobrased
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   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 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   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TOBI PODHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 92678 Luxembourg   Start Trial PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1280520 C01280520/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520 122015000021 Germany   Start Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292 C01273292/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Boehringer Ingelheim
Harvard Business School
Moodys
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.