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Serving leading biopharmaceutical companies globally:

Cerilliant
Medtronic
Chubb
Johnson and Johnson
Queensland Health
Fish and Richardson
Novartis
QuintilesIMS
UBS
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Generated: October 18, 2017

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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 Amneal Pharms, Chiesi Usa Inc, Akorn Inc, Fera Pharms, Pulmoflow Inc, Sandoz Inc, Novartis Pharms Corp, Somerset Theraps Llc, Bausch And Lomb, Novartis Pharms, Lupin Atlantis, Alcon Pharms Ltd, Apotex Inc, Novartis, Teva Pharms Usa, Akorn, Lilly, Mylan Labs Ltd, Hospira, West-ward Pharms Int, X Gen Pharms, Igi Labs Inc, Fresenius Kabi Usa, Apothecon, Watson Labs Inc, Baxter Hlthcare Corp, and Xellia Pharms Aps, and is included in forty-eight NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tobramycin has two hundred and twenty-six patent family members in forty countries and seven supplementary protection certificates in six countries.

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

Summary for Generic Name: tobramycin

US Patents:10
Tradenames:11
Applicants:27
NDAs:48
Drug Master File Entries: see list18
Suppliers / Packagers: see list29
Bulk Api Vendors: see list43
Clinical Trials: see list90
Patent Applications: see list6,247
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tobramycin at DailyMed

Pharmacology for Ingredient: tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063080-001Apr 30, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
NEBCIN
tobramycin sulfate
INJECTABLE;INJECTION050519-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Hospira
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
tobramycin sulfate
INJECTABLE;INJECTION063081-006Jun 2, 1993RXNoYes► Subscribe► Subscribe► Subscribe
Somerset Theraps Llc
TOBRAMYCIN
tobramycin
SOLUTION/DROPS;OPHTHALMIC207444-001Jun 28, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
TOBREX
tobramycin
SOLUTION/DROPS;OPHTHALMIC062535-001Dec 13, 1984ATRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063128-001Nov 27, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063112-001Apr 30, 1991APRXNoYes► Subscribe► Subscribe► Subscribe
Alcon Pharms Ltd
TOBRAMYCIN
tobramycin
SOLUTION/DROPS;OPHTHALMIC063176-001May 25, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063118-001Jul 29, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
tobramycin sulfate
INJECTABLE;INJECTION063081-003Jul 31, 1990RXNoYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms
TOBI
tobramycin
SOLUTION;INHALATION050753-001Dec 22, 1997► Subscribe► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,439,862Phospholipid-based powders for drug delivery► Subscribe
7,628,978Stabilized preparations for use in metered dose inhalers► Subscribe
7,393,544Dispersion for pulmonary delivery of a bioactive agent► Subscribe
7,306,787Engineered particles and methods of use► Subscribe
7,871,598Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use► Subscribe
8,168,598Optimised formulation of tobramycin for aerosolization► Subscribe
6,565,885 Methods of spray drying pharmaceutical compositions► Subscribe
8,246,934Respiratory dispersion for metered dose inhalers comprising perforated microstructures► Subscribe
8,877,162Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery► Subscribe
7,905,230Metered dose inhaler with lockout► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tobramycin

Country Document Number Estimated Expiration
Denmark1280520► Subscribe
Hungary0500846► Subscribe
World Intellectual Property Organization (WIPO)0185137► Subscribe
Taiwan200301131► Subscribe
Portugal1610850► Subscribe
South Korea20030067718► Subscribe
Eurasian Patent Organization003665► Subscribe
Iceland5415► Subscribe
World Intellectual Property Organization (WIPO)03004005► Subscribe
Japan2003525841► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TOBRAMYCIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2015Austria► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
2015000021Germany► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
2015 00017Denmark► SubscribePRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1273292/01Switzerland► SubscribePRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
0722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
US Department of Justice
Moodys
Argus Health
Dow
Daiichi Sankyo
Federal Trade Commission
Cerilliant
Chubb
Express Scripts

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 verifification 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.

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