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Tobramycin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tobramycin?

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, Bausch And Lomb, Novartis Pharms, 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, Claris, and Xellia Pharms Aps, and is included in forty-six NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and one patent family members in forty countries.

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

Summary for Generic Name: tobramycin

Tradenames:11
Patents:11
Applicants:25
NDAs:46
Drug Master File Entries: see list18
Suppliers / Packagers: see list28
Bulk Api Vendors: see list43
Clinical Trials: see list28
Patent Applications: see list6,619
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pulmoflow Inc
KITABIS PAK
tobramycin
SOLUTION;INHALATION205433-001Dec 2, 2014RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063127-001Nov 27, 1991DISCNNoNo► Subscribe► Subscribe
Fresenius Kabi Usa
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION050789-001Jul 13, 2004RXNoNo► Subscribe► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,442,388► SubscribeY ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,368,102► SubscribeY ► 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, 19975,508,269► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 20137,097,827► 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
7,306,787Engineered particles and methods of use► Subscribe
6,309,623 Stabilized preparations for use in metered dose inhalers► Subscribe
7,628,978Stabilized preparations for use in metered dose inhalers► Subscribe
8,877,162Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery► Subscribe
7,871,598Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use► 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
Canada2335940► Subscribe
European Patent Office2851067► Subscribe
Israel135126► Subscribe
Poland339732► Subscribe
Australia2002245181► 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
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
2015 00017Denmark► SubscribePRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1273292/01Switzerland► SubscribePRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
/2015Austria► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
0722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
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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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