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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
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AstraZeneca
Chinese Patent Office
Novartis
Deloitte
US Department of Justice
McKinsey
QuintilesIMS

Generated: June 28, 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, 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, Claris, and Xellia Pharms Aps, and is included in forty-seven NDAs. There are eleven 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 nine 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 Generic Name: tobramycin

Tradenames:11
Patents:11
Applicants:26
NDAs:47
Drug Master File Entries: see list18
Suppliers / Packagers: see list26
Bulk Api Vendors: see list43
Clinical Trials: see list90
Patent Applications: see list6,662
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
West-ward Pharms Int
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063117-001Apr 26, 1991APRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
TOBRAMYCIN
tobramycin
SOLUTION;INHALATION091589-001Oct 10, 2013ANRXNoNo► Subscribe► Subscribe
Fresenius Kabi Usa
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION065122-001Nov 29, 2002APRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063100-001Jan 30, 1992APRXNoNo► Subscribe► Subscribe
Igi Labs Inc
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION063120-001Oct 31, 1994DISCNNoNo► 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, 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
7,473,433Pulmonary delivery of polyene antifungal agents► Subscribe
7,628,978Stabilized preparations for use in metered dose inhalers► Subscribe
8,709,484Phospholipid-based powders for drug delivery► Subscribe
6,309,623 Stabilized preparations for use in metered dose inhalers► Subscribe
7,306,787Engineered particles 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
Australia9677298► Subscribe
South Korea101066788► Subscribe
Slovakia285806► Subscribe
Spain2222294► Subscribe
Canada2335940► 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
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
00722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
2015000021Germany► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Citi
Colorcon
Cipla
McKinsey
Johnson and Johnson
Teva
Chubb
Farmers Insurance
Cerilliant

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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