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Tobramycin - Generic Drug Details

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Tobramycin is the generic ingredient in eleven branded drugs marketed by Amneal Pharms, Chiesi Usa Inc, Akorn Inc, Fera Pharms, Pulmoflow Inc, Alcon, Alcon Labs Inc, 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 eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and twenty-four patent family members in fifty-one 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 / Packaging: see list28
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tobramycin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYes7,097,827► subscribeY ► subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYes7,559,325► subscribeY ► subscribe
Xellia Pharms Aps
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION205685-001Sep 16, 2014RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: tobramycin

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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
6,673,335 Compositions and methods for the pulmonary delivery of aerosolized medicaments► subscribe
7,138,141Dispersible macromolecule compositions and methods for their preparation and use► subscribe
6,479,049 Methods and compositions for the dry powder formulation of interferons► 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
South Korea20040075897► subscribe
New Zealand331353► subscribe
Egypt24019► 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
00722Netherlands► 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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