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TOBI PODHALER Drug Profile

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Which patents cover Tobi Podhaler, and what substitute generic drugs are available?

Tobi Podhaler is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and sixty-nine patent family members in thirty-eight 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.

Summary for Tradename: TOBI PODHALER

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list44
Clinical Trials: see list5
Patent Applications: see list10,427
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TOBI PODHALER at DailyMed

Pharmacology for Tradename: TOBI PODHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,368,102► SubscribeY ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,516,741► SubscribeY ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,442,388► SubscribeY ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes8,715,623► SubscribeY ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes7,559,325► SubscribeY ► Subscribe
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Expired Patents for Tradename: TOBI PODHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 20137,097,827► Subscribe
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Non-Orange Book Patents for Tradename: TOBI PODHALER

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
7,905,230Metered dose inhaler with lockout► Subscribe
8,877,162Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery► Subscribe
7,473,433Pulmonary delivery of polyene antifungal agents► Subscribe
9,421,166Pulmonary delivery of aminoglycoside► Subscribe
7,326,691Compositions comprising amphotericin B, methods, and systems► 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 Tradename: TOBI PODHALER

Country Document Number Estimated Expiration
South Korea100743404► Subscribe
Japan4526702► Subscribe
MexicoPA05007156► Subscribe
European Patent Office1458360► Subscribe
China1169520► 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: TOBI PODHALER

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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