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Serving leading biopharmaceutical companies globally:

AstraZeneca
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US Army
Fuji
Boehringer Ingelheim
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Generated: December 12, 2017

DrugPatentWatch Database Preview

TOBI PODHALER Drug Profile

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When do Tobi Podhaler patents expire, and what generic alternatives 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 eighty-nine patent family members in thirty-eight countries and seven supplementary protection certificates in six countries.

The generic ingredient in TOBI PODHALER is tobramycin. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Drug patent expirations by year for TOBI PODHALER

Pharmacology for TOBI PODHALER

Medical Subject Heading (MeSH) Categories for TOBI PODHALER

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisTOBI PODHALERtobramycinPOWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► 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
8,246,934Respiratory dispersion for metered dose inhalers comprising perforated microstructures► Subscribe
8,080,263Dispersion for pulmonary delivery of a bioactive agent► Subscribe
6,946,117 Stabilized preparations for use in nebulizers► Subscribe
8,513,204Compositions comprising amphotericin B, mehods and systems► Subscribe
7,871,598Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use► Subscribe
7,473,433Pulmonary delivery of polyene antifungal agents► Subscribe
9,421,166Pulmonary delivery of aminoglycoside► Subscribe
8,877,162Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery► Subscribe
9,554,993Pulmonary delivery particles comprising an active agent► Subscribe
7,205,343Stabilized bioactive preparations and method 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 Tradename: TOBI PODHALER

Country Document Number Estimated Expiration
Japan2001517692► Subscribe
Canada2304820► Subscribe
European Patent Office1019021► Subscribe
Portugal1610850► Subscribe
Yugoslavia18300► Subscribe
Japan2010047615► Subscribe
Iceland5415► Subscribe
Denmark1458360► Subscribe
European Patent Office1282405► Subscribe
Japan2003535017► 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
/2015Austria► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION 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
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
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Cerilliant
Citi
McKesson
Johnson and Johnson
Harvard Business School
Argus Health
Cantor Fitzgerald
US Army

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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