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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Teva
US Army
McKesson
Farmers Insurance
Deloitte
Covington
UBS
Federal Trade Commission

Generated: July 21, 2017

DrugPatentWatch Database Preview

BETHKIS Drug Profile

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What is the patent landscape for Bethkis, and when can generic versions of Bethkis launch?

Bethkis is a drug marketed by Chiesi Usa Inc and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-three patent family members in twenty-six countries.

The generic ingredient in BETHKIS 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.

Summary for Tradename: BETHKIS

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list43
Clinical Trials: see list1
Patent Applications: see list6,344
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BETHKIS at DailyMed

Pharmacology for Tradename: BETHKIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc
BETHKIS
tobramycin
SOLUTION;INHALATION201820-001Oct 12, 2012RXYesYes7,696,178► SubscribeY ► Subscribe
Chiesi Usa Inc
BETHKIS
tobramycin
SOLUTION;INHALATION201820-001Oct 12, 2012RXYesYes6,987,094► SubscribeY ► Subscribe
Chiesi Usa Inc
BETHKIS
tobramycin
SOLUTION;INHALATION201820-001Oct 12, 2012RXYesYes7,939,502► Subscribe ► Subscribe
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Non-Orange Book Patents for Tradename: BETHKIS

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
8,168,598Optimised formulation of tobramycin for aerosolization► 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: BETHKIS

Country Document Number Estimated Expiration
Slovakia16432003► Subscribe
Australia2002319226► Subscribe
Estonia05392► Subscribe
Slovakia285806► Subscribe
Czech Republic299348► 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: BETHKIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2015Austria► SubscribePRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292/01Switzerland► SubscribePRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
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:

US Army
Daiichi Sankyo
Harvard Business School
McKesson
Argus Health
Accenture
Dow
Colorcon
Cerilliant
Express Scripts

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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