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Generated: November 22, 2017

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CAYSTON Drug Profile

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Which patents cover Cayston, and when can generic versions of Cayston launch?

Cayston is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug.

This drug has forty-seven patent family members in eighteen countries and nine supplementary protection certificates in nine countries.

The generic ingredient in CAYSTON is aztreonam. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aztreonam profile page.

Medical Subject Heading (MeSH) Categories for CAYSTON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: CAYSTON

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
6,660,249 Inhalable dry powder aztreonam for treatment and prevention of pulmonary bacterial infections► Subscribe
9,345,663Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections► Subscribe
9,533,000Inhalable aztreonam for treatment and prevention of pulmonary bacterial infections► Subscribe
8,841,286Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections► Subscribe
7,138,419Process for manufacturing bulk solutions and a lyophilized pure .alpha.-aztreonam lysinate► 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: CAYSTON

Country Document Number Estimated Expiration
Norway20032946► Subscribe
Cyprus1114621► Subscribe
Germany122011100043► Subscribe
Norway329643► Subscribe
Canada2530774► Subscribe
Australia2002231244► Subscribe
Germany60144291► Subscribe
Norway20101377► Subscribe
Australia2004257632► Subscribe
Canada2433280► 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: CAYSTON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
11/024Ireland► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
90027-1Sweden► SubscribePRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921
C/GB11/049United Kingdom► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTERED: UK EU/1/09/543/001 20090921
851Luxembourg► Subscribe91851, EXPIRES: 20240921
2011 00021Denmark► Subscribe
5Finland► Subscribe
00492Netherlands► SubscribePRODUCT NAME: AZTREONAM, NIET IN EEN SAMENSTELLING MET ARGININE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN AZTREONAM, ANDERS DAN EEN ARGININEZOUT, IN HET BIJZONDER ALS AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647/01Switzerland► SubscribePRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
C0030France► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/543/001 DU 20090921; REGISTRATION NO/DATE AT EEC: EU/1/09/543/001 DU 20090921
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Serving leading biopharmaceutical companies globally:

Healthtrust
Accenture
Dow
Farmers Insurance
Argus Health
Citi
Mallinckrodt
McKesson
Deloitte
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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