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Serving leading biopharmaceutical companies globally:

Cerilliant
US Army
Harvard Business School
Colorcon
Farmers Insurance
Daiichi Sankyo
Cantor Fitzgerald
Deloitte
McKinsey
McKesson

Generated: October 24, 2017

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Aztreonam - Generic Drug Details

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What are the generic drug sources for aztreonam and what is the scope of aztreonam patent protection?

Aztreonam
is the generic ingredient in four branded drugs marketed by Gilead, Bristol Myers Squibb, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eight drug master file entries for aztreonam. Four suppliers are listed for this compound.

Summary for Generic Name: aztreonam

US Patents:4
Tradenames:4
Applicants:4
NDAs:5
Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list41
Clinical Trials: see list43
Patent Applications: see list7,855
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:aztreonam at DailyMed

Pharmacology for Ingredient: aztreonam

Ingredient-typeMonobactams
Drug ClassMonobactam Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION050632-001May 24, 1989RXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
AZTREONAM
aztreonam
INJECTABLE;INJECTION065439-002Jun 18, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
AZTREONAM
aztreonam
INJECTABLE;INJECTION065439-001Jun 18, 2010RXNoNo► Subscribe► Subscribe► Subscribe
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
AZTREONAM
aztreonam
INJECTABLE;INJECTION065439-003Jun 18, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION050632-002May 24, 1989RXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
AZACTAM
aztreonam
INJECTABLE;INJECTION050580-003Dec 31, 1986APRXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
AZACTAM
aztreonam
INJECTABLE;INJECTION050580-002Dec 31, 1986APRXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
AZACTAM
aztreonam
INJECTABLE;INJECTION050580-001Dec 31, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aztreonam

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
9,533,000Inhalable 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
9,345,663Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections► 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: aztreonam

Country Document Number Estimated Expiration
Australia2014271333► Subscribe
Norway329643► Subscribe
Hong Kong1089359► Subscribe
Germany122011100043► Subscribe
Denmark1641436► Subscribe
Norway20032946► Subscribe
Austria502623► Subscribe
Spain2360692► Subscribe
Canada2708703► Subscribe
Denmark2301524► 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: AZTREONAM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/049United Kingdom► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTERED: UK EU/1/09/543/001 20090921
11/024Ireland► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
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
5Finland► Subscribe
1353647/01Switzerland► SubscribePRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
2011 00021Denmark► Subscribe
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
851Luxembourg► Subscribe91851, EXPIRES: 20240921
90027-1Sweden► SubscribePRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Cantor Fitzgerald
Merck
Argus Health
Express Scripts
AstraZeneca
Fish and Richardson
Citi
Healthtrust
Harvard Business School

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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