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Serving 500+ biopharmaceutical companies globally:

Merck
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Federal Trade Commission
Covington
Teva
Chubb
Baxter
Chinese Patent Office
McKesson
Cipla

Generated: August 18, 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 thirty-nine patent family members in eighteen countries.

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

Summary for Generic Name: aztreonam

Tradenames:4
Patents:4
Applicants:4
NDAs:5
Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list41
Clinical Trials: see list42
Patent Applications: see list7,379
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
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
Gilead
CAYSTON
aztreonam
FOR SOLUTION;INHALATION050814-001Feb 22, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
AZTREONAM
aztreonam
INJECTABLE;INJECTION065439-002Jun 18, 2010APRXNoNo► 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
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
9,533,000Inhalable aztreonam 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
Denmark1641436► Subscribe
Norway20101377► Subscribe
Austria502623► Subscribe
Israel156596► Subscribe
Norway329643► 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
851Luxembourg► Subscribe91851, EXPIRES: 20240921
5Finland► 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
11/024Ireland► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
1353647/01Switzerland► SubscribePRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
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Serving 500+ biopharmaceutical companies globally:

UBS
McKesson
Harvard Business School
Citi
Cerilliant
Colorcon
Accenture
Cipla
Medtronic
Johnson and Johnson

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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