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Aztreonam - Generic Drug Details

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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.

This ingredient has thirty-seven 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 list15
Patent Applications: see list5,225
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 Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION050632-002May 24, 1989RXYes► subscribe► subscribe
Bristol Myers Squibb
AZACTAM IN PLASTIC CONTAINER
aztreonam
INJECTABLE;INJECTION050632-003May 24, 1989DISCNNo► subscribe► subscribe
Bristol Myers Squibb
AZACTAM
aztreonam
INJECTABLE;INJECTION050580-002Dec 31, 1986RXYes► 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
8,841,286Inhalable aztreonam lysinate formulation 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
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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
World Intellectual Property Organization (WIPO)2005007132► subscribe
Israel221036► 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
1353647/01Switzerland► subscribePRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
90027-1Sweden► subscribePRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921
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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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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