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Serving leading biopharmaceutical companies globally:

Cipla
Teva
Cantor Fitzgerald
Fish and Richardson
McKesson
Novartis
Medtronic
Farmers Insurance
AstraZeneca
Harvard Business School

Generated: January 21, 2018

DrugPatentWatch Database Preview

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-six patent family members in eighteen countries.

There are eight drug master file entries for aztreonam. Three suppliers are listed for this compound.
Pharmacology for aztreonam
Ingredient-typeMonobactams
Drug ClassMonobactam Antibacterial
Medical Subject Heading (MeSH) Categories for aztreonam

US Patents and Regulatory Information for aztreonam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa AZTREONAM aztreonam INJECTABLE;INJECTION 065439-002 Jun 18, 2010 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-003 May 24, 1989 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa AZTREONAM aztreonam INJECTABLE;INJECTION 065439-001 Jun 18, 2010 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-003 Dec 31, 1986 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-002 May 24, 1989 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
West-ward Pharms Int AZTREONAM aztreonam INJECTABLE;INJECTION 065286-002 Mar 23, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-002 Dec 31, 1986 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
9,533,000 Inhalable aztreonam for treatment and prevention of pulmonary bacterial infections ➤ Subscribe
6,660,249 Inhalable dry powder aztreonam for treatment and prevention of pulmonary bacterial infections ➤ Subscribe
7,138,419 Process for manufacturing bulk solutions and a lyophilized pure .alpha.-aztreonam lysinate ➤ Subscribe
9,345,663 Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections ➤ Subscribe
8,841,286 Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for aztreonam

Supplementary Protection Certificates for aztreonam

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
11/024 Ireland ➤ Subscribe PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
00492 Netherlands ➤ Subscribe PRODUCT 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
1353647/01 Switzerland ➤ Subscribe PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
5 Finland ➤ Subscribe
0492 Netherlands ➤ Subscribe PRODUCT NAME: AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
851 Luxembourg ➤ Subscribe 91851, EXPIRES: 20240921
90027-1 Sweden ➤ Subscribe PRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921
2011 00021 Denmark ➤ Subscribe
C0030 France ➤ Subscribe PRODUCT 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
C/GB11/049 United Kingdom ➤ Subscribe PRODUCT NAME: AZTREONAM LYSINE; REGISTERED: UK EU/1/09/543/001 20090921
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Teva
Fuji
Moodys
Boehringer Ingelheim
Argus Health
Healthtrust
Harvard Business School
Julphar
Cantor Fitzgerald

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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