Last Updated: August 8, 2026

CAYSTON Drug Patent Profile


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When do Cayston patents expire, and when can generic versions of Cayston launch?

Cayston is a drug marketed by Gilead and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Cayston

A generic version of CAYSTON was approved as aztreonam by FRESENIUS KABI USA on June 18th, 2010.

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Summary for CAYSTON
Recent Clinical Trials for CAYSTON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Gilead SciencesPhase 2
University of DundeePhase 2
Gilead SciencesPhase 4

See all CAYSTON clinical trials

US Patents and Regulatory Information 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;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CAYSTON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 7,208,141 ⤷  Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 7,427,633 ⤷  Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 8,399,496 ⤷  Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 7,214,364 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CAYSTON

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Cayston aztreonam EMEA/H/C/000996Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents. Authorised no no no 2009-09-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CAYSTON

See the table below for patents covering CAYSTON around the world.

Country Patent Number Title Estimated Expiration
Argentina 053305 PROCESO PARA LA FABRICACION DE SOLUCIONES MASIVAS Y LISINATO DE AZTREONAM ALFA PURO LIOFILIZADO ⤷  Start Trial
Austria 502623 ⤷  Start Trial
Australia 2002231244 ⤷  Start Trial
Australia 2004257632 ⤷  Start Trial
Australia 2009233632 ⤷  Start Trial
Australia 2012202089 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CAYSTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1353647 C300492 Netherlands ⤷  Start Trial 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 91851 Luxembourg ⤷  Start Trial 91851, EXPIRES: 20240921
1353647 CA 2011 00021 Denmark ⤷  Start Trial
1353647 365 Finland ⤷  Start Trial
1353647 11C0030 France ⤷  Start Trial 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
1353647 1190027-1 Sweden ⤷  Start Trial MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/09/543/001, 2009-09-23; PERIOD OF VALIDITY (FROM - UNTIL): 2021-12-21 - 2024-09- 22
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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