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Last Updated: January 27, 2023

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. Four 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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Drug patent expirations by year for CAYSTON
Drug Prices for CAYSTON

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Recent Clinical Trials for CAYSTON

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SponsorPhase
University of DundeePhase 2
Gilead SciencesPhase 2
Children's Hospital & Research Center OaklandPhase 4

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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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
>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/000996
Cayston 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

Supplementary Protection Certificates for CAYSTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1353647 2011C/029 Belgium See Plans and Pricing PRODUCT NAME: AZTREONAM LYSINE; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
1353647 1190027-1 Sweden See Plans and Pricing 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
1353647 91851 Luxembourg See Plans and Pricing 91851, EXPIRES: 20240921
2158901 122018000044 Germany See Plans and Pricing PRODUCT NAME: AZTREONAMIYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647 365 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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