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Last Updated: January 18, 2021

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CAYSTON Drug 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. There are four patents protecting this drug.

This drug has fifty-six patent family members in twenty-one countries.

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

US ANDA 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

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

SponsorPhase
Gilead SciencesPhase 2
University of DundeePhase 2
Gilead SciencesPhase 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   Start Trial   Start Trial Y   Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CAYSTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2158901 2018C/001 Belgium   Start Trial PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
2158901 122018000042 Germany   Start Trial PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647 CA 2011 00021 Denmark   Start Trial
1353647 365 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Medtronic
Harvard Business School
Baxter
Mallinckrodt

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