CAYSTON Drug Patent Profile

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 18^th, 2010.

Summary for CAYSTON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	6
Patent Applications:	6,559
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CAYSTON
What excipients (inactive ingredients) are in CAYSTON?	CAYSTON excipients list
DailyMed Link:	CAYSTON at DailyMed

See drug prices for CAYSTON

Recent Clinical Trials for CAYSTON

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

Sponsor	Phase
Gilead Sciences	Phase 2
University of Dundee	Phase 2
Gilead Sciences	Phase 4

See all CAYSTON clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CAYSTON

J01DF	Monobactams
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010

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

International Patents for CAYSTON

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1641436
Australia	2012202089
Australia	2014271333
Canada	2530774	FORMULATION D'AZTREONAME LYSINATE INHALABLE, POUR LE TRAITEMENT ET LA PREVENTION D'INFECTIONS BACTERIENNENES PULMONAIRES (INHALABLE AZTREONAM LYSINATE FORMULATION FOR TREATMENT AND PREVENTION OF PULMONARY BACTERIAL INFECTIONS)
European Patent Office	2452672
Brazil	PI0411949

Supplementary Protection Certificates for CAYSTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1353647	27/2011	Austria		PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647	2011C/029	Belgium		PRODUCT NAME: AZTREONAM LYSINE; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
1353647	365	Finland
2158901	2018C/001	Belgium		PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
1353647	SPC/GB11/049	United Kingdom		PRODUCT NAME: AZTREONAM LYSINE; REGISTERED: UK EU/1/09/543/001 20090921
1353647	C01353647/01	Switzerland		PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010