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:	33
Clinical Trials:	6
Patent Applications:	8,090
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
University of Dundee	Phase 2
Gilead Sciences	Phase 2
Children's Hospital & Research Center Oakland	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
Germany	122011100043
Israel	221036
Spain	2428030
Denmark	2301524
Australia	2014271333

Supplementary Protection Certificates for CAYSTON

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