CAYSTON Drug Patent Profile
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When do Cayston patents expire, and what generic alternatives are available?
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.
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 |
Recent Clinical Trials for CAYSTON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Dundee | Phase 2 |
Gilead Sciences | Phase 2 |
UCSF Benioff Children's Hospital Oakland | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for CAYSTON
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a 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/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 |
International Patents for CAYSTON
See the table below for patents covering CAYSTON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1353647 | AZTREONAM INHALABLE DESTINE AU TRAITEMENT ET A LA PREVENTION D'INFECTIONS BACTERIENNES PULMONAIRES (INHALABLE AZTREONAM FOR TREATMENT AND PREVENTION OF PULMONARY BACTERIAL INFECTIONS) | ⤷ Try a Trial |
Australia | 2002231244 | ⤷ Try a Trial | |
Cyprus | 1114621 | ⤷ Try a Trial | |
Denmark | 2301524 | ⤷ Try a Trial | |
Canada | 2433280 | AZTREONAM INHALABLE DESTINE AU TRAITEMENT ET A LA PREVENTION D'INFECTIONS BACTERIENNES PULMONAIRES (INHALABLE AZTREONAM FOR TREATMENT AND PREVENTION OF PULMONARY BACTERIAL INFECTIONS) | ⤷ Try a Trial |
European Patent Office | 2158901 | Alpha aztreoname lysinate (Alpha aztreonam lysinate) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CAYSTON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1353647 | 300492 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923 |
1353647 | CA 2011 00021 | Denmark | ⤷ Try a Trial | |
1353647 | C300492 | Netherlands | ⤷ Try a 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 |
2158901 | C 2018 012 | Romania | ⤷ Try a Trial | PRODUCT NAME: AZTREONAM LIZINA; NATIONAL AUTHORISATION NUMBER: EU/1/09/543/001; DATE OF NATIONAL AUTHORISATION: 20090921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/09/543/001; DATE OF FIRST AUTHORISATION IN EEA: 20090921 |
2158901 | 2018C/001 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923 |
1353647 | C01353647/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |